[Federal Register Volume 63, Number 74 (Friday, April 17, 1998)]
[Notices]
[Pages 19256-19258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10227]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00530; FRL-5780-7]


Clarification of Treated Articles Exemption; Availability of 
Draft PR Notice

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: EPA is soliciting comments on proposed guidance clarifying the 
criteria that pesticide products must meet to be eligible for the 
``treated articles exemption.'' The proposal is available as a draft 
Pesticide Registration (PR) notice entitled ``Eligibility of Pesticide 
Products For Exemption From Registration as Treated Articles pursuant 
to 40 CFR 152.25(a),'' which is available upon request as indicated 
under Unit IV.

DATES: Written comments, identified by the docket number [OPP-00530], 
must be received on or before May 18, 1998.

ADDRESSES: By mail, submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division

[[Page 19257]]

(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under Unit IV of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. The public docket is 
available for public inspection in Rm. 119 at the Virginia address 
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Walter Francis, Environmental 
Protection Agency, (7502C), 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: 6E, Crystal Station #1, 2800 
Crystal Drive, Arlington, VA, (703) 308-6419, fax: (703) 308-4687, e-
mail: francis.walter @epamail.epa.gov.

SUPPLEMENTARY INFORMATION:
    Electronic Availability: Electronic copies of this document and 
various support documents are available from the EPA Home page at the 
Federal Register - Environmental Documents entry for this document 
under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).
Fax on Demand
    Using a faxphone to call (202) 401-0527 and select item (6110) for 
a copy of this document and the PR notice.
    40 CFR 152.25(a) was promulgated in 1988. Since that time 
enforcement actions have been taken by the Agency where it deemed 
necessary. The products involved in those actions were dealt with so as 
to resolve individual issues arising in each matter. As noted in the 
proposed PR notice, in recent years, a large variety of treated 
products and substances with diverse claims have appeared in the 
marketplace. To address this, the Agency has decided to replace this 
approach with comprehensive guidance set forth in a PR notice. Until 
such guidance is finalized, the Agency will continue the approach it 
has been utilizing in this area. This Federal Register notice announces 
the availability of the draft Pesticide Registration (PR) Notice and 
solicits comments on the proposed guidance. If, after reviewing any 
comments, EPA determines that changes to the Notice are warranted, the 
Agency will revise the draft PR notice prior to release.

I. Purpose

    The purpose of the proposed PR notice is to clarify current EPA 
policy with respect to the scope of the ``treated articles exemption.'' 
It addresses the types of claims which are permitted for pesticide 
products that may be exempt from registration under this provision.

II. Applicability

    The proposed PR notice will apply to manufacturers, formulators, 
producers and registrants of pesticide products, and to manufacturers, 
producers, and distributors who incorporate pesticides into consumer 
articles that are intended for sale or distribution under the terms of 
the ``treated articles exemption.'' Examples of consumer articles that 
are potentially affected include cutting boards, sponges, cat litter, 
toothbrushes, juvenile toys, pillows, tablecloths, and clothing.

III. Contents of the PR Notice

    This notice clarifies the conditions under which the ``treated 
articles exemption'' will apply. To qualify for the ``treated articles 
exemption,'' (1) a product must be treated with a pesticide registered 
under FIFRA specifically for protecting the product, 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. The draft PR notice provides examples of acceptable 
and unacceptable wording for use on labels and advertisements for 
products that qualify for the ``treated articles exemption.''
    Companies will not be expected to be in immediate compliance with 
any new elements specified in the draft PR notice; where label language 
is included or precluded as part of this clarification, companies will 
have a period to conform their product labels and literature to the PR 
notice. The final PR notice will establish a date after which EPA will 
expect full compliance with the guidance; the draft PR notice announced 
today states that full compliance with the PR notice will be expected 
no later than 60 days following issuance of the final PR notice. While 
immediate compliance with the new elements specified in the guidance is 
not expected before the expiration of any grace period, the Agency 
strongly encourages companies to conform their marketing of products to 
this guidance as soon as they can, and if possible well in advance of 
the expiration of any grace period in the final PR notice.
    Even though this Federal Register notice and the draft PR notice 
indicate that EPA will not expect immediate compliance with the new 
elements of the final guidance until the expiration of any grace period 
specified in the PR notice, EPA wants to make it clear that this 
position 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 consistent with the provisions of the rule. Furthermore, for the 
present and until the expiration of any grace period specified in the 
final PR notice, EPA will maintain and enforce the policy articulated 
below, as extracted from the settlements of multiple recent enforcement 
proceedings on what claims may be made for treated articles without 
obtaining registration. Those settlements collectively indicate that 
unregistered products may be marketed, even though they may not comply 
with the guidance in the draft PR notice, provided that: (1) no implied 
or explicit public health claims of any kind are made; (2) the claims 
concerning the presence of a pesticide in the treated article are 
limited to protection of the treated article only; (3) when such claims 
involve antibacterial properties, (a) the words ``antibacterial,'' 
``antimicrobial,'' or ``germicidal,'' or related terms, are not a part 
of the name of the product, and (b) the permissible claims are 
qualified by statements indicating that the presence of the 
antibacterial properties does not protect users and others against 
disease and that users should follow prudent hygienic measures, i.e., 
cleaning and washing the article; and 4) the pesticide in a treated 
article is present only as a result of using a pesticide product which 
is registered under FIFRA and labeled for use in treating the article 
in question. The following language is an example of an acceptable 
formulation of such claims and contains appropriate qualifying 
statements:
    ``Antibacterial properties are built-in to inhibit the growth of 
bacteria that may affect this product. The antibacterial properties 
do

[[Page 19258]]

not protect users or others against bacteria, viruses, germs, or 
other disease organisms. Always clean and wash this product 
thoroughly before and after each use.''


    If applicable, the following statement may also be used:
    ``Antibacterial properties will not wash off and are intended 
only to protect the product.''


    All references to ``antibacterial'' properties and the required 
qualifying statements must be located together, must be printed in type 
of the same size, style, and color, and must be given equal prominence. 
Moreover, such references may not be given any greater prominence than 
other described product features.

IV. Public Record and Electronic Submissions

    The official record for this notice, as well as the public version, 
has been established under docket control number ``OPP-00530'' 
(including comments and data submitted electronically as described 
below). A public version of this record, including printed, paper 
versions of electronic comments, which does not include any information 
claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The official record is 
located at the Virginia address in ``ADDRESSES'' at the beginning of 
this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number ``OPP-00530''. Electronic comments on this 
notice may be filed online at many Federal Depository Libraries.

V. Schedule for Finalizing the PR Notice

    EPA plans to issue and make effective the final PR notice as soon 
as possible. We anticipate that the guidance will be made final and 
effective within the next 6 months.

List of Subjects

    Environmental protection, Antimicrobial pesticides, Treated 
articles exemption.

    Dated: April 8, 1998.

Marcia E. Mulkey,
Director, Office of Pesticide Programs.

[FR Doc. 98-10227 Filed 4-16-98; 8:45 am]
BILLING CODE 6560-50-F