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