Antimicrobial Use Site Index

United States Environmental Protection Agency

Office of Chemical Safety and Pollution Prevention

Office of Pesticide Programs

Antimicrobials Division

July 14, 2015
Use Site Index – Overview of Webinar

•Background•Introduction• Food Use Description Flow Chart

•Use Site Index Instructions

• Summary and Concluding Remarks

•Questions
Background: Antimicrobial Use Site Index (USI)

• “Final Rule for Data Requirements for Antimicrobial Pestic

published on May 8, 2013

• Final Rule codified 12 antimicrobial use patterns that were 

in Appendix B to the 2008 Proposed Rule

•USI updates information in Appendix B of the 2008 propos

• Twelve major use patterns have not changed, but there a 

notable differences
Background: Antimicrobial USI

Appendix B of 2008 Proposed Rule July 2015 Antimicrobial Use Site 

A list of general use patterns and specific use sites Includes guidance on how to dete

requirements

Many use sites designated as “indoor” Indoor and outdoor are no longe

Some major use patterns had no food use

designations for specific use sites

Within general use pattern categ

sites are also organized according 

food use designations

Limited guidance on the relationship between

food use categories and presence or absence of

residues with regard to requirements for dietary

exposure assessment, tolerance, and tolerance

exemption

Food use description flow chart i

information on the relationship bcategories and presence or absen

with regard to requirements for d

assessment, tolerance, and tolera

No descriptions of key terms Key terms are described 
Introduction: Antimicrobial Use Site Index

What does the USI do?

• Provides guidance to help identify data necessary to reg

antimicrobial pesticide products

•Compiles specific use sites categorized into twelve gene

pattern categories

•Designates specific use sites into “food use” categories, 

direct food, indirect food, and nonfood uses
Introduction: Key Components of Use Site 

•General use pattern categories

•Specific use sites

•Food use categories
Introduction: Key Components of Use Site Index

•General use pattern categories serve as links to tables of d

requirements for environmental fate, nontarget organisms

nontarget plants

• Specific use sites are associated with general use pattern c

• Food use categories are specifically applicable to toxicolog

residue chemistry data requirements
1212Major MajorUseUsePatterns 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 Spas12. Aquatic Areas
Introduction: Specific Use Sites of USI

• USI serves as a compilation of specific use sites commonly listed on antimicro

labels

• Specific use sites identify where an antimicrobial pesticide is to be used

• Specific use sites are listed within general use patterns and categorized by foo

• Examples of specific use sites and associated general use patterns

Specific Use Site General Use PatternMetalworking Fluids Materials Preservatives (7)

Commercial/Industrial Cooling Water (Once‐Through) Industrial Processes and Water Systems (8)

Fruit and Vegetable Rinses Food Handling/Storage Establishments, Premises and

Equipment (2)

Ornamental Ponds/Aquaria Aquatic Areas (12)Boat/Ship Hull/Bottom Antifouling Coatings and Ballast Water Treatments (9)
Introduction: Request for Public Comment

• The USI is a living document that will be updated periodically

• USI was posted in the docket on July 1, 2015 for a 30‐day comment period

• EPA plans to review comments, update as needed, and post a revised version 

February 1, 2016

• The Agency is especially interested in receiving comments regarding

• Simplifications• Missing information

• Redundancies• Errors• More consistent label terminology

• The USI can be accessed from the website, www.regulations.gov. The docket 

HQ‐OPP‐2015‐0302
Food Use Description Flow Cha
Descriptions of Direct Food, Indirect Fo

Nonfood Uses

•Designation is determined by the use pattern (how the pe

applied)

• Not dependent on whether residues are expected or present i

following application (although such residues generally are not 

with nonfood uses)

•Presence of residues determines whether or not a to

exemption from the requirement of a tolerance (tole

exemption) is required based on the definition of pe

chemical residue per FFDCA section 201(q)
Direct Food Uses

•When an antimicrobial pesticide is intended to be directly 

food or applied to a material or article for the purposes of 

food

• Examples include: fruit and vegetable washes/rinses, foggi

poultry areas, and egg washing treatments

• These types of use are generally subject to FFDCA clearanc
Indirect Food Uses

• Application of the antimicrobial pesticide in or on a material or 

comes into contact with food and may result in residues in or o

the use is not intended for pesticidal treatment of food

• As a result of contact with a surface and/or material that has b

and/or impregnated with an antimicrobial pesticide, there is a 

residues in or on food

• Examples include: sanitization of food‐contact dishes, utensils

processing equipment, and countertops; disinfection of food‐u

impregnation of cutting boards, conveyor belts, or food contai

packaging for a pesticidal purpose other than treating food

• These types of uses may be subject to FFDCA clearances
Nonfood Uses

• The antimicrobial pesticide is not expected to come into co

(directly or indirectly) with food as a result of its intended 

•Reasonable certainty of no residues in or on food

• Examples include: fuel tanks, human footwear, or nonfood 

under the sink) of eating establishments

• These types of uses are generally not subject to an FFDCA 

•No dietary exposure assessment is conducted
FFDCA Clearances

• When the use of a pesticide creates a reasonable expectation of res

appropriate FFDCA clearances need to be in place or the food will b

adulterated and subject to seizure

• The appropriate FFDCA clearance is determined by applying the def

“pesticide chemical residue” under FFDCA section 201(q)

• If the substance being applied and for which there is a reasonable expectation of resid

a pesticide chemical, a tolerance or tolerance exemption is required under FFDCA 408

• If the substance being applied and for which there is a reasonable expectation of resid

not a pesticide chemical, FDA may need to issue a food additive regulation or food con

under FFDCA 409

• Nonfood uses do not require FFDCA clearances since there is no rea

expectation of residues in/on food
FIFRA Safety Finding

• Even if an antimicrobial pesticide is not subject to EPA’s re

the FFDCA section 408 (because it does not meet the statu

definition of “pesticide chemical” under 201(q)), EPA still m

evaluate human dietary risk to ensure that the use of the 

food will be safe
Food Use Description Flow Chart

• Assumes that a determination under FFDCA section 201(q) has 

and that any of the residues in/on food would meet the definit

pesticide chemical residues (PCRs)

• EPA would then have jurisdiction under FFDCA section 408 to d

tolerance or exemption from the requirement of a tolerance is 

• Flow chart is not designed to delineate jurisdiction under FFDC

EPA and FDA
Food 

DescrFlow C

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?

No Yes 

Dietary exposure assessment 

conducted for safety finding 

(FIFRA)

A tolerance or exemption from the 

requirement 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 FCNTheoretical 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 foodJustification based on product chemistry and/or environmental fate 

characteristics (i.e., volatility, solubility)

Residue data

No dietary exposure assessment is required
Food 

DescrFlow C

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?

No Yes 

Dietary exposure assessment 

conducted for safety finding 

(FIFRA)

A tolerance or exemption from the 

requirement 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 FCNTheoretical 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 foodJustification based on product chemistry and/or environmental fate 

characteristics (i.e., volatility, solubility)

Residue data

No dietary exposure assessment is required

1

2 3

4

5
Food Use Description Flow Chart

Nonfood Use

•No residues are expected in/on food

•No dietary exposure assessment is needed

•No tolerance or exemption is needed
Food Use Description Flow Chart

Direct and Indirect Food Uses – Residues E

•If residues are expected but the

uses are strictly residential:

•Dietary exposure assessment

conducted to make a safety

finding (FIFRA)

•No tolerance or exemption is

needed
•If residues are expected but the

uses are not strictly residential:

•Dietary exposure assessment

conducted to make a safety

finding

•A tolerance or exemption is

needed

Food Use Description Flow Chart

Direct and Indirect Food Uses – Residues E
Food Use Description Flow Chart

Direct and Indirect Food Uses – No Residue

Expected
AD Decision Process

Residues are not expected Residues are ex
Use Site Index Instructions
USE SITE INDEX GUIDANCE FOR PROPO

LABELS

• AD Pesticide labels need to include clear use instructions concernin

the pesticide product is intended to come into contact with food, e

directly or indirectly.

• There are 12 general use patterns subdivided into the following cat

‐ Direct food uses

‐ Indirect food uses

‐ Nonfood uses
How to Use The Use Site Index to Determine Data

Requirements 

Identify the applicable general use pattern categories and whi

specific use patterns are most similar to each proposed use pathat appears on the label.

Example:Company X has a new disinfectant containing a new active

ingredient that will be used in Dairy farms (not for use in milki

stalls, milking parlors , or milk houses), veterinary clinics, hosp

and homes on floors, walls, tables, handling/restraining

equipment, shoe baths, cages, bathtubs, toilets, sinks, counter

and appliances.For these uses, what are the general use pattern categories ba

on the USI? What are the specific use patterns? 
What are the General and Specific Use Patterns

General Use Pattern #1:

Specific Use Patterns: Dairy Farms ‐ floors, walls, tables, and restraining/handling equipment, and shoe baths

General Use Pattern #4: Residential and Public Access PremisesSpecific Use Patterns: Homes ‐ floors, walls, tables, toilets, sinks, counters, appliancesGeneral Use Patterns #5: Medical Premises and Equipment

Specific Use Patterns: Veterinary Clinics ‐ floors, walls, tables, cages, and

countersHospitals ‐ floors, walls, tables, toilets, sinks, and counters
Use Site Index Instructions  

Based on the identified specific use pattern, determine if the use is co

be direct food, indirect food, or nonfood.

Direct Food

Use

Indirect

Food Use Nonfood
Dairy Farms (from general use pattern #1):

Indirect Food: No sites because label indicated not for use in

milking stalls, milking parlors, or milk houses.

Nonfood – floors, walls, tables, restraining/handling equipment and shoe baths

Homes (from general use pattern #4):

Indirect Food: tables, counters and appliances

Nonfood: floors, walls, toilets and sinks

Hospitals/Veterinary Clinics (from general use pattern #5) :

Nonfood ‐ floors, walls, tables, cages, toilets, sinks and counters

How would you characterize the food use category 

the specific use patterns from the example?
Food 

DescrFlow C

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?

No Yes 

Dietary exposure assessment 

conducted for safety finding 

(FIFRA)

A tolerance or exemption from the 

requirement 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 FCNTheoretical 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 foodJustification based on product chemistry and/or environmental fate 

characteristics (i.e., volatility, solubility)

Residue data

No dietary exposure assessment is required

4 5

1
Use Site Index Instructions  

Once the proposed use has been determined with 1 of the 12

general use patterns, as well as the appropriate food use

category, consult the antimicrobial data requirements tables

in 40 CFR 158W. (Food use categories only apply to Tox and

Residue chemistry data requirement tables)
Data Requirements Table

Guideline Number Column: These are not data requirements.

Data Requirement Column Use Pattern Columns

Guideline No. Data requirement 

Food Uses Nonfood 

Indirect food 

uses (>200 ppb)

Indirect food uses 

(≤200 ppb)

Swimming pools, aquatic 

areas, wood preservative

metal working fluids 

Acute Testing

870.11 Acute oral toxicity—rat R R R 

870.12 Acute dermal toxicity R R R 870.13 Acute inhalation toxicity—rat R R R 870.24 Primary eye irritation—rabbit R R R 870.25 Primary dermal irritation R R R 870.26 Dermal sensitization R R R 870.26 Acute neurotoxicity—rat R CR R 
Subchronic Testing

870.31 90-Day oral toxicity—rodent R R R 

870.315 90-Day oral toxicity—nonrodent R CR R 

870.32 21/28-Day dermal toxicity CR CR CR 

870.325 90-Day dermal toxicity CR CR CR 

870.3465 90-Day inhalation toxicity—rat CR CR CR 

870.62 90-Day neurotoxicity—rat R CR R 

Chronic Testing

870.41 Chronic oral toxicity—rodent R CR R 870.42 Carcinogenicity—two rodent species— rat and mouse preferred R CR R 

Developmental Toxicity and Reproduction

870.37 Prenatal developmental toxicity—rat and rabbit preferred RRR

870.38 Reproduction and fertility effects RRR870.63 Developmental neurotoxicity CR CR CR 

Mutagenicity

870.51 Reverse mutation assay RRR

870.5300870.5375 In vitro mammalian gene mutation R R R 870.5385870.5395 In vivo cytogenetics R R R 

Special Testing

870.7485 Metabolism and pharmacokinetics R CR R 

870.72 Companion animal safety CR CR CR 

Guideline No. Data requirement 

Food Uses 

Indirect food uses 

(>200 ppb)

Indirect food uses 

(≤200 ppb)

Swimming po

aquatic areas, 

preservatives, 

working flu
Subchronic Testing

870.31 90-Day oral toxicity—rodent R R R 

870.315 90-Day oral toxicity—nonrodent R CR R 

870.32 21/28-Day dermal toxicity CR CR CR 

870.325 90-Day dermal toxicity CR CR CR 

870.3465 90-Day inhalation toxicity—rat CR CR CR 

870.62 90-Day neurotoxicity—rat R CR R 

Chronic Testing

870.41 Chronic oral toxicity—rodent R CR R 

870.42 Carcinogenicity—two rodent species— rat and mouse preferred R CR R 

Developmental Toxicity and Reproduction

870.37 Prenatal developmental toxicity—rat and rabbit preferred RRR

870.38 Reproduction and fertility effects RRR870.63 Developmental neurotoxicity CR CR CR 

Mutagenicity

870.51 Reverse mutation assay RRR

870.5300870.5375 In vitro mammalian gene mutation R R R 870.5385870.5395 In vivo cytogenetics R R R Special Testing

Guideline No. Data requirement 

Food Uses N

Indirect food uses 

(>200 ppb)

Indirect food uses 

(≤200 ppb)

Swimming po

aquatic areas, w

preservatives, m

working flui
Summary

The Antimicrobial USI

• Provides guidance intended to help registrants identify data

required to register their antimicrobial pesticide products

• Explains how to use information about general antimicrobial

pesticide use patterns, specific use sites, and food use

classifications to determine data requirements

• Designates specific use sites into “food use” categories,

including direct food, indirect food, and nonfood uses
Summary

• The USI is a living document that will be updated periodically

• USI was posted in the docket on July 1, 2015 for a 30‐day comment period

• EPA plans to review comments, update as needed, and post a revised vers

USI by February 1, 2016

• The Agency is especially interested in receiving comments regarding

• Simplifications• Missing information• Redundancies• Errors• More consistent label terminology

• The USI can be accessed from the website, www.regulations.gov. The doc

is EPA‐HQ‐OPP‐2015‐0302
Contact Information

• EPA CONTACTS

Terria Northern, northern.terria@epa.gov, 703 347

‐02

Don Wilbur, wilbur.don@epa.gov, 703 347

‐8894

Pat Jennings, jennings.pat@epa.gov, 703 308

‐8569

Steven Weiss, Weiss.steven@epa.gov, 703 308

‐8293
QUESTION AND ANSWER SESSIO
CONCLUDING REMARKS

• Thanks for attending today’s webinar on the antimicrobial use site index.

• For the Agency to consider your comments on the USI, please submit them to 

July 31, 2015. Again the docket can be accessed at www.regulations.gov. The 

is EPA‐HQ‐OPP‐2015‐0302