AHFA 2016 Regulatory Summit. Antimicrobial Material Preservatives & Sustainability Considerations

Transcription

1 Material AHFA 2016 Regulatory Summit Scientific and Regulatory Excellence Antimicrobial Material Preservatives & Sustainability Considerations Erin Tesch Technology Sciences Group Inc. (TSG) th Street, NW Suite 1000 Washington, DC

2 Topics Covered Regulatory Landscape of Antimicrobials Material Preservation versus Infection Reduction Antimicrobial Label Claims Industry Initiatives Sustainability Considerations 2

3 Regulatory Landscape of Antimicrobials EPA categories of Antimicrobials Public Health (i.e. disinfectants, sanitizers, fungicides) Non-Public Health (all antimicrobial material preservatives) All undergo rigorous evaluation by EPA EPA approval the government has established, through sound science, that the antimicrobial chemical, when used according to label directions, poses no unreasonable adverse effects on man or the environment. 3

4 Material Preservation is Not Infection Prevention Purpose of Antimicrobials as Materials Preservatives To protect the integrity of the fabric or other substrates (coatings and plastics) Confusion exists Marketing professionals do not understand FIFRA and make claims not approved under EPA s Treated Article Policy Few EPA approved products that make claims to kill and reduce exposure to public health pathogens Copper Development Association - Copper Alloys Sherwin Williams - Paintshield Cupron Inc. Antifungal Socks 4

5 Material Preservatives and Acceptable Label Claims Pesticide Registration Notice Examples of Acceptable Treated Article Claims Article treated to resist deterioration by mold fungus Inhibits the growth of bacterial odors This product contains an antimicrobial agent to control odors Specially treated to resist mildew growth Protection against odor causing bacteria and fabric degradation Examples of Unacceptable Claims Anti-microbial vinyl that's treated to fight microbes and bacteria Antimicrobial Vinyl Waiting Room Chair 5

6 Antimicrobial Pesticide Products & EPA Approved Label Claims Sherwin Williams - Paintshield: Kills 99.9% of Staphylococcus aureus, Enterobacter aerogenes, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE),and Escherichia coli [within] [after] 2 hours of exposure on a painted surface Cupron Anti-Fungal Fibers and Fabrics III: Cupron enhanced fibers/fabric prevent(s) the growth of 99.9% of T. mentagrophytes, athlete s foot Antimicrobial Copper Alloys-Group I: Copper Alloy Continuously reduces bacteria* contamination, achieving 99.9% reduction *Staphylococcus aureus, Enterobacter aerogenes, Methicillin-Resistant Staphylococcus aureus (MRSA), Escherichia coli O157:H7, Pseudomonas aeruginosa and, Vancomycin Resistant Enterococcus faecalis (VRE). 6

7 Pressure on Materials Preservatives Restrictions on retailers and other user groups Kaiser Permanente Ongoing attacks by non-governmental groups Regulatory initiatives Required reduction of VOCs (less solvents) increases use of water based products Resulting in trends toward increased microbial susceptibility and use of materials preservatives. 7

8 Current trend in finding Green alternatives. Same rigorous EPA evaluation process. Lack of a clearly established EPA approval process for biochemicals with antimicrobial uses has hindered, in part, availability of alternatives. 8

9 INDUSTRY INITIATIVES Silver Task Force North America Consumer Specialty Products Association 9

10 Silver Task Force North America (formerly U.S. Silver Task Force) Formed in 2009 to address EPA s Re-evaluation of Silver as an Antimicrobial Active Ingredient. Silver is widely used in textile material preservation as well as use in medical devices, food packaging and many other areas. 29 member companies Purpose to Address and fund data generation associated with EPA s Re-evaluation of silver. Advocate safe use of silver in EPA and FDA regulated products. Educate consumers (website under development) 10

11 Consumer Specialty Products Association Microbiology Preservative Subcommittee Committed to establishing best practices and acceptable standards to address concern of microbiological quality within consumer, household and industrial products. Preservation Efficacy Testing (PET) Task Force Survey of consumer product companies to determine Preservative Efficacy Test (PET) methods. Develop guidance on preservation selection, PET method, product testing and quality expectations. Preservation Stewardship Task Force Communicate the necessity of effective preservative strategies within consumer and industrial products. 11

12 Sustainability Considerations Making products better and last longer Contributes to sustainable production Manufacturers are faced with numerous considerations: Broad Spectrum efficacy Shelf-life stability Product compatibility Safety in Use Cost effectiveness Commercial availability Appropriate regulatory approval Environmental favorable profile Exposure conditions Consumer use habits 12

13 Sustainability Considerations Prevention of microbial contamination and product spoilage results in a positive impact on sustainability by preventing premature disposal of consumer products and raw materials during production. reduces environmental impact of product disposal in landfills, energy consumption required to re-manufacture and transport product as a result of microbial spoilage. 13

14 Conclusions Antimicrobial materials preservatives play an important role in textile preservation Engagement is needed with key stakeholders (regulators, NGOs, retailers and consumers) to understand and address concerns 14

15 Conclusions Efforts to move toward green alternatives for antimicrobial materials preservatives should be supported but need to be tempered with practical realities Not necessarily successful if significantly higher concentrations required or sufficient efficacy is not performed. Responsible use of preservatives through a holistic approach is critical to making positive impact on sustainability. 15