Michele E. Wingfield, Senior Science Advisor

Antimicrobials Division

UDM/OECD Workshop

November 16, 2011

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 CURRENT STATUS

 QUESTIONS ON IMPLEMENTATION

 MEETINGS WITH STAKEHOLDERS

 IMPLEMENTATION STRATEGY

 HIERARCHY APPROACH FOR LABELING

 SCIENTIFIC ADVISORY PANEL

 GUIDELINE REVISIONS

 RULEMAKING

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 April 2011 – WNT Meeting

◦ Method did not achieve approval by WNT.

◦ Concerns raised by Germany on Test Guidelines and 

Guidance Document

 September 2011 – Meeting of Experts and Regulators

◦ Many, but not all, issues resolved

 VMG revising Test Guidelines based on feedback from 

June 2011 VMG meeting and September meeting

 Spring 2012 – Meeting of WNT

◦ Test Guidelines will not be put forward for approval

 June 2012 – Results of collaborative study to be 

reported to VMG

 Guidelines vs. Guidance Document

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 Implementation phases/timeline 

 Products/claims affected - scope 

 Transition process away from current 

claims – registration

 EPA resources/responsibilities/tasks

 Other federal resources 

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Outreach – all stakeholders 

 Data collection – lab

 SAP –availability of experts, 

questions to be asked

 Possible rulemaking

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 Will each OECD Test Guideline (bacteria, 

mycobacteria, fungi, viruses) be implemented at 

the same time or phased in -- priorities? 

 Are the current OECD guidelines, as written, 

sufficient for EPA’s purposes? Preparation of 

SOPs

 Assessment of any missing details to reduce 

interpretation of method and complete 

standardization- additional studies

 Assessment of availability and vendors of 

materials and supplies necessary to perform the 

method (e.g., vials, carriers)

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 Demonstration studies – generate baseline log 

reduction values for a variety of antimicrobial 

products, including the use of the new test 

criteria (5 min contact time, OSL, hard water).

◦ Bacteria

◦ Mycobacterium

 Towelettes – how to proceed?

◦ Integration of MLB studies on new Petri dish 

method

 LR calculations and interpretation of results

 Training

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 Met with infection control experts

 Included experts from CDC, FDA, APIC, Society 

for Healthcare Epidemiology of America (SHEA), 

Association for the Healthcare Environment 

(AHE) and academia.

 Discussed new method, microbial risk 

assessment for establishing performance 

measures, expanded use of disinfection 

hierarchy and increasing education of 

environmental services staff on the use of 

disinfectants.

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 Met with industry stakeholders

 Discussed new method

 Timelines for transition to new 

method

 Implementation strategy

 Expansion of disinfection hierarchy

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 As the collaborative studies progress, the Agency 

will continue to hold meetings with both infection 

control experts and industry stakeholders.

 Stakeholder meetings will start in early 2012 and 

meet on a quarterly basis.

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Baseline Studies to assess new test criteria.

 Evaluated a variety of registered products and 

tested according to current label conditions and 

proposed conditions.

◦ Proposed hard water – 375ppm

◦ Proposed three-part organic soil

 Pre-cleaning?

◦ Standardized contact time – 5 min

◦ Temperature at testing – room temperature

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 Baseline studies lead to initiative to conduct a 

larger collaborative study

 Collaborative is not intended to revalidate the 

methods

 Collaborative will start in January 2012

 Collaborative designed to evaluate method 

optimization and answer some of the issues raised 

at the WNT

 Monthly conference calls with the VMG

 Collaborative results to be submitted to VMG by 

June 2012

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 CURRENT THOUGHTS

 Possible SAP question

◦ 5 log10 reduction – Mycobacteria

◦ 4 log10 reduction – Bacteria

◦ 4 log10 reduction – Fungi

◦ 4 log10 reduction – Viruses

 Design reporting format, possibly spreadsheets

 Clear presentation and interpretation of LR data 

(e.g., complete kill, substitution rules, and 

averaging of LR)

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◦Streamlining strategy

◦Impact on implementation 

process?

◦Impact on label claims?

◦Separate initiative?

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 Topics to be presented.

◦ Quantitative method test design.

◦ Disinfection hierarchy.

◦ Proposed performance standards

 Develop background documents

◦ Charge questions

 Federal Register Notice

◦ Announce meeting

◦ Request Panel member nominations

 Management briefings

 Rehearsal

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 Proposed date: 2ND Quarter 2014

 Draft responses to SAP 

recommendations: 4TH Quarter 2014

 Revise 810 guidelines

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 Initiate rulemaking – December 2013

◦ Decisions on scope of rule and proposed topics

 New Registration paradigm

 New labeling categories

 Use of hierarchy 

 Retire Use Dilution Test

 Proposed Rule - Fall 2014

 Final Rule – December 2016

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