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

1. Update on Antimicrobial ActivitiesPresented at the Consumer Specialty Product Assoc. Joan Harrigan Farrelly, Director Antimicrobials Division, OPP, EPA December 8, 2008

2. Overview • 158W - Proposed data requirements • Clostridium difficile update • 810 Guidelines Status • Repeat Testing Policy • Slime/Biofilm • Antimicrobial Testing Program • Policy Changes/Clarifications • Wrap Up

3. 158W – Proposed Rule • 158W – published for comment on 10/ 8 /08 • EPA held public workshop November 6, 2008 • Agency to extend the public comment period for an additional 90 days

4. 158W - History • Beginning in 1984 antimicrobial pesticides used the same data requirements as used by agricultural chemicals (“conventional pesticides”) • In August 1996 Food Quality Protection Act (FQPA) amendments to FIFRA and FFDCA became law • FIFRA, as amended by FQPA, required EPA to clarify data requirements for antimicrobial pesticides • Part 158W was developed to address antimicrobial pesticide data requirements

5. 158W Proposed Rule • Would establish: • 12 Use Patterns, and • 9 new data requirements

6. 158W - 12 Use Patterns • Agricultural premises and equipment • Food handling/storage establishments premises and equipment • Commercial, institutional and industrial premises and equipment • Residential and public access premises • Medical premises and equipment • Human drinking water

7. 158W - 12 Use Patterns • Materials preservatives • Industrial processes and water systems • Antifouling coatings and ballast water • Wood preservatives • Swimming pools • Aquatic areas Note: Agency assesses sites within use patterns with significant exposure: e.g., Heating, Ventilation, Air-Conditioning and Refrigeration (HVAC-R) systems

8. 158W New Data Requirements 9 New Study Requirements • 4 Human Health Related Studies: • Developmental neurotoxicity (toxicology - 158.2230; OPPTS 870.6300) • Immunotoxicity (toxicology - 158.2230; OPPTS 870.7800) • Soil residue dissipation (post-application exposure – 158.2270; OPPTS 875.2200) • Non-dietary ingestion exposure (post-application exposure – 158.2270; OPPTS 875.3000)

9. 158W New Data Requirements 9 New Study Requirements • 5 Environmental (environmental fate – 158.2280) Related: • Activated sludge sorption isotherm study (OPPTS 835.1110) • Photodegradation in soil (OPPTS 835.2410) • Ready biodegradability study (OPPTS 835.3110) • Porous pot study (OPPTS 835.3220) • Modified activated sludge, respiration inhibition test (OPPTS 850.6800)

10. Because the rule was long in coming – over ten years – it largely codifies existing practices Discusses Agency’s goal of relying on weight of evidence and structure activity relationship analysis where applicable EPA will address public comments received on Proposed Rule Goal: finalize proposed rule in 2010 Finalizing 158W

11. 810 Guidelines • Draft guidelines for sterilants, disinfectants, and sanitizers are completed • The guidelines are scheduled to be published for public comment no later than March 2009 • Anticipate earlier publication • Goal of finalizing the guidelines by the end of the calendar year.

12. 810 Guidelines • Draft guidelines for claims against Bacillus anthracis have also been completed. • Finalizing the Response to Comments for the 2007 Bacillusanthracis SAP. • These guidelines are scheduled to go out for public comment by March 2009 as well. • Listed in AD’s Workplan for FY 2009

13. 810 Guidelines AD is continuing work on revising the air, water, and material textile guidelines. Also listed in AD’s 2009 Workplan Will request input from industry representatives prior to proposal for comment.

14. Future Guideline Development The 810 guidelines are living documents. As new guidelines/methods are adopted, the guidelines will be amended to incorporate these changes. Examples: Clostridium difficile, biofilm, quantitative tests for disinfectants.

15. Update on Clostridium difficile Currently working with infection control user groups (APIC, SHEA, ASHES,) CDC and FDA to develop science-based parameters for efficacy testing. OPP’s BEAD Microbiology Laboratory is also conducting research with various strains of Clostridium difficile and various culture media to help identify a representative strain to be used for efficacy testing along with the appropriate media to help stimulate sporulation.

16. C. difficile Update OPP is working to develop an interim guidance that describes the registration performance standard. Goal is to post interim guidance on the web around the end of the calendar year.

17. Repeat Testing Policy In the past AD allowed “Repeat Testing” of a failing lot if only 2 tubes failed. Now, the merits of this practice seem questionable given challenges to the use dilution test (UDT) and the lack of a statistical basis for such flexibility. As a result, AD believes it is ill advised to issue a repeat testing policy at this time.

18. OECD Hard Surface Disinfectant Methods The Agency believes transitioning to quantitative efficacy test methods will provide a better measure of product performance. As such, the Agency is committed to implementing new methods as soon as possible.

19. OECD Hard Surface Disinfectant Methods The Validation Management Group met with the statistician in October to review the ring-trial data. Preliminary analysis suggests additional studies may need to be conducted to ensure the methods are successfully validated. This would delay AD’s adoption of the quantitative test for another year.

20. OECD Update Once the test methods are validated, AD can adopt them for use prior to OECD issuing the final test guidelines. In the early part of 2009, AD will establish a team to develop an implementation strategy for the new quantitative methods.

21. OECD Update • The quantitative test method implementation strategy will include a process and the timing for transitioning from the existing qualitative tests to the new quantitative tests. • AD will ask stakeholders to provide representatives to participate on the implementation team.

22. Clarification for the use of the Terms Biofilm and Slime on Labels Historically, AD did not allow the terms “biofilm” and “slime” to be used interchangeably. AD has decided to not limit the use of the term “biofilm” to public-health related products. The use of the term “slime” is also not limited to non-public health products. When using the term “biofilm” or “slime” in labeling, the use site will determine whether efficacy data will need to be submitted for the registration.

23. Clarification for the use of the Terms Biofilm and Slime on Labels Traditional industrial slimicide uses will not need to submit efficacy data when the term “biofilm” is used. As always, the registrant must have data in their files to support their label claims, and EPA can request that data on a case-by-case basis to make registration decisions.

24. Clarification for the use of the Terms Biofilm and Slime on Labels Efficacy data will need to be submitted for biofilm or slime claims on the following types of products: Disinfectants and sanitizers. Dental unit waterline products. Certain food processing water applications where the claim extends to pathogen reduction in the water and/or on the food. Consultation is advised with AD when making biofilm claims on antimicrobial product labels.

25. Antimicrobial Testing Program Efforts are underway to accelerate confirmatory efficacy testing of public health pesticide via the antimicrobial testing program (ATP) To date, the program has focused on sterilants and disinfectants. In the future, sanitizers and distributor products will also be evaluated or tested.

26. Antimicrobial Testing Program Sample collection is the limiting step in the ATP. The Agency looked at a number of options to address sample collection. Registant direct shipment appear to be the most efficient. As such, the Agency appreciates the willingness of the antimicrobial industry to support confirmatory efficacy testing by shipping products to Agency contract laboratories for testing.

27. Antimicrobial Testing Program The “Registrant Direct Shipment” option will be implemented within the next 15 days. The Agency has developed individual letters to all companies that will list their products that require testing. Companies will be asked to ship a product sample to EPA’s Analytical Chemistry Laboratory for analysis.

28. Antimicrobial Testing Program Once the sample is received, a second letter will be sent to each company requesting a second sample (same lot) be shipped to an identified state laboratory for efficacy testing. This two step approach will enable the Agency to rapidly develop the analytical test parameters and manage throughput. The Agency appreciates your cooperation and leadership in helping to ensure public health products perform as labeled.

29. Policy Changes and Clarifications Evolving science often requires changes in longstanding practices and/or policies. The merits of the repeat testing policy have been reviewed and the practice discontinued. Emerging pathogens have necessitated new policies such as the disinfection hierarchy which will allow product use for emerging viral pathogens in the event of a public health emergency while registration is ongoing.

30. Policy Changes and Clarifications A stand alone sporicidal claim for Clostridium difficile seems appropriate rather than requiring the claim to be added to a sterilant product label. As policy and other changes evolve, the Agency will post them on it web page Some changes may require OMB review Agency intends to ensure a level playing field in announcing and obtaining compliance with evolved policies.

31. Policy Changes and Clarifications Will make every effort to streamline reconsideration and clarification of policies given the important public health role of antimicrobial pesticide products. Suggestions on how to better communicate evolving policies are welcome.

32. Wrap Up Looking forward to continue working with the industry on areas of mutual interest. Questions