Document ID: EPA-HQ-OPP-2006-0351-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-22T04:00Z

SEQ CHAPTER \h \r 1 

***DRAFT OF 9/7/06***

PESTICIDE REGISTRATION (PR) NOTICE 2006-XX

ATTENTION:	Persons Responsible for Registration and Reregistration of
Pesticide Products

SUBJECT:		Use of Antimicrobial Pesticide Products in Heating,
Ventilation, Air Conditioning and Refrigeration Systems (HVAC&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, October 1st at least one year from date of this Notice].  As of
[insert date, October 1st 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,
October 1st at least one year from date of this Notice] which have not
complied with this guidance would risk being in violation of FIFRA.

I.  HVAC&R Systems 

	HVAC&R is the term which should be utilized to refer to this use site. 
Refrigeration Systems have been included as 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.		

II.  The Concerns

								

	A.  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. 

	B. 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.

	C.  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.

 

	D.  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. 

												

III.  Guidance 

	A.  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.	

	B.  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.					
		

IV.  What Registrants Should Do

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

	A.  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:

	"Notification of label change relative to PR Notice 2006-XX.  This
notification is consistent with the guidance in PR Notice 2006-XX and
the requirements of EPA's regulations at 40 CFR 156.10 and 40 CFR
152.46, and no other changes have been made to the labeling or the
confidential statement of formula of this product.  I understand that it
is a violation of 18 U.S.C. Sec. 1001 to willfully make any false
statement to EPA.  I further understand that if this notification is not
consistent with the guidance of PR Notice 2006-XX and the requirements
of 40 CFR 156.10 and 40 CFR 152.46, this product may be in violation of
FIFRA and I may be subject to regulatory and/or enforcement action and
penalties under sections 12 and 14 of FIFRA."

	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. 

	B.  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.

	C.   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.

V.  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, October 1st 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,
October 1st 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:  October 1st 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.		

	

VI.  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

VII.  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.

 

VIII. 	For Further Information						

	If you have questions, you may contact Tracy Lantz in the
Antimicrobials Division 

(703) 308-6415 or Lantz.tracy@epa.gov. 			

							

							James Jones, Director

							Office of Pesticide Programs

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