Innovation creates a need for new standards. However, the associated topics cannot always be readily assigned to a category within the existing structure of standardization activity. In such cases, new standards committees must be created at ISO, CEN and DIN. It is important for the OSH lobby and other stakeholders to be involved and informed of the scope for exerting influence from the outset. Procedures – and obstacles – can be illustrated by the example of biotechnology.
Before a working committee is formed, experts meet several times to discuss whether the subject actually warrants a new committee (see also KANBrief 2/14). ISO has classified biotechnology as an innovative area with strong potential for standardization. It constituted an ISO Task Force as early as 2009. Two years later, an international workshop was organized in order to explore possible standardization topics and to discuss the formation of an ISO/TC biotechnology committee. The OSH lobby was not involved at this point. DIN took the initiative and following approval by the DIN management board, applied for the formation of ISO/TC Biotechnology. In order for further experts to be involved at national level, a DIN workshop was held in September 2012 at which standardization in the area of biotechnology was examined by papers from a number of quarters. The stakeholders were not all automatically involved at this point; the occupational safety and health lobby, for example, learnt of the workshop only from associations that had been invited.
A planning meeting for the constitution of a working committee was held at DIN two months after the workshop. The purpose was:
• To discuss possible standardization topics. For example, the OSH representatives argued successfully against biorisk management being included within the scope of the committee's tasks.
• To sound out interest in standardization work in order to determine whether financing is assured; participation requires contributions to financing (For example, the cost per member of the Biotechnology Working Committee is E 1,055 as at 2014. Information on the financing of standardization activity. Develop Standards Consensus based standardization Financing standards projects).
• To present the schedule and the further procedure, and to consider where the committee could be situated within DIN's structure. DIN decided to make the national mirror committee a sub-committee of NAL, the Food and Agricultural Products Standards Committee. The majority of those attending the meeting considered this inappropriate. DIN however saw no possibility for a dedicated standards committee to be created in the short term.
• To explain standardization procedures, since approximately 90% of those present were working in standardization for the first time.
• To draft German comments on the scope of activities of the planned international Technical Committee. This scope was to be determined by the ISO Technical Management Board (TMB: The Technical Management Board is responsible for supervising the Technical Committees and Technical Advisory Boards).
Starting-shot for standardization work
In February 2013, the ISO members approved the foundation of ISO/TC Biotechnology. Responsibility for the secretariat was assigned to DIN.
This was followed in September 2013 by foundation of the German mirror committee. At an inaugural meeting, it must be determined whether all stakeholders (In accordance with the DIN classification, the stakeholders include the private sector, the public sector, consumer protection agencies, trade unions, the OSH lobby, the scientific and research community, the environ- mental protection lobby, other nongovernmental organizations, users (such as test institutes and assessors), and regulatory institutions) are involved; should a stakeholder not be represented, DIN must determine this stakeholder's interest in participation. Not all stakeholders were represented in the Biotechnology working group, and the initial selection of the participants was unclear. KAN was invited in its capacity as a representative of the OSH community. Other representatives of the German accident insurance institutions with an interest were not invited, however.
At the inaugural meeting held by ISO in December 2013, four working committees were set up as subordinate committees. These were those of Terminology, Biobanks and bioresources, Analytical methods, and Bioprocessing. At the ISO meeting, which was attended by around 50 experts from 15 countries, the German mirror committee was not able to carry through its decision to add technical equipment to the scope.
When new national Working Committees and European/international Technical Committees are formed, the occupational safety and health lobby must be well networked in order to be informed in time and in turn to be able to exert influence during the process.
In accordance with the Guidelines for Standards Committees in DIN, it is DIN's task to ensure that all stakeholders are involved; as the experience with the Biotechnology Working Committee shows, this responsibility begins before the inaugural meeting.
Dr Anja Vomberg