Michele E. Wingfield, Senior Science Advisor Antimicrobials Division UDM/OECD Workshop November 16, 2011

1 Official Use Only Do Not Cite or Quote CURRENT STATUS

 QUESTIONS ON IMPLEMENTATION

 MEETINGS WITH STAKEHOLDERS

 IMPLEMENTATION STRATEGY

 HIERARCHY APPROACH FOR LABELING

 SCIENTIFIC ADVISORY PANEL

 GUIDELINE REVISIONS

 RULEMAKING

2 Official Use Only Do Not Cite or Quote April 2011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

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## Data collection

– lab

 

## SAP

– availability of experts, questions to be asked

 

## Possible rulemaking

Official Use Only Do Not Cite or Quote 5 Will each OECD Test Guideline (bacteria, mycobacteria, fungi, viruses) be implemented at the same time or phased in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

Official Use Only Do Not Cite or Quote 9 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

Official Use Only Do Not Cite or Quote 11 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

Official Use Only Do Not Cite or Quote 12 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

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### 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?

Official Use Only Do Not Cite or Quote 14 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: 2 ND 

## Quarter 2014

 

## Draft responses to SAP recommendations: 4 TH 

## 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

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### Proposed Rule

- Fall 2014

 

### Final Rule

– December 2016

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