Final Report of the Third Workshop on Food Allergen Methodologies

March 7-9, 2005
Vancouver, B.C.

Sponsored by:
Food Directorate, Health Canada
The Food Allergen Research and Resource Program at the University of Nebraska (FARRP)
in collaboration with the Canadian Food Inspection Agency

1.0 Workshop Overview

1.1 Background

The Third Workshop on Food Allergen Methodologies was held March 7-9, 2005 in Vancouver. As with the previous workshop, the meeting was hosted by the Food Directorate of Health Canada, in partnership with the Food Allergy Research and Resource Program of the University of Nebraska (FARRP) and with the contributions of the Canadian Food Inspection Agency.

The workshop attracted 81 participants, representing government, the food industry, the test kit manufacturing industry, consumer protection groups and a range of international regulatory bodies, including the U.S. Food and Drug Administration, the European Food Safety Authority, and the European Commission. Participants came from across Canada and the U.S., and from around the world, including as far away as Japan, Australia, the United Kingdom, Belgium, Italy and Austria.

The goal of the workshop was continued progress towards increased understanding of current allergen methodology issues, greater harmonization of policies and practices and increased collaboration at the national and international levels. In particular, the workshop program focused on exploring how advancements in methodology and validation can contribute towards improved food safety and food quality, and ultimately better protection of the food allergic consumer.

1.2 Program

The program featured presentations that represented the diversity of participation and were grouped around the following session themes:

1. Regulatory environment for food allergens and threshold levels
2. New developments in allergen methodologies
3. New developments in commercial detection for food allergens
4. Validation of methods / Development of reference materials
5. Sampling and application to QA/QC
6. Consumer groups / Consumer perspective on food allergens
7. Industry perspectives on food allergens
8. Improving the food supply to reduce food-related allergic reactions

A meeting of the AOAC Taskforce on Food Allergens was also held in conjunction with the workshop.

2.0 Workshop Summary

People with allergies represent a growing segment of society who faces serious and ongoing health and quality of life concerns. While there is consensus that avoidance is the most substantive remedy available to allergic consumers, it was equally clear from the workshop that many parties have a role to play in making avoidance as viable an option as possible. The commitment to mitigate consumer risk to the greatest extent possible and support a quality of life comparable to that of non-allergic consumers was a recurrent theme.

The workshop provided a forum for discussion on a range of important changes in the regulatory environment related to food allergens, particularly new U.S. legislation that takes effect on January 1, 2006, current proposed regulatory changes to the Canadian Food and Drug Act, and Annex IIIa of Directive 2003/89/EC of the European Parliament and Council.

It was an important opportunity for all interests - government, industry and consumer groups - to seek clarification, propose priority initiatives to accompany these changes and articulate issues for resolution. In addition, participants discussed a range of food allergen topics, including complexities around producing widely-applicable reference materials, the legacy of the "may contain" statement, sanitation and equipment barriers to traceability, and purchasing behaviour of the food allergic consumer.

It also gave participants an opportunity to learn about a range of emerging testing technologies and methods, as well as new test kit product offerings.

The date for the next conference was confirmed to be October 16-18, 2006 in Quebec City.

2.1 Session 1 - Regulatory environment for food allergens and threshold levels

Dr. Samuel Ben Rejeb chaired this session that included reflections on American, Canadian, European, Japanese and Australian experiences with, and approaches to, threshold levels in different regulatory environments.

It was clear from the presentations that there are a number of important recent, and upcoming changes, in the regulatory environment in many jurisdictions. Key examples include new U.S. legislation that takes effect on January 1, 2006, current proposed regulatory changes to the Canadian Food and Drug Act, and Annex IIIa of Directive 2003/89/EC of the European Parliament and Council.

Presentations in this session highlighted that there are commonalities in approach in terms of the types of allergens being dealt with and the overall effort to create greater certainty for consumers and industry through regulation. A range of presentations dealt with regulatory requirements for labelling ingredients and/or processing aids and the intended and unintended consequences of such requirements. Issues around the use of precautionary statements were raised in this session and were a recurring point of discussion throughout the workshop.
In some instances international thinking and approaches varies significantly, for example around thresholds. From the suggestion that enough data has been gathered to form the basis of threshold development for some foods, to the position that any detectable presence of food must be declared and so thresholds are inappropriate, a spectrum of views was presented.

It was noted in the discussion that most of the information on threshold levels found in literature to date has been based on levels of allergens implicated in allergic reactions, rather than minimum amounts required to elicit a reaction. Participants debated the dynamic relationship between science and policy and the challenge of regulating often in the absence of complete science. Many participants reiterated the significance of current and upcoming regulatory change and the challenge of ensuring that industry and consumers are educated about, and equipped for, such changes.

2.2 Session 2 - New developments in allergen methodologies

This session featured presentations on both traditional ELISA-based methodological advancements, as well as the opportunities presented by both new application of existing technology to allergen research (e.g. DNA-based multi-allergen screening) and emerging new technology (e.g. 2 D difference fluorescence gel electrophoresis).

Participants discussed strengths of individual technologies, for example, the potential of 2 D difference fluorescence gel electrophoresis to reduce data variability. Speakers presented the limitations of particular technologies and there was discussion of the value that can be achieved through a combination of testing approaches. For example, there was discussion that, an exclusively ELISA-based testing approach may be cost-prohibitive and that PCR testing is not appropriate for foods in which the amount of protein is dominant over DNA content. Conversely, in some instances, a combination ELISA and PCR approach offers cost benefits and broad coverage of testing requirements.

A presentation on the possibility of developing hypoallergenic knock out varieties of naturally-occurring strains of foods (e.g. soybean), still with acceptable nutritional value, highlighted the potential benefit of this work for improved food safety and quality.

Discussion in this session included identification of the urgent need for standardized certified reference materials, which was reiterated throughout the workshop.

2.3 Session 3 - New developments in commercial detection for food allergens

During this session, representatives from the following organizations presented information about available food allergen tests, including data and performance results related to upcoming product offerings:

• Neogen
• Tepnel Biosystems
• R-Biopharm
• Tecra International Pty Ltd.
• ElisaSystems
• Morinaga Institute of Biological Sciences
• Charm Sciences Inc. (AllerGiene ATP Hygiene System)
  

Product offerings were made available for participants' viewing at a poster session later in the day.

2.4 Session 4 - Validation of methods / Development of reference materials

The purpose of this session was to facilitate sharing of international experiences in the validation of methods and development of reference materials.

The results of work by a variety of agencies were presented. Many presentations emphasized the collaboration between agencies and kit manufacturers in validation work. Discussion of this work included the need for standardized reference materials as well as the importance of understanding the effect of food processing on allergens, including its effects on detectability.

Validation work underway around the world is being conducted based on a variety of evaluation methods. Presenters and participants were in agreement that there is an urgent need for a coordinated approach towards international guidelines for method validation.

2.5 Session 5 - Sampling and application to QA/QC

This session provided information on a variety of sampling methodologies and approaches, and included extensive discussion of the significance of sampling uncertainty as a cause of error in the monitoring and enforcement of programs focusing on food safety. It was stated that the goal of sampling is to ensure the greatest possible accuracy (closeness of measured value to true value) and precision (closeness of measured values to each other).

The role of sampling as part of an integrated allergen inspection program was discussed, as well as the importance and complexity of a sampling strategy.

Of particular interest was a discussion of the challenge posed by studied lot-to-lot variation in ELISA products which are being used in validation and monitoring efforts. It was suggested that validation should include quantitation so that variation can be estimated, and that validation should include multiple lots.

2.6 Session 6 - Consumer groups / Consumer perspective on food allergens

In this session, consumer groups articulated the growing importance of food allergies as a health concern, and the ripple effect of this issue that magnifies that real impact of this concern on the community e.g. daycare and school policy, etc.

This session included a lengthy discussion of precautionary labeling, with an emphasis on the proliferation of "may contain" statements and the emergence of "allergen-free" messages. A significant lack of clarity and uniformity in precautionary statements was identified, e.g. identification of 27 variations of "may contain" in recent years.

Presenters pointed to the market impact of "may contain" statements on consumer choice, cautioning that products labelled "may contain" will not be chosen, not just by individuals, but also by the family units, institutions and community organizations who serve them. Conversely, it was suggested that food allergic consumers are extremely brand-loyal, to the benefit of companies demonstrating good allergen control practices.

This session reflected the broadly-held view that consumers, food manufacturers, test kit manufacturers and regulators are, and must continue to be, joined in a common effort to protect the food allergic consumer.

2.7 Session 7 - Industry Perspectives on Food Allergens

In this session, industry participants affirmed that, while allergens present challenges, it is possible to manage allergens in a manufacturing environment.

This session included a survey of a variety of food safety management challenges for industry, including issues related to personal health, regulatory environment, consumer satisfaction and business risk. Particular issues related to thresholds, allergen presence in extracts/derivatives, allergen detection and allergen removal were identified.

Presenters described the important role of the ingredient label as a key communication tool in the relationship between a company and its product consumers - rather than a vehicle for regulatory compliance. Discussion included identification of concerns about upcoming requirements to label ingredients/processing aids around which there is no established allergenic potential.

This session also included a lengthy discussion of sanitation effectiveness as a key component of an allergen control plan in a manufacturing setting.

2.8 Session 8 - Improving the food supply to reduce food-related allergic reactions

This session presented information about how advancements in food allergen methodology and research can contribute to improved food safety.

This session presented the perspective that addressing the current allergy "epidemic" requires an alignment of academic, government and industry research and development. It was suggested that Canada has a unique opportunity to be a world leader in food safety, innovation and environmentally-responsible production based on its infrastructure, expertise and history of contributions in allergy research.

The particular merits of a multidisciplinary approach, e.g. that of Canada's Network of Centers of Excellence, to undertaking and applying innovative research on the development, persistence, prevention and treatment of food allergy were presented.

This session explored opportunities to decrease the chances of allergic sensitization in at-risk individuals, decrease the number of allergic reactions in those already sensitized and minimize the severity of allergic reactions in allergic individuals.

This session included presentation of work towards a variety of objectives in support of these goals, including improved allergen detection and diagnostic tools, development of novel therapeutic tools and the development of genetically- engineered hypoallergenic plants.

It also included a discussion of the importance of understanding both the nature and impact of food processing in foods in order to better manage allergenicity of foods. A key recommendation from this work, in addition to the development of reference material, was to develop recognized normalization agents for each allergenic food that can be used to translate allergen quantities in foods among clinicians, researchers and the industry.

3.0 Workshop Outcomes

As a result of discussions throughout the workshop, updates on current research pointed to the significant contribution of food allergen research to improved food safety and food quality. In particular, the possibility of developing hypoallergenic knock out varieties of naturally-occurring strains of foods (e.g. soybean), still with acceptable nutritional value, was identified. Research leading to identification of allergen sources within foods (e.g. gluten) also holds promise for developing increasingly pure varieties of foods in which traces of other food allergens could be eliminated (e.g. oats).

In discussions around the session themes, participants reached consensus on the need to reduce duplication of efforts and ensure that the greatest possible volume of research can be accepted and referenced by the largest number of laboratories around the world.

Participants also identified a series of themes for action in support of this objective:

1. the need to complete test kit validation against a range of food matrices so that these results can be made widely available;
2. the need to create a single repository to house allergen research results from around the world in a single, widely accessible format and location;
3. the urgent need to develop widely-applicable reference material for allergen testing in a variety of matrices to support reproduceability and eliminate duplication;
4. the need to develop internationally-recognized standardized allergen testing methods and practices;
5. the need to ensure greater access for interested laboratories to participate in trials happening around the world, in support of more-widespread recognition of individual work; and
6. the need to ensure that the necessary regulatory definitions, protocols and policies are in place prior to the coming into force of new regulatory or legislative provisions.