Page 1 of 13 Antimicrobial Pesticides Use Site Index 1
June 2015

Contents
I. Introduction 2 II. How to Use this Use Site Inde x to Determine Data Requirements 2 III. Descriptions of Direct Food, Indirect Food, and Nonfood Uses 3 Direct Food Use 3 Indirect Food Use 3 Nonfood Use 4 IV. FFDCA Clearances 4 V. Food Use Description Flow Chart 4 VI. Use Site Index 6 1. Agricultural Premises and Equipment 6 Direct Food Uses 6
Indirect Food Uses 6
Nonfood Uses 6 2. Food Handling/Storage Establishments, Premises and Equipment 7 Direct Food Uses 7
Indirect Food Uses 7
Nonfood Uses 8 3. Commercial, Institutional and Industrial Premises and Equipment 8 Nonfood Uses 8
4. Residential and Public Access Premises 9 Indirect Food Uses 9
Nonfood Uses 9 5. Medical Premises and Equipment 10 Nonfood Uses 10 6. Human Drinking Water Systems 10 Nonfood Uses 10
7. Materials Preservatives 10 Indirect Food Uses 10
Nonfood Uses 11
8. Industrial Processes and Water Systems 11 Indirect Food Uses 11
Nonfood Uses 12 9. Antifouling Coatings and Ballast Water Treatments 12 Indirect Food Uses 12
Nonfood Uses 12
10. Wood Preservatives 12 Nonfood Uses 12 11. Swimming Pools and Spas 13 Nonfood Uses 13 12. Aquatic Areas 13 Indirect Food Uses 13
Nonfood Uses 13

1 This updates the previous version posted to th e docket on 10/10/08 (ID: EPA-HQ-OPP-2008-0110-0043)Page 2 of 13 

### I. Introduction

The Environmental Protection Agency (the agency) codified twelve antimi crobial use patterns in 40 CFR part 158W. The Agency has developed an Antimicrobial Pesticide Use Site Index (USI) to provide guidance about antimicrobial pesticid e use sites and general antimicrobial pesticide use patterns. This USI guidance document is in tended to assist poten tial registrants and applicants by helping them to identify the data that are necessary to register their product(s).

This document provides guidance about antimicrobial use patterns, and is also used by EPA, the public, and the companies to identif y data requirements for antimicrobi al pesticide products. As a guidance document, the association of a par ticular antimicrobial use site with a general antimicrobial pesticide use pattern should be view ed as a recommendation only and is not to be construed as binding on either EP A or any outside parties. EP A may depart from the guidance where circumstances warrant a nd without prior notice.

Pesticide product labels provide critical informa tion about how to safely handle and use pesticide products. In order to ensure no unreasonabl e adverse effects on human health or the environment, FIFRA and its regulations requi re, among other things, that product labeling specifically states where and how a pesticide is inte nded to be used. Where a pesticide is to be used is generally referred to as the “pesticide us e site.” For antimicrobial pesticides, the use sites are diverse and constantly e volving as new products are developed. The USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels. The specific use sites are further orga nized into categories of twelve general use patterns. The general use patterns are broad desi gnations and are used as colu mns in the antimicrobial data requirements tables (found in 40 CFR Part 158W) to identify which data requirements might be pertinent to the particular pest icide use site. EPA has developed the Antimicrobial Pesticide Use Site Index to provide additional information about these use patterns.

Antimicrobial pesticide labels need to include clear use directions concerning whether the pesticide product is intended to come into contac t with food, either directly or indirectly. Therefore, the twelve general use patterns are subdivided into direct food uses, indirect food uses, and/or nonfood uses, as applicable. Fo r example, within th e general use pattern Residential and Public Access Premises , specific use sites include Household/Domestic Dwellings, Human
Footwear and Pet Living/Sleeping Quarters

. Household/Domestic Dwellings is listed under both the indirect food use subcategory as well as the nonfood use subcategory. Th is is because within the specific use site category of Household/Domestic Dwellings , there is a potential for indirect food contact for some uses (e.g., if a product is registered for use on ki tchen countertops), but there are also uses within this category that would be considered nonfood (e.g., a product registered for use in the bathroom). Additiona lly, the registrant may re strict the use site of House/Domestic Dwellings to nonfood by explicitly stating “non-food” (or other approved language) on the label.



### II. How to Use this Use Site Index to Determine Data Requirements

The column headings of the data requirement ta bles in 40 CFR 158W are arranged differently for human health (toxicology and residue chemistry), occupational (applicator and post-application), and ecological (nontarget organism, plant, and en vironmental fate). These different column headings designate how the use site index is us ed because the toxicology and residue chemistryPage 3 of 13 data requirements are dependent upon the FFDCA c onsiderations of whether a specific use is a food use. For each individual data requirement , consult the test notes to determine the applicability of the data requirements. Note : “R” means required and could be viewed as representing the submission of a study 50 to 100 percent of the time and “CR” means “conditionally required” and could be viewed as representing the submission of a study up to 50 percent of the time. Some basic steps for using the Use Site I ndex are listed below:

1. Determine which of the twelve general use patter ns is applicable to use(s) involved in the proposed registration. 2. Within the general use pattern category, identify which specific use pattern is most similar to each proposed use pattern. 3. For ecological data requirements, consult the Nontarget Organism, Nontarget Plant Protection, and Environmental Fate Data Require ment Tables to verify whether data are required for that use pattern. For ex ample, Guideline Number 850.3020, Honeybee Acute Contact Data are Required (R) for Wood Preservatives, Not Required (NR) for Industrial Processes and Antifoul ants, but Conditionally Required (CR) for the All Other Use Pattern Category. 4. For human health data requirements:

a. Determine if the use is c onsidered to be direct f ood, indirect food, or nonfood (see figure 1 below). b. Consult the antimicrobial data requireme nts tables for Toxicology and Residue Chemistry in 40 CFR 158W. (Note: “food use” categories are only applicable to the toxicology and residue chemistry data requirements tables.)



### III. Descriptions of Direct Food, I ndirect Food, and Nonfood Uses

Direct Food Use A use is generally considered to be a direct food use if an antimi crobial pesticide is intended to be directly applied to food (def ined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpos e of treating food. Use patterns that fall into this category include, but are not limited to: fruit and vegetable rinses, fogging of poultry areas, and egg washing treatments. These types of uses are generally subject to a FFDCA clearance.

Indirect Food Use A use is generally considered to be an indirect food use if the use involves appl ication of the antimicrobial pesticide in or on a material or ar ticle that comes into contact with food and may result in residues in or on food, but the use is no t intended for pesticidal treatment of food. As a result of contact with a surface and/or material th at has been treated and/or impregnated with an antimicrobial pesticide, there is a potential for residues in or on food. For example, food may come into contact with an object, material, and/ or surface that has been directly treated and/or impregnated with an antimicrobial pesticide. Although the pesticide does not have directions for direct application to food or for treatment of fo od by application to a f ood contact material or article, exposure to an antimicrobial pesticid e may occur and may result in residues in or on food. Use patterns that fall into this category include, but are notlimited to: sanitization of foodcontact dishes, utensils , food-processing equipment, and co untertops; disinfection of food-use areas; and impregnation of cutting boards, conveyor belts, or food containe rs and/or packagingPage 4 of 13 for a pesticidal purpose other than treating food. These types of uses may be subject to a FFDCA clearance.

Nonfood Use A use is generally considered to be a nonfood us e when there is a reas onable certainty of no residues in or on food, for example because the antim icrobial pesticide is not expected to come into contact (directly or indirec tly) with food as a result of its intended use. Use patterns that fall into this category include, but are not limited to: fuel ta nks, human footwear, or nonfood areas (e.g., under the sink) of eati ng establishments. These types of uses are not subject to a FFDCA clearance.

IV. 

### FFDCA Clearances

For a substance that is applied for a specific direct or indirect use on food that meets the definition of “pesticide chemical residu e” under FFDCA section 201(q), a tolerance or exemption from the requirement of a tolerance will be required if there is a reasonable expectation that residues of the pesticide will be present in or on food. For a substance that is applied for a specific direct or indirect use on food that is excluded from the definition of “pesticide chemical residue” under FFDCA section 201(q), the US Food and Drug Administration (FDA) may need to issue a food a dditive regulation or food contact notification. Depending upon how residues of pesticides are clas sified under FFDCA s ection 201(q), if a food contains a pesticide residue it may be considered adulterated and subject to seizure if appropriate FFDCA clearance(s) are not in pl ace (i.e., a tolerance, toleranc e exemption, FDA food additive regulation and/or food contact notification (FCN)). See 21 U.S.C. §§ 334, 342, 346a, and 348.

EPA has made it a requirement of FIFRA registrati on that, if a pesticide b ears directions for use on food or may be reasonably expected to re sult in residues on f ood, all necessary FFDCA clearances must be in place. 40 C.F.R. § 152.112( g). Because direct food use pesticides, by definition, contain label direc tions for use on food, all necessa ry clearances under the FFDCA must be in place to obtain FIFRA registration. Because indirect food uses are generally considered to have a reasonable expectation of resulting in residues on food, all necessary clearances under the FFDCA also must be in place to obtain a FIFRA registration. However, EPA will not require that FFDCA cl earances be obtained for indire ct food uses if an applicant can demonstrate that the use does not have a re asonable expectation of resulting in residues on food. No FFDCA clearances are required for n onfood uses because there is no reasonable expectation of residues on food for these uses.



### V. Food Use Description Flow Chart

Figure 1 below assumes that a determination under FFDCA section 201(q) has been made and the residues in/on food would meet the definition of pesticide chem ical residues. Therefore, EPA would have jurisdiction under FFDCA section 408 to determine if a tolerance or exemption from the requirement of a tolerance is needed. For residues that do not meet the definition of pesticide chemical residues and are under th e jurisdiction of FDA under FFDCA section 409, EPA still must make a safety finding by conducting any appropriate dietary exposure assessments if the residues result from the use of FIFRA-registered pesticides . This flow chart is not designed to delineate jurisdic tion under FFDCA between EPA and FDA.Page 5 of 13 Figure 1. Food Use Description Flow Chart



# Direct
Food Use Indirect
Food Use Nonfood

Use

Are residues expected
in/on food for this use? Are residues expected
in/on food for this use? No residues expected
in/on food for this use

No

Yes

Is the use strictly residential?

Yes No

Dietary exposure
assessment conducted for

safety finding (FIFRA)

A tolerance or exemption from the

re q uirement of a tolerance is needed No tolerance or exemption from the requirement of a tolerance is needed Registrant must provide
rationale and/or
demonstrate that
there is no
reasonable expectation of
residues in/on
food*

*Examples of rationale include but are not limited to:

 Data and/or rationale used to support FDA food additive regulation or FCN

 Theoretical high-end calculations/modeling demonstrating that there is no reasonable expectation of residues in/on food

 Justification of residue removal via a potable water rinse

 Label restrictions limiting exposure to food

 Justification based on product chemistry and/or environmental fate characteristics (i.e., volatility, solubility)

 Residue data No dietary exposure assessment is requiredPage 6 of 13 

### VI. Use Site Index

1. Agricultural Premises and Equipment

Direct Food Uses Irrigation Systems (Food crops)

Indirect Food Uses Agricultural/Farm Premises Agricultural/Farm Structures /Buildings and Equipment Animal Drinking Water Barns/Barnyards/Auction Barns Beehives - Active (Honey Producing) Beehives/Bee Colony (Diseased/Nuisance) Beehives - Empty (Honey Producing) Dairy Farm Milk Handling Facilities/Equipment Dairy Farm Milk Storage Rooms/Houses/Sheds Dairy Farm Milking Equipment Dairy Farm Milking Stalls/Parlors Empty Containers to Be Used for Raw Agricultural Commodities Fish Hatchery Buildings/Areas (Nonaquatic) Greenhouses - Empty (Food Crops) Mushroom Houses - Empty Premises/Equipment Potato Seed Piece Storage Premises/Equipment Seed Houses/Stores/Storage Areas/Warehouses

Nonfood Uses Agricultural Uncultivated Areas Agricultural/Farm Equipment/Shoe Baths Beehives - Empty (Non-honey Producing) Egg Handling Equipment (Hatching) Egg Handling Rooms (Hatching) Egg Plants/Hatcheries/Brooder Ro oms/Shoe Baths (Hatching) Egg Washing Treatments (Hatching) Fur Farm Equipment/Premises Greenhouses - Empty (Nonfood crops) Greenhouses - In Use (Nonfood crops) Irrigation Systems (Nonfood crops) Tobacco Processing Plant Premises/EquipmentPage 7 of 13 2. Food Handling/Storage Establishments, Premises and Equipment

Direct Food Uses Egg Washing Treatments (Commercial) Fruit and Vegetable Rinses Fruit and Vegetable Fumigation

Indirect Food Uses Airtight Storage (Food Contact Areas) Barges Beverage Processing Plant Premises (Food Contact) Commercial Shipping C ontainers - Feed/Food Commercial Transportation Facilities - Feed/Food Dairies/Cheese Processing Plant Equipment (Food Contact) Dishwashing Water Eating Establishments (Food Contact) Eating Establishments Equipm ent/Utensils (Food Contact) Eating Establishments Food Handling Areas (Food Contact) Eating Establishments Food Se rving Areas (Food Contact) Egg Handling Equipment (Commercial) Egg Handling Rooms (Commercial) Egg Packing Plants (Commercial) Empty Containers to Be Used For Processed Feed/Food Feed Mills/Feed Processing Plants Feed/Food Storage Areas Feed/Food Treatment - Storage/Processing Fish/Seafood Processing Plant Equipment (Food Contact) Food Catering Facilities Premises Food Dispensing Equipment/Vending Machines Food Marketing/Storage/Distribution Equipment/Utensils (Food Contact) Food Processing Plant Equipment (Food Contact) Food Processing Water Systems Food Stores/Markets/Supermarkets Premises Food/Grocery/Marketing/Stor age/Distribution Facility Grain/Cereal/Flour Bins Grain/Cereal/Flour Elevators Grain/Cereal/Flour Storage Areas Handling Equipment Meat Processing Plant Equipment (Food Contact) Meat/Fish Markets Premises Poultry Processing Plant Equipment (Food Contact) Processing/Handling Equipment (Food Contact Surfaces) Railroad Cars - Feed/FoodPage 8 of 13 Nonfood Uses Beverage Processing Plant Premises (Nonfood Contact) Dairies/Cheese Processing Plant Premises (Nonfood Contact) Eating Establishments (Nonfood Contact) Eating Establishments Food Hand ling Areas (Nonfood Contact) Eating Establishments Food Se rving Areas (Nonfood Contact) Eating Establishments N onfood Areas (Nonfood Contact) Fish/Seafood Processing Plant Premises (Nonfood Contact) Food Processing Plant Premises (Nonfood Contact) Food Processing Plant Nonfood Handling Areas Hydrostatic Sterilizer Water Systems Meat Processing Plant Premises (Nonfood Contact) Pasteurizer/Warmer/Cannery/Retort Water Systems Poultry Processing Plant Premises (Nonfood Contact) Processing/Handling Equipment (Nonfood Contact)

3. Commercial, Institutional and In dustrial Premises and Equipment

Nonfood Uses Airtight Storage (Nonfood Contact Areas) Carpets (Commercial Sanitizer) Commercial/Instituti onal/Industrial Floors Commercial/Institutional/Industrial Premises/Equipment Commercial Storage/Warehouses Premises Commercial Transportation Facilities - N onfeed/Nonfood Diapers (Commercial Laundry) Dust Mops/Cloths/Tool Covers /Dusters (Laundry/Dry Clean) Heating, Ventilation, and Air - Conditioning (HVAC) Systems Industrial /Construction Areas Laundry (Commercial) Laundry (Drycleaning) Laundry Equipment Machinery (Non - Food) Nonfeed/Nonfood Commoditie s (Temporary Storage) Nonfeed/Nonfood Containers - Empty/Full Nonfeed/Nonfood Storage Areas - Empty/Full Nonfeed/Nonfood Treatments - Storag e/Processing/Handling Equipment Refuse/Solid Waste Transportati on Facilities/Ha ndling Equipment Ships and BoatsPage 9 of 13 4. Residential and Public Access Premises

Indirect Food Uses Household/Domestic Dwellings Household/Domestic Dwellings Food Handling Areas

Nonfood Uses Airports (Non Eating Areas) Animal Kennels/Sleeping Quarters (Commercial) Automobiles, Taxis, Limousines , Recreational Vehicles, & Tires Cuspidors/Spittoons Household Sickrooms Prem ises/Contents/Utensils Clothing Air Treatments (Com mercial/Household) Bathroom Premises/Hard Surfaces Carpets (Household Sanitizer) Diaper Pails (Empty) Diapers (Household/Coin - Operated Laundry) Diapers (Presoak) Domestic/Commercial Nonpotable Water (Waterbed Water) Residential Filters (Air/A ir Conditioner/Furnace) Heating, Ventilation, and Air Conditioning (HVAC) Systems Household Trash Compactor/Food Disposal Household/Domestic Dwellings Contents (Nonfood Contact) Household/Domestic Dwellings Nonfood Handling Areas Household/Domestic Dwellings Premises (Nonfood Contact) Human Bedding/Mattresses Human Camping Equipment Human Grooming Instruments (Brushes, Combs) Human Wigs Humidifier Water Laundry (Household/Coin-Operated) Paths/Patios Paved Areas (Private Roads/Sidewalks) Pet Living/Sleeping Quarters Portable/Chemical Toilets/Latrine Buckets Refuse/Solid Waste Cont ainers (Garbage Cans) Refuse/Solid Waste Sites Refuse/Solid Waste Transportati on Facilities/Ha ndling Equipment Residential Floors (Antimicrobials Only) Toilet Bowls (Interior Surfaces) Toilet Tanks/Water Closets Water Urinals (Interior Surfaces) Vehicular Holding Tanks (Nonfood Contact)Page 10 of 13 5. Medical Premises and Equipment

Nonfood Uses Air Treatments (Hospital) Ambulances Barber/Beauty Shop Equipment (Barber Chair/Cabinets) Barber/Beauty Shop Instru ments (Shavers/Scissors) Biological Specimens (Organs/Tissues/Milk Samples) Cadavers and Caskets Carpets (Hospital Sanitizer) Dental Water Lines Drinking Unit Water Lines Diapers (Hospital Laundry) Hospital Conductive Floors Hospital Critical Items (Surgical Instruments/Pacemakers) Hospital Janitorial Equipment Hospital Noncritical Items (Bedpans/Furniture) Hospital Semicritical Items (Catheters/Inhalation Equipment) Hospital/Medical Instituti ons Nonconductive Floors Hospitals/Medical Institutions Critical Pr emises (Burn Wards, Operating Room Area) Hospitals/Medical Institutions Noncritical Premises Hospitals/Medical Institutions Patient Premises Hospitals/Medical Institutions Premises (Human/Veterinary) Household Sickrooms Prem ises/Contents/Utensils Human Waste (Typhoid Stools/Feces/Urine) Laundry (Hospital) Medical Waste Morgues/Mortuaries/Autopsy/Embalming Equipment Morgues/Mortuaries/Autopsy/Embalming Instruments Nursing Homes Morgues/Mortuaries/Autopsy/Embalming Room Premises Reverse Osmosis Water System (Nonpotable Water) Upholstery (Hospital/Commercial) Veterinary Hospitals/Medical Institutions Premises Vomitus

6. Human Drinking Water Systems

Nonfood Uses Public Water Systems Reverse Osmosis Water System Individual Water Systems Emergency Water Systems Water Purifier Units 7. Materials Preservatives

Indirect Food Uses Adhesives, Industrial (Indi rect Food Contact Surfaces) Coatings, Industrial (Indirect Food Contact Surfaces)Page 11 of 13 Dispersions/Emulsions/Solutions/Sus pensions (Indirect Food Contact) Paper/Paperboard (Indirect Food Contact Surfaces) Plastic Products (Indirect Food Contact Surfaces) Rubber Products (Indirect Food Contact Surfaces)

Nonfood Uses Adhesives, Industrial (Nonfood Contact Surfaces) Coatings, Industrial (Nonfood Contact Surfaces) Caulks (Nonfood contact surfaces) Diapers, Disposable Dispersions/Emulsions/Solutions /Suspensions (Nonfood Contact) Electrical Supplies/Equipment Emulsions, Resin/Latex/Polymer Feathers/Felt/Felt Products/Furs Fuels/Oil Storage Tank Bottom Water Fuels/Oil (Crude) Heating, Ventilation, and Ai r Conditioning (HVAC) Systems Hides/Leather/Leather Products (Surfaces) Janitorial Products (In- Container/Nonfood Areas) Metalworking Fluids Recovery Drilling Muds/Packer Flui ds (Preservative Incorporation) Paints (In-Can) Paper/Paperboard (Nonfood Contact) Paints/Latex/Oil/Varnish (Applied Film) Paints (Finger) Plastic Products (Nonfood Contact) Rubber Products (Nonfood Contact) Slurries Specialty Industrial Products Textiles/Textile Fibers /Cordage Products Textile Auxiliaries (e.g. sizing agents, fi nishing agents, spinning preparations)

8. Industrial Processes and Water Systems

Indirect Food Uses Pulp/Paper Mill Water Systems (Indirect Food Contact)Page 12 of 13 Nonfood Uses Air Conditioner/Refrigeration Condensate Water Systems Air Washer Water Systems Bilge Water Coal Slurry Systems Commercial/Industrial Cooling Water [Recirculating] Commercial/Industrial Cooling Water [Once - Through] Evaporative Condenser Water Systems Gas/Oil Drilling Muds/Pack er Fluids [Offshore] Gas/Oil Drilling Muds/Packer Fluids [Terrestrial] Gas/Oil Fracturing Fluid Systems Gas/Oil Pipelines Maintenance Gas/Oil Recovery Injection Water Systems Gas/Oil Secondary Reco very Injection Water Heat Exchanger Water Systems Heating, Ventilation, and Ai r Conditioning (HVAC) Systems Hydrostatic Sterilizer Water Systems Immersion Ultrasonic Tank Water Industrial Processing Water (Nonfood Contact) Industrial Waste Disposal Systems Industrial Drainage Systems Influent Water Filtration Systems Industrial Scrubbing System Industrial Wastewater Treatment Systems Laboratory Equipment Water Baths Leather Processing Water/Liquors Pasteurizer/Can Warmer/Cannery/Ret ort Water Systems (Nonfood Contact) Photo Processing Wash Water Pulp/Paper Mill Water Systems (Nonfood Contact) Recirculating Electrodeposition Systems Reverse Osmosis Water Syst em (Non potable water) Terrestrial Nonfood Sewage Systems Textile Mill Water Systems

9. Antifouling Coatings and Ballast Water Treatments

Indirect Food Uses
Crab/Lobster Pots Nets Used for Aquaculture

Nonfood Uses
Ballast Water Treatments Boat/Ship Hull/Bottom Aquatic Structures/Equipment

10. Wood Preservatives

Nonfood Uses
Pressure/Thermal TreatmentPage 13 of 13 Non-pressure Treatment

Non-pressure Treatment - Remedial Non-pressure Treatment - Sapstain

11. Swimming Pools and Spas

Nonfood Uses Swimming Pool Water Systems Spa and Hot Tub Water Systems

12. Aquatic Areas

Indirect Food Uses Agricultural Drainage Systems Commercial Fishery Water Systems Intermittently Flooded Areas/Water Lakes/Ponds/Reservoirs (With Human or Wildlife Use) Streams/Rivers/Channeled Water

Nonfood Uses Lakes/Ponds/Reservoirs (Without Human or Wildlife Use) Ornamental Ponds/Aquaria Salt Water Sites