Regulating Antimicrobials -- Wood Preservative Products -- in the United States

1. Regulating Antimicrobials -- Wood Preservative Products -- in the United States Frank T. Sanders, Director ANTIMICROBIALS DIVISION Office of Pesticide Programs, OPPTS United States Environmental Protection Agency

2. Topics to be Discussed • Background • How Wood Preservative Products are Regulated in the U.S. • International Activities • Overview of changing Trends & Issues in regulating antimicrobials in the U.S. • Pressure Treated Wood • Metal Working Fluids • Antifoulant Paints

3. BACKGROUND

4. Background on EPA Regulatory Program • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to register pesticide products, including antimicrobial pesticide products, for sale and distribution in the United States • EPA’s Antimicrobial Division is responsible for registering Antimicrobial Pesticides – Wood Preservatives are considered Antimicrobials in the U.S.

5. Applicable Statutes Food Quality Protection Act (FQPA) Pesticide Registration Improvement Act (PRIA) Federal Food Drug And Cosmetic Act (FFDCA) Federal Insecticide Fungicide And Rodenticide Act (FIFRA) Tolerance Established Product Registered

6. Primary Functions Under FIFRA Manage the registration of pesticide products under the Federal Insecticide, Fungicide and Rodenticide Act • Pesticide registration (section 3) • New Chemicals • New Uses • Amendment • Old Chemical

7. AD Organizational Structure

8. Area of ResponsibilityAntimicrobials under FIFRA AD: Non-AD: Antimicrobials regulates chemicals used in or on environmental surfaces, as well as in air or in water, they include: Excluded from antimicrobials jurisdiction are (because either regulated by the FDA or are non-antimicrobials:

9. AD Scope of Work • Currently there are more 200 active ingredients • Also, more than 5,000 products are registered with AD • Roughly 60% are public health products • More than 3.3 billion pounds used/yr (includes chlorine water treatment)

10. Other Areas of Responsibility • AD also has the lead for: • Antimicrobial Homeland Security Coordination; • Antimicrobials Testing Program; • OECD Biocides Initiatives; • NAFTA Biocides Harmonization Initiatives; • 158W Data Requirement development; • Wood Preservatives (CCA, Pentachlorophenol and Creosote) • Antifoulants • And More….

11. Cost of Applying for Registration under the Pesticide Registration Improvement Act (PRIA)

12. What is PRIA? • Industry Sponsored Bill Introduced in Congress on September 22, 2003 • Objectives of Bill: a. Predictability of product registration b. Accountability for meeting timeframes c. Reduce New Chemical backlog d. Adequate Funding – Maintenance Fees/Tolerance Fees e. Meet Registration and Reregistration Deadlines

13. When Did PRIA Become Law? • The President signed the bill January 23, 2004. • The Act was effective March 23, 2004

14. PRIA Fees There are many facets to the PRIA: • Renewable in 5 years if mandates are being met • Allows OPP to collect $116M in Fees over a 5 year period. • (Estimated to generate additional $15-20M per year for Program in registration fees) • OPP appropriated budget allocation must remain at FY02 level • Requires annual report to Congress • Allows for judicial review for timeframes missed (see Chart on next slide)

15. PRIA Fee Categories for Antimicrobials

16. PRIA Fee Categories for Antimicrobials

17. PRIA Fee Categories for Antimicrobials

18. Major Impacts of PRIA • AGENCY OPTIONS: 1. Register Product within category time frames 2. Renegotiate Due Date (data deficiencies) 3. Deny application (Applicants rights - appeal - resubmit the application with the corrections and pay another fee).

19. Process Flow Review AD PM’s AD Decision RASBB Reviewers PSB

20. How Wood Preservatives are Regulated in the U.S.

21. Typical Human Exposure Scenarios for Wood Preservatives • Application: • Pressure-treatment, thermal treatment, spraying, dipping, brushing, mixing/loading (dermal/inhalation) • Post-application: • Handling treated wood products (occupational – dermal/inhalation) • Contact with treated wood products (children: dermal, incidental oral)

22. Data Requirements for Wood Preservatives

23. Subchronic testing: 90 day oral study (rodent) 90 day dermal study 90 day inhalation (rat) Developmental Toxicity and Reproduction Prenatal developmental toxicity - rat Prenatal developmental toxicity - rabbit Reproduction and fertility effects Mutagenicity battery Chronic testing Chronic toxicity – rodent Chronic toxicity – non-rodent Carcinogenicity- rat Carcinogenicty- mouse Acute toxicity battery Toxicology Data for Wood Preservatives

24. Human Exposure Data for Wood Preservatives • Product use and description of human activity information • Worker/home owner exposure monitoring • Application • Dermal Exposure • Inhalation Exposure • Outdoor Biological Monitoring Conditionally Required • Post-application

25. Human Exposure Data for Wood Preservatives • Determine parent compound, and/or major metabolite/ degradate (Transformation products) • Surface Wipe Sampling – dis-lodgeable residues from wood surfaces for post-application scenarios for occupational and residential contact with treated wood • Guidance available at Consumer Product Safety Commission (CPSC) Protocol

26. Human Exposure Data for Wood Preservatives • If proposed wood treatment uses involve scenarios which may result in residues of parent compound or metabolites/degradates, in food items • Residue chemistry data must be submitted which is pertinent to such scenarios. • And/or, in lieu of these data, the registrant may be required to add restriction (s) to the label • Examples of food uses: • Plant stakes • Honey bee hives • Truck beds • Water and animal feed trough

27. Environmental Risk Assessment Data • Various routes of exposure to environment • Terrestrial habitat • Decks, poles, etc., leaching into soil • Uptake of residues into food items (plants, insects) • Aquatic habitat • Runoff of residues from terrestrial structures • Direct leaching into water from piers, pilings • Continuous leaching/sloughing from boat hulls • Direct exposure as well as food-chain exposure

28. Environmental Fate Data • Needed for all WPs : • Hydrolysis study • Adsorption/desorption studies • Needed under certain conditions: • Photodegradation in water • Soil column leaching • Accumulation studies in fish • Aerobic soil metabolism • Anaerobic soil metabolism • Aerobic aquatic metabolism • Anaerobic aquatic metabolism

29. Environmental Fate Data • Special Leaching Studies • Determine amount of parent compound and degradates/metabolites released into the environment • Wood Preservatives: • Aquatic leaching from wood study (Standard Method of Determining The Leachability of Wood Preservatives, American Wood-Preservers’ Association Standard E11-97) • Soil leaching from wood study (Upon request the Agency can provide guidance on this study.) • Also needed for considering incidental oral exposure in residential scenarios

30. Environmental Exposure Assessment Data • Environmental fate studies identify major transformation products • Need to consider exposure of transformation products, as well as parent compound • May need ecological effects data on transformation products resulting in significant exposure

31. Environmental Exposure Assessment Data • Monitoring data used if available • Usually need to rely on models • A Wood Preservatives • Models being developed for terrestrial • Leaching information and dilution models for Aquatic

32. Ecological Effects Data • Basic data needs for wood preservatives • Avian acute oral LD50 (bobwhite quail) or mallard duck, 850.2100 • Fish acute LC50s with a coldwater (rainbow trout) and a warmwater (bluegill sunfish) species, 850.1075 • Aquatic invertebrate EC50 with a freshwater species (Daphnia magna),850.1010 • Wood preservatives may also need a honeybee study to determine toxicity • Agency guidance upon request

33. Ecological Effects Data • For wood intended for aquatic environments EPA needs preservatives, as well as : • Acute LC50or EC50 with estuarine/marine fish, bivalve and shrimp species • Fish early-life stage study • Invertebrate life cycle study • Seedling emergence - dose response using rice (Oryza sativa • Vegetative vigor - dose response using rice (Oryza sativa • Aquatic plant growth (algal and aquatic plant toxicity)

34. Ecological Effects Data • The following tests are needed under certain conditions: • Aquatic organism (fish, oyster, and food chain) bioavailability/biomagnification/toxicity tests, 850.1710, 1730, 1850 • Whole sediment, acute invertebrates, freshwater (850.1735) and/or estuarine/marine (850.1740) • Acute pore water toxicity to invertebrates (no guideline number) • Whole sediment chronic test (no guideline number) • Fish life-cycle test, 850.1500 • Aquatic Field Studies, 850.1950 • Ecological monitoring studies (no guideline number)

35. AD INTERNATIONAL ACTIVITIES

36. International Coordination • EPA’s Antimicrobial Program continues to enjoy a growing working relationship with its international counterparts. • Most activities are coordinated with or through the following organizations/initiatives: • European Union (EU) • North America Free Trade Agreement (NAFTA) • Organization for Economic Cooperation and Development (OECD)

37. OECD Projects • Draft Test Guidelines for Leaching of Wood Preservatives from Treated Wood • The objective is to develop test guidelines that all countries can use in evaluating wood preservatives. EPA will be presenting its concerns during the Task Force meeting today. • Harmonization of Efficacy Test Methods for Antimicrobials used on Hard Surfaces and in Treated Articles • The objective is to develop harmonized test methods and performance standards for biocides used on hard surfaces and in treated articles. • The contractor presented a revised report to the Steering Group and it is envisioned that focus will be placed on the hard surface disinfectant for now.

38. OECD Projects • Use of Biocides for Ships’ Ballast Water • AD is participating in an OECD discussion of work currently in progress in government and industry to address ballast water issues. • The TFB will consider whether they should be providing input in the broad arena of ballast water issues.

39. Communicating with Registrants

40. Communicating Guidance and Policy -- Development • Within AD there are management meetings, planning meetings, Team Leader consistency meetings, Branch Meetings; and All-Hands Meetings on various schedules • All OPP Divisions participate in the development and/or agreement of cross-cutting PR Notices • OPP releases PR Notices as draft for comment first • Specific regulatory and policy issues are addressed when needed through various methods • OD Generals, Management Planning Meetings • Claims Board • Labeling Unit • Science Advisory Panel • Field and External Affairs Division – regulatory approaches

41. Communicating Guidance and Policy -- Mechanisms • Monthly Industry Association Meetings • Antimicrobials National Workshops- 7th Workshop, to be held in November 2005 • Antimicrobial Hotline/Ombudsman; PM’s, Branch Chiefs, AD Immediate Office • AD has built its own database of stakeholders to communicate more effectively • Included in the listing is every company that has an antimicrobial registered product. • Also included are any consultants, trade groups, associations, regional contacts, states and any other stakeholder that has shown an interest in antimicrobial pesticides. • AD has piloted its Antimicrobials Registration Information System (ARIS) – will be updating system with more policy guidance and clarity features • AD website contains latest AD policies and guidance documents: http://www.epa.gov/oppad001/

42. CHANGING TRENDS & ISSUES IN THE U.S.

43. Some Changing Trends and Issues for Antimicrobials • Bio-terrorism – Anthrax • Pressure Treated Wood • Treated Articles • Use of Structural Activity Relationship Process for reregistration

44. Changing Trends and Issues for Antimicrobials • 158(W) • Ballast Water: New Use Site • Antifoulant paint use alternatives for TBT • Biofilm protocols/registration: Dental unit water lines/hard surface disinfectant • Endangered Species

45. In Conclusion • In keeping pace with this ever changing market the Agency will continue to work closely with all its stakeholders and seek to understand all points of view so that it may continue to reap the benefit of an open and inclusive decision-making process