Developing Standards and Influencing Regulations
A critical unmet need for innovation across industry sectors is the infrastructure and support needed to demonstrate alignment to relevant standards and the associated analytical competencies. NBIC is actively addressing this need by establishing networks and collaborations and engaging in a variety of initiatives and research projects with the aim of supporting academic and industry communities in developing biofilm standards and influencing regulations.
Biofilm Alliance: A Network for Regulatory Sciences, Academic Research, and Industry Collaboration
Regulatory science plays a vital role in evaluating products aimed at controlling biofilms before they hit the market. To ensure these products meet their purpose of reducing or eliminating biofilm formation, scientific evidence is crucial.
We are delighted to announce that we have secured funding from Innovate UK to establish the UK Regulatory Science and Innovation Network. This initiative is led by a core team comprising representatives from the National Biofilms Innovation Centre (NBIC), Manchester Metropolitan University, Industrial Microbiological Services Limited (IMSL), and Swansea University. Together, this strategic and collaborative partnership aims to harness the power of regulatory science to unlock innovation and drive progress in the complex field of biofilm mitigation and control technologies.
The Need for Funding in Biofilm Standardisation
One of the major problems preventing effective development of biofilm-related standards is the lack of readily available funding to support metrology and incremental research that would lead to normative activities.
NBIC has published a position paper, recommending actions for funders, standardisation organisations and regulators that would support and enable the academic and industry communities in pursuing standardisation initiatives.
Biofilm Standardisation Initiatives
- NBIC is working closely with British Standard Institute (BSI), contributing to the CH/216 committee on ‘Chemical Disinfectants and Antiseptics’, and working group CH/216/3 on Biofilms and Products that is working on a guideline on ‘Methodologies for Antibiofilm New Product Claims’.
- NBIC is actively participating in the European Committee for Standardization (CEN) TC 216 WG 5 Strategy Group – Biofilm Task Force, concentrated on exploring possible new areas of standardisation work.
- NBIC is providing input to biofilm standards under the Association for Materials Protection and Performance (AMPP). Currently working on three biofilm-related standards in the fields of biocides, oil and gas systems and microbiologically influenced corrosion.
Biofilm RegulatoryToolBox
NBIC is co-leading the EU COST Action: RegulatoryToolBox ‘Building Consensus on Biofilm Regulatory Decision Making’. RegulatoryToolBox is a collaborative network that connects researchers, industry leaders, and regulatory bodies to drive consensus on biofilm models and methodologies. Our mission is to improve decision-making around anti-biofilm products and processes by:
- Evaluating novel biofilm methods
- Reaching scientific and methodological consensus
- Informing stakeholders and promoting educational initiatives
Despite the critical role of regulatory science in determining market access and product claims, it has fallen behind modern research practices. This disconnect has created a gap between fundamental science and current regulatory standards, especially in assessing public health benefits and environmental impact. RegulatoryToolBox aims to bridge this gap by fostering collaboration and advancing biofilm science.
EURO-MIC
NBIC is participating in the EU COST Action: Euro-MIC ‘European Microbially Influenced Corrosion Network – New Paths for Science, Sustainability and Standards’.
The main aim of Euro-MIC is to encourage a synergistic collaboration and communication, closing the gap between materials scientists, engineers, microbiologists, chemists and integrity managers to encourage sufficient interaction between academia and industry, in the context of microbially influenced corrosion research and control.
EURO-MIC Working Group 5 on ‘Enabling Standardisation’, is working on the transition of new detection and mitigation methods into routine process control and inspection measures though the development of standardised procedures. WG5 is initiating round robin tests for selected technologies and is working on increasing presence of Euro-MIC members in relevant standardisation committees such as NACE International, ASTM, Energy Institute, DNV GL and ISO.
IBBS Biofilm Standardisation Fora
During the 18th International Biodeterioration and Biodegradation Symposium (IBBS) a panel session was held with leading research and industry experts to discuss industrial and academic perspectives on the importance of standard biofilm test methods. Discussions included the need for biofilm methods in the oil and gas industry, the advantages and disadvantages of a standard test method versus best practices guidelines, and how regulatory hurdles are placing constraints on biofilm technology development and innovation.
NBIC co-organised a Roundtable Discussion on biofilm standards and methods at the 19th IBBS. Led by members of the International Biofilm Standards Task Group, the session brought together 26 representatives from academia, industry, and several groups active in biofilm standardisation. A key highlight was the participation of five standardisation organisations – American Society for Testing and Materials (ASTM), International Biodeterioration Research Group (IBRG), British Standards Institution (BSI), European Committee for Standardization (CEN) and Association for Materials Protection and Performance (AMPP), creating a rare opportunity for all these key stakeholders to collaborate in one room. Presentations from these organisations were followed by smaller group discussions, where attendees explored the challenges and benefits of harmonising biofilm standardisation initiatives.
Partners
Interested in Working with Us?
If you’re interested in working with us or learning more about our biofilm standardisation initiatives, please contact our Biofilms Standards and Regulatory Programme Manager, Paulina Rakowska.
Dr Paulina Rakowska
Biofilms Standards and Regulatory Programme Manager
Paulina develops and manages external relationships with government and policy makers to deliver step changes in biofilm standards and regulations, and works with NBIC Co-Directors to identify and deliver investment to NBIC’s core partners that enable the development of biofilm standards and biofilm biobanks.