Page 1 of 28 

## January 2 7 , 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 antimicr obial pesticides that w as 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 antimic robial 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 U SI was posted in the docke t (EPA

HQ

- 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 s pecific 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 mee ting 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 ) d ocument . 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;Page 2 of 28 • 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 o r 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 comme nt 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. I t 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.Page 3 of 28 Comment 2 : ACC states that t here 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 detaile d 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 gen eral 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 envir onmental 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 er rors 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 bro ader. In the context of the USI, t he 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) , depend s 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, indirec t food, and nonfood uses and to provide guidance on whether labeled uses necessitate the establishment of a tolerance or exemption from tolerance

Commen t 3 : The Panel b elieves that i t 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. T he USI document only provide s guidance and the refore is non

- binding.

D efinitions

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 “in dustrial 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.Page 4 of 28 EPA Response 4 : There is no definiti on 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, be auty 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 conside red 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 a re 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 de scribed by the categories they have been placed in and by descr iptions 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 “Non f ood” 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 appl y 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 conce rns 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 relatedPage 5 of 28 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 resid ues, 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 toleran ce 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 (“residenti al” 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 c ontact 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 regulation 1 established or the use would result in food that is

adulterated.

Hard s urface 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) e ven 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.Page 6 of 28 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 posi tion 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 t hat 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 r equiring 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 inco rporated 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 i n 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 approve d 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 fo llowed by further rinsing and use of a registered sanitizing solution (or other approved sanitization method). R elevant 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, sta te, 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 f ood 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 Hum an Services, FDA, Food Code 2013, available at http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM374510.pdf (last accessed Aug. 31, 2015).Page 7 of 28 • See sections 4

- 603.14 related to requirements for cleaning of equipment, ut ensils
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 s anitization methods must be criteria of section 7

- 204.11.

• 7

- 204.11 Sanitizers, Criteria. Chemical SANITIZERS, including chemical sanitizing solutions generated on

site, 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 Chemic als 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 Code 4

Section 9.2

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

District of Columbia, Municipal Regulations for Food and Food Operations 5

Title 25A

- section 18 (last updated in 2012)

• 3404.1 Chemical sanitizers and other chemical antimicrobials applied to food

c ontact 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 EPA

registered 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 EPA

registered label use instructions.

4 Available at http://arlingtonva.s3.amazonaws.com/wp

- content/uploads/sites/22/2014/01/County

- Code

- 9

- 2

- Food

and

- Handling

- Code.pdf

. 5 Available at http://www.dcregs.dc.gov/Gateway/TitleHome.aspx?TitleNumber=25

- A

.Page 8 of 28 The Food Code does not apply to food pr ocessing 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 r egulations, 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 facilit ies to prevent that from happening.

EPA Response 8 : T his 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 commod ities 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 expe ctation of residues in/on food. T he 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 speci fic 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 reas onable 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 o f its
intended use , it is considered nonfood

.

R egarding the model US F ood C ode 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 SectionPage 9 of 28 408 (as amended by FQPA and ARTCA) . Therefore, if the Agency believes that if ther e is a reasonable expectation of pesticide chemical residues in/on food as it moves in interstate

commerce , a tolerance regulation is required.



## S pecific Comments on Use Pattern Sites

Comments on Use Site Index Category #1

– Agricultural Premises and Equi pment

Comment 9 : The Panel is concerned that existing and long

- standing science policies under

Disinfectant Technical Science Section s (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 use s 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 regis trants 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

l abeling guidance (i.e. DIS/TSS 15, 17, 18 and 19). The Agency is developing l abeling g uidance

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

- specific

types

- 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 ar e 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

.Page 10 of 28 EPA Response 10 : The Agency has consolidated the use sites under th e Agricultural Premises and Equipment major use pattern category to make them b roader.

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 : T he 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 F ood C ontact
N otification ;

• Theo retical high

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

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

• Justification based on product chemistry and/or environmental fate charact eristics (i.e., volatility, solubility)

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

surfaces

.Page 11 of 28 

### 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” re moved 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 info rmation 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. P oultry facilities are considered agricultural premises and

have be en 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 ar e 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 t he 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 t hey 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.Page 12 of 28 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 (F ood 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 regard ing 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 chemical s ” 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 pest icide chemical s 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 fo od as a RAC, or du ring 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 US I

.

• “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 : Th e 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 no w 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 ar e 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 an d 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 : Th e 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.

F ood/Grocery/Marketing/Storage/Distribution Facility” would no w 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 Agen c y 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 Plant s.

• 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 typ es 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 c ontact. 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
suggest s , “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 thi s 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 : T he label should specify major areas where the product will be applied such as breakrooms, pantri es, 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 A gency 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 Storag e 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 “non

food 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 : T he 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. T he Agency
will not assume that all unqualified directions for use in homes/residential dwellings ha ve the potential to be indirect food use s ; w hen 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 revis ion
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 : T he 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, o r diapers after the presoak also are nonfood uses.

EPA Response 23 : T he 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 wit h 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 [int erior 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 als o 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 site s , and has removed them

.

“ Cadavers ” and “Biological Specimens” have been re moved as use site s, 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 w ater u nit l ines ” 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);” “Hos pital
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 area s, 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). A s 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 sho uld 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 gi ve 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., ind irect 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 prod uct 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. Wher e 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 tha t 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 i ndirect food uses. Simi larly,
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 th e 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 practi cal. 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 cont act 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” i n 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 re vised 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 “ i nks/dyes” as examples under the broader category of “ industrial matrice s

. ”

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

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

EPA Response : The US I has been revised to list “ p olymers” as example s 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
consolidate d 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 “p aints ” 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 : N on

- 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 co ver?

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 m aterials .”

• 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 combin ed.

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 contaminatio n 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 th is 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.

E PA 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 subheadi ngs).

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 slur ries 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 U SI 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 t hat 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/L obster 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. Th e 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. Exoskeleto n 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 reconsid ered.

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 s uggests 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
de cision

- 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 provide s 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 t he pesticide label should provide information on where the treated wood will
be used ; for example, marine pilings, telephone poles, railroad ties, decks, roofs, e t c

.

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

sec tion 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 updat ed, 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 unle ss 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 publi c 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 “Non

pressure Treatment

– Heavy Duty” to capture thermal pentachlorophenol applications.

EPA Response 46 : The Agency has removed t hermal 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 (man

made, 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 believe s that “Splash Pads” and “Water Parks” are covered under Swimming Pools and Spa Water Systems. Nonetheless, a separate c ategory has been added to Use Site (Water Parks Water System s ) 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 d efined 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 i s 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 : T he 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 exa mples 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 , EPA

HQ

- OPP

- 2015

- 030 2

.



## 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 t he 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 Whe ther a Use Site is a Food Use and Requires a Tolerance Regulation ;Page 27 of 28 (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. Addin g 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. Identifyin g 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 :

• T he 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 g uidance to determine whether a use site is a food use and requires a tolerance regulation (See (1) f above).Page 28 of 28 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 consolid ated (See (2) c above);

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

• Each of the 12 major use pattern s in the USI has been organized into the subcategories, direct food; indirect food; and nonfood (See (2) e above);

• T he USI provide s 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

.