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  "*     \         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
          |                        WASHINGTON, D.C. 20460

                                         MAR  - 6 20QD
                    PESTICIDE REGISTRATION (PR.) NOTICE 2000 - 1 *   PREVENTION P^STOIDES AND
                                                                             TOXIC SUBSTANCES
             NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS
                    AND REGISTRANTS OF PESTICIDE PRODUCTS

 ATTENTION:      Persons Responsible for Registration of Pesticide Products

 SUBJECT:         Applicability of the Treated Articles Exemption to Antimicrobial Pesticides

        This notice clarifies current EPA policy with respect to the scope of the "treated articles
 exemption" in 40 CFR 152.25(a). This exemption covers qualifying treated articles and
 substances bearing claims to protect the article or substance itself. EPA does not regard this
 exemption as including articles or substances bearing implied or explicit public health claims
 against human pathogens. This notice addresses the types of claims which are not permitted for
 antimicrobial pesticide products exempt from registration under this provision and gathers
 together in one place guidance the Agency has offered in recent years on labeling statements
 which it believes would or would not be covered under this provision.  This notice also explains
 the requirement that the pesticide in a treated article be "registered for such use."

       This notice provides guidance to producers and distributors of pesticide treated articles
 and substances, and to producers and distributors of pesticides used as preservatives to protect
 treated articles from microbial deterioration.

 I.     BACKGROUND

       EPA regulations in 40 CFR 152.25(a) exempt cerfain treated articles and substances from
 regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) if specific
 conditions are met The specific regulatory language is:

        Section IS2.25 Exemptions for pesticides of a character Hot requiring FIFRA regulation

       "(a) Treated artL-.les or substances. An article or substance treated with, or containing, a pesticide
       to protect the Seated article or substance itself (for example, paint treated with a pesticide to protect
       the paint coating, or wood products treated to protect the wood against insect or fungus infestation)
       if the pesticide is registered for such use."

       Known as the "Treated Articles Exemption," section 152.25(a) provides an exemption
*
  This version, makes corrections to the February 3, 2000 PR Notice 2000-1. Corrections in
bold/italics or editorial deletions were made on pages 3,4, 7, and 9.
                              Internet Address (URL)  http://www.epa.gov
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  from all requirements of FIFRA for qualifying articles or substances treated with, or containing a
  pesticide, if:

        (1) the incorporated pesticide is registered for use in or on the article or substance, and;
        (2) the sole purpose of the treatment is to protect the article or substance itself.

        The exemption gives two examples of treatments that are intended to protect only the
  treated article or substance itself. In the first case, paint is being protected from deterioration of
  the paint film or coating. In the second case, wood is being protected from fungus or insect
  infestations which may originate on the surface of the wood.  Pesticides used in this manner are
  generally classified as preservatives. Other pesticides are incorporated into treated articles
  because of their ability to inhibit the growth of microorganisms which may cause odors or to
  inhibit the growth of mold and mildew. Because of this treatment, it is claimed that a fresher
  and more pleasing surface can be maintained.

       To qualify for the treated articles exemption, both conditions stated above must be met. If
 both are not met, the article or substance does not qualify for the exemption and is subject to
 regulation under FIFRA.

       In recent years, the marketplace has experienced a proliferation of products that are
 treated with pesticides and bear implied or explicit public health claims for protection against
 bacteria, fungi and viruses, as well as specific claims against pathogenic organisms which may
 cause food poisoning, infectious diseases or respiratory disorders.  Examples of such articles
 include toothbrushes, denture cleansers, children's toys, kitchen accessories such as cutting
 boards, sponges, mops, shower curtains, cat litter, vacuum cleaner bags, pillows, mattresses and
 various types of finished consumer textiles. In many cases, these products have made public
 health claims that extend beyond the protection of the article itself, and thus, they do not qualify
 for the treated articles exemption.

 H.    TYPES  OF ANTIMICROBIAL CLAIMS

       A.  Public Health Claims

       Because  consumers have long associated the following widely used claims and references
 to microorganisms harmful to humans with products providing public health protection, EPA
 considers an article or substance to make a public health claim if any of the following claims are
 made either explicitly or implicitly:

       1.  A claim for control of specific microorganisms or classes of microorganisms that are
 directly or indirectly infectious or pathogenic to man (or both man and animals). Examples of
 specific microorganisms include Mycobacterium tuberculosis, Pseudomonas aeruginosa, E. coli,
HIV, Streptococcus and Staphylococcus aureus.

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        2. A claim for the product as a sterilant, disinfectant, virucide or sanitizer, regardless of
  the site of use of the product, and regardless of whether specific microorganisms are identified.

        3. A claim of "antibacterial," "bactericidal," or "germicidal" activity or references in any
  context to activity against germs or human pathogenic organisms implying public health related
  protection is made.

        4. A claim for the product as a fungicide against fungi infections or fungi pathogenic to
  man, or the product does not clearly indicate it is intended for use against non-public health
  fungi.

        5. A claim to control the spread of allergens through the inhibition or removal of
 microorganisms such as mold or mildew.

        6. A non-specific claim that the product will beneficially impact or affect public health
 by pesticidal means at the site of use or in the environment in which applied.

        7. An unqualified claim of "antimicrobial" activity. Refer to Unit IV.C.

        B. Non-Public Health Claims

        EPA considers a product to make a non-public health claim if any of the following
 applies:

        1. A claim to inhibit the growth of mildew on the surface of a dried paint film or paint
 coating.

        2. A claim to inhibit microorganisms which may cause spoilage or fouling of the treated
 article or substance.

        3.  A claim to inhibit offensive odors in the treated article or substance.

       4.  EPA considers terms such as "antimicrobial," "fungistatic," "mildew-resistant" and
 "preservative," as being acceptable for exempted treated articles  or substances provided that they
 are properly, and very clearly, qualified as to their intended non-public health use. Refer to Unit
 IV.C. Use of these terms in product names or elsewhere in the labeling in bolder text than
 accompanying information may render such qualifications inadequate.

III.     PAST EPA LABELING CLAIMS INTERPRETATIONS

      A. Odor and Mildew-Resistant Properties May Be Claimed

      Over the past twenty-five years the Agency has issued several interpretations concerning

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the exemption from FIFRA regulations of certain types of antimicrobial treated article claims
associated with mildew-resistant paint, films and coatings. In the same period, EPA has also
issued other interpretations concerning certain types of odor-resistant antimicrobial treated article
claims.
                                                                                        \
       During this period there has been widespread dissemination and adoption by the
antimicrobial pesticide product community of these EPA interpretations regarding mildew-      \
resistant and odor-resistant claims under the "treated articles exemption." Furthermore, the
Agency continues to treat these general types of claims as covered by the term "to protect the
treated article or substance itself because mitigation of these non-public health related
organisms can contribute to the protection of the appearance and maintenance of the intended
useful life of the treated article or substance. Because during this period, there has also been
widespread rnisinterpretation of EPA's guidance, the Agency has developed a representative set
of statements designed to clarify its position in this area.   Consequently, if they otherwise qualify
for the exemption, properly labeled treated articles and substances bearing claims such as those   :
described under Unit IV.B. continue to be eligible for the treated articles exemption.

       B. Product Names May Not Contain Public Health Claims

       The Agency regards trademarked product names of treated articles or substances [or
references to trademarked names of registered pesticides] as potential sources of public health
claims that could render a product ineligible for the "treated articles exemption" just as could
other direct or indirect public health claims on or in a product's packaging or in its labeling or
advertising literature.  The Agency has maintained this position hi enforcement actions against
pesticide-treated articles,  such as pesticide-treated cutting boards and other items, which bore
names suggesting health or other benefits beyond mere preservation of the treated article itself.
In determining the eligibility of a treated article or substance for the exemption, the Agency will
examine the product name, its context, labeling claims and other related elements on a case-by-
case basis

IV.    TREATED ARTICLE LABELING CLAIMS

       Products treated with antimicrobial pesticides with claims such as those described in
Section A below are likely to not be acceptable under the "treated articles exemption" because
they imply or express protection that extends beyond the treated article or substance itself.
Products treated with antimicrobial pesticides registered for such use and which only bear claims
for protection of the article or substance itself such as those described in Section B below are
likely to be acceptable and eligible for the "treated articles exemption", assuming all other
conditions have been met. Section C below contains examples of appropriate qualifying and
prominence statements which have been extracted from multiple enforcement proceedings
dealing with claims that can be made for treated articles without obtaining registration.

  A.   Examples of Labeling  Claims That the Agency is Likely to Consider Unacceptable

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        Under the Exemption

        The following examples are not intended to be an all-inclusive listing of unacceptable
 treated article labeling claims.  If persons are not sure whether their antimicrobial pesticides are
 covered by the provisions of this section, the Agency encourages them to request a written
 opinion from the Antimicrobials Division at one of the addresses listed under Unit VH

        These examples represent claims or types of claims for a treated article that would lead to
 a requirement to register the article as a pesticide product.

 o Antibacterial

 o Bactericidal

 o Germicidal

 o Kills pathogenic bacteria.

 o Effective against E. coli and Staphylococcus.

 o Reduces the risk of food-borne illness from bacteria.

 o Provides a germ-resistant surface.

 o Provides a bacteria-resistant surface.

 o Surface kills common gram positive and negative bacteria.

 o Surface controls both gram positive and negative bacteria.

 o  Surface minimizes the growth of both gram positive and negative bacteria.

 o  Reduces risk of cross-contamination from bacteria.

 o  Controls allergy causing microorganisms.

 o  Improves indoor air quality through the reduction of microorganisms.

  B.   Examples of Labeling Claims the Agency is Likely to Consider Acceptable Under
       the Exemption

       The following examples are  not intended to be an all-inclusive listing of acceptable
treated article labeling claims. If persons are not sure whether their antimicrobial pesticides are

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 covered by the provisions of this section, the Agency encourages them to request a written
 opinion from the Antimicrobials Division at one of the addresses listed under Unit VII.

         1. Mold and Mildew Resistant Claims

 o This article has been treated with a fungistatic agent to protect the product from fungal growth.

 o Mildew Resistant - treated with a fungistatic agent to protect the paint itself from the growth
   of mildew.

 o Mildew Resistant - This paint contains a preservative which inhibits the growth of mildew on
   the surface of this paint film.

 o Mildew Resistant - Extends useful life of article by controlling deterioration caused by
   mildew.

 o Algae Resistant - This article contains a preservative to prevent discoloration by algae.

 o A fungistatic agent has been incorporated into the article to make it resistant to stain
   caused by mildew.

 o Article treated to resist deterioration by mold fungus.

 o Article treated to resist deterioration from mildew.

 o The fungistatic agent in this article makes it especially useful for resisting deterioration
   caused by mildew.

 o  Dry coating of this paint mildew resistant.

 o  Dried paint film resists mold fungus.

 o  Dry enamel coating resists discoloration from mildew.

 o  Cured sealant is mildew resistant.

 o  Dried film resists stains by mold.

 o A mold or mildew resisting component has been incorporated in this article to make its dry
  film mildew resistant.

o Specially formulated to resist mildew growth on the paint film.

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  o  Gives mildew-resistant coating.                      !

  o  The mildew resistance of this outside house paint film makes it especially useful in high
    humidity areas.

  o  Retards paint film spoilage.

  o  Resists film attack by mildew.

        2.  Odor Resistant Claims

  o  This product contains an antimicrobial agent to control odors.

 o  This product contains an antimicrobial agent to prevent microorganisms from degrading the
   product.

 o Resists Odors - This product has been treated to resist bacterial odors.

 o Inhibits the growth of bacterial odors.

 o Resists microbial odor development.

 o Retards the growth and action of bacterial odors.

 o Guards against the growth of odors from microbial causes.

 o Guards against degradation from microorganisms.

 o Reduces odors from microorganisms.

 o Odor-resistant.

 o Acts to mitigate the development of odors.

       C. Antimicrobial Qualifying and Prominence Considerations

       EPA does not believe that claims such as "antimicrobial," "fungistatic," "mildew-
resistant," and "preservative" or related terms are consistent with the intent of 40 CFR 152.25(a)
if they are:  (1) part of the name of the product; or (2) not properly qualified as to their intended
non-public health use. Examples of permissible statements would include, but not be limited to:
"Antimicrobial properties built in to protect the product" and "Provides mildew-resistant dried
paint coating." All references to the pesticidal properties and the required qualifying statements
should be located together, should be printed in type of the same size, style, and color, and

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should be given equal prominence. Moreover, such references should not be given any greater
prominence than any other described product feature.

       In addition, treated articles or substances intended for microbial odor control or article
preservation in areas where food-borne or disease-causing organisms may be present have the
potential to create the impression that the article provides protection against food-borne and
disease-causing bacteria. This potential should be addressed through very careful narrowing and
qualification of the non-public health claims. A complete assurance that there is no misleading
impression could be achieved through use of language like: "This product does not protect users
or others against food-borne (or disease-causing) bacteria. Always clean this product thoroughly
after each use." or "This product does not protect users or others against bacteria, viruses, germs
or other disease organisms. Always clean this product thoroughly after each use."

V.     ADDITIONAL INFORMATION

       A.  Registration of Treated Articles Making Public Health Claims

       Treated articles or substances with implied or explicit public health claims or which
otherwise fail to qualify for exemption are pesticide products subject to all requirements of
FEFRA. They may not be legally sold or distributed unless they are registered with EPA or
unless such claims have been removed and the article otherwise qualifies for exemption. To
obtain a registration, an applicant must submit acceptable data supporting all the proposed claims
under which the product will be marketed and meet all other applicable registration requirements.
Refer to 40 CFR Parts 152,156, and 158.

       The Agency currently has no established protocols for the development of data to support
public health claims on treated articles for which registration is sought. Acceptable protocols for
product testing reflecting actual use conditions need to be submitted and approved by EPA prior
to the development of these data. As part of this review process, the Agency will require that
these protocols be independently validated for accuracy and reproducibility.  Antimicrobial
treated articles requiring registration must meet the same efficacy performance standards that are
required for corresponding antimicrobial public health products. For any questions regarding the
need for registration or the registration requirements for specific treated articles or substances,
contact the Antimicrobials Division at the address listed under Unit VH

       B. The Term "Registered for Such Use"

       In order to qualify for the treated articles exemption, 40 CFR 152.25(a) specifies that an
article or substance must be treated with, or contain, a pesticide to protect the treated article or
substance itself. The terms "treated with, or containing, a pesticide" and "if the pesticide is
registered for such use" in 40 CFR 152.25(a) refer to actual incorporation or adding of an
antimicrobial pesticide specifically registered for that use. To qualify under  the "treated articles
exemption" (assuming the article or substance otherwise qualifies), it is not sufficient that the

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 antimicrobial pesticidal substance in the treated article merely resemble or have activity like a
 registered pesticide.  The antimicrobial pesticide in the treated article or substance must be
 present in the article or substance solely as the result of incorporating an antimicrobial pesticide
 which is registered for treating the specific article or substance.

        Because of the wide range of exposure scenarios associated with the use of treated
 articles such as cutting boards and conveyor belts used hi the food processing industry, and the
 wide range of household consumer uses, the Agency has interpreted 40 CFR 152.25(a) to mean
 that the registration and the labeling of the antimicrobial pesticide intended for incorporation into
 the treated article or substance needs to include specific listings of the articles or substances that
 may be treated. Accordingly, in registration actions over the past several years, EPA has not
 permitted broad general use patterns, such as the preservation of hardsurfaces, plastics,
 adhesives or coatings for the registered pesticide. Instead, it has required that specific listings
 such as toys, kitchen accessories and clothing articles be reflected in the product registration and
 labeling as a prerequisite for incorporation of the pesticide into an article or substance under 40
 CFR 152.25(a).

 VI.   EFFECTIVE DATE AND PROCEDURES

       In order to remain in compliance with FIFRA and avoid regulatory or enforcement
 consequences as described here and below, it is the Agency's position that producers,
 distributors, and any other person selling or distributing pesticide treated articles and substances
 not in compliance with the Agency's interpretation of 40 CFR 152.25(a), as clarified by this
 notice, need to bring their products, labeling and packaging, any collateral literature,
 advertisements or statements made or distributed in association with the marketing (sale or
 distribution) of the treated article or substance into full compliance with the regulation as
 clarified by this notice as soon as possible.

       Because some of the elements of this interpretation may not have been well understood
 by the regulated community, the Agency expects that some companies may need up to a year in
 order to comply with those elements that have been clarified by this notice.  Therefore, for the
 present, the Agency is following the approach set forth iin the April 17, 1998 Federal Register
 (63 FR 19256).  Although non-public health claims for microbial odor control and mold and
 mildew claims associated with deterioration, discoloration, and staining were not specifically
 mentioned in the April 17,1998 Federal Register, such claims are also consistent with the
 enforcement approach set forth in that notice, as well as with this guidance,  provided that they
 are properly, and very clearly, qualified as to their non-public health use. The Agency will begin
 to rely on the guidance provided in this Notice on February 11, 2001. Products in commerce &
 after that date which make statements, etc. that do not reflect the clarification offered in this
notice would risk being considered out of compliance with 40 CFR 152.25(a).

VH.  ADDRESSES

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Bv mail:
Antimicrobials Division (75IOC)
U. S. Environmental Protection Agency
1200 PesBsylvama Avenust NW
Washington, D. C. 20460-0001

Bv courier:
Antimicrobials Division (751OC)
U. S. Environmental Protection Agency
Room 300, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202-4501

Vm.  FOR FURTHER INFORMATION CONTACT

      If you have questions about the content of this notice, you should contact Debra Edwards
at (703)308-7891.
                                     Marcia E. Mulkey, Director
                                     Office of Pesticide Programs
                                       10

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          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                  WASHINGTON, D.G. 20460
                                             OFFICE OF
                                         PREVENTION, PESTICIDES AND
                                           TOXIC SUBSTANCES
                Special Notice
      for Antimicrobial Registrants
If you have an e-mail address,  please send it to
  Michael Hardy via an e-mail note with the
              following statement:

     "Please add my name to your e-mail
                  directory."

          Michael's E-mail Address is
         "Hardy.Michael@epa.gov"
                Frank T. Sanders, Director
                  Antimicrobial Division
                Office of Pesticide Programs
                Internet Address (URL)  http://www.epa.gov
      Recycled/Recyclable . Printed with Vegetable Oil Based Inks on Recycled Paper (Minimum 25% Postconsumer)

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