PPDC Registration Review Workgroup Meeting Agenda September 28, 2004 8: 30  9: 00 am Arrive and Sign In 9: 00  9: 10 am Welcome Jim Jones 9: 10  9: 30 am Review Agenda Jay Ellenberger Introductions, Ground Rules 9: 30  9: 45 am General Update Vivian Prunier Schedule for Registration Review Rule 9: 45  10: 00 am Break 10: 00  10: 30 am Discussion on Regulatory and Science Changes since 1984 Rich Dumas ESA/ Endocrine Disruptors Jay Ellenberger 10: 30  10: 45 am Introduction to Feasibility Study Susan Lewis 10: 45  12: 00 noon Conventional Study Ray Kent, Dana Spatz Group Discussion 12: 00  1: 00 pm Lunch 1: 00  2: 00 pm BPPD Study Linda Hollis Group Discussion 2: 00  3: 00 pm Antimicrobial Study Jack Housenger, Debbie Smegal Group Discussion 3: 00  3: 15 pm Break 3: 15  3: 45 pm Discussion of Aggregate Findings Susan Lewis 3: 45  4: 15 pm Plan Presentation to Full PPDC Meeting in October Jay Ellenberger 4: 15  5: 00 pm Discussion of Future Projects Jay Ellenberger, Vivian Prunier End Use Registrations Documentation of Decisions 10/ 5/ 04 3 Registration Review Rule Development PPDC Registration Review Workgroup September 28, 2004 10/ 5/ 04 4 Rule making Process ° ANPRM  2000 ° PPDC recommendations   May 2004   Design of registration review process   Test the design ° Feasibility study  NOW ° Publish proposed rule  2005 ° Final rule  2006 10/ 5/ 04 5 Design Requirements for Registration Review ° High efficiency  50 chemical cases ( 80 AIs)

per year ° Sound science, transparent, open process,

credible/ value added decisions ° Flexible process that's built to last 10/ 5/ 04 6 PPDC Recommendations ° Need reliable, predictable schedule ° Address new issues when they arise

outside of registration review ° Tailor review to depth/ scope of issues   new data may be required ° Registration review should be a safety net 10/ 5/ 04 7 PPDC's " Tailored Approach"

° Assemble baseline information for each case   current registrations   bibliography of studies   last risk assessments   use patterns   incidents ° Invite public comment on baseline information ° Ask, " What's changed since last risk assessments?"

° Are new data or new risk assessment needed?

° Invite public comment on findings 8 Registration Review Flowchart Identify/ Assemble information stakeholder input Review information Decision:

Are new assessments required?

NO YES Decision:

Are data currently available?

Conduct new assessment( s). Registrant provides data;

Agency reviews.

YES NO Complete Registration Review Decision/ Document 10/ 5/ 04 10 Part 158 Guidelines Promulgated 1984 Began performing shortterm and intermediate term human health risk assessments 1995 Implementation Paper for the New Paradigm for Ecological Risk Assessment 1993 Antimicrobial and Biopesticides divisions established 1995 * Full Implementation of WPS * Agricultural Reentry DCI * Occupational/ Residential Turf DCI 1996 Began Performing Probabilistic Dietary Risk Assessments.

FQPA ° Aggregate Risk Assessments ° Cumulative Risk Assessments ° Sanitizers and food contact disinfectants to EPA ° Indirect food additives jointly regulated by EPA & FDA ° Safety Factor for sensitivity to infants and children 1996 1998 Highlights of Changes since 1984 Joint Counterpart Endangered Species Act Section 7 Consultation Regulations and Technical Overview Document 2004 . * Endocrine testing program * More Probabilistic Risk Assessments ° Update Biochemical and Microbial data requirements ° Revise Part 158 Guidelines 2005 2006 10/ 5/ 04 12 Feasibility Study PPDC Registration Review Workgroup September 28, 2004 10/ 5/ 04 13 Feasibility Study ° At the May 2004 meeting, PPDC recommended a study to test the registration review decision process ° EPA agreed with this suggestion ° Feasibility study was conducted in June and July 2004 ° Letters/ calls to registrants of the 28 cases 10/ 5/ 04 14 Feasibility Study ° Purpose: test the decision process and gather data on program costs.

° This is a simulation, not a " pilot"

° Randomly select 28 cases among potential candidates for first five years of program   283 total cases in program ° Assemble " baseline" information   Current uses, bibliography of studies, last risk assessments, incidents 10/ 5/ 04 15 Feasibility Study ° Ask: What do we know, what do we need to know, and what is the value of the new information?

° Possible outcomes   No new assessment   New assessment, no new data   New assessment, new data 10/ 5/ 04 16 The Feasibility Study Did Not ° Consult with registrants or other stakeholders ° Prepare use/ usage reports ° Search open literature ° Conduct new assessments ° Call in new data 10/ 5/ 04 17 General Findings ° Process is feasible ° Highlighted importance of consultation ° Information technology/ management needs ° Identified regulatory issues ° Identified process design issues 10/ 5/ 04 19 Registration Review Process Proposed Conventional Pesticide Case Study PPDC Workgroup Meeting Ray Kent, Health Effects Dana Spatz, Environmental Fate and Effects September 28, 2004 10/ 5/ 04 20 Conventional Pesticide Case Background Regulatory History ° First registered: late 1980' s Use Profile ° Post emergence herbicide ° Acts through foliar uptake ° Controls wide range of broadleaf weeds in cereal crops ° Also has non food uses ° Applied by air and ground equipment 10/ 5/ 04 21 Conventional Pesticide Case Background Human Health Risk Assessment Status ° Recent dietary risk assessment ° Recent aggregate food & water assessment ° No residential uses   no assessment needed ° Last occupational assessment at time of first registration 10/ 5/ 04 22 Conventional Pesticide Case Background Hazard Profile For Human Health ° Low to moderate acute toxicity via the oral, inhalation, and dermal routes of exposure ° It is a skin sensitizer and a mild eye irritant ° Repeated dose oral toxicity studies resulted primarily in decreased body weights and body weight gains accompanied by decreased food consumption ° No evidence for significant toxicity to specific target organs 10/ 5/ 04 23 Conventional Pesticide Case Background Hazard Profile For Human Health ( cont.)

° No evidence of neurotoxicity or neuropathy from available studies ° Developmental and reproductive toxicity studies indicated no increased susceptibility of offspring ° Based on carcinogenicity studies, the chemical is classified as Group C ( possible human carcinogen)

° Negative for mutagenicity ° Complete toxicology data base 10/ 5/ 04 24 Conventional Pesticide Case Background FQPA Factor for Human Health ° The Special FQPA default safety factor ( 10x) is reduced to 1x since there is no indication of increased susceptibility in developmental toxicity studies in rats and rabbits and rat reproduction studies, and conservative exposure estimates are unlikely to underestimate risk. 10/ 5/ 04 25 Conventional Pesticide Case Background Human Health Risk Assessment Profile:

Occupational and Residential Exposure and Risk ° Most recent occupational risk assessment conducted during initial registration of chemical ( not included in recent assessment).

° No residential uses Dietary Exposure and Risks ° Tox studies suggest an acute dietary risk assessment is unnecessary.

° Chronic dietary exposure estimates are < 1% of the dose that would be of concern.

° Dietary assessment is considered protective of potential cancer concerns 10/ 5/ 04 26 Conventional Pesticide Case Background Human Health Risk Assessment Profile ( cont.)

Drinking Water and Aggregate Risk ° Drinking water risk assessment completed recently.

° Aggregate risk assessment completed recently ° Food and water chronic exposures are < 1% of the dose that would be of concern for all population subgroups. 10/ 5/ 04 Standard Evaluation Procedures including methodology for conducting ecological risk assessments.

1986 Rejection Rate Analysis provided guidance which helped registrants improve studies submitted for registration/

reregistration.

1993 Implementation Paper for the New Paradigm instituted the use of risk quotients and comparisons to levels of concern. Also required ground water monitoring to insure effectiveness of mitigation.

1993 Implementation of refined modeling for estimated concentrations in the aquatic environment.

1995 Guidelines for Ecological Risk Assessment standardizes the methods and procedures for conducting ecological risk assessments. 1998 Science Policy Council Handbook   Risk Characterization, provides guidance for enhanced ecological risk characterizations.

FQPA requires estimated concentrations of pesticides and their degradates in drinking water. As a result,

number of modeling scenarios for ecological risk assessment increases. 1996 2000 Major Milestones in Ecological Risk Assessments and Drinking Water Exposure Assessments Conducted in OPP 1984   Present and Future Joint Counterpart Endangered Species Act Section 7 Consultation Regulations requires Agency to use best available scientific and commercial information, consider critical habitat, and indirect effects. Publication of the Overview of the Ecological Risk Assessment Process in OPP: Endangered and Threatened Species Effects Determinations 2004 Industry begins to submit Probabilistic Risk Assessments.

2001 Implementation of Probabilistic Models,

based in part on the recommendations of ECOFRAM, a multistakeholder group convened in 1997.

2005 2006 10/ 5/ 04 28 Conventional Pesticide Case Background Ecological Effects Risk Assessment ° Ecotoxicity and environmental fate assessments were completed in late 1980' s ° More recently, a drinking water exposure assessment was conducted for a tolerance reassessment decision ° No new uses added since the initial registration 10/ 5/ 04 29 Stressor Response Profile For Ecological Effects ° Practically non toxic to birds on an acute and dietary basis ° Practically non toxic to both warmwater and coldwater fish ° Practically non toxic to aquatic invertebrates Conventional Pesticide Case Background 10/ 5/ 04 30 Status of Ecotoxicity Studies ° Studies submitted since registration include:

  Avian reproduction   Seed germination/ seedling emergence   Vegetative vigor   Aquatic plant growth ° Avian reproduction and aquatic plant studies have been screened ° Terrestrial plant data have been reviewed, but not yet incorporated into a risk assessment Conventional Pesticide Case Background 10/ 5/ 04 31 Environmental Exposure Profile ° Primary routes of dissipation are hydrolysis and microbial degradation ° Half lives are less than one week in acidic environments and 1 4 weeks under more alkaline conditions ° High mobility in soil based on laboratory studies ° Little mobility observed in field studies ° Volatilization and bioaccumulation are not important pathways Conventional Pesticide Case Background 10/ 5/ 04 32 PPDC Workgroup Response Discussion Opinion:

° Easy Off?

° Need New Risk Assessment( s)?

° Need New Risk Assessment( s), New Data? 10/ 5/ 04 33 OPP's Illustrative Results For Conventional Pesticide Case Study 10/ 5/ 04 34 OPP's Illustrative Results For Conventional Pesticide Case Study Major Issues For Human Health ° Occupational risk should be updated because it has not been updated since the first registration of the chemical.

° No new studies are required to update risk assessments. 10/ 5/ 04 35 Ecological Risk Assessment ° An ecological risk assessment has not been completed for this chemical.

° What exists today is an ecological hazard assessment and an exposure assessment.

° Represents what was commonly done prior to the early 1990' s ° At the time of its registration, the use of risk quotients ( RQs)

and their comparison to Agency levels of concern had not been fully implemented.

OPP's Illustrative Results For Conventional Pesticide Case Study 10/ 5/ 04 36 OPP's Illustrative Results For Conventional Pesticide Case Study Ecological Risk Assessment ° The registration was granted conditional on satisfying several data gaps, including non target plant data.

° The registrant submitted data to satisfy the conditions of the registration.

° Based upon the information available for this chemical and other chemicals in its class, OPP expects that the potential risks of concern will be primarily for non target plants,

including endangered species. 10/ 5/ 04 37 Major Issues for Ecological Risk ( cont.)

° An ecological risk assessment needs to be completed.

° Hazard and exposure need to be integrated into an ecological risk assessment to determine if there are any level of concern ( LOC) exceedences.

° An FQPA drinking water assessment was recently completed,

therefore no further work is required in this area.

OPP's Illustrative Results For Conventional Pesticide Case Study 10/ 5/ 04 38 OPP's Illustrative Results For Conventional Pesticide Case Study Major Issues For Ecological Risk ( cont.)

° In order for the risk assessment to conform with EPA's agreements on ESA as a result of the Joint Counterpart Endangered Species Act Section 7 Consultation Regulations, the Agency will also need to:

1) incorporate the best available scientific and commercial information ( literature search);

2) consider critical habitat; and 3) address indirect effects.

° Possible consultation with the Services and/ or mitigate risk 10/ 5/ 04 40 Registration Review Proposed Process

Biochemical Pesticide Case Study PPDC Workgroup Meeting Linda Hollis September 28, 2004 10/ 5/ 04 41 Biochemical Pesticide Case Background Regulatory Background ° First Registered: 1970s ° RED: 1990s ° In the mid 1980s, EPA compiled the scientific information and EPA policies on the regulation of pheromones and other semiochemicals ° This compilation provided the basis for regulatory relief based on the low toxicity of the class of compounds and low exposure when used in a trap and/ or at low application rates 10/ 5/ 04 42 Use Profile ° While use sites include what would be considered food or feed sites, the use pattern is classified as Terrestrial Non

Food Crop. The chemical is used in a trap and not applied directly to food or feed.

° Terrestrial Non Food Crop: agricultural crops, soils and vegetables, orchards and deciduous fruit trees, grapes and other food commodities ° Terrestrial Non Food & Outdoor Residential:

ornamental shade trees, ornamental herbaceous plants,

ornamental non flowering plants, ornamental woody shrubs and vines Biochemical Pesticide Case Background 10/ 5/ 04 43 Biochemical Pesticide Case Background Nature of Biochemical Pesticides ° Natural substances, or synthetically derived compounds that are structurally and functionally equivalent ° Non toxic to the target pest and generally non toxic to other organisms ° Typically used at low application rates ° Compounds do not have toxic endpoints for Tier I studies, and therefore do not trigger higher tiered studies such as subchronic or chronic studies. 10/ 5/ 04 44 Biochemical Pesticide Case Background Hazard Profile For Human Health ° Mammalian toxicology database is complete and sufficient to characterize the toxicity and assess the risk of the chemical ° Very low acute toxicity for all routes of exposure ° Exposure is limited because of use pattern ( used in traps) 10/ 5/ 04 45 Biochemical Pesticide Case Background Hazard Profile For Ecological Effects, Exposure and Risks ° Effects to non target organisms are not expected because mode of action is specific to target pest ° Exposures to birds, fish, or aquatic organisms are not expected because the chemical is enclosed in a dispenser within a trap 10/ 5/ 04 46 Biochemical Pesticide Case Background Occupational/ Residential Exposure & Risks ° No occupational studies triggered due to lack of significant toxicological concerns ° Limited exposure if label instructions are followed   The chemical is used in small quantities and enclosed in a retrievable trap resulting in very low exposure   Release rate from the trap is comparable to the release from insect pest during peak infestation periods   Individuals setting up trap are exposed to higher concentrations than emitted from the trap   There is no toxicological concern to the user if a trap is only set up once a year 10/ 5/ 04 47 Biochemical Pesticide Case Discussion Opinion:

° Easy Off?

° Need New Risk Assessment( s)?

° Need New Risk Assessment( s), New Data? 10/ 5/ 04 48 OPP's Illustrative Results For Biochemical Pesticide Case Study 10/ 5/ 04 49 OPP's Illustrative Results For Biochemical Pesticide Case Study Human Health Risk and/ or Ecological Risk Assessment ° All data requirements are satisfied ° Risk assessment completed in the 1990s is still valid ° No new or modified human health or ecological risk assessment needed ° EPA has determined that a tolerance or tolerance exemption are not needed for this chemical when used in a trap due to lack of pesticides residues found on food or feed commodities 10/ 5/ 04 51 PPDC Workshop Registration Review September 28, 2004 Antimicrobials Division Office of Pesticide Programs 10/ 5/ 04 52 Background ° AD was created in August 1996.

° Second Multidisciplinary Division in OPP.

° AD is a One Stop Shopping Division   All Science and Regulatory Decisions are made within the Division for the Registration and Reregistration of Antimicrobial Products. 10/ 5/ 04 53 Antimicrobial Registration Facts ° Actives registered = > 250 ° Products registered = > 5000 ° Approximately 50% of registered antimicrobials are public health products.

° Use = > 3.3 billion/ lbs/ yr*

  * When chlorine water treatment is included 10/ 5/ 04 54 What Is An Antimicrobial Pesticide?

The definition in FIFRA is:

A pesticide that intended to disinfect, sanitize,

reduce or mitigate growth or development of microorganisms or it protects inanimate objects,

industrial processes or systems, surfaces, water,

or other chemical substances from contamination,

fouling, or deterioration caused by bacteria,

viruses, fungi, protozoa, algae, or slime. 10/ 5/ 04 55 What Is Considered To Be A Pest? ( 40 CFR 152.5)

An antimicrobial pest is any fungus,

bacterium, virus or other microorganism, except for those on or in living man or other living animals,

and those on or in processed food or processed animal feed, beverages,

drugs and cosmetics. 10/ 5/ 04 56 Antimicrobial Efficacy ° Non public health products   Wood preservatives   Antifoulant paints   Material preservatives ° Public health products   Hospital disinfectants   Food contact sanitizers 10/ 5/ 04 57 Levels of Efficacy ° Sterilant ( ETO, Gluteraldehyde)

° Disinfectant ( Quats, Hydrogen peroxide)

° Sanitizer ( Quats, Hydrogen peroxide)

° Bacteriostat ( inhibition of bacterial growth)

( Triclosan, Silver)

° Other ( i. e., fruit and vegetable rinses, treated articles with public health claims, unique delivery systems i. e., sponges) 58 Use Patterns   Agricultural premises and equipment   Food handling/ storage establishments, premises and equipment   Commercial, institutional and industrial premises and equipment   Residential and public access equipment   Medical premises and equipment   Human drinking water systems   Materials preservatives   Industrial processes and water systems   Antifouling coatings   Wood preservatives   Swimming pools   Aquatic areas 10/ 5/ 04 59 Reregistration/ Registration Review ° AD has to make reregistration and registration review decisions for its own chemicals.

° Challenging due to dual jurisdictional issues,

history, and broad use patterns and labeling. 10/ 5/ 04 60 Food Use Jurisdiction ° FDA ° EPA ° FDA/ EPA Dual Jurisdiction 10/ 5/ 04 61 What is an Antimicrobial " Food Use"?

° Direct contact with food   Fruit and vegetable wash in field ° Sodium hypochlorite ° Indirect food contact   Food contact adhesive/ coating   Pulp and paperboard use   Preservatives 10/ 5/ 04 62 Dual Jurisdiction Uses ( EPA and FDA)

° FDA is responsible for granting the indirect food additive clearance under FFDCA section 409 ° EPA is responsible for granting the registration under FIFRA 10/ 5/ 04 63 Dual Jurisdiction Uses ( EPA and FDA)

° Prior to FQPA   EPA did not review the safety determination made by FDA for the indirect food additive clearance under section 409 ° After FQPA   Section 2( bb) of FIFRA required EPA to not only assess all dietary risks from use of a pesticide, but also to ensure that it met the standards of section 408 10/ 5/ 04 64 Dual Jurisdiction Uses ( EPA and FDA)

° Section 2( bb): Unreasonable Adverse Effects on the Environment.

  " The term means .( 2) a human dietary risk from residues that result from a use of any pesticide in or on any food inconsistent with the standard under section 408 " 10/ 5/ 04 65 Typical Toxicology Data Requirements for An Antimicrobial Chemical Indirect Food Acute toxicity battery 90 sub chronic study in rodent and non rodent developmental toxicity study Mutagenicity battery 2 Generation Reproductive study Food Use Indirect food +

Other data case by case 10/ 5/ 04 66 Dual Jurisdiction Uses ( EPA and FDA)

° Issues created   Standards for 408 and 409 are different   FDA requires less data than EPA and EPA needs data to show that 408 standards are met   Many dual jurisdiction food uses never assessed 10/ 5/ 04 67 Antimicrobial Uses/ Labels ° Broad use patterns as material preservatives   Exposure scenarios not covered by current SOPs   Many times not evaluated at time of registration   Aggregation issues with other antimicrobial uses 10/ 5/ 04 68 Antimicrobial Uses/ Labels ° Example of an aggregation nightmare   Antimicrobial X is used as:

° a material preservative in plastics and textiles ° a slimicide in pulp/ paper mills ° a swimming pool disinfectant ° a carpet sanitizer 10/ 5/ 04 69 Consequences and Next Steps ° Develop policies, methodologies and SOPs as reregistration and registration review are ongoing ° Require data to confirm our analyses ° Require that labels are more " use specific" 10/ 5/ 04 71 Registration Review Proposed Process Antimicrobial Pesticide Case Study PPDC Workgroup Meeting Deborah Smegal September 28, 2004 10/ 5/ 04 72 Antimicrobial Pesticide Case Background Regulatory History ° First Registered: Mid 1980s ° RED: Mid 1990s, Pre FQPA ° Pesticide Type:

° Disinfectant ° Algaecide ° Bacteriostat regulator ° Microbiocide/ Microbiostat ° Fungicide/ Fungistat 10/ 5/ 04 73 Use Profile ° Indirect food uses: Pulp/ paper, dishwashing liquids ( products touch food contact surfaces); has FDA 409 clearance ° Non food indoor uses: Cleaners, laundry detergents,

textiles/ fabrics, consumer/ institutional products, paints, oil field systems, air washer systems, air conditioning/ humidifying systems,

cooling water systems, papermills, absorbent clays, metal working fluids, printing inks, adhesives ° Outdoor uses: Open industrial waste water systems, sewage settling ponds, sewage systems, ground wood/ saw dust ( as an absorbent)

Antimicrobial Pesticide Case Background 10/ 5/ 04 74 Antimicrobial Pesticide Case Background Last Major Assessments ° Registration Eligibility Decision ( RED): Mid 1990s, Pre FQPA ° Toxicology Assessment ( complete database)

° Occupational Assessment ( complete assessment at time, not all application methods evaluated, exposure database has significant limitations)

° Residential Assessment ( very limited, children not assessed,

not all uses evaluated; lacked residential Standard Operating Procedures) 10/ 5/ 04 75 Antimicrobial Pesticide Case Background Last Major Assessments Cont.

° Ecological Toxicity Assessment ( hazard only, no plant data or chronic fish or invertebrate data)

° Environmental Fate Assessment ° Ecological risks not estimated ( no Risk Quotients or levels of concern estimated; not standard practice at that time)

° No dietary, drinking water or aggregate assessments ( no SOP's at that time)

° Recent Heating Ventilation and Air Conditioning ( HVAC)

Assessment ° Occupational Assessment ° Residential Assessment 10/ 5/ 04 76 Hazard Profile For Human Health ° High to moderate toxicity for acute oral, dermal, eye and skin irritation ° Severe gastrointestinal irritant following repeated oral exposure ° Developmental and reproductive effects only in the presence of maternal toxicity ° Negative for genotoxicity ° No evidence of carcinogenicity in two chronic rodent studies ° No reported human incidence data Antimicrobial Pesticide Case Background 10/ 5/ 04 77 Antimicrobial Pesticide Case Background Occupational/ Residential Exposure & Risks ° No risks of concern for all worker scenarios in RED after mitigation measures ° No risks of concern for residential handlers of paints or adhesives using a paintbrush ° No risks of concern from HVAC use 10/ 5/ 04 78 Environmental Fate ° Stable to hydrolysis under normal conditions; may rapidly hydrolyze at warmer temperature and/ or high pH ° Parent compound expected to have a relatively short half life in the environment ( photoreactive in water)

° The major degradate has a much longer half life than the parent raising chronic concerns ° Unlikely to bioaccumulate Antimicrobial Pesticide Case Background 79 Antimicrobial Pesticide Case Background Hazard Profile for Ecological Effects, Exposure, & Risk ° Only have acute studies ° Practically non toxic to slightly toxic to birds ° Slightly to moderately toxic to freshwater fish and terrestrial invertebrates ° Moderately to highly toxic to estuarine/ marine invertebrates ° Slightly toxic to estuarine/ marine fish ° Exposure to non target aquatic organisms is expected from industrial discharges to surface water ° Discharges may adversely affect aquatic life. Chronic effects to invertebrates are also possible due to slow degradation of degradates ° In the RED, deferred to Office of Water, since aquatic environments are regulated under National Pollution Discharge Elimination System ( NPDES)

permitting program ( current practice in mid 1990s). 10/ 5/ 04 80 PPDC Workgroup Response Discussion Opinion:

° Easy Off?

° Need New Risk Assessment( s)?

° Need New Risk Assessment( s), New Data? 10/ 5/ 04 81 OPP's Illustrative Results For Antimicrobial Pesticide Case Study 82 OPP's Illustrative Results For Antimicrobial Pesticide Case Study Human Health Risk Assessment ° Dietary [ FQPA changed OPP policy; Pre FQPA, AD was not required to conduct dietary assessment for indirect food uses that have an FDA 409 clearance ( such as pulp and paper uses)]

° Residential ( many uses not evaluated   lacked SOPs)

° Residential handler cleaning floors ( mopping)

° Child crawling on treated floors ° Textiles/ fabrics ° Hand soap/ consumer products ° Occupational ( high end use scenarios not assessed, e. g., airless sprayer for painting scenario; worker cleaning floors)

° Drinking water assessment from industrial discharges to surface water ( new models available)

° Aggregate assessment ( not previously required) 10/ 5/ 04 83 OPP's Illustrative Results For Antimicrobial Pesticide Case Study Ecological Risk Assessment ° Complete assessment is not available ( only hazard and environmental fate assessments)

° Need to evaluate endangered species 10/ 5/ 04 84 OPP's Illustrative Results For Antimicrobial Pesticide Case Study Potential Data Needs ° May need up to 8 worker/ residential exposure studies and activity descriptions; existing data have significant limitations[ American Chemistry Council ( ACC) Biocides task force developing database]

° May need up to 5 ecological toxicity studies and possibly 6 environmental fate studies based on vague label language for potential outdoor uses that trigger additional data and new data requirements ° Studies may not be needed if labels are clarified to remove " open industrial waste water" ( or clarify that it is not a once through use) and preclude outdoor wood preservation uses ( i. e., ground wood as an absorbent)

° Studies include: plant toxicity data, chronic invertebrate toxicity data,

aerobic and anaerobic soil, aerobic and anaerobic aquatic,

absorption/ desorption, special wood leaching 10/ 5/ 04 85 OPP's Illustrative Results For Antimicrobial Pesticide Case Study Other Issues ° Label's uses need clarification based on consultation with registrant ° Seeking to work with OW NPDES permitting program ° Coordinate with FDA; previously deferred to them 10/ 5/ 04 87 Feasibility Study Aggregate Results The ultimate outstanding data needs in a given case are expected to be significantly influenced by internal and external consultations. For practical reasons, this step was omitted in the pilot.

17.7%

83.3%

58.3 75.0%

0.0%

New Assessment,

New Data 5.9%

0.0%

25.0 33.3%

8.3 16.7%

New Assessment,

No New Data 76.4%

16.7%

0.0 8.3%

83.3 91.7%

No New Assessment Environmental Human Health Biopesticides ( 10 cases)

Antimicrobials ( 6 cases)

Conventionals ( 12 cases)