CSPA Microbiology Preservative Subcommittee (MPS)

Transcription

1 Consumer Specialty Products Association CSPA Microbiology Preservative Subcommittee (MPS) Supporting & Enhancing the Microbiological Quality of Consumer, Household, and Industrial Products Tony A. Rook R&D Manager, Microbiology Resource Center The Sherwin-Williams Company Chair, Microbiology Preservative Subcommittee Consumer Specialty Products Association Microbiology Symposium October 20, 2015

2 Agenda Historical Perspective on Microbial Control of Consumer, Household, and Industrial Products CSPA Microbiology Preservative Subcommittee (MPS) Recent Accomplishments of the MPS Preservation Stewardship Task Force Future Initiatives

3 Overview of Consumer, Household, and Institutional Product Preservation Historical Perspective of Product Susceptibility to Microbial Spoilage Historical formulations used conventional chemical preservatives High levels of solvents and low water content provided some innate capacity to resist microbial spoilage Historical formulation and conventional preservatives protected products during manufacturing and throughout its lifetime of use by the consumer

4 Trends Towards Increased Microbial Susceptibility for Consumer Products Dispersants Surfactants Availability of Nutrients Rheology Modifiers Defoamers Water High Water Activity (A w ) Fragrances Neutral to Alkaline ph

5 Trends Towards Increased Microbial Susceptibility Water Based Formulation Market Trends + Gov t & NGO Regulatory Pressures Renewable / Biodegradable Resources Eco-Labeling Low Monomers

6 Trends Towards Increased Microbial Susceptibility Consequences of Inadequate wet-state preservation Color Issues Viscosity Drift ph Drift Malodor Off-Gassing

7 Overview of Consumer, Household, and Institutional Product Preservation Need for Industry Guidance of Microbiological Quality of CH&I Products Microbiological Quality Assessments Microbiological Manufacturing Controls Microbiology Risk Assessments Preservation Staff Training

8 Consumer Specialty Products Association CSPA Microbiology Preservative Subcommittee (MPS)

9 The CSPA Microbiology Preservative Subcommittee (MPS) Who are the Members of the MPS? Representatives of CSPA Member Companies with a focus on Microbiology, Formulation, and Regulation Companies represent Marketers, Formulators, Contract Testing Laboratories, and Preservative & Chemical Suppliers Shared subcommittee of the CSPA Cleaning Products and Antimicrobial Products Divisions

10 The CSPA Microbiology Preservative Subcommittee (MPS) MPS Charter and Mission Statement The Microbiology Preservative Subcommittee is committed to establishing best practices and acceptable standards to address the increasing concern for microbiological quality within consumer, household and institutional products

11 The CSPA Microbiology Preservative Subcommittee (MPS) Challenges of the MPS The major challenges created by compliance to green initiative trends are: Increased vulnerability of products to microbial spoilage have placed more emphasis on microbial quality assessments, effective preservation, microbial manufacturing controls and practical risks assessment Constraints on available / acceptable / robust preservatives which have limited the availability and application of chemical preservatives

12 Microbiological Quality Assessments Progress towards Industry Guidance MMG Microbiological Examination of Household and Institutional Products: Method Guideline for Microbial Enumeration Tests MGG Microbiological Quality of Household and Institutional Products, General Guidelines MGG Microbiological Quality of Raw Materials, General Guidelines Available at the Consumer Specialty Products Association (

13 Microbiological Quality Assessments Industry Survey Survey of CSPA Member Companies was conducted in 2010 with directed questions on the topics of raw material testing, finished product testing, and manufacturing hygiene Results published in trade journal: HAPPI Publication: May 2011, 48(5): Findings Microbiological quality testing is common among household & institutional product manufacturers, however industry guidance is needed

14 Preservation Selection & Efficacy Progress towards Industry Guidance Guidance for Preservative Selection, Preservative Efficacy test method, Product testing and Quality Expectations Considerations Overview of Product Preservation Selection of Preservative based on Product Chemistry Fundamentals of Preservative Efficacy Method Acceptance Criteria Guidance Preservative Efficacy Test (PET) Task Force

15 Preservative Efficacy Test (PET) Task Force Progress towards Industry Guidance Survey of CSPA Member Companies was conducted with directed questions pertaining to the key parameters of the PET methods Results published in trade journal: HAPPI Publication: April 2015: Findings Many companies employ PET methods with internal modifications Many variations exist between methods but contain core similarities A clear need for standardized guidance for conducting PET studies

16 Preservative Efficacy Test (PET) Task Force Progress towards Industry Guidance General and Method Guidance for Preservative Efficacy Testing Guidance documents are currently in DRAFT MGG DRAFT Determining Effective Preservation of Household and Industrial Products, General Guidelines Overview of considerations for effective preservation MMG DRAFT Preservative Efficacy Test, Method Guidelines Detailed considerations for preservative efficacy method development

17 Preservation Stewardship Task Force Preservation Stewardship Task Force was commissioned to address the need of communicating the necessity of Effective Preservative Strategies within consumer and industrial products Pressure on Preservatives Trend toward more sustainable/natural materials Restrictive use of conventional preservatives Trend towards Compliance to Eco labeling (e.g. DfE) Ongoing attack by NGOs Restrictions by Retailers

18 Federal Regulation of Preservatives within Consumer, Household, and Institutional Products Preservatives used in CH&I product formulations are federally regulated by U.S. EPA under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) as Antimicrobial Pesticides. U.S. EPA Registration of preservatives require scientific demonstration of efficacy against microbial contamination in a variety of product types Toxicity evaluations are completed to demonstrate the preservative does not harm humans or the environment Costs associated with the registration process and data generation can reach $10 million for a new preservative product containing a new active ingredient

19 Preservation Stewardship Task Force Progress towards Industry Guidance Response to trends toward more natural preservatives with a trade journal white paper Happi, May 2012, 49(5): Concerns with Natural or Non traditional preservatives Lack of regulatory oversight Lack of ecological and toxicological testing Potential for supply and quality issues Microbicidal efficacy gaps

20 Preservation Stewardship & Advocacy DfE Eco Label Compliance Permitted Safer Chemical Ingredients * Chemical verified to be of low concern based on experimental and modeled data The chemical has met DfE criteria for its functional ingredient class, but has some hazard profile issues. While it is best inclass chemical and among the safest for a particular function, the function fulfilled by the chemical should be considered an area for safer chemistry innovation. Benzoic acid Benzoic acid, potassium salt Benzoic acid, sodium Salt DL alpha Tocopherol DL Lactic acid L Lactic acid Pentaerythritol, tetrakis(3,5 di tertbutyl 4 hydroxyhydrocinnamate) Potassium sorbate Potassium sorbate (E,E) Sodium propionate Sorbic acid Tocopherol acetate Vitamin E acetate 1,2 Benzisothiazol 3(2H) one 2 Phenoxyethanol (*Yellow, due in part to its status as a Hazardous Air Pollutant (HAP) under the Clean Air Act.) Dehydroacetic acid Magnesium nitrate (*Only allowed as a preservative stabilizer) Magnesium(II) nitrate, hexahydrate (*Only allowed as a preservative stabilizer) Methyl chloro isothiazolinone Methyl isothiazolinone Sodium nitrate (*Only allowed as an oxidant and preservative stabilizer) *

21 Preservative Stewardship & Advocacy MPS-DfE Working Group A working group was commissioned to address concerns with the initial wording of the DfE s Safer Chemistry Innovation MPS members worked directly with the DfE MPS communicated industry concerns regarding the Permitted Safer Chemical Ingredients for Preservative Class Weak activity; Microbicidal spectrum gaps Significantly higher concentrations required than traditional actives Limited Use within Alkaline Products DfE provided insight on their assessment of preservatives class

22 Preservation Stewardship & Advocacy Progress of the MPS DfE Working Group MPS continues to actively engage the DfE DfE attends MPS Sessions at CSPA Mid Year & Annual Meetings White Paper prepared at the DfE s request to provide an Overview of Preservatives Prepared by the CSPA Preservation Stewardship Task Force Overview of preservatives classification, activity, EPA label limits, etc. Optimizing preservative performance Good manufacturing practice Happi, May 2014, 79 85

23 Preservation Stewardship & Advocacy Progress of the MPS DfE Working Group Current Available Preservatives and Effective ph Ranges

24 Preservation Stewardship & Advocacy Progress of the MPS DfE Working Group Efficacy Gaps if Only Preservatives Classified as Low Concern are Available

25 Preservation Stewardship & Advocacy Retail Driven Sustainability Programs Retailer Sustainability Programs are impacting preservatives Some Aspects of Retailer Sustainability Programs Focus on Household Cleaning and Personal Care Products Online Chemical Disclosure (required by Jan 2015) Chemical Reduction / Elimination of 10 High Priority Chemicals 3 of 10 priority chemicals listed are preservatives EPA Design for the Environment (DfE) Labeling Sustainability index for ingredients

26 Preservation Stewardship Task Force Goals Communicate to key stakeholders (Regulators, NGO's, Retailers, and Consumers) our position on the necessity for the Responsible Use of Preservatives within Consumer, Household, and Institutional products through a holistic approach of product preservation. Regulatory Engagement with EPA Office of Pesticide Programs Focus is to provide awareness of the Preservation Stewardship Position Engagement with key Non Governmental Organizations Environmental Defense Fund (EDF) and National Resources Defense Council (NRDC) Goal is to understand the NGO s Perception of Preservatives House Energy and Commerce Committee Professional Staff Provide broad awareness of our Preservation Stewardship Position Communicate the MPS as Thought Leaders for Preservation Stewardship

27 Preservation Stewardship Task Force Position Paper on Preservation Stewardship (In Draft) CSPA Member Companies depend on preservatives for protection of Consumer and Institutional products from microbial contamination Preservatives prevent product spoilage and ensure quality and safety throughout the shelf life of the product during consumer use Spoilage can breakdown products and compromise product performance Preservatives are designed to control microbial contamination within Consumer and Institutional products at the lowest possible concentration and toxicity level Inadequately preserved Consumer & Institutional products may result in adverse health related issues, particularly in immunocompromised individuals and otherwise sensitive subpopulations

28 Preservation Stewardship Task Force Position Paper on Preservation Stewardship (In Draft) CSPA Member Companies recognize that preservatives have a positive impact on overall sustainability of products and processes The current trend towards the increasing use of naturally derived ingredients and water based formulations within the Consumer and Institutional products marketplace inherently creates products with higher susceptibility to microbial contamination and biodegradation Use of EPA registered preservatives can increase the shelf life of products so the consumers can anticipate using the entire contents of the product they purchased without spoilage Prevention of microbial spoilage is economically beneficial, and results in a positive impact on sustainability by preventing premature disposal of both consumer products and raw materials used during production. This reduces the environmental impact of product disposal, packaging in landfills, and energy consumption required to re manufacture and transport products as a result of microbial spoilage.

29 The CSPA Microbiology Preservative Subcommittee (MPS) CSPA Microbiology Preservative Subcommittee Provides industry guidance by developing microbiological quality best practices & standards for the manufacturing of consumer, household & industrial products Continues to develop and execute a strategy for Preservation Stewardship & Advocacy

30 THANK YOU