July 14, 2015 Antimicrobial Use Site Index Webinar – Qs &As 

QUESTIONS SUBMITTED BEFORE THE WEBINAR 

Q1: I'm interested in submitting an application for an existing antimicrobial pesticide for a 

new use as a disinfecting wipe to treat surfaces that may contact food. Would this be 

considered a direct, indirect, or non-food use? Would a tolerance or exemption from a 

tolerance be required? Would a risk assessment be required? 

Answer: Thanks for your question! This would be considered an indirect food use since the use 

pattern indicates that the wipe may be used on surfaces that may contact food. The presence of 

residues would determine whether or not a tolerance or exemption would be required, and a 

dietary exposure assessment would be conducted based on this determination. If there are no 

reasonable expectations of residues in food, then a dietary assessment would not be required. If 

residues are expected, then a dietary assessment would be conducted. If the use is not strictly 

residential, then a tolerance or exemption would be required if residues are expected. 

Q2: I'm interested in submitting an application for a bathroom cleaner. I'm concerned 

that language on the label allowing use on countertops would push my product into the 

"indirect food use category". Would that happen? 

Answer: If the application is for use only in bathroom areas and areas where food would not be 

present, a dietary assessment would not be conducted, and a tolerance or exemption would not be 

required. It is important that the label clearly indicate that it is for use in bathrooms only. If the 

label is ambiguous (i.e., saying countertops instead of the more clear, bathroom countertops), 

then the Agency would conduct a dietary assessment. Another way to ensure clarity is to state 

that the product should not be used on surfaces that may contact food. 

Q3: I would like to register a product that is a fruit and vegetable wash. The fruit and 

vegetables will be rinsed with potable water after treatment and this is clearly stated on the 

label. I have conducted studies that indicate that there will be no residues on the fruit and 

vegetables after rinsing with potable water. Would this be considered a non-food use since 

there are no residues? 

Answer: This is considered a direct food use since the product will be applied directly to the 

food items. It is the use pattern that determines the designation. Even though the studies show 

that there will be no residues, the use will still be classified as a direct food use. The data may 

support a tolerance exemption since no residues were observed in the studies; however, the 

Agency would need to review the data to make a decision about the need for a tolerance. 

Q4: I would like to register a product that will be impregnated into a cutting board to 

protect the plastic. I realize that this is an indirect food use. Another company has a food 

contact notification with FDA for this active ingredient for the same type of use. Can I use 

that food contact notification to register my product? 

Answer: You cannot use the other company’s FCN to register your product with EPA. FCNs 

are company-specific, so your company would need to petition FDA for an FCN for the ai in 

order for EPA to register the use for your company. EPA would also need to make a safety 

finding based on the use even though FDA had granted an FCN. 
Q5: I have a product registered for use to be impregnated into a cutting board to protect 

the plastic and have a food use notification with FDA for this use. I would like to add food 

use contact paper and adhesives to my label. Can I use the plastic cutting board food 

contact notification to register my product? 

Answer: You cannot use the plastic cutting board FCN for food use paper and adhesives. FCNs 

are use-specific, so your company would need to petition FDA for an additional FCN or food 

additive regulation for these newly proposed uses. Additionally, EPA would also need to make a 

safety finding based on the uses even though FDA had granted any appropriate clearances under 

FFDCA section 409. 

Q6: Can a proposed use be listed in more than one of the 12 major use patterns in the use 

site index? 

Answer: Yes, This is typical. In these cases the registrant must address the required data 

requirements for all of the applicable use sites 

Q7: If the proposed use is for a residential application and will only be used indoors, are 

the environmental fate studies still required? 

Answer: Yes. 158W no longer differentiates between indoor and outdoor uses for antimicrobial 

uses. If a proposed use has a potential to release down the drain or to the environment then the 

data requirement must be addressed 

Q8: What should a registrant do if the proposed use does not fit into any of the 12 major 

use patterns in the use site index? 

Answer: Contact the PM for the active ingredient or one of the POCs listed on AD’s webpage 

QUESTIONS SUBMITTED DURING THE WEBINAR 

David Swain - SRC: General Use Pattern #4 (Residential Premises) under Indirect Food 

Uses does not include "tables". In the example given, how was it determined "tables" were 

indirect food use? 

Answer: EPA: this use is covered under Household/domestic Food Handling Areas in the USI 

(#4). Tables may be considered food handling areas. 

Diane Boesenberg: What does periodically mean - how many comments would need to be 

received to warrant updating the USI? 

EPA: The USI will be updated as appropriate, not on the number of comments. Stakeholders 

wanting to request an extension of the comment period can do so in writing. 

Diane Boesenberg: Is there opportunity to extend the 30-day comment period? 

Answer: Comments and requests to extend the comment period should be submitted in writing 

to EPA. 

Diane Boesenberg: Based on Q2 is the Agency requiring Non-food use products to contain 

a claim that a product is not to be used on indirect food surfaces? 

Answer: As long as the Agency can clearly understand that the use is limited to bathrooms, then 

the label does not need to include a statement that prohibits use on food contact surfaces. 
JStrickland: Are food processing aids still only under FDA jurisdiction? 

Answer: You should contact the Agency with your specific jurisdictional questions. (More 

information is needed to fully answer this question.) 

Diane Boesenberg: Can this Q&A be posted with the responses as minutes? 

Answer: Yes. This document will be posted in the docket. 

Jolynn: will the slides be available online? 

Answer: Yes. The slides will be available in the docket. 

Dee Wilson: Is the presentation available to share with other company personnel that were 

unable to attend the webinar? 

Answer: Yes. The slides will be available in the docket 

Jamie Quon: Are all these considerations for the active ingredient(s) only? Or are inerts 

also subject to this? 

Answer: If by “these considerations” you mean whether you need a tolerance or tolerance 

exemption for inert ingredients in a product containing an active ingredient that requires a 

tolerance or tolerance exemption for that specific use, then yes, the inerts must be food-use 

cleared (including a possible petition for a tolerance or tolerance exemption). 

John Dubeck: Will EPA use FDA”s threshold of regulation (dietary concentration less than 

0.5 ppb) to determine that indirect uses do not give rise to residues? 

Answer: No. If we have reasonable expectation of residues in or on food, then a tolerance or 

tolerance exemption and a dietary assessment is required. The applicant may submit data or a 

rationale, as explained on the Food Use Description Flow Chart. 

Gary Eilrich: How many locations are required for establishment of food use or indirect 

food use tolerances? 

Answer: If this question is related to residue data, then the geographic location is not an 

important factor. The Agency encourages applicants to contact the Agency to discuss a protocol 

prior to conducting residue trials.