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 whethe r or not a tolerance or exem ption would be required, and a dietary exposure assessment w ould be conducted based on this determination. If there are no reasonable expectations of residues in food, then a dietary assessment woul d not be required. If residues are expected, then a diet ary assessment would be conducted. If the use is not strictly residential, then a tolerance or exemption would be required if re sidues are expected.

Q2: I'm interested in submitting an applicat ion 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 w ould not be conducted, and a tolera nce or exemption would not be required. It is important that the label clearly in dicate that it is for use in bathrooms only. If the label is ambiguous (i.e., saying countertops instea d 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 aft er 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 si nce the product will be applied directly to the

food items. It is the us e pattern that determines the desi gnation. 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 residue s 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 w ill be impregnated into a cutting board to protect the plastic. I realize th at this is an indirect food us e. Another company has a food

contact notification with FDA for this active in gredient 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 FC N 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 comp any. 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 FC N 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 F DA 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 a ddress the required data requirements for all of the applicable use sites

Q7: If the proposed use is for a residential a pplication 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 pot ential 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 ingredie nt or one of the POCs listed on AD’s webpage

QUESTIONS SUBMITTED DURING THE WEBINAR David Swain - SRC: General Use Pattern #4 (R esidential Premises) under Indirect Food Uses does not include "tables". In the exampl e given, how was it determined "tables" were

indirect food use?

Answer: EPA: this use is covered under H ousehold/domestic Food Handling Areas in the USI (#4). Tables may be cons idered food handling areas.

Diane Boesenberg: What does periodically me an - 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 incl ude a statement that prohibits use on food contact surfaces.JStrickland: Are food processing ai ds still only under FDA jurisdiction? Answer: You should contact the Agency with your specific jurisdicti onal 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 sh are with other company personnel that were

unable to attend the webinar?

Answer: Yes. The slides w ill be available in the docket

Jamie Quon: Are all these considerations for th e active ingredient(s) only? Or are inerts also subject to this? Answer: If by “these consider ations” you mean whether you n eed a tolerance or tolerance exemption for inert ingredients in a product cont aining 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 expectati on 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 re lated to residue data, then th e geographic location is not an important factor. The Agency encourages applican ts to contact the Agency to discuss a protocol prior to conducting residue trials.