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January 27, 2016

THE ENVIRONMENTAL PROTECTION AGENCY’S RESPONSE 

TO PUBLIC COMMENTS ON THE ANTIMICROBIAL PESTICIDE 

USE SITE INDEX

Introduction

On May 8, 2013, the Environmental Protection Agency (the Agency, EPA) published data 

requirements for antimicrobial pesticides in the Federal Register as a final rule. Among other 

things, this final rule codified 12 major use patterns that were presented in Appendix B to the 

proposed rule for antimicrobial pesticides that was published on October 8, 2008. These 12 use 

patterns were developed specifically for antimicrobial pesticides. The Agency developed a draft 

Antimicrobial Pesticide Use Site Index (USI) to provide guidance about antimicrobial use sites 

and general antimicrobial use patterns. This USI guidance document is intended to assist 

potential registrants and applicants by helping them to identify the data that are necessary to 

register their product(s). A revised antimicrobial pesticide USI was posted in the docket (EPAHQ-OPP-2015-0302; http://www.regulations.gov) on July 1, 2015 for public comment. This 

USI updated the information in Appendix B of the 2008 proposed rule. 

By the end of the public comment period, which closed on August 31, 2015, EPA received 

comments from the American Chemistry Council’s Biocides Panel (ACC or Panel) and the 

Consumer Specialty Products Association (CSPA). The ACC submitted numerous specific 

comments regarding modifying the USI. These specific comments were also supported by the 

CSPA. 

In addition to the comments that the ACC submitted during the public comment period, the ACC 

also submitted draft supplemental comments to the Agency on 11/16/2015. These comments 

were discussed at a meeting with the Agency on 11/17/2015. These draft supplemental 

comments consisted exclusively of specific changes to Sections I through VI of EPA’s USI. 

These materials are posted in the EPA docket at EPA-HQ-OPP-2015-0302.

Following the meeting between EPA and ACC on 11/17/2015, the ACC submitted on 

11/24/2015 materials to replace those submitted to EPA on 11/16/2015. These supplemental 

materials consisted of specific changes to EPA’s USI which are summarized at the end of this 

Response to Comments (RtC) document. These materials are also posted in the EPA docket at 

EPA-HQ-OPP-2015-0302.

Based on comments the Agency received from ACC and CSPA, there have been a number of 

changes to the USI, including:

• Clarifying that the USI is a guidance document and that the sites in the USI are not 

intended for use in labeling;
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• Simplifying the USI by organizing example use sites into broader groups;

• Using a tabular format to provide examples of use sites organized by food use description 

(i.e., direct food use, indirect food use, and nonfood use) within each major use pattern 

category to make it easier to follow;

• Clarifying that “food” is defined under Federal Food, Drug, and Cosmetic Act (FFDCA) 

under 21 U.S.C. Section 321(f) and that definition applies, as appropriate, to all food use 

descriptions;

• Revising the description of “nonfood use” to provide better clarity;

• Deleting from the USI some example use sites that were ambiguous, too vague, too 

specific, or incorrectly categorized regarding major use pattern category or food use 

description; and

• Incorporating many of ACC’s suggestions of specific use sites to include in the materials 

preservatives and wood preservatives general use pattern categories.

In this Response to Comments document, the Agency presents each comment submitted and 

EPA’s response to each comment. The Agency’s responses to public comments reflect changes 

that appear in the revised USI posted to the docket.

General Comments

Data Requirements versus Labeling 

Comment 1: ACC states that the USI’s “Introduction” section suggests that the sites in the 

proposed USI are or will be required labeling for products. The Panel therefore is concerned that 

the USI also is intended to be a broad product labeling initiative, which is outside of the intent or 

purpose of the USI. Since the USI was made available, Panel members have repeatedly raised 

concerns regarding how EPA plans to require incorporation of the categories and sites within the 

USI on product labeling such as:

- whether the listed sites are the only ones that will be allowed;

- how the new requirements will be implemented; and

- the timing for label revisions.

If the sites in the USI are not intended for use in labeling, the Agency should include a clear 

statement to that effect. Such a statement will be helpful both for registrants and for state 

regulators in terms of understanding the purpose of the USI. The Panel therefore requests the 

Agency revise its statements within the USI’s “Introduction” section so the intent of the USI is 

clear.

EPA Response 1: The USI is a guidance document only. It is not intended as a comprehensive

listing of use sites and the use sites and terms in the USI are not mandatory for use on the label. 

A statement has been added to the Introduction section of the USI to make this clear.
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Comment 2: ACC states that there must be a balance between providing sufficient detail in the 

USI so that a registrant can determine appropriate data requirements without being so 

prescriptive and detailed that questions constantly arise regarding whether an additional use on a 

product label rises to the level of triggering additional requirements. Further, clarification is 

needed to determine when the addition of a more specific use site under a more general 

description of a site rises to the level of a “new use” as defined under PRIA. The Panel believes 

that additional guidance from the Agency on when additional risk assessment decisions are 

needed, whether related to a food-use determination, for environmental exposures or other 

assessments, would help clarify whether a new site becomes a new use, which also may trigger 

the need for additional data requirements to be addressed. While the flow chart is helpful, the 

Panel believes it contains numerous errors and is misleading due lack of completeness. 

Although the Panel acknowledges that necessary guidance for assessments is outside of the 

purpose of the USI, the Panel strongly encourages the Agency to work as quickly as possible to 

develop this guidance, whether for dietary risk, environmental risk assessments or other types of 

assessments, as it has a direct bearing on the potentially relevant data requirements.

EPA Response 2: The Agency has simplified the USI by making the use sites listed broader. In 

the context of the USI, the determination of whether a use site is “new” for purposes of 

categorizing an application under PRIA, and whether it may require additional data (and 

FFDCA clearances), depends upon how the use site is described on the product label and the

currently registered uses of the active ingredient in question. The Agency believes that the food 

use description flow chart serves its intended purpose to illustrate how different use sites may be 

categorized as direct food, indirect food, and nonfood uses and to provide guidance on whether 

labeled uses necessitate the establishment of a tolerance or exemption from tolerance

Comment 3: The Panel believes that it is critically important that the Agency add language to 

clarify that the listed sites within the index are representative for the purposes of determining 

data requirements and not inclusive of all possible use sites that may appear on product labels.

EPA Response 3: The Agency has revised the specific site listings under each of the twelve 

general use pattern categories to include broader descriptions of the types of use sites that may be 

included within a category. As noted under the Introduction section of the USI, the Agency 

recognizes that use sites are diverse and constantly evolving. The USI document only provides

guidance and therefore is non-binding.

Definitions

Comment 4: Some terms used within the proposed USI lack clear definitions. In particular, 

there is no clear definition of what is meant by “commercial” or “industrial.” Both terms need to 

be defined under the USI if the Agency intends to use them to describe use sites. Otherwise, 

such terms should be eliminated and the sites described in a different manner.

For both “commercial use” and “industrial use” the Agency should provide clarification: (1) 

what does the term mean for the USI; and (2) what term should be used on pesticide labels if that 

term is used under the final guidance to describe a use site.
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EPA Response 4: There is no definition or description of commercial use under FIFRA. In the 

past, the Agency has considered commercial uses to be those that take place in commercial 

establishments, such as dry cleaners, commercial laundries, restaurants, grocery stores, auto 

repair shops, beauty shops, and barber shops. These are just a few examples of commercial 

establishments and are not intended to be an exhaustive list. In addition, there is no definition or 

description of industrial use under FIFRA. In the past, the Agency has considered industrial uses 

to be those that take place in industrial facilities, such as pulp and paper manufacturing facilities, 

textile manufacturing facilities, and industrial cooling water systems. These are just a few 

examples of industrial facilities and are not intended to be an exhaustive list. 

Comment 5: There are many terms used in the USI that have specific definitions, e.g., 

“processed food,” “processing facility,” etc. The Panel thus recommends that the USI include a 

list of terms and definitions and reference the original authority for the definitions, such as 

FDA’s “Antimicrobials Food Additive Guidance.”

EPA Response 5: The USI provides guidance about antimicrobial pesticide use patterns and is 

also to be used by EPA, the public, and registrants to identify data requirements for antimicrobial 

pesticide products. For purposes of determining which data requirements would apply to 

antimicrobial pesticide products, including whether uses are considered food or non-food, the 

Agency believes that the terms and example use sites present in the USI are adequately described

by the categories they have been placed in and by descriptions of certain terms in the guidance.

Comment 6: The Panel recommends that the Agency clarify that “food” is defined under Federal 

Food, Drug, and Cosmetic Act (FFDCA) under 21 U.S.C. § 321(f) and that definition applies, as 

appropriate, to the terms “Direct Food,” “Indirect Food,” and “Nonfood” Uses.

EPA Response 6: 

The Agency agrees that it is appropriate to clarify that the term, “food,” in the USI has the same 

meaning as the definition of food in the FFDCA and should apply to all of the different food-use 

descriptions. The previous reference to FFDCA 21 U.S.C. § 321(f) that was listed in the direct 

food description has been moved to a separate paragraph before the descriptions are introduced. 

It is also clearly delineated that the definition of food in the FFDCA is applicable to all of the 

food-use descriptions.

Comment 7: The Panel has concerns regarding when a particular use is determined to be 

“nonfood.” The USI does not provide clarity on this critical issue other than to say that a “use is 

generally considered to be a nonfood use when there is a reasonable certainty of no residues in or 

on food.”

With limited exceptions, EPA seems to hold that all uses of antimicrobial pesticides could be 

determined to be a food use even though the expectation of a meaningful or even measurable 

pesticide residue in the food is low or nonexistent and the likelihood of occurrence is rare. The 

Panel believes the Agency is in the process of developing guidance on nonfood uses that would 

provide clarification and potentially provide relief from onerous assumptions and the related 
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impact on data requirements. The Panel requests the opportunity to speak with the Agency about

this guidance, and in the meantime, the Panel reserves the right to provide further comments on 

this issue.

EPA Response 7: The description of nonfood use will be changed as follows: “A use is 

generally considered to be a nonfood use if the antimicrobial pesticide is not expected to come 

into contact (directly or indirectly) with food as a result of its intended use and, therefore, there is 

no reasonable expectation of residues in/on food.” This amended description is more closely 

aligned with the language in both the FFDCA Clearance section as well as the Food Use 

Description Flow Chart. Again, it is important to note that the food-use description is not

dependent on the presence of residues, it is based on how the pesticide is used. If the pesticide 

product is intended to come into contact (directly or indirectly) with food as defined by FFDCA, 

that use will be considered either a direct or indirect food use regardless of the presence of

residues. When an antimicrobial pesticide is not expected to come into contact (directly or 

indirectly) with food as a result of its intended use, it is considered nonfood. The Agency is in 

the process of developing guidance regarding indirect food uses and welcomes the opportunity to 

discuss this with interested stakeholders.

Determination of When a Tolerance Regulation under FFDCA § 408 Must Be 

Established

Comment 8: The Panel requests that the Agency amend its USI to remove reference to “strictly 

residential” uses and to reflect that hard surface disinfectants (HSD) with potable water rinse 

(PWR) used in nonresidential settings are nonfood uses, not subject to tolerance regulations, to 

food use data requirements, or dietary risk assessments.

The determination of food versus nonfood use is related to the Agency’s apparent position on a 

potable water rinse following the use of disinfectants on non-residential (“residential” is defined 

under 40 CFR § 152.3) food contact surfaces, with a broad definition of what constitutes a food 

contact surface. The Panel believes that the Agency may not be fully aware of the existing 

regulations and ordinances for non-residential food contact surfaces that effectively should make 

such uses nonfood. Products for uses determined to be “food uses” as defined in the statute must 

have an appropriate tolerance regulation1 established or the use would result in food that is 

adulterated.

Hard surface disinfectants (HSD) used on food contact surfaces in various settings, which are 

distinct from food contact sanitizing solutions (FCSS), have traditionally been regulated solely 

under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) even when the U.S. Food 

 1 Throughout this document the use of “tolerance regulation” includes both numerical tolerances and exemptions 

from tolerances; both require that a regulation be established.
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and Drug Administration (FDA) had authority for residues of FCSS under FFDCA § 409. In 

contrast, FCSS are subject to regulation under FFDCA and tolerance regulations must be 

established for all components.

The Agency’s stated position is that residential use of pesticides in or around the home is not 

subject to the FFDCA and EPA does have the authority under FIFRA to assess such exposures.2 

The Panel therefore believes that tolerance regulations do not apply to HSD used in residential 

settings, regardless of whether used on food contact surfaces followed by a potable water rinse 

(PWR) (i.e., kitchen counters). Further, the Panel believes that tolerance regulations do not 

apply to HSD used in non-residential settings, in any food handling establishment, when 

followed by a PWR on food contact surfaces and that such uses are nonfood uses unlikely to 

result in any residues in food. The remote possibility of any potential residue of the HSD that 

remains after the PWR and the required sanitization step would be infinitesimal and impossible 

to determine. As such, those uses should be considered as non-food uses.

There is no reasonable basis for requiring labeling to restrict the HSD to residential uses only, as 

existing laws and regulations prohibit the misuse of such products on food contact surfaces in 

food handling establishments. The basis for this position follows.

The US Food Code, as incorporated into local, state, and federal governmental laws and 

ordinances, addresses the use of cleaners and sanitizers on food contact surfaces (including 

equipment and utensils) in all retail food and food service establishments.3 Whether 

incorporated in total by reference or by effectively repeating the text, the Food Code requires that 

all food contact surfaces be pre-cleaned by an approved method, rinsed in a specified manner, 

and that an EPA-approved food contact sanitizing solution (or other approved sanitization 

method such as high temperature or steam) be used on the surface prior to any contact with food. 

It is prohibited to use a hard-surface disinfectant on any such food contact surfaces except 

potentially in the cleaning step, which must be followed by further rinsing and use of a registered 

sanitizing solution (or other approved sanitization method). Relevant parts of the Food Code are 

included below:

“The Food Code is a model for safeguarding public health and ensuring food is 

unadulterated and honestly presented when offered to the consumer. It represents 

FDA's best advice for a uniform system of provisions that address the safety and 

protection of food offered at retail and in food service.

This model is offered for adoption by local, state, and federal governmental 

jurisdictions for administration by the various departments, agencies, bureaus, 

divisions, and other units within each jurisdiction that have been delegated 

compliance responsibilities for food service, retail food stores, or food vending 

operations. Alternatives that offer an equivalent level of public health protection 

to ensure that food at retail and foodservice is safe are recognized in this model.

 2 See 72 FR 60934, 60950 (October 26, 2007). 3 U.S. Department of Health and Human Services, FDA, Food Code 2013, available at 

http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM374510.pdf (last 

accessed Aug. 31, 2015).
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• See sections 4-603.14 related to requirements for cleaning of equipment, utensils 

and surfaces and 4-603.16 for required rinsing prior to sanitization.

• See section 4-7 for requirements for sanitization of all equipment, utensils and 

surfaces using specified methods. Outside of temperature-based (including 

steam), all chemical sanitization methods must be criteria of section 7-204.11.

• 7-204.11 Sanitizers, Criteria.

Chemical SANITIZERS, including chemical sanitizing solutions generated onsite, and other chemical antimicrobials applied to FOOD-CONTACT SURFACEs 

shall:

(A) Meet the requirements specified in 40 CFR 180.940 Tolerance exemptions for 

active and inert ingredients for use in antimicrobial formulations (Food-contact 

surface sanitizing solutions), or

(B) Meet the requirements as specified in 40 CFR 180.2020 Pesticide Chemicals 

Not Requiring a Tolerance or Exemption from Tolerance-Non-food 

determinations.”

Examples of local health code incorporation of food code into local regulations include:

Arlington County, VA, Food and Food Handling Code4

Section 9.2-3: Incorporates the prevailing U.S. Food Code into its local ordinances.

District of Columbia, Municipal Regulations for Food and Food Operations5

Title 25A-section 18 (last updated in 2012)

• 3404.1 Chemical sanitizers and other chemical antimicrobials applied to foodcontact surfaces shall meet the requirements of 40 C.F.R. § 180.940 – Tolerance 

exemptions for active and inert ingredients for use in antimicrobial formulations 

(food-contact surface sanitizing solutions).

• 1813.1 A chemical sanitizer used in a sanitizing solution for a manual or 

mechanical operation at contact times specified in § 2002.2 shall meet the criteria 

specified in § 3404 Sanitizer, Criteria, shall be used in accordance with the EPAregistered label use instructions, and shall be used as specified in §§ 1813.2 

through 1813.6.

• 1813.6 If a chemical sanitizer other than chlorine, iodine, or a quaternary 

ammonium compound is used, it shall be applied in accordance with the EPAregistered label use instructions.

 4 Available at http://arlingtonva.s3.amazonaws.com/wp-content/uploads/sites/22/2014/01/County-Code-9-2-Foodand-Handling-Code.pdf. 5 Available at http://www.dcregs.dc.gov/Gateway/TitleHome.aspx?TitleNumber=25-A.
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The Food Code does not apply to food processing facilities. However, such facilities are under 

the jurisdiction of FDA for ensuring that all processed food meets the statutory requirements 

under FFDCA, including compliance with FSMA and all related laws and regulations. Under 

those laws and regulations, HSD with PWR cannot be used to sanitize any food contact surface. 

Similarly to what is required under the Food Code, processing facilities must follow specific and 

prescribed steps for cleaning and sanitizing all surfaces and equipment. If a FCSS is used for 

sanitization, it must be EPA-registered and tolerances must be established to allow that use. The 

use of just a HSD with a PWR would result in food that is adulterated, and there are sufficient 

controls in place in food processing facilities to prevent that from happening.

EPA Response 8: This comment concerns non-residential and residential uses and the need for 

tolerance regulations (as defined above). As stated in the USI, strictly residential uses are not 

subject to tolerance regulations under FFDCA Section 408. By “strictly residential uses,” the 

Agency means products that are applied solely in residential settings and not in any type of 

commercial or institutional establishment. This is based on the premise that food commodities 

that contain residues from the use of pesticides in residential settings will not enter interstate 

commerce, whereas products that can be applied in commercial settings may indeed result in 

residues in food commodities that enter interstate commerce and are thus subject to any 

appropriate tolerance regulations. 

Regardless of whether FFDCA applies, the Agency still must make a safety finding for strictly 

residential uses under FIFRA §2(bb)(2). Uses are considered nonfood only if the antimicrobial 

pesticide is not expected to come into contact (directly or indirectly) with food as a result of its 

intended use and, therefore, there is no reasonable expectation of residues in/on food. The 

presence of a potable water rinse (PWR) on a product label does not change the food use 

classification. It is important to note that a PWR is simply a mechanism or rationale for 

demonstrating that residues on food-contact surfaces can be removed to some extent by rinsing 

with potable water. The Agency does not assume that a PWR removes all residues and always 

results in a “no reasonable expectation of residues” situation for direct and/or indirect food uses. 

However, an applicant may provide a scientific rationale that a PWR will remove all residues for 

a specific product. Even in a situation where it can be demonstrated that all or a majority of 

residues can be removed by a potable water rinse, the use would still not be classified as 

nonfood; it would be classified as a direct or indirect food use with no reasonable expectation of 

residues. It is important to note that the food-use description is not dependent on the presence of 

residues, it is based on how the pesticide is used. If the pesticide product is intended to come 

into contact (directly or indirectly) with food as defined by FFDCA, that use will be considered 

either a direct or indirect food use regardless of the presence of residues. When an antimicrobial 

pesticide is not expected to come into contact (directly or indirectly) with food as a result of its 

intended use, it is considered nonfood. 

Regarding the model US Food Code and its incorporation into certain local and state laws and 

ordinances, the Agency acknowledges that some states and local authorities may have various 

codes and regulations dealing with the safety of food. However, the jurisdiction for ensuring that 

food is not adulterated by pesticide chemical residues rests with the EPA under FFDCA Section 
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408 (as amended by FQPA and ARTCA). Therefore, if the Agency believes that if there is a 

reasonable expectation of pesticide chemical residues in/on food as it moves in interstate 

commerce, a tolerance regulation is required.

Specific Comments on Use Pattern Sites

Comments on Use Site Index Category #1 – Agricultural Premises and Equipment

Comment 9: The Panel is concerned that existing and long-standing science policies under 

Disinfectant Technical Science Sections (DIS/TSS) 18 and 19 regarding determination of food or 

nonfood use in these sites has been annulled without notice or comment.6 In particular, the 

guidance allows hard surface disinfectants used in farm and poultry premises to be regulated as 

nonfood uses if the appropriate label instructions are followed. The USI appears to abrogate that 

guidance without basis. The Agency should revise it accordingly. If the Agency believes that 

each registrant must demonstrate that uses following the DIS/TSS guidance for labeling do not 

have a reasonable expectation of resulting in residues on food, then the Panel strongly 

recommends that the Agency reconsider. Outside of the potential for inconsistent 

determinations, this would be an unnecessary burden to both registrants and the Agency for no 

benefit. Rather, the Agency should reiterate its position as to when uses in agricultural premises 

and equipment are considered to be nonfood.

EPA Response 9: The adoption of the 810 Efficacy Guidelines has made the Disinfectant 

Technical Science Section (DIS/TSS) efficacy protocols obsolete. Therefore, the DIS/TSS has 

been removed from the Agency website. The Agency recognizes that the DIS/TSS also included 

labeling guidance (i.e. DIS/TSS 15, 17, 18 and 19). The Agency is developing labeling guidance 

for antimicrobial products that will be posted on the website titled “Labeling Guidance for

Specific Types of Pesticides” at http://www.epa.gov/pesticide-labels/label-guidance-specifictypes-pesticides. The draft guidance will be made available for public comment. The USI 

provides updated guidance on whether a use site is considered a direct, indirect, or nonfood use. 

If the pesticide product is intended to come into contact (directly or indirectly) with food as 

defined by FFDCA, that use will be considered either a direct or indirect food use regardless of 

the presence of residues. When an antimicrobial pesticide is not expected to come into contact 

(directly or indirectly) with food as a result of its intended use, it is considered nonfood.

Comment 10: Within the USI’s Agricultural Premises and Equipment section, there are use sites 

that are very broad categories (i.e., agricultural/farm premises) as well as extremely specific (i.e., 

potato seed piece storage premises/equipment). It would be helpful to consider general 

categories with some examples rather than the highly specific sites.

 6 Available at http://www.epa.gov/oppad001/sciencepolicy.htm. 
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EPA Response 10: The Agency has consolidated the use sites under the Agricultural Premises 

and Equipment major use pattern category to make them broader. 

Comment 11: The use site “Warehouses” under Indirect Food Uses is too vague and should be 

further refined if listed under Indirect Food Uses. Warehouses holding already-packaged food 

products for sale should not be considered indirect food uses, as there is no potential for contact 

with food.

EPA Response 11: The label should identify equipment, surfaces, and substrates to be treated in 

warehouses. The cited surfaces and substrates determine whether the use would be indirect food 

or nonfood. If the warehouse is holding already packaged food, then the surfaces and substrates 

will generally be considered nonfood contact. If an application within the warehouse may result 

in food contact, the use generally will be considered an Indirect Food Use. If the pesticide 

product is intended to come into contact (directly or indirectly) with food as defined by FFDCA, 

that use will be considered either a direct or indirect food use regardless of the presence of 

residues. When an antimicrobial pesticide is not expected to come into contact (directly or 

indirectly) with food as a result of its intended use, it is considered nonfood.

Comment 12: The items listed under Indirect Food Uses should be considered nonfood if food is 

covered or removed during application and treated surfaces are rinsed with potable water prior to 

contact with food, which is consistent with existing guidance. Floors, walls, and other structural 

components should be added to nonfood uses, for clarification.

EPA Response 12: Covering and/or removing food does not automatically eliminate the 

potential for residues to contact food after application of antimicrobial pesticides to areas where 

food is present and therefore these may be considered indirect food uses.

Whether or not a label requires potable water rinse is not, by itself, a rationale for identifying a 

non-food use. The potable water rinse and other information depicting the magnitude of the 

residue potentially present on food items can be a factor for determining what type of dietary 

assessment is needed. Examples of data and/or rationale to inform the dietary risk assessment 

could include, but are not limited to:

• Data and/or rationale used to support FDA food additive regulation or Food Contact 

Notification;

• Theoretical high-end calculations/modeling demonstrating that there is no reasonable 

expectation of residues in/on food;

• Data/justification on residue removal via a potable water rinse;

• Justification based on product chemistry and/or environmental fate characteristics (i.e., 

volatility, solubility).

The Agency agrees that floors, walls, and other structural components of a building are nonfood 

surfaces.
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Comments on Use Site Index Category #2: Food-Handling/Storage Establishments, 

Premises, and Equipment

Comment 13: Section III “Direct Food Use” of the USI indicates fogging of poultry areas is 

classified as a direct food use.7 This type of application has typically required removal of 

poultry prior to fogging. We therefore suggest that when all “food” removed prior to 

application, it is a nonfood use. Additionally, we suggest the fogging of poultry areas use site be 

moved to the agriculture premises section.

EPA Response 13: The reason for fogging poultry areas with antimicrobial products is to control 

microbes on or in structures, buildings and equipment. However, the Agency believes that this 

use could result in indirect food exposures and is appropriately classified as an indirect food use. 

The applicant would have to provide additional information to support a conclusion that residues 

resulting from such a use are not expected and will not result in the need of conducting a dietary 

assessment, per FIFRA regulations. Poultry facilities are considered agricultural premises and 

have been moved to that section.

Comment 14: Clear definitions are needed for various categories including the terms 

“establishment,” “premises,” and “facilities.” The definition of these terms should not include 

walls, floors and other structural components. Those are all separate from food processing 

activities. If the distinction is not made clear, then terms including them should be moved to the 

“Nonfood Uses” section of this category.

For restaurants, there are useful area designations such as “front of the house,” where customers 

are served. The term “back of house” is where food preparation occurs. The terms 

“establishment,” “premises,” etc., would benefit from this type of clarification. Likewise, the 

bathroom in a restaurant, also on “premises,” should not be subject to tolerance considerations. 

The Panel’s general comments above should be considered; if the use is on a surface that the 

Food Code determines to be a food contact surface, then only registered food contact sanitizing 

solutions may be used or the appropriate sanitization steps followed prior to contact to food.

EPA Response 14: The USI provides guidance about antimicrobial pesticide use patterns and is 

also to be used by EPA, the public, and registrants to identify data requirements for antimicrobial 

pesticide products. For purposes of determining which data requirements would apply to 

antimicrobial pesticide products, the Agency believes that the terms and example use sites 

present in the USI are adequately described by the categories they have been placed in and by 

some newly added descriptions for certain of the terms used in the guidance. Upon submitting 

an application, applicants are encouraged to make the specific distinctions between food and 

non-food uses in the labeling (e.g., restaurant-dining room, bathrooms). The Agency will review 

the labeling of antimicrobial pesticide products to determine whether residues of the pesticide 

product are likely to come into contact with food, directly or indirectly.

 7 USI at 3.
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Comment 15: With regard to the sites listed under “Indirect Food Uses:”

• “Dishwashing water” should be deleted. It is not a pesticide material or application site. 

EPA Response: The term “dishwashing water” is intended to describe use of a product that is 

added to water used in dishwashing which forms a solution that is used to sanitize dishes. The 

Agency believes there will be indirect contact based on the solution coming in contact with 

dishware. Therefore, the site will be retained as an example.

• “Eating Establishments (Food Contact)” should be deleted. There are clear specific 

categories below it.

EPA Response: The use site, “Eating Establishments (Food Contact)” has been included in a 

broader category, “Eating Establishments/Equipment/Utensils/Food Handling/Serving Areas.”

• “Food Dispensing Equipment/Vending Machines” should be nonfood as vending 

machines dispense packaged foods. There is no food contact direct or indirect.

EPA Response: The Agency has decided that this use site is too specific and it has been deleted 

from the USI. The Agency stresses that the examples listed are not intended to represent every 

use site and are only intended to provide guidance.

• “Food Processing Water Systems” – the term “water” should be deleted. This entry may 

be in the wrong category. The use site listing for “food processing water systems” does 

not adequately address when EPA has jurisdiction (for raw agricultural commodities) and 

when the use is instead regulated by FDA (processed foods); jurisdiction should be 

explained if this site is retained here or is moved to the agricultural premises section. 

EPA Response: The comment confuses the provisions in FIFRA and FFDCA regarding 

jurisdiction over pesticides used in processing water. Products have been registered for use in 

processing water where raw agricultural commodities (RACs) are treated. FFDCA Section 

201(q)(1)(B)(i) states that substances are not considered “pesticide chemicals” if those 

substances are included in water that comes into contact with the food, in the preparing, packing, 

or holding of the food for commercial purposes. That FFDCA section goes on to state that these 

same substances will be considered pesticide chemicals if they are included for use in water that 

comes into contact with RACs if they are applied in the field, or at a treatment facility where 

RACs are the only food treated and treatment is in a manner that does not change the status of 

the food as a RAC, or during transport of the commodity between the field and the treatment 

facility. Regardless of whether FDA or EPA regulates the residues in food, FIFRA requires that 

the products be registered. Therefore, this use site will remain in the USI.

• “Food Stores/Markets/Supermarkets Premises” should be nonfood as it is too broad, and 

the majority of products handled are packaged as a finished goods, requiring no food 

handling in the classic sense.
Page 13 of 28

EPA Response: The Agency has deleted this use site. The USI has been revised and certain 

terms have been removed or consolidated to include broader descriptions of the types of use sites 

that may be represented under this major use pattern category. “Food 

Stores/Markets/Supermarkets Premises” would now be included under “Eating 

Establishments/Equipment/Utensils/Food Handling/Serving Areas.” As clarification, the 

Agency believes that not all food products in this category would be packaged as “finished 

goods.” There are foods in these settings that are not contained in packages and could be 

exposed to pesticides. As stated in EPA Response 14, upon submitting an application, applicants 

are encouraged to make specific distinctions between food and non-food uses on the labeling.

• “Food/Grocery/Marketing/Storage/Distribution Facility” should be deleted. Distribution 

systems do not process food. They handle packaged foods, receiving and sending them 

without processing.

EPA Response: The Agency has deleted this use site. The USI has been revised and certain 

terms have been removed or consolidated to include broader descriptions of the types of use sites 

that may be represented under this major use pattern category. 

Food/Grocery/Marketing/Storage/Distribution Facility” would now be included under “Eating 

Establishments/Equipment/Utensils/Food Handling/Serving Areas.” As clarification, the 

Agency believes that not all food products in this category would be handled as just “packaged 

foods.” There are foods in these settings that are not contained in packages and could be 

exposed to pesticides. As stated in EPA Response 14, upon submitting an application, applicants 

are encouraged to make specific distinctions between food and non-food uses on the labeling.

• “Handling Equipment” should be deleted because it is too vague. 

EPA Response: The Agency has deleted this use site. The USI has been revised and certain 

terms have been removed or consolidated to include broader descriptions of the types of use sites 

that may be represented under this major use pattern category. “Handling Equipment” is now 

included under the broader categories “Eating Establishments/Equipment/Utensils/Food 

Handling/Serving Areas” and “Egg Handling Equipment/Handling Rooms/Packing Plants.

 

• Meat/Fish Markets Premises” should be deleted because the term is too broad.

EPA Response: The Agency has deleted this use site. The USI has been revised and certain 

terms have been removed or consolidated to include broader descriptions of the types of use sites 

that may be represented under this major use pattern category. “Meat/Fish Market Premises” is 

now included under the broader category “Eating Establishments/Equipment/Utensils/Food 

Handling/Serving Areas.”

• Entries related to “water systems” – It is not clear how these water systems are food 

handling processes. In each instance, these processes start with drinking water, which is 

addressed in another section. In nonfood uses, the sterilizer and pasteurizing water 

systems do not have food contact. These uses should be considered as nonfood. 
Page 14 of 28

EPA Response: Based on recent revisions to the Index, “water systems” have been further 

characterized to reflect how it would be considered in food handling processes. “Food 

Processing Water Systems” is considered a category under Indirect Food Use. As the comment

suggests, “Hydrostatic Sterilizer Water Systems” and Pasteurizer Water Systems” are now 

considered Nonfood use categories.

EPA Response 15: Agency responses to Comment 15 are provided point-by-point above. In 

general, a number of specific use sites in the USI have been revised and certain terms have been 

removed or consolidated to include broader, less prescriptive descriptions of the types of use 

sites that may be represented under this major use pattern category. The Agency stresses that the 

examples listed in the USI are not intended to represent every use site and are only intended to 

provide guidance.

Comments on Use Site Index Category #3: Commercial, Institutional and Industrial 

Premises and Equipment

Comment 16: As discussed above, the use of the terms “commercial” and “industrial” are not 

well defined and should be either clearly defined or eliminated. The inability of registrants to 

include the term “commercial” on labels is inconsistent with the use of those terms here.

EPA Response 16: Refer to the Agency’s response to comment 4.

Comment 17: Only nonfood uses are listed under this section. It is unclear where food premises 

in these types of facilities would fall and how that would be consistent with similar sites under 

the general use pattern of “FOOD-HANDLING/STORAGE ESTABLISHMENTS, PREMISES 

AND EQUIPMENT”.

EPA Response 17: The label should specify major areas where the product will be applied such 

as breakrooms, pantries, and kitchens in commercial/industrial facilities. If the pesticide product 

is intended to come into contact (directly or indirectly) with food as defined by FFDCA, that use 

will be considered either a direct or indirect food use regardless of the presence of residues. 

When an antimicrobial pesticide is not expected to come into contact (directly or indirectly) with 

food as a result of its intended use, it is considered nonfood.

Comment 18: What is the purpose of the Agency adding ships and boats to this use site? If the 

Agency is adding ships and boats, other modes of commercial transportation should be added 

(i.e., trains and planes). The Panel suggests changing ‘Ships and Boats’ to Various Modes of 

Transportation such as, but not limited to, ships/boats/airplanes/buses/trains.

EPA Response 18: The Agency agrees that ships and boats are captured under the Commercial 

Transportation/Vehicles Facilities use site. Ships and boats have been removed from this 

category.
Page 15 of 28

Comment 19: It is unclear what is meant by ‘Full’ in the use site ‘Nonfeed / Nonfood Containers 

– Empty/Full’. Does this indicate the product can be used on nonfood containers with contents? 

It would be helpful to have examples.

EPA Response 19: The current format of the Use Site Index does not include specific examples, 

but is intended as a guide to broad categories of potential antimicrobial uses. The 

Nonfeed/Nonfood Containers use sites have been removed since they are captured under the 

Storage use site. 

Comments on Use Site Index Category #4: Residential and Public Access Premises

Comment 20: For residential uses, the USI seems to lump just about every possible item in a 

household into the indirect food section. Only a specific qualifier seems to remove the item from 

the indirect food category, e.g., “non-food uses of a table” or “non-food uses of a chair” or “nonfood uses on a counter.” Any label that has the use site “home” would need to provide a 

rationale and/or demonstrate for every individual use item listed that there would be no 

reasonable expectation of antimicrobial residue. It apparently is up to the discretion of the 

reviewer that any home surface could have some food and residue. It is confusing, and how a 

registrant would word a label to avoid confusion by the reviewer as well as the end user is 

unclear.

EPA Response 20: The Agency has revised the example under indirect food uses for this 

category to state “Household/Domestic Dwellings (Food Handling Areas).” This revision 

clarifies that not all items in a household would be considered indirect food uses. The Agency 

will not assume that all unqualified directions for use in homes/residential dwellings have the 

potential to be indirect food uses; when needed, EPA will seek clarification on the label and the

intended use.

Comment 21: It is confusing to have household domestic dwellings in both indirect food and 

nonfood. Dwellings are a house and a structure and should not include its contents. Identifying 

all “household/domestic dwellings” as indirect food use is extremely vague and overbroad.

EPA Response 21: The Agency has revised the example under indirect food uses for this 

category to state “Household/Domestic Dwellings (Food Handling Areas).” This revision 

clarifies that not all items in a household would be considered indirect food uses. 

Comment 22: Definitions are needed to ensure consistent meaning of the terms being used and 

clearer explanation of when a use is considered to be nonfood or indirect food.

EPA Response 22: The stated purpose of the USI Guidance Document is to inform the public of 

common antimicrobial pesticide use patterns. The USI guidance document is intended to be used 

in combination with the USI Index lists to help potential registrants and applicants identify the 

data that are necessary to support registration of their products.
Page 16 of 28

Comment 23: Some of the sites are overly vague (e.g., “household /domestic dwelling”) while 

others are overly specific (e.g., “human wig,” “toilet bowls (interior surface),” and “diapers 

(presoak)”). It would be helpful to consider general categories with some examples rather than 

the highly specific sites. This would avoid questions of whether the outside surface of toilets, 

doll wigs, or diapers after the presoak also are nonfood uses.

EPA Response 23: The stated purpose of the USI Guidance Document is to inform the public of 

common antimicrobial pesticide use patterns. The USI guidance document is intended to be used 

in combination with the USI Index listing to help potential registrants and applicants identify the 

data that are necessary to support registration of their products. The Agency does agree that that 

some of the sites are overly specific (i.e., human wigs, toilet bowls [interior surface], and diapers 

[presoak]). Those sites have been deleted.

Comments on Use Site Index Category #5: Medical Premises and Equipment

Comment 24: The listing should include “Assisted Living Facilities”.

EPA Response 24: This Use Site has been added to this category.

Comment 25: “Biological Specimens” are not a "use site" and are excluded from requiring 

registration under 40 CFR § 152.25(c). As such, biological specimens should be removed along 

with cadavers, human waste and vomitus, which also are not use sites. Such sites also would be 

excluded under 40 CFR § 152.25(c).

EPA Response 25: The Agency agrees that substances used on "Biological Specimens," in 

certain circumstances, are exempt from the need for a registration. These circumstances include: 

(1) Embalming fluids; (2) Products used to preserve animal or animal organ specimens, in 

mortuaries, laboratories, hospitals, museums and institutions of learning; and (3) Products used 

to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.

The Agency agrees that “vomitus” and “human waste” are not use sites, and has removed them. 

“Cadavers” and “Biological Specimens” have been removed as use sites, since they are 

encompassed under broader categories.

Comment 26: “Dental Water Lines” and “Drinking Water Unit Lines” belong in section 6, 

Human Drinking Water Systems.

EPA Response 26: The Agency agrees with this comment, “drinking water unit lines” and 

“dental water lines” have been moved to Human Drinking Water Systems.

Comment 27: “Diapers (Hospital Laundry)” is a duplicative listing as it is included in “Laundry 

(hospital).”

EPA Response 27: The Agency agrees that these listings are duplicative. "Diapers (Hospital 

Laundry)" has been deleted.
Page 17 of 28

Comment 28: Semi-critical and critical use sites fall under FDA jurisdiction and do not belong 

on EPA’s USI. Thus, “Hospital Critical Items (Surgical Instruments/Pacemakers);” “Hospital 

Semi-critical Items (Catheters/Inhalation Equipment);” “Hospitals/Medical Institutions Critical 

Premises (Burn Wards, Operating Room Area);” and “Hospitals/Medical Institutions Noncritical 

Premises” should be deleted.

EPA Response 28: EPA has jurisdiction over certain sterilants (including gaseous sterilants) 

which can be used on critical and semi-critical items. Additionally, EPA-regulated products may 

be used as part of a decontamination process for critical and semi-critical items and areas, where 

pre-cleaning and disinfection are required prior to sterilization or high-level disinfection

involving the use of liquid chemical sterilants, the latter being products which fall under FDA’s 

jurisdiction. See FIFRA Sections 2(u) and 2(mm)(3). As part of an effort to clarify and simplify 

the USI, these “critical” and “semi-critical” uses are now addressed by the following heading in 

the USI: Critical and Noncritical items (patient care items and noncritical environmental 

surfaces). 

Comment 29: The reference to “Critical” and “Noncritical” Premises is confusing. "Critical" 

refers to items that enter sterile tissue or vascular systems. The Panel suggests that all premises 

in hospitals/medical institutions are "noncritical" and the use site should be simply 

"Hospital/Medical Institutions Premises," removing all 

critical/noncritical/patient/human/veterinary options. Furthermore, "hospital premises" in and of 

itself is not a use site that is called out on labels. It may be more appropriate to give examples of 

subcategories such as walls, floors, surfaces, as needed.

EPA Response 29: As described in the response to Comment 28, certain areas in hospitals can 

be designated “critical care,” such as burn wards and operating rooms. However, these individual 

references to these types of areas have been removed from the USI since they fall under broader 

categories.

Comment 30: “Household Sickrooms Premises/Contents/Utensils” -- "Household" sickrooms 

are residential "rooms" and should not be included here.

EPA Response 30: The Agency agrees that the household sickroom premise use site is

residential, and should be included under Category 4. 

Comment 31: “Reverse osmosis water system (non-potable water)” is already listed in Section 

8, “Industrial Processes & Water Systems,” so it should be deleted from this section as it is 

duplicative.

EPA Response 31: The Agency agrees that this use site is not relevant to this category. It has 

been removed from this category.
Page 18 of 28

Comments on Use Site Index Category #7: Materials Preservatives

Comment 32: In regards to pesticides used to treat an article, it is unclear whether the USI refers 

to how the pesticide is used (e.g., in-can paint preservative) or to where the treated article will be 

used (e.g., the type of surface where the paint is used).

EPA Response 32: If a pesticide product is labeled for use as a materials preservative, then it 

would fall under this general use pattern category, and the use site is the material/article that is 

being treated, regardless of where the treated material/article is ultimately used. Where the 

treated object/article may possibly be used/located, however, would have a bearing on whether 

that article has the potential to come into contact with food indirectly (i.e., indirect food use). 

Comment 33: Some of the other use sites seem to overlap with “Material Preservatives.” For 

example, a cutting board or countertop containing an antimicrobial coating or impregnated with 

antimicrobial could conceivably fall under “Residential/Public Access Premises” – Food 

Handling Areas; Preserved Conveyor Belt - #2 Food Handling – Food Processing Plant 

Equipment. The hierarchy needs to be clarified as this could affect the data requirements.

EPA Response 33: If a pesticide product is labeled for use as a materials preservative, then it 

would fall under use pattern 7 (Materials Preservatives), and the use site is the material/article 

that is being treated, regardless of where the treated material/article is ultimately used. Where 

the treated object/article may possibly be used or located, however, would have bearing on 

whether that article has the potential to come into contact with food indirectly (i.e., indirect food 

use). EPA reviews that product label in order to make a determination on whether or not there is 

potential for contact with food.

Comment 34: It seems redundant to continually use the statements in parentheses “Indirect 

Food Contact Surfaces” when the heading of the section is already indirect food uses. Similarly, 

the Nonfood use section contains numerous references to Nonfood Contact Surfaces.

EPA Response 34: The Agency agrees. These redundant qualifiers have been removed.

Comment 35: The Agency needs to clarify whether all ingredients comprising a treated article 

with indirect food contact, including all ingredients in the antimicrobial product used in the 

treated article, require 408 or 409 clearance and, if so, which. This guidance is needed, but 

should be provided separately, as it is outside the purpose of the USI.

EPA Response 35: The Agency agrees that this question should be addressed separately, as it 

falls outside the purpose of the USI. 

Comment 36: It seems that treated article manufacturers are demanding more and more that 

their treated articles are listed on the EPA-registered master labels. So, for materials 

preservatives it may be helpful to add another level of clarity by listing some more specific 

treated articles covered by it. For example, plastics would include, but not be limited to hoses, 

belts, or an indication of plastic articles subject to microbial attack (such as shower curtains, 

tarps, rubber gaskets/washers).
Page 19 of 28

EPA Response 36: The Agency has revised the USI to include broader descriptions of the types 

of use sites that may be represented under a category. The Agency believes that these general 

descriptions are inclusive/representative of the wide range of treated articles that may be 

produced. As noted under the Introduction section of the USI, the Agency recognizes that use 

sites are diverse and constantly evolving; consequently, attempting to compile a comprehensive 

list of specific types of treated articles may not be practical. The intention of the USI document 

is only to provide guidance, and the document is non-binding. 

Comment 37: Indirect Food Uses:

• Adhesives (Industrial) – why is the term “industrial” in parentheses? Clarification is 

needed where there are food contact uses in industrial settings. The word industrial 

should be removed as it does not clarify the statement.

EPA Response: The term “industrial” has been removed. The USI has been further revised in 

order to clarify that adhesives would be considered indirect food uses only when they have the 

potential to contact food. 

• Coatings (Industrial) – why is the term “industrial” in parentheses? Clarification is 

needed where there are food contact uses in industrial settings. The word industrial 

should be removed as it does not clarify the statement.

EPA Response: The term “industrial” has been removed. The USI has been further revised in 

order to clarify that coatings would be considered indirect food uses only when they have the 

potential to contact food.

• Would inks and dyes be considered under coatings?

EPA Response: The USI has been revised to list “inks/dyes” as examples under the broader 

category of “industrial matrices.”

• What about polymers used in papermaking and for coatings for papermaking – would 

these be considered under “dispersions/emulsions...”?

EPA Response: The USI has been revised to list “polymers” as examples under the broader 

category of “industrial matrices.”

EPA Response 37: Agency responses to Comment 37 are provided above. In general, a number 

of specific use sites in the USI have been revised, and certain terms have been removed or 

consolidated to include broader descriptions of the types of use sites that may be represented 

under this category. The Agency stresses that the examples listed are not intended to represent 

every use site, and are only intended to provide guidance.
Page 20 of 28

Comment 38: Nonfood Uses

• Adhesives (Industrial) – why is the term “industrial” in parentheses?

EPA Response: The term “industrial” has been removed. The USI has been further revised in 

order to clarify that “adhesives” not in contact with food are considered nonfood uses.

• Coatings (Industrial) – why is the term “industrial” in parentheses? This should also 

include paints, rather than paints being listed separately below. Would inks and dyes be 

considered under coatings?

EPA Response: The term “industrial” has been removed. The USI has been further revised in 

order to clarify that “paints” not in contact with food are considered nonfood uses.

• Caulks – this should be changed to “Building Materials”? 

EPA Response: The USI has been revised to list “caulks” as an example under the broader 

category of “construction materials.”

• Diapers – disposable should be removed.

EPA Response: Non-disposable (i.e., cloth) diapers have been included as an example under the 

broader category of “textiles.” The Agency has retained “disposable diapers” as a separate 

example, as this use site is considered to be a mixture of paper and plastic materials.

• What is meant by Electrical Supplies Equipment – what is this supposed to cover?

EPA Response: The USI has been revised to remove this use site. The Agency believes that 

electrical supplies/equipment are adequately represented by the broader example categories of 

“construction materials” and “plastic and rubber nonfood contact materials.” 

• Feather/Felt... – can this go under textiles?

EPA Response: The USI has been revised to list “feathers” and “felt” as examples under the 

broader category of “textiles.”

• Fuels/Oil Storage Tank Bottom Waster and Fuels/Oil Crude should be combined.

EPA Response: The USI has been revised to consolidate these and similar use sites as examples 

under the broader category of “industrial matrices.”

• Hides/Leather, etc. – for these products, it is not only surface treatment, but also the 

solutions and curing solutions used for the treatment of the hides, etc. Biocides are also 

used in the brine water to prevent bacterial contamination and contamination in transit. 
Page 21 of 28

EPA Response: “Leather/hides” are listed as examples under the broader category of “textiles.” 

When the intention is to treat solutions used to treat or cure leather/hides, the solution is the use 

site. The Agency believes that these types of solutions are adequately represented by the example 

“dispersions/emulsions/solutions/suspensions” under the broader category of “industrial 

matrices.”

• Instead of Janitorial products, why not HI & I?

EPA Response: The USI has been revised to remove this example. The Agency believes that 

“janitorial products” are adequately represented by 

“dispersions/emulsions/solutions/suspensions” under the broader category of “industrial 

matrices.”

• Metalworking Fluids – should also include metal cleaning fluids.

EPA Response: The USI has been revised to include “metal cleaning fluids” as examples under 

the broad category of “industrial matrices.” 

• Paints and paints/latex/oil/varnish, etc. – covered under “Coatings.”

EPA Response: These USI has been revised to consolidate these examples under the example 

“coatings.”

• Paints (Finger) – why not use the heading “Arts & Crafts” since there are more examples 

in this group than finger paints (e.g., crayons, stickers, colored chalk and pencils which 

can all be subheadings).

EPA Response: The Agency has revised the USI to include a broad example category for “Arts 

& Crafts Materials,” which includes as examples: finger paints, crayons, colored chalk, and 

pencils.

• Slurries – should be covered by “dispersions ...” Add slurries to this subheading.

EPA Response: The USI has been revised to list “slurries/pastes/gels” as examples under the 

broader category of “industrial matrices.”

• Textiles/Textile Fibers ... and textile auxiliaries should be combined.

EPA Response: These USI has been revised to consolidate these examples under the broader 

category of “textiles.”

• What is a specialty industrial product that has not been covered here?

EPA Response: This example has been removed from the USI.
Page 22 of 28

• What about use in other pesticide products (a materials preservative in an insecticide, for 

example)?

EPA Response: The USI has been revised to include a broad example category for “nonfood 

pesticide formulations.”

EPA Response 38: Agency responses to Comment 38 are provided above. In general, a number 

of specific use sites in the USI have been revised, and certain terms have been removed or 

consolidated to include broader descriptions of the types of use sites that may be represented 

under this category. The Agency stresses that the examples listed are not intended to represent 

every use site, and are only intended to provide guidance.

Comments on Use Site Index Category #9: Antifoulant Coatings and Ballast Water 

Treatments

Comment 39: “Nets Used for Aquaculture” and “Crab/Lobster Pots” are listed as indirect food 

use. The Panel suggests that the Agency reconsider those listings. By their very nature, crab and 

lobster pots are very short-term events for any contact. Traps and pots are generally checked 

every other day. The bait in the traps will be consumed in this period of time so this frequency is 

a fact associated with effectively harvesting crabs and lobsters. Also for the crab/lobster pots, 

any contact would be with the exoskeleton and not the edible meat. Exoskeleton contact with 

antifoulant coatings on the pots in this limited period of time is unlikely to result in any residues 

in the final food. By design, these coatings leach very slowly for an extended life of the coating. 

This categorization should be reconsidered.

EPA Response 39: Based on the long-term duration of fish exposed in nets used for aquaculture, 

the Agency will keep the nets used for aquaculture in the USI. 

The rationale that ACC presented for no longer characterizing crab/lobster pots as an indirect 

food use has convinced the Agency that crabs/lobsters are in traps for a minimal duration with

minimal contact from these types of uses. The Agency will no longer consider this use site as an 

indirect food use.

Comment 40: The Panel also suggests that there may be a basis for categorizing nets used for 

aquaculture as nonfood uses and that guidance on a nonfood versus food use decision should be 

developed to avoid the need for excessive and unnecessary testing and to ensure consistency in 

decision-making. A case-by-case approach is likely to result in disparate decisions.

EPA Response 40: See EPA response #39.
Page 23 of 28

Comments on Use Site Index Category #10: Wood Preservatives

Comment 41: In regards to pesticides used to treat an article, does the USI refer to where the 

article is treated or where the treated article will be used (i.e., wood preservation vs. treated 

wood)?

EPA Response 41: The USI provides guidance on what data are needed to support the use sites 

associated with the pesticide product. In the case of wood preservatives, the pesticide will be 

used on wood and the pesticide label should provide information on where the treated wood will 

be used; for example, marine pilings, telephone poles, railroad ties, decks, roofs, etc.

Comment 42: Unlike most other use site categories, EPA only lists Nonfood Uses for Wood 

Preservatives. The Agency needs to clarify whether or not the nonfood use classification applies 

to both the preservative and the treated wood or just the preservative.

EPA Response 42: EPA will only consider uses for wood preservatives that have appropriate 

clearances by FDA under 21CFR178.3800 (Preservatives for wood) to be indirect food uses. 

Chemicals that do not have these appropriate clearances should not contact food and will be 

considered nonfood uses by the Agency. 

Comment 43: If the use site category is also determined by where the treated wood is used, a 

note referring the user of the guide to other use groups should be added to Wood Preservative 

section 10 and appropriate explanation provided.

EPA Response 43: The use site index has been revised to provide examples of where the treated 

wood will be used. A note referring to other use groups is no longer necessary. 

Comment 44: Considering the index cannot list all potential uses of treated wood, it is expected 

that registrants will need to seek a determination from EPA on whether or not a specific use site 

would be considered an indirect food use. It is recommended that when the index is updated, the 

sites for which a determination has been made are added to the index. This would assist 

registrants and reduce the number of inquiries to the agency.

EPA Response 44: See EPA response to comment 42. 

Comment 45: Wood preservative labels do not include all the potential uses of the treated wood, 

although most do provide the general use categories. If the use site is based upon where the 

wood will be used, will EPA assume that all treated wood has the potential to be an indirect food 

use unless the labeled use sites exclude such uses or restrictions are placed on the label and/or 

residue data is submitted? The Agency needs to provide specific guidance on what would 

constitute an indirect food use of treated wood and allow for additional public input.

EPA Response 45: See EPA response to comment 42. 
Page 24 of 28

Comment 46: In regards to the Section 10 list in the index, “Pressure/Thermal Treatment” is 

misleading as there are non-pesticidal thermal or heat treatments of wood. In line with the other

use sites listed, suggest this be revised to “Pressure Treatment – Heavy Duty” and add “Nonpressure Treatment – Heavy Duty” to capture thermal pentachlorophenol applications.

EPA Response 46: The Agency has removed thermal treatment from all heavy duty wood 

preservatives labels. There are no non-pressure treatment application methods approved for 

heavy duty wood preservatives.

Comments on Use Site Index Category #11: Swimming Pools

Comment 47: Assuming the examples for product use descriptors provided by EPA in the USI 

proposal is not an exhaustive list, does EPA consider other recreational water systems (manmade, hydrologically isolated and contained), including “Splash Pads” and “Water Parks” for 

instance, covered in Swimming Pools and Spas Water Systems, without specifically listing each?

EPA Response 47: The Agency believes that “Splash Pads” and “Water Parks” are covered 

under Swimming Pools and Spa Water Systems. Nonetheless, a separate category has been 

added to Use Site (Water Parks Water Systems) to cover Splash Pads and Water Parks. 

Formatting Recommendation

Comment 48: The Panel recommends that the Agency consider using a tabular format to 

provide the examples of use sites within each use pattern category to make it easier to follow. 

This approach also would make clear that the sites are examples only. Enclosed (Attachment A) 

is a possible format that would more clearly explain when a use site is considered to be a food 

use (as defined under FFDCA) and would require a tolerance regulation. The Panel is willing to 

work with the Agency to develop a user-friendly approach and identify appropriate example use 

sites.
Page 25 of 28

Attachment A: Possible formatting to identify whether a use site is considered to be a food use 

requiring a tolerance regulation.

Direct Food Use Indirect Food Use Non-Food Use

Antimicrobial is 

applied directly to 

food (FFDCA 

definition) 

Antimicrobials are 

applied to surfaces that 

may come in contact 

with food (FFDCA

definition) and leave a 

biocide residue on 

food. 

Antimicrobial use 

results in reasonable 

certainty of no residues 

on food. 

Example Use Sites Example Use Sites Example Use Sites

Agricultural Premises 

And Equipment

Food Handling/Storage 

Establishments, 

Premises and 

Equipment

Commercial, 

institutional and 

Industrial Premises and 

Equipment

Residential and Public 

Access Premises

Medical Premises and 

Equipment

Human Drinking Water 

Systems

Material Preservation

Industrial Processes 

and Water Systems

Antifouling Coatings 

and Ballast Water 

Treatments

Wood Preservation 

Swimming Pools and 

Spas

Aquatic Areas

EPA Response 48: The Agency has adopted the tabular format proposed by the Panel, and the 

USI has been revised to include broader descriptions of the types of use sites that may be 

represented under each major use pattern category. Certain terms have been removed or 

consolidated, and others have been added. The Agency stresses that the examples listed are not 

intended to cover every use site, and are only intended to provide guidance.
Page 26 of 28

COMMENTS SUBMITTED FOLLOWING THE PUBLIC COMMENT 

PERIOD

Comments Submitted by ACC Biocides Panel on 11/16/2015

In addition to the comments that the ACC Biocides Panel submitted during the public comment 

period, the ACC Biocides Panel also submitted draft supplemental comments to the Agency on 

11/16/2015. These comments were discussed at a meeting with EPA on 11/17/2015. These 

supplemental comments consisted exclusively of specific changes to Sections I through VI of 

EPA’s revised USI. These materials are posted in the EPA docket at www.regulations.gov, EPAHQ-OPP-2015-0302.

Comments Submitted by ACC Biocides Panel on 11/24/2015 

Following the meeting between EPA and ACC Biocides Panel on 11/17/2015, the ACC Biocides 

Panel submitted on 11/24/2015 materials to replace those submitted to EPA on 11/16/2015. 

These supplemental materials consisted of specific revisions to EPA’s revised USI. Suggestions

that the ACC Biocides Panel submitted to the Agency on 11/24/2015 include:

(1) Suggested revisions to the text to EPA’s revised Antimicrobial Use Site Index (USI) 

(i.e., Sections I thorough V) ACC’s suggested revisions to the text include:

a. Organizing the text of EPA’s revised USI into three sections rather than five 

sections;

b. Revising Section II of EPA’s revised USI (How to Use this USI to Determine 

Data Requirements);

c. Omitting Section III of EPA’s revised USI (Descriptions of Direct Food, Indirect 

Food, and Nonfood Uses;

d. Omitting EPA’s Food Use Description Flow Chart – Although ACC omitted this 

section of EPA’s revised USI, in the cover letter (dated 11/24/2015) that 

discussed their submission of supplemental information, ACC acknowledged the 

value of this decision tree and suggested that EPA should include this in future 

guidance on risk assessment subject to certain [unspecified] refinement;

e. Adding definitions of institutional use and residential use;

f. Adding a section, Determination of Whether a Use Site is a Food Use and 

Requires a Tolerance Regulation;
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(2) Suggested revisions to Part VI. EPA’s USI, (specific use sites listed by major use 

pattern category), including:

a. Tabulating rather than listing specific use sites for the 12 major use pattern 

categories with specific examples of use sites for each use pattern category;

b. Organizing example use sites into broader groups than those included in EPA’s 

revised USI;

c. Omitting irrelevant and overly specific use sites from EPA’s revised USI;

d. Adding descriptors to clarify use sites included in EPA’s revised USI;

e. Organizing specific use sites within the 12 major use patterns into food use and 

non-food use categories and subdividing food use categories into direct and 

indirect food use; and

f. Identifying in the table of use site examples for the 12 major use patterns specific 

use sites that typically trigger a need for a Tolerance or exemption.

These materials are posted in the EPA docket at www.regulations.gov, EPA-HQ-OPP-2015-

0302.

The Agency’s Response to Comments Submitted by ACC Biocides 

Panel on 11/24/2015

Regarding ACC’s suggested revisions to the text to EPA’s revised antimicrobial USI from (1) 

above:

• The Agency is has consolidated some section headings that were posted in the docket at 

the beginning of the Public Comment period (See (1) a-c above). 

• The Agency has decided to retain the Food Use Description Flow Chart in the USI (See 

(1) d above). The Agency believes that this flow chart is central to understanding 

whether or not a dietary exposure assessment and/or a tolerance or exemption from a 

requirement for a tolerance is needed and that such information is key to determining data 

requirements.

• Sections III and IV of the text of the USI provide guidance to determine whether a use 

site is a food use and requires a tolerance regulation (See (1) f above).
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Regarding ACC’s suggested revisions to Part VI of EPA’s USI (specific use sites listed by major 

use pattern category) from (2) above:

• The Agency has adopted the tabular format suggested by ACC (See (2) a above);

• The USI has been revised to include broader descriptions of the types of use sites that 

may be represented under each category (See (2) b above);

• Certain terms have been omitted or consolidated (See (2) c above);

• Certain terms have been clarified (See (2) d above);

• Each of the 12 major use patterns in the USI has been organized into the subcategories, 

direct food; indirect food; and nonfood (See (2) e above);

• The USI provides guidance on whether the establishment of a tolerance or exemption 

from a tolerance is required for a use. The determination of whether a use may require a 

tolerance or tolerance exemption is also dependent upon how the use is described on the 

product label.