Update on Antimicrobial Activities Presented at the Consumer Specialty Product Assoc. Joan Harrigan...

Update on Antimicrobial ActivitiesUpdate on Antimicrobial ActivitiesPresented at the Presented at the

Consumer Specialty Product Assoc.Consumer Specialty Product Assoc.

Joan Harrigan Farrelly, DirectorJoan Harrigan Farrelly, Director

Antimicrobials Division, OPP, EPAAntimicrobials Division, OPP, EPA

December 8, 2008December 8, 2008

OverviewOverview

• 158W - Proposed data requirements158W - Proposed data requirements• Clostridium difficile Clostridium difficile updateupdate• 810 Guidelines Status810 Guidelines Status• Repeat Testing PolicyRepeat Testing Policy• Slime/BiofilmSlime/Biofilm• Antimicrobial Testing ProgramAntimicrobial Testing Program• Policy Changes/ClarificationsPolicy Changes/Clarifications• Wrap UpWrap Up

158W – Proposed Rule158W – Proposed Rule

158W – published for comment on 10/ 8 /08158W – published for comment on 10/ 8 /08

EPA held public workshop November 6, 2008EPA held public workshop November 6, 2008

Agency to extend the public comment period for Agency to extend the public comment period for an additional 90 daysan additional 90 days

158W - History158W - History Beginning in 1984 antimicrobial pesticides used the same data Beginning in 1984 antimicrobial pesticides used the same data

requirements as used by agricultural chemicals (“conventional requirements as used by agricultural chemicals (“conventional pesticides”)pesticides”)

In August 1996 Food Quality Protection Act (FQPA) In August 1996 Food Quality Protection Act (FQPA) amendments to FIFRA and FFDCA became lawamendments to FIFRA and FFDCA became law

FIFRA, as amended by FQPA, required EPA to clarify data FIFRA, as amended by FQPA, required EPA to clarify data requirements for antimicrobial pesticidesrequirements for antimicrobial pesticides

Part 158W was developed to address antimicrobial pesticide Part 158W was developed to address antimicrobial pesticide data requirementsdata requirements

158W Proposed Rule158W Proposed Rule

Would establish:Would establish:

12 Use Patterns, and12 Use Patterns, and

9 new data requirements9 new data requirements

158W - 12 Use Patterns158W - 12 Use Patterns

Agricultural premises and equipmentAgricultural premises and equipment Food handling/storage establishments premises and Food handling/storage establishments premises and

equipmentequipment Commercial, institutional and industrial premises and Commercial, institutional and industrial premises and

equipmentequipment Residential and public access premisesResidential and public access premises Medical premises and equipmentMedical premises and equipment Human drinking waterHuman drinking water

158W - 12 Use Patterns158W - 12 Use Patterns

Materials preservativesMaterials preservatives Industrial processes and water systemsIndustrial processes and water systems Antifouling coatings and ballast waterAntifouling coatings and ballast water Wood preservativesWood preservatives Swimming poolsSwimming pools Aquatic areasAquatic areas

Note: Agency assesses sites within use patterns with significant Note: Agency assesses sites within use patterns with significant exposure: exposure: e.g., e.g., Heating, Ventilation, Air-Conditioning Heating, Ventilation, Air-Conditioning and Refrigeration (HVAC-R) systemsand Refrigeration (HVAC-R) systems

158W New Data Requirements158W New Data Requirements

9 New Study Requirements9 New Study Requirements 4 Human Health Related Studies:4 Human Health Related Studies:

• Developmental neurotoxicity (Developmental neurotoxicity (toxicology - 158.2230; toxicology - 158.2230; OPPTS 870.6300OPPTS 870.6300))

• Immunotoxicity (Immunotoxicity (toxicology - 158.2230; toxicology - 158.2230; OPPTS OPPTS 870.7800870.7800))

• Soil residue dissipation (Soil residue dissipation (post-application exposure – post-application exposure – 158.2270; 158.2270; OPPTS 875.2200OPPTS 875.2200))

• Non-dietary ingestion exposure (Non-dietary ingestion exposure (post-application post-application exposure – 158.2270; exposure – 158.2270; OPPTS 875.3000OPPTS 875.3000))

158W New Data Requirements158W New Data Requirements

9 New Study Requirements9 New Study Requirements 5 Environmental (5 Environmental (environmental fate – 158.2280environmental fate – 158.2280) )

Related:Related:

• Activated sludge sorption isotherm study (Activated sludge sorption isotherm study (OPPTS OPPTS 835.1110835.1110))

• Photodegradation in soil (Photodegradation in soil (OPPTS 835.2410OPPTS 835.2410))

• Ready biodegradability study (Ready biodegradability study (OPPTS 835.3110OPPTS 835.3110))

• Porous pot study (Porous pot study (OPPTS 835.3220OPPTS 835.3220))

• Modified activated sludge, respiration inhibition test Modified activated sludge, respiration inhibition test ((OPPTS 850.6800OPPTS 850.6800))

Finalizing 158W Finalizing 158W

Because the rule was long in coming – over ten years – it Because the rule was long in coming – over ten years – it largely codifies existing practiceslargely codifies existing practices

Discusses Agency’s goal of relying on weight of evidence Discusses Agency’s goal of relying on weight of evidence and structure activity relationship analysis where applicableand structure activity relationship analysis where applicable

EPA will address public comments received on Proposed EPA will address public comments received on Proposed RuleRule

Goal: finalize proposed rule in 2010Goal: finalize proposed rule in 2010

810 Guidelines810 Guidelines

Draft guidelines for sterilants, disinfectants, Draft guidelines for sterilants, disinfectants, and sanitizers are completedand sanitizers are completed

The guidelines are scheduled to be published The guidelines are scheduled to be published for public comment no later than March 2009for public comment no later than March 2009

Anticipate earlier publicationAnticipate earlier publication

Goal of finalizing the guidelines by the end of Goal of finalizing the guidelines by the end of the calendar year.the calendar year.

810 Guidelines810 Guidelines Draft guidelines for claims against Draft guidelines for claims against Bacillus Bacillus

anthracisanthracis have also been completed. have also been completed.

Finalizing the Response to Comments for the Finalizing the Response to Comments for the 2007 2007 BacillusBacillus anthracisanthracis SAP. SAP.

These guidelines are scheduled to go out for These guidelines are scheduled to go out for public comment by March 2009 as well.public comment by March 2009 as well.

Listed in AD’s Workplan for FY 2009Listed in AD’s Workplan for FY 2009

810 Guidelines810 Guidelines

AD is continuing work on revising the air, AD is continuing work on revising the air, water, and material textile guidelines.water, and material textile guidelines.

Also listed in AD’s 2009 WorkplanAlso listed in AD’s 2009 Workplan

Will request input from industry Will request input from industry representatives prior to proposal for comment.representatives prior to proposal for comment.

Future Guideline DevelopmentFuture Guideline Development

The 810 guidelines are living documents. The 810 guidelines are living documents.

As new guidelines/methods are adopted, As new guidelines/methods are adopted, the guidelines will be amended to the guidelines will be amended to incorporate these changes.incorporate these changes. Examples: Examples: Clostridium difficileClostridium difficile, biofilm, , biofilm,

quantitative tests for disinfectants.quantitative tests for disinfectants.

Update on Update on Clostridium difficileClostridium difficile Currently working with infection control user Currently working with infection control user

groups (APIC, SHEA, ASHES,) CDC and FDA to groups (APIC, SHEA, ASHES,) CDC and FDA to develop science-based parameters for efficacy develop science-based parameters for efficacy testing.testing.

OPP’s BEAD Microbiology Laboratory is also OPP’s BEAD Microbiology Laboratory is also conducting research with various strains of conducting research with various strains of Clostridium difficile Clostridium difficile and various culture media to and various culture media to help identify a representative strain to be used help identify a representative strain to be used for efficacy testing along with the appropriate for efficacy testing along with the appropriate media to help stimulate sporulation.media to help stimulate sporulation.

C. difficileC. difficile Update Update

OPP is working to develop an interim OPP is working to develop an interim guidance that describes the registration guidance that describes the registration performance standard.performance standard.

Goal is to post interim guidance on the Goal is to post interim guidance on the web around the end of the calendar year. web around the end of the calendar year.

Repeat Testing PolicyRepeat Testing Policy In the past AD allowed “Repeat Testing” of a In the past AD allowed “Repeat Testing” of a

failing lot if only 2 tubes failed.failing lot if only 2 tubes failed.

Now, the merits of this practice seem Now, the merits of this practice seem questionable given challenges to the use dilution questionable given challenges to the use dilution test (UDT) and the lack of a statistical basis for test (UDT) and the lack of a statistical basis for such flexibility.such flexibility.

As a result, AD believes it is ill advised to issue a As a result, AD believes it is ill advised to issue a repeat testing policy at this time.repeat testing policy at this time.

OECD Hard Surface OECD Hard Surface Disinfectant MethodsDisinfectant Methods

The Agency believes transitioning to The Agency believes transitioning to quantitative efficacy test methods will provide quantitative efficacy test methods will provide a better measure of product performance. a better measure of product performance.

As such, the Agency is committed to As such, the Agency is committed to implementing new methods as soon as implementing new methods as soon as possible.possible.

OECD Hard Surface Disinfectant OECD Hard Surface Disinfectant MethodsMethods

The Validation Management Group met with the The Validation Management Group met with the statistician in October to review the ring-trial statistician in October to review the ring-trial data.data.

Preliminary analysis suggests additional studies Preliminary analysis suggests additional studies may need to be conducted to ensure the may need to be conducted to ensure the methods are successfully validated.methods are successfully validated.

This would delay AD’s adoption of the This would delay AD’s adoption of the quantitative test for another year.quantitative test for another year.

OECD UpdateOECD Update

Once the test methods are validated, AD can adopt Once the test methods are validated, AD can adopt them for use prior to OECD issuing the final test them for use prior to OECD issuing the final test guidelines.guidelines.

In the early part of 2009, AD will establish a team to In the early part of 2009, AD will establish a team to develop an implementation strategy for the new develop an implementation strategy for the new quantitative methods.quantitative methods.

OECD UpdateOECD Update

The quantitative test method implementation strategy The quantitative test method implementation strategy will include a process and the timing for transitioning will include a process and the timing for transitioning from the existing qualitative tests to the new from the existing qualitative tests to the new quantitative tests.quantitative tests.

AD will ask stakeholders to provide representatives to AD will ask stakeholders to provide representatives to participate on the implementation team.participate on the implementation team.

Clarification for the use of the Clarification for the use of the Terms Biofilm and Slime on LabelsTerms Biofilm and Slime on Labels

Historically, AD did not allow the terms “biofilm” and “slime” Historically, AD did not allow the terms “biofilm” and “slime” to be used interchangeably.to be used interchangeably.

AD has decided to not limit the use of the term “biofilm” to AD has decided to not limit the use of the term “biofilm” to public-health related products.public-health related products.

The use of the term “slime” is also not limited to non-public The use of the term “slime” is also not limited to non-public health products.health products.

When using the term “biofilm” or “slime” in labeling, the When using the term “biofilm” or “slime” in labeling, the use use sitesite will determine whether efficacy data will need to be will determine whether efficacy data will need to be submitted for the registration.submitted for the registration.


Traditional industrial slimicide uses will Traditional industrial slimicide uses will notnot need to submit efficacy data when the term need to submit efficacy data when the term “biofilm” is used. “biofilm” is used.

As always, the registrant must have data in As always, the registrant must have data in their files to support their label claims, and their files to support their label claims, and EPA can request that data on a case-by-case EPA can request that data on a case-by-case basis to make registration decisions. basis to make registration decisions.


Efficacy data will need to be submitted for biofilm or slime Efficacy data will need to be submitted for biofilm or slime claims on the following types of products:claims on the following types of products:

Disinfectants and sanitizers.Disinfectants and sanitizers. Dental unit waterline products.Dental unit waterline products. Certain food processing water applications where the claim Certain food processing water applications where the claim

extends to pathogen reduction in the water and/or on the extends to pathogen reduction in the water and/or on the food.food.

Consultation is advised with AD when making biofilm Consultation is advised with AD when making biofilm claims on antimicrobial product labels.claims on antimicrobial product labels.

Antimicrobial Testing ProgramAntimicrobial Testing Program

Efforts are underway to accelerate confirmatory Efforts are underway to accelerate confirmatory efficacy testing of public health pesticide via the efficacy testing of public health pesticide via the antimicrobial testing program (ATP)antimicrobial testing program (ATP)

To date, the program has focused on sterilants and To date, the program has focused on sterilants and disinfectants.disinfectants.

In the future, sanitizers and distributor products will In the future, sanitizers and distributor products will also be evaluated or tested.also be evaluated or tested.


Sample collection is the limiting step in the ATP.Sample collection is the limiting step in the ATP.

The Agency looked at a number of options to address sample The Agency looked at a number of options to address sample collection.collection.

Registant direct shipment appear to be the most efficient.Registant direct shipment appear to be the most efficient.

As such, the Agency appreciates the willingness of the As such, the Agency appreciates the willingness of the antimicrobial industry to support confirmatory efficacy testing antimicrobial industry to support confirmatory efficacy testing by shipping products to Agency contract laboratories for by shipping products to Agency contract laboratories for testing.testing.


The “Registrant Direct Shipment” option will be The “Registrant Direct Shipment” option will be implemented within the next 15 days. implemented within the next 15 days.

The Agency has developed individual letters to all The Agency has developed individual letters to all companies that will list their products that require companies that will list their products that require testing.testing.

Companies will be asked to ship a product sample to Companies will be asked to ship a product sample to EPA’s Analytical Chemistry Laboratory for analysis.EPA’s Analytical Chemistry Laboratory for analysis.


Once the sample is received, a second letter will be sent to Once the sample is received, a second letter will be sent to each company requesting a second sample (same lot) be each company requesting a second sample (same lot) be shipped to an identified state laboratory for efficacy testing.shipped to an identified state laboratory for efficacy testing.

This two step approach will enable the Agency to rapidly This two step approach will enable the Agency to rapidly develop the analytical test parameters and manage throughput.develop the analytical test parameters and manage throughput.

The Agency appreciates your cooperation and leadership in The Agency appreciates your cooperation and leadership in helping to ensure public health products perform as labeled.helping to ensure public health products perform as labeled.

Policy Changes and Policy Changes and ClarificationsClarifications

Evolving science often requires changes in longstanding Evolving science often requires changes in longstanding practices and/or policies.practices and/or policies.

The merits of the repeat testing policy have been reviewed and The merits of the repeat testing policy have been reviewed and the practice discontinued.the practice discontinued.

Emerging pathogens have necessitated new policies such as Emerging pathogens have necessitated new policies such as the disinfection hierarchy which will allow product use for the disinfection hierarchy which will allow product use for emerging viral pathogens in the event of a public health emerging viral pathogens in the event of a public health emergency while registration is ongoing.emergency while registration is ongoing.

Policy Changes and ClarificationsPolicy Changes and Clarifications

A stand alone sporicidal claim for A stand alone sporicidal claim for Clostridium difficile Clostridium difficile seems seems appropriate rather than requiring the claim to be added to a appropriate rather than requiring the claim to be added to a sterilant product label.sterilant product label.

As policy and other changes evolve, the Agency will post As policy and other changes evolve, the Agency will post them on it web pagethem on it web page

Some changes may require OMB reviewSome changes may require OMB review

Agency intends to ensure a level playing field in announcing Agency intends to ensure a level playing field in announcing and obtaining compliance with evolved policies.and obtaining compliance with evolved policies.

Policy Changes and Policy Changes and ClarificationsClarifications

Will make every effort to streamline reconsideration Will make every effort to streamline reconsideration and clarification of policies given the important public and clarification of policies given the important public health role of antimicrobial pesticide products. health role of antimicrobial pesticide products.

Suggestions on how to better communicate evolving Suggestions on how to better communicate evolving policies are welcome. policies are welcome.

Wrap UpWrap Up

Looking forward to continue working with the Looking forward to continue working with the industry on areas of mutual interest.industry on areas of mutual interest.

Questions Questions

Update on Antimicrobial Activities Presented at the Consumer Specialty Product Assoc. Joan Harrigan...

Documents

Transcript of Update on Antimicrobial Activities Presented at the Consumer Specialty Product Assoc. Joan Harrigan...