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Tony A. RookR&D Manager, Microbiology Resource CenterThe Sherwin-Williams Company
Chair, Microbiology Preservative SubcommitteeConsumer Specialty Products Association
Microbiology SymposiumOctober 20, 2015
CSPA Microbiology Preservative Subcommittee (MPS)
Consumer Specialty Products Association
Supporting & Enhancing the Microbiological Quality of Consumer, Household, and Industrial Products
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
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
High Water Activity (Aw) Neutral to Alkaline pH
Availability of Nutrients
Water
Rheology Modifiers
DispersantsDefoamers
Surfactants
Fragrances
Trends Towards Increased Microbial Susceptibility for Consumer Products
Trends Towards Increased Microbial Susceptibility
Low Monomers
Renewable / Biodegradable
Resources
Gov’t & NGO Regulatory Pressures+
Eco-Labeling
Water Based FormulationMarket Trends
Consequences of Inadequate wet-state preservation
Color Issues Viscosity Drift
Malodor
Off-Gassing
pH Drift
Trends Towards Increased Microbial Susceptibility
Need for Industry Guidance of Microbiological Quality of CH&I Products
Overview of Consumer, Household, and Institutional Product Preservation
Microbiological Quality Assessments
Microbiological Manufacturing Controls
Microbiology Risk Assessments
Preservation
Staff Training
CSPA Microbiology
Preservative Subcommittee
(MPS)
Consumer Specialty Products Association
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
The CSPA Microbiology Preservative Subcommittee (MPS)
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
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
Microbiological Quality AssessmentsProgress towards Industry Guidance
MMG 001.1 2014 Microbiological Examination of Household and Institutional Products: Method Guideline for Microbial Enumeration Tests
MGG 002.1 2014 Microbiological Quality of Household and Institutional Products, General Guidelines
MGG 003.1 2014 Microbiological Quality of Raw Materials, General Guidelines
Available at the Consumer Specialty Products Association (www.cspa.org)
Microbiological Quality AssessmentsIndustry 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
HAPPI Publication: May 2011, 48(5): 82-87
Findings –Microbiological quality testing is common among household & institutional product manufacturers, however industry guidance is needed
Results published in trade journal:
Guidance for Preservative Selection, Preservative Efficacytest 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
Preservation Selection & Efficacy Progress towards Industry Guidance
Preservative Efficacy Test (PET) Task ForceProgress towards Industry Guidance
Survey of CSPA Member Companies was conducted with directed questions pertaining to the key parameters of the PET methods
HAPPI Publication: April 2015: 74-78
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
Results published in trade journal:
General and Method Guidance for Preservative Efficacy Testing
Guidance documents are currently in DRAFT
MGG 004.1 DRAFT Determining Effective Preservation of Household and Industrial Products, General Guidelines Overview of considerations for effective preservation
MMG 005.1 DRAFT Preservative Efficacy Test, Method Guidelines Detailed considerations for preservative efficacy method development
Preservative Efficacy Test (PET) Task ForceProgress towards Industry Guidance
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
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
Preservation Stewardship Task ForceProgress towards Industry Guidance Response to trends toward more ‘natural’ preservatives
with a trade journal white paper
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
Happi, May 2012, 49(5): 69-74
Preservation Stewardship & AdvocacyDfE Eco‐Label Compliance
Benzoic acid
Benzoic acid, potassium salt
Benzoic acid, sodium Salt
DL‐alpha‐Tocopherol
DL‐Lactic acid
L‐Lactic acid
Pentaerythritol, tetrakis(3,5‐di‐tert‐butyl‐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)
Chemical verified to be of low concernbased 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‐ in‐class chemical and among the safest for a particular function, the function fulfilled by the chemical should be considered an area for safer chemistry innovation.
Permitted Safer Chemical Ingredients *
* http://www.epa.gov/dfe/saferingredients.htm
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
Preservative Stewardship & AdvocacyMPS-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
Preservation Stewardship & AdvocacyProgress of the MPS‐DfE Working Group
Happi, May 2014, 79‐85
Preservation Stewardship & AdvocacyProgress of the MPS‐DfE Working Group
Current Available Preservatives and Effective pH Ranges
Preservation Stewardship & AdvocacyProgress of the MPS‐DfE Working Group
Efficacy Gaps if Only Preservatives Classified as Low Concern are Available
Preservation Stewardship & AdvocacyRetail 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
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
Preservation Stewardship Task Force Goals
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
Preservation Stewardship Task ForcePosition Paper on Preservation Stewardship (In Draft)
Preservation Stewardship Task ForcePosition Paper on Preservation Stewardship (In Draft)
CSPA Member Companies recognize that preservatives have a positiveimpact 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.
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
The CSPA Microbiology Preservative Subcommittee (MPS)
THANK YOU
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