Draft PRN 2006-A: Use of Antimicrobial Pesticide Products in Heating, Ventilation, Air Conditioning and Refrigeration Systems (HVAC&R)

Notice To: Manufacturers, Formulators, Producers And Registrants Of Pesticide Products

Attention: Persons Responsible for Registration and Registration of Pesticides Products

Subject: Use of Antimicrobial Pesticide Products in Heating, Ventilation, Air Conditioning and Refrigeration Systems (HVA&R) 

This notice provides guidance to registrants of EPA-registered sanitizer, disinfectant and other antimicrobial products whose labels bear general directions for use on or incorporation within hard, non-porous or porous surfaces, but which are not specifically registered for treatment of Heating, Ventilation, Air Conditioning and Refrigeration Systems (HVAC&R also referred to as HVAC. Some labels currently use the term HVAC but for reference purposes of this PR Notice, HVAC&R will be used).

Excluded from this notice are registrants of pesticide products that have been registered for treatment of air filters, drain pans, evaporative or cooling coils and which provide specific directions for these uses and bear no other directions for use on hard, non-porous or porous surfaces. Also excluded are pesticide registrants of products that have been previously approved for use in “ducts,” “ductwork,” “HVAC,” or “HVAC&R.” Finally, excluded products also include those products with specific use patterns and directions for use that do not include statements referring to hard, non-porous or porous surfaces. For example, excluded products include those registered exclusively for use as wood preservatives, pool and spa chemicals, and antifoulant paints.

The EPA is concerned that sanitizer, disinfectant and other antimicrobial products are being used to treat the surfaces of HVAC&R systems including, but not limited to, use as part of air duct cleaning. EPA concerns include (1) the potential human exposure and health risks to applicators and building occupants from the use of these products have not been assessed for this use; (2) no data have been submitted or reviewed to demonstrate that products not specifically registered for HVAC&R use are efficacious when used in HVAC&R systems; and (3) these products were not specifically approved for this use at the time of registration. These concerns are discussed in greater detail in Unit II, Concerns.

To alleviate these concerns, registrants of products subject to this Notice should add a “Do Not Use” statement (described herein) to the labeling of products subject to this notice. As of the effective date of this notice, EPA will review all applications for new pesticide product registrations, for amendments to registered products, notifications regarding registered products, and for reregistration of registered products using this guidance, and expects that registrants of existing products will begin to revise their labeling accordingly before [insert date, at least one year from date of this Notice]. As of [insert date, at least one year from date of this Notice] the Agency will monitor registered products using this guidance to determine whether their labeling is consistent with 40 CFR 156.10(a)(5), 156.10 (b) (2), and FIFRA. Pesticide products that are released for shipment by registrants and /or distributors on or after [insert date, at least one year from date of this Notice] which have not complied with this guidance would risk being in violation of FIFRA.

1. HVAC&R Systems
2. The Concerns
3. Guidance
4. What Registrants Should Do
5. Compliance
6. Addresses
7. Scope Of Policy
8. For Further Information

This PR Notice describes the Agency’s implementation of the requirements set forth in Agency regulations and FIFRA, and provides general guidance to EPA and to affected parties. While the requirements in FIFRA and Agency regulations are binding on EPA, registrants, applicants, and the public, this notice is intended to provide guidance to EPA personnel, pesticide registrants and applicants, and the public. As a guidance document, this policy is not binding on either EPA or any outside parties, and the EPA may depart from the guidance where circumstances warrant and without prior notice. Registrants and applicants may propose alternatives to the recommendations described in this Notice, and the Agency will assess them for appropriateness on a case-by-case basis. If a product does not meet the requirements of 40 CFR Part 156 and section 2(q) of FIFRA, the Agency may find the product to be misbranded and may take appropriate enforcement and/or regulatory action. As stated above, the Agency believes that the guidance described in this notice should reduce potential risks to human health that could arise from unauthorized use of affected products in or on HVAC&R systems or their components.

1. HVAC&R Systems

   HVAC&R is the term which should be utilized to refer to this use site.  Refrigeration Systems have been included they are an additional means of cooling.  The movement of air through these large scale systems is often accomplished by the use of sealed tubes or channels called ducts.  These large scale refrigeration systems are often found in commercial process areas such as food processing, storage, and distribution areas.  The term HVAC&R refers to systems which refrigerate, which exclusively air condition, and systems which exclusively heat, as well as those in which one system provides for both heating and cooling.  These HVAC&R systems are present in industrial, institutional, commercial, and residential establishments.

   For the purposes of this PR Notice, HVAC&R systems include, but are not limited to: air ducts, duct fittings, duct liners, fans, supply ducts, return ducts, exhaust ducts, intakes, outlets, louvers, diffusers, dampers, plenums, outdoor air intakes, air handling units, and any other ductwork and similar components.

2. The Concerns

   1. Labeling/Use

      The labeling of registered disinfectant, sanitizer, and other antimicrobial products typically states that these products are intended for use on hard, non-porous surfaces and lists some, but not all, of the surfaces or sites that these products are intended to be used on. The term “hard, non-porous surfaces” refers to surfaces that are rigid, solid, and do not contain pores through which substances such as fluids or light may pass. It is possible that users of antimicrobial products labeled for “hard non-porous surfaces” could misinterpret the labeling to imply that they may be used in HVAC&R systems since many of these systems include components made of hard, non-porous materials. For example, if one of the surfaces listed on the labeling is “steel” or “stainless steel,” it is possible that a user might misinterpret the label language believing that the product is safe for use in HVAC&R system ductwork that is made of steel or another similar surface material. However, the Agency’s registration of a particular use site or surface in one context may not mean that the registration allows use on another use site/surface. Even if an antimicrobial product includes general directions for use on hard, non-porous surfaces such as stainless steel, treatment is vastly different for a stainless steel countertop, which is completely accessible to the user of the product, compared to treatment of metal ductwork in a HVAC&R system, which is relatively inaccessible. Similarly, labels of some antimicrobial products may state that the product is for use on “porous surfaces.” Many ductwork systems are lined with fiberglass ductboard, which is a porous surface. It is possible that a user might misinterpret the label language believing that the product is safe for use in HVAC&R system ductwork that is lined with fiberglass ductboard or another similar material.

      Among other things, the Agency believes that the terms “hard, non-porous surfaces” and “porous surfaces” without specific directions for HVAC&R use are not adequate to describe or permit the use of antimicrobial products in HVAC&R systems. If the labeling of sanitizers, disinfectants, and other antimicrobial products were to clearly list all the use surfaces/sites on which these product may be used (i.e., floors, walls, countertops, garbage cans, kitchens, bathrooms), then the phrases “hard, non-porous surfaces” and “porous surfaces” would not be necessary. For many years the Agency has approved disinfectant, sanitizer and other antimicrobial labels using the terminology “hard, non-porous surfaces” and “porous surfaces”. These phrases acknowledge that it is not practical to list all of the surfaces/sites where a disinfectant, sanitizer, or other antimicrobial product can be used. Thus, the terms “hard, non-porous surfaces” and “porous surfaces” were used to describe the type of surface on which a disinfectant/sanitizer or other antimicrobial product could be used within a given site such as bathrooms. Many products list only “hard, non-porous surfaces” or “porous surfaces” and others use phrases including “such as” when defining the approved surfaces and sites. The Agency will continue to use the broad generic terms “hard, non-porous surfaces” and “porous surfaces” to describe in general the surfaces or a given site on or at which a disinfectant/sanitizer product could be used. However, the Agency recognizes that there are some use sites that should have specific Agency approval such as HVAC&R systems.

      The Agency has information from various sources indicating that registered sanitizer and disinfectant products are being used in HVAC&R systems without specific directions for that use. For example, the Agency has received calls from consumers inquiring about antimicrobials, not specifically registered for HVAC&R systems, that have been recommended for use in their home HVAC&R systems by ductwork cleaning companies. Information on adverse health effects experienced by building occupants has been reported to the Agency as a result of duct cleaning and exposures to antimicrobials that were applied to HVAC&R systems in residential and commercial settings. The National Antimicrobial Information Network (NAIN) received about 150 calls related to the possible application of antimicrobial pesticide products in HVAC&R systems during an 18-month period. EPA has also identified Internet web sites which endorse the use of products that have not been specifically approved for use in HVAC&R systems. EPA is concerned that the application of these types of products to HVAC&R system ductwork may result in adverse exposures and health risks to both product applicators and building occupants. EPA believes that the best solution to avoid adverse risks and consumer confusion is the clarification of label instructions and specific approval by EPA of products intended for use in HVAC&R systems.

      An additional source of concern arises because some disinfectant/sanitizer products bear labeling which identifies them as HVAC&R “cleaners,” but do not make HVAC&R disinfectant/sanitizer claims. The fact that these products are registered as disinfectant/sanitizer products yet bear non-pesticidal HVAC&R cleaning claims could lead to an assumption that the products are registered for pesticidal purposes in HVAC&R systems. Accordingly EPA no longer expects to approve such “cleaner” claims for products which are not registered for HVAC&R pesticidal claims because they may mislead consumers to believe that the product may be used for pesticidal purposes in HVAC&R systems.

   2. Potential Exposure And Risks

      The application of an antimicrobial product to an HVAC&R system represents a use pattern substantially different from other hard surface treatments. Application to HVAC&R systems usually requires larger volumes of the antimicrobial to be applied to both internal and external components than would be typically used as a disinfection/sanitizer application to a hard surface such as a bathroom vanity top. In addition, these systems are typically inaccessible and could create unique exposure scenarios for applicators, thus there is a greater potential for the applicator to be exposed to large amounts of pesticide. Post application exposure to building occupants is also a concern. When the HVAC&R system resumes operation after treatment, the potential exists for the pesticide to be readily spread throughout the building. For products that do not bear specific directions for HVAC&R use the Agency has not determined whether the potential exposure to people occupying the building could lead to unreasonable adverse effects.

      Antimicrobial products approved for use on “hard, non-porous surfaces” and “porous surfaces,” have not undergone comprehensive assessment of the risk potential from use of these active and other ingredients for HVAC&R use patterns. Consequently, the Agency has several concerns regarding the use of disinfectant/sanitizer products in/on HVAC&R systems. In addition to product efficacy issues, the Agency’s primary concern rests with the potential human exposures and health risks to applicators and building occupants from the use of these products in or on any surfaces that are part of HVAC&R systems. Data and other information suggest that exposure to airborne pesticides not approved for use in HVAC&R systems may cause health effects as detrimental or worse than the health effects caused by the exposure to the biocontaminants that the pesticides are intended to control.

      The Agency must perform exposure and risk assessments for products intended to be used to treat HVAC&R systems. At this point, the Agency has not evaluated the potential exposures and health risks associated with HVAC&R system use for the majority of registered antimicrobial products labeled for use on “hard non-porous” and “porous surfaces.” The Agency is concerned that the use of antimicrobial products in this fashion could lead to potential adverse health effects.

   3. Efficacy Concerns

      The existence of microorganisms, such as mold, mildew, and bacteria in the indoor environment has been well documented. The presence of microorganisms in indoor environments may be associated with human-health effects, such as respiratory problems, infectious diseases, and hypersensitivity or other allergic reactions. Since air passing through air handling systems deposits microbes and their spores into the air ducts where they can transport back into the indoor environment, the control of microorganisms is an important component in protecting indoor environments.

      HVAC&R systems typically are relatively inaccessible and not easily disassembled. EPA has no data to demonstrate how a liquid product could be adequately applied to all surfaces within an established ductwork system and remain on those surfaces for an effective contact time necessary for antimicrobial activity. In addition, most antimicrobial products intended for use on hard surfaces require that surfaces be precleaned prior to treatment. The Agency has concerns as to whether these systems will be thoroughly precleaned to the degree necessary for an antimicrobial product to be used effectively. An inadequately cleaned surface would compromise the efficacy of these antimicrobial products.

      The Agency is concerned that there is not enough information available to determine the efficacy of antimicrobial products used as a preventive or mitigative control strategy in HVAC&R systems. The effectiveness of these agents when applied under real-life conditions and the longevity of the antimicrobial effects are not well studied. EPA believes that extension of “hard non-porous” general efficacy claims to the specialized HVAC&R use site should be supported by efficacy data specific to those sites. This type of claim should involve data developed using an efficacy method specifically developed for HVAC&R applications which at this time has not been submitted to the Agency.

   4. Public Outreach

      EPA is attempting to address its concerns about the use of antimicrobials on HVAC&R systems in several different ways. Under FIFRA, the burden is on the registrant to demonstrate that its product may be efficaciously used on HVAC&R systems without creating unreasonable adverse effects. The Agency released a letter dated March 14, 2002, (Appendix A) directed to the HVAC&R industry to advise them of our concerns regarding the appropriate use of antimicrobial products in HVAC&R systems. Following the release of this letter, in addition to communicating our concerns to the registrants, we are currently involved in an effort to educate user groups and associations regarding the appropriate use of antimicrobial pesticides in HVAC&R systems.

3. Guidance

   1. Applicability

      EPA has considered ways in which the labeling could be revised to address its concerns regarding risk and efficacy. In this notice, EPA is specifying labeling language that it believes could address its current concerns for sanitizer, disinfectant, and other antimicrobial products whose labels bear directions for use on, or incorporation within, hard, non-porous or porous surfaces, but which have not been specifically approved for use in HVAC&R systems.

      The Agency believes that the best solution would be placement on affected labels of an exclusionary statement. The specific use in HVAC&R systems could subsequently be requested to be added by the registrant and after reviewing the request and supporting data as well as assessing associated risk, if approved by the Agency, the use could be added to the label and the exclusionary statement could be removed. This would involve submission of appropriate and adequate data by the registrant as well as specific use directions on the label in order to support use on this site. The Agency believes that the most prudent method for ensuring against the use of those products not intended for HVAC&R systems, is the addition of a “Do Not Use” statement to the labeling.

      The Agency considered a possible alternative to the “Do Not Use” statement which was to specify that all surfaces that could be treated with a product be listed on the label, hence not using the term “such as” as part of the label language. All product labeling would specify those surfaces and sites for which each product is intended to be used by incorporating text similar to “For use on hard non-porous surfaces of floors, walls, countertops, and garbage cans in kitchens and bathrooms”. Under this option, registrants would list every specific surface and site where their product could be used (e.g., if the labeling did not list “door handles” it could not be for use on that surface even though it is a hard non-porous surface.) EPA concluded that this is not a viable option as it would cause registrants to amend their labeling to include very comprehensive language regarding all sites/surfaces for use.

      This notice is not intended for, and does not apply to the following:

      1. Products with specific use patterns and directions for use which do not include statements referring to hard, non-porous or porous surfaces. Such excluded products may include those registered exclusively for use as wood preservatives, pool and spa chemicals, and antifoulant paints.
      2. Products which are currently registered specifically for use in HVAC&R system components such as air filters, drain pans, evaporative or cooling coils, and which provide specific directions for these uses and bear no other directions for use on hard, non-porous or porous surfaces.
      3. Products which have been previously registered and approved by the Agency specifically for use in “ducts,” “ductwork,” “HVAC,” or “HVAC&R” systems.
   
   
   2. Label Statement

      Registrants of products to which this notice applies should add the following labeling statement to the Directions for Use section of each affected product; i.e. products bearing non-specific claims for use on “hard non-porous” and “porous surfaces”:

      “Do not use in or on air ducts, duct fittings, duct liners, fans, supply ducts, return ducts, exhaust ducts, intakes, outlets, louvers, diffusers, dampers, plenums, outdoor air intakes, air handling units, or any other ductwork of heating, ventilation, air conditioning, or refrigeration (HVAC&R) systems.”

       

      If your product does not include approved pesticidal claims for HVAC&R, but does include HVAC&R, duct, or ductwork cleaning claims, these cleaning claims should be deleted and the above statement be added.




4. What Registrants Should Do

   Registrants should modify their product labeling to ensure compliance with FIFRA as follows:

   1. Registrants who adopt the exact wording set forth in this notice should submit a notification (according to PR Notice 98-10) for each affected product. As part of such notification the registrant should submit one copy of the revised labeling (with changes clearly marked in a way that can be photocopied) along with a completed Application for Registration form (EPA Form 8570-1). A photocopy of the EPA application form is acceptable. The application form should bear the following statements:
       

      EPA may review the notification to determine whether or not the wording is consistent with that contained in this notice. Any proposed changes to the restrictive statement should be submitted by amendment, not by notification. This notification is in accordance with an Agency- initiated action and is not subject to a registration service fee.

   
   
   2. Registrants who wish to propose alternative labeling statements should submit an amendment in which all label language will be thoroughly reviewed by the Agency. The amendment should consist of a completed Application for Registration form (EPA Form 8570-1) and four (4) copies of the revised labeling (with changes clearly marked in a way that can be photocopied). A photocopy of the EPA application form is acceptable. This amendment is in accordance with an Agency-initiated action and is not subject to a registration fee.
   
   
   3. If, after modifying affected product labels, you wish to amend your label to add use of the product in HVAC&R systems, EPA recommends that you contact the appropriate Product Manager to schedule a meeting to discuss possible directions for use, as well as efficacy, human exposure, and toxicology data requirements, as applicable, for the intended HVAC&R use pattern. An amendment to add specific directions for use to a registration would be subject to a registration service fee.



5. Compliance

   It is the registrant’s responsibility to ensure that the labeling for each product complies with FIFRA and its EPA regulations. In order for registrants and distributors to remain in compliance with FIFRA and its implementing regulations, registrants and distributors need to ensure that their products, labeling, and packaging (as well as statements made in association with the sale or distribution of the pesticide product) comply with, among other things, FIFRA Sections 12(a)(1)(E) and 2(q)(1)(A) and 40 CFR 156.10(a)(5) and 156.10 (b)(2). Registrants are reminded that they are responsible for informing their supplemental distributors when they change their labeling, and for monitoring the labeling of their supplemental distributors to ensure that they also make the appropriate changes.

   As of the date of issuance of this notice, EPA will review all applications for new pesticide product registrations, amendments to registered products, notifications regarding registered products, and reregistration of registered products using this guidance. As of [insert date, at least one year from date of this Notice], the Agency will monitor registered products using this guidance to determine whether their labeling is consistent with 40 CFR 156.10(a)(5), 156.10 (b) (2), and FIFRA. Pesticide products that are released for shipment by registrants and/or distributors on or after [insert date, at least one year from date of this Notice] which do not comport with this guidance would risk being in violation of FIFRA as misbranded.

   To give sufficient time for pesticide products in the channels of trade to be distributed or sold to users or otherwise disposed of, the Agency is providing a period of time for companies to make changes to their labeling as per this guidance. Therefore, pesticide products released for shipment prior to [insert date, at least one year from date of this Notice] will be considered existing stocks in the channels of trade and may be sold, used, or otherwise disposed of until exhausted. Registrants and distributors should take corrective measures as soon as possible

6. Addresses

   Registrants should send notifications to one of the following addresses.

   U.S. Postal Service Deliveries
   
   The following official mailing address should be used for all correspondence or data submissions sent to OPP by mail:
   
   Document Processing Desk (NOTIF) or (AMEND) as applicable
   Office of Pesticide Programs (7510P)
   U.S. Environmental Protection Agency
   1200 Pennsylvania Ave., NW
   Washington, D.C. 20460-0001

    

   Personal/Courier Service Deliveries
   
   The following address should be used for all correspondence or data submissions that are hand-carried or sent by courier service Monday through Friday, from 8:00 AM to 4:30 PM, excluding Federal holidays:
   
   Document Processing Desk (NOTIF) or (AMEND) as applicable
   Office of Pesticide Programs (7504P)
   U.S. Environmental Protection Agency
   Room S4900, One Potomac Yard
   2777 South Crystal Drive
   Arlington, Virginia 22202-4501




7. Scope Of Policy

   This PR Notice describes the Agency’s implementation of the requirements set forth in Agency regulations and FIFRA, and provides general guidance to EPA and to affected parties. While the requirements in FIFRA and Agency regulations are binding on EPA, registrants, applicants, and the public, this notice is intended to provide guidance to EPA personnel, pesticide registrants and applicants, and the public. As a guidance document, this policy is not binding on either EPA or any outside parties, and the EPA may depart from the guidance where circumstances warrant and without prior notice. Registrants and applicants may propose alternatives to the recommendations described in this Notice, and the Agency will assess them for appropriateness on a case-by-case basis. If a product does not meet the requirements of 40 CFR Part 156 and section 2(q) of FIFRA, the Agency may find the product to be misbranded and may take appropriate enforcement and/or regulatory action. As stated above, the Agency believes that the guidance described in this notice should reduce potential risks to human health that could arise from unauthorized use of affected products in or on HVAC&R systems or their components.

8. For Further Information

   If you have questions, you may contact the Antimicrobials Division Ombudsman ([email protected]).