158W Implementation Update. Pat Jennings Environmental Engineer EPA/OCSPP/OPP/AD/RASSB March 11, 2015

Transcription

1 158W Implementation Update Pat Jennings Environmental Engineer EPA/OCSPP/OPP/AD/RASSB March 11, 2015

2 AGENDA Overview of the Final Rule: Data Requirements for Antimicrobial Pesticides 158W Implementation Data Requirements by Discipline Summary 2

3 Overview of Final Rule: Data Requirements for Antimicrobial Pesticides Antimicrobial data requirements relocated to 40 CFR part 158, subpart W Codifies 12 antimicrobial use patterns Agency has developed a use-site index (USI) to provide guidance about antimicrobial use sites and general use patterns USI is intended to help identify data necessary to register a product 3

4 Overview of Final Rule Provides improved definitions for antimicrobial pesticides used for public health and nonpublic health purposes Preamble includes Response-to-Comments section Discusses alternative testing Codifies eleven new data requirements New data requirement: Has never been required or has rarely been required on a case-by-case basis and Has not been routinely considered during the Agency s evaluation of data needed for assessing risks 4

5 Overview: Data Requirement Table Structure Guideline Number Column: These are not data requirements. Data Requirement Column Use Pattern Columns Test Substance by Product Type Test Note Number 5

6 Overview: Structure of Data Requirements in 158W Retains most of the existing original pesticide data requirements from Part 158, while tailoring to be specific to antimicrobials Studies are tiered and categorized as required (R), conditionally required (CR),or not required (NR) Conditionally required (CR) versus Required (R) CR means a study is less likely to be required up to 50% of the time R could be viewed as representing a study to be submitted % of the time Clarifying test notes provide conditions for data requirements Product type being supported is specified (MP, EP) Test substances are specified (TGAI, TEP, PAIRA, etc.) 6

7 12 Major Use Patterns 7

8 Overview: 12 Major Use Patterns 1. Agricultural Premises & Equipment 2. Food Handling/Storage Establishments, Premises and Equipment 3. Commercial, Institutional and Industrial Premises and Equipment 4. Residential and Public Access Premises 5. Medical Premises and Equipment 6. Human Drinking Water Systems 7. Materials Preservatives 8. Industrial Processes and Water Systems 9. Antifouling Coatings and Ballast Water Treatments 10. Wood Preservatives 11. Swimming Pools and Spas 12. Aquatic Areas 8

9 158W Implementation There is flexibility in Implementing 158W: Alternative approaches can be accepted 158W data requirements can be waived Additional data can be required beyond 158W 9

10 158W Implementation: Use Site Index EPA will issue a proposed guidance document, Antimicrobial Pesticide Use Site Index, for public comment Use sites are organized into 12 general use patterns Specific use patterns are listed for each general category Specific use patterns are characterized as either: Direct food Indirect food Non-food USI food use categories are particularly applicable to toxicology and residue chemistry data requirements tables Consult test notes in data tables to determine applicability of the individual data requirements 10

11 158W Implementation: Changes in Data Requirements Eleven New Data Requirements Changed some existing data requirements From conditionally required to required Number of test species Types of use patterns for which the data are required Use patterns and exposure potential delineate data requirements Data may be required for transformation/degradation products or leachate residues of the parent compound under specific conditions 11

12 158W Implementation: Changes in Data Requirements Final rule recognizes the unique down-the-drain uses associated with antimicrobials Codifies data requirements needed to assess: Potential impacts of antimicrobials and/or their degradates to wastewater treatment plant (WWTP) microorganisms The potential for antimicrobials to be removed prior to discharge of WWTP effluent WWTP data requirements are used to predict toxicity, sorption, and biodegradation Having these data helps us to assess potential risks less conservatively 12

13 158W Implementation: Agency Support Meetings with regulated community/other stakeholders to address questions on key topics Written guidance on data requirements by use pattern is under development Contact AD s Product Managers with questions about new application submissions or current registrations The Agency will be issuing clarifications/editorial corrections to this final rule 13

14 158W Implementation: Agency Support The Agency will provide information and guidance on how EPA will evaluate potential exposures and risks to antimicrobial pesticides via recorded informational presentations based on: Specific scientific disciplines (e.g., Toxicology, Toxicity to Nontarget Organisms, Environmental Fate, Residue Chemistry, etc.) Use Patterns (e.g., Cooling Water Systems, Wood Preservatives, Materials Preservatives for Textiles and Plastics, etc.) Contact Pat Jennings ( ) or Steven Weiss ( ) with questions and suggestions for these presentations 14

15 158W Implementation: Agency Support AD recently conducted an internal presentation on cooling water system uses that included: Function of cooling water systems Types of cooling water systems (recirculating and once-through) Biofouling potential in once-through versus recirculating cooling water systems Basic approaches for modeling ecological exposures (freshwater vs. estuarine/marine and water column vs. benthic) Ecological exposure modeling methodology for cooling water systems Evaluating potential effects to aquatic organisms Evaluating potential dietary exposure and effects to humans from ingestion of drinking water and fish Basic data requirements For external stakeholders, presentations will be recorded as webinars and posted on EPA s website 15

16 Data Requirements by Scientific Discipline Toxicology Data Requirements, Nontarget Organism Data Requirements, Nontarget Plant Protection Data Requirements, Applicator Exposure Data Requirements, Post-application Exposure Data Requirements, Environmental Fate Data Requirements, (includes data requirements for toxicity and fate in wastewater) Residue Chemistry Data Requirements,

17 Data Requirements by Scientific Discipline: Eleven New Data Requirements TOXICOLOGY (1) Developmental Neurotoxicity (Test notes 28, 29, and 30) (2) Immunotoxicity (Test note 8) NONTARGET OGANISMS NONTARGET PLANT PROTECTION APPLICATOR EXPOSURE POST- APPLICATION EXPOSURE (3) Soil residue dissipation (Test notes 2 and 3) ENVIRONMENTAL FATE (4) Activated sludge respiration inhibition (ASRI) test (Test note 21) (5) Ready biodegradability study (Test notes 3, 4, and 18) (6) Porous pot study (Test notes 3 and 18) (7) Simulation test aerobic sewage treatment: activated sludge units (Test Notes 3 and 18) (8) Simulation tests to assess the biodegradability of chemicals in discharged wastewater (Test notes 3 and 18) (9) Activated sludge sorption isotherm study (Test notes 19 and 20) (10) Photodegradation in soil (Test note 10) RESIDUE CHEMISTRY (11) Nature of residue on surfaces (Test note 4) 17

18 Data Requirements by Scientific Discipline: Toxicology Table Organized by the following Use Pattern Categories/Subcategories: Food Uses Nonfood Uses Data categories include: Acute testing Subchronic testing Chronic testing Developmental Toxicity and Reproduction Mutagenicity Special testing 18

19 Data Requirements by Scientific Discipline: Nontarget Organisms and Nontarget Plants Tables organized by these use pattern categories: Industrial processes and water systems (e.g., cooling towers) Antifoulant coatings and paints Wood preservatives Aquatic Areas All other use patterns No new data requirements New criteria may trigger data; green algae toxicity now required for labeling Data may be required for transformation/degradation products or leachate residues of the parent compound under some conditions 19

20 Data Requirements by Scientific Discipline: Applicator Exposure Table organized by occupational and residential use sites No new exposure data requirements Criteria for testing: Dermal and inhalation exposure data may be required if there is evidence of toxicity and potential for exposure to occur (see table test notes) Biological monitoring data may be conditionally required (see table test notes) 20

21 Data Requirements by Scientific Discipline: Post-Application Exposure Table organized by occupational and residential use sites New data requirement for soil residue dissipation (See test notes 2 and 3) Soil residue dissipation may be conditionally required for residential wood preservative uses Criteria for testing: chemical toxicity and exposure potential 21

22 Data Requirements by Scientific Discipline: Environmental Fate Table organized by the following use pattern categories: Industrial processes and water systems Antifoulant coatings and paints Wood preservatives Aquatic areas All other use patterns Seven categories of data requirements Seven New data requirements: one for wood preservatives and six for toxicity and fate in WWTPs 22

23 Residue Chemistry Data Requirements Data categories include: Supporting information Food Contact Surfaces or Impregnated Materials Higher Tiered Use patterns include: Agricultural premise Indirect food Direct food Aquatic 23

24 SUMMARY This Final Rule: Codifies data requirements/use pattern combinations required to register an antimicrobial pesticide product Codifies 12 antimicrobial use patterns AD has developed a use-site index (USI) to provide guidance about antimicrobial use sites and general use patterns; Use Site Index (USI) food use categories are particularly applicable to toxicology and residue chemistry data requirements tables Data requirements tables for each scientific discipline contain test notes that provide specific information with regard to chemical and use characteristics to determine which data are and are not needed 24

25 SUMMARY AD is committed to assisting the regulated community throughout the implementation of this regulation via: Informational presentations Guidance material Meetings with stakeholders If you have questions or suggestions for informational presentations, contact Pat Jennings ( ) or Steven Weiss ( ) AD s PMs are available to answer any of your questions regarding new application submissions or current registrations for AD ombudsman is OPP_AD_Ombudsman@epa.gov List of AD contacts can be found at 25