[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Notices]
[Pages 7007-7008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3219]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00530B; FRL-6489-7]


Pesticides; Clarification of Treated Articles Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: EPA is announcing the availability of PR Notice 2000-1 
clarifying the Agency's policy with respect to the applicability of the 
``treated articles exemption'' in 40 CFR 152.25(a) to antimicrobial 
pesticides. The notice discusses EPA's past and present guidance on how 
treated articles and substances qualify for the exemption, as well as 
the distinction between public health and non-public health 
antimicrobial claims, by providing specific examples of claims and 
related terms which the Agency believes are or are not consistent with 
40 CFR 152.25(a). This notice also explains the requirement that the 
pesticide in a treated article be ``registered for such use.''

FOR FURTHER INFORMATION CONTACT: Debbie Edwards, Senior Advisor, 
Antimicrobial Division, Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-7891; fax: (703) 308-
6467; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to manufacturers, distributors, and any other 
person selling or distributing pesticide treated articles and 
substances, and to manufacturers, distributors, and any other person 
selling or distributing pesticides used as preservatives to protect 
treated articles from microbial deterioration. Since other entities may 
also be interested, the Agency has not attempted to describe all the 
specific entities that may be affected by this action. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of this 
Document, and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents, from the Internet EPA 
Home page at http://www.epa.gov/. To access this document, on the Home 
Page select ``Laws and Regulations'' and then look up the entry for 
this document under the ``Federal Register--Environmental Documents.'' 
You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. Fax-on-demand. You may request a faxed copy of the Pesticide 
Registration (PR) Notice 2000-1 titled ``Applicability of the Treated 
Articles Exemption to Antimicrobial Pesticides'' by using a faxphone to 
call (202) 401-0527 and selecting item 6110. You may also follow the 
automated menu.

II. Background

    The ``treated articles exemption'' in 40 CFR 152.25(a) was 
promulgated in 1988. As provided by 40 CFR 152.25(a), in order to 
qualify for the ``treated articles exemption,'' (1) a product must be 
treated with a pesticide registered under FIFRA for incorporation into 
a specific treated article or substance, and (2) the claims allowed for 
such treatment must be limited to protection of the treated article 
only. If these two conditions are met, the product would qualify for 
the ``treated articles exemption'' and would be exempt from all FIFRA 
requirements. Since that time, enforcement actions have been taken by 
EPA where it deemed necessary. The products involved in these actions 
were dealt with so as to resolve individual issues arising in each 
matter. In recent years, however, a large variety of non-exempt 
antimicrobial treated products and substances with diverse claims have 
appeared in the marketplace. To address this case-by-case approach and 
to avoid marketplace confusion, the Agency decided to provide 
comprehensive guidance as set forth in a PR Notice to clarify EPA 
policy with respect to the applicability of the ``treated articles 
exemption'' and to provide examples of acceptable and unacceptable 
claims for use on labels and advertisements which the Agency believes 
are consistent with 40 CFR 152.25(a).
    In the Federal Register of April 17, 1998 (63 FR 19256) (FRL-5780-
7), EPA published a notice of availability of a draft PR Notice 
soliciting comments on proposed guidance clarifying the criteria 
considered by EPA for determining whether antimicrobial pesticides are 
eligible for the ``treated articles exemption,'' as well as to make it 
clear that the Agency continues to consider any public health claim as 
not being consistent with the provisions of 40 CFR 152.25(a). Comments 
were to be received by May 18, 1998. In the Federal Register of May 18, 
1998 (63 FR 27280) (FRL-00530A), EPA extended the comment period until 
June 30, 1998. In response, the Agency received 107 comments to the 
draft PR Notice from a wide spectrum of the antimicrobial community. 
This Federal Register notice announces the availability of PR Notice 
2000-1 titled ``Applicability of the Treated Articles Exemption to 
Antimicrobial Pesticides.''

III. Comments to the Draft Notice

    In developing PR Notice 2000-1, the Agency evaluated 107 comments 
received in response to the April 17, 1998 draft notice. At the same 
time, treated article issues were discussed in two antimicrobial 
workshops and in numerous meetings with individuals and representatives 
of the antimicrobial pesticide community. Among the principal concerns 
raised during these dialogs were the Agency's position regarding 
aesthetic claims and the 60-day time frame for compliance with any new 
elements of the final notice. In evaluating these concerns, EPA has 
come to the conclusion that properly worded aesthetic claims continue 
to fall within the scope of the ``treated articles exemption'' because 
mitigation of non-public health related organisms which are responsible 
for mildew and odors can contribute to the protection of the appearance 
and maintenance of the intended shelf life of the treated article or 
substance. EPA has also been made aware of the complexities associated 
with the manufacture and distribution of treated paint and textile 
products and believes that February 11, 2001, would be an appropriate 
time frame for implementing any new elements of the final notice.
    Other concerns were raised about the Agency's position regarding 
the use of terms such as ``antibacterial,''

[[Page 7008]]

``germicidal,'' ``antimicrobial,'' and ``mildew-resistant'' and the 
need for certain types of qualifying and prominent language displayed 
in association with these terms. EPA continues to believe that the 
terms ``antibacterial,'' ``germicidal'' and similar language imply a 
public health benefit regardless of the context in which they are used 
on the labeling and are thus, inappropriate for products intended 
merely for the non-public health protection of treated articles and 
substances. On the other hand, the Agency believes that while terms 
such as ``antimicrobial'' and ``mildew-resistant'' have the same 
potential for misinterpretation, if such terms are properly qualified 
and are not prominently displayed on the labeling, these terms would be 
acceptable for articles and substances claiming the exemption.
    Throughout its deliberations, EPA has strived to develop clear 
guidance, consistent with past and present Agency practice, to create a 
``level playing field'' for all affected entities. Furthermore, EPA 
believes that the provisions of PR Notice 2000-1 will have a minimum 
impact on small business entities, and the Agency is committed to 
continue to work closely with the antimicrobial community and other 
affected parties in cases where compliance with the requirements of 
this notice might present difficulties which are presently unknown.

IV. Contents of PR Notice 2000-1

    PR Notice 2000-1 clarifies the conditions under which the ``treated 
articles exemption'' will apply and provides examples of acceptable and 
unacceptable claims for use on labels and advertisements which the 
Agency believes are consistent with 40 CFR 152.25(a). PR Notice 2000-1 
also discusses the requirement that the pesticide in a treated article 
be ``registered for such use.''

V. Effective Date and Procedures

    In order to remain in compliance with FIFRA and avoid regulatory or 
enforcement consequences as described, 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 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 in the April 
17, 1998 Federal Register. 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 would risk being considered 
out of compliance with 40 CFR 152.25(a). The Agency also wants to make 
it clear that inclusion of this date does not authorize marketing of 
treated articles which do not comply with EPA's interpretation of the 
``treated articles exemption'' in 40 CFR 152.25(a). The Agency has 
consistently interpreted and applied this rule to prohibit implied or 
explicit public health claims for unregistered products and continues 
to regard any public health claims as not being consistent with the 
provisions of 40 CFR 152.25(a).

List of Subjects

    Environmental protection.

    Dated: February 4, 2000.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.
[FR Doc. 00-3219 Filed 2-10-00; 8:45 am]
BILLING CODE 6560-50-F