Date: Aug 20, 1998
[Federal Register: April 17, 1998 (Volume 63, Number 74)][Notices] [Page 19256-19258]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr17ap98-43]
ENVIRONMENTAL PROTECTION AGENCY
Clarification of Treated Articles Exemption; Availability of Draft PR Notice
AGENCY: Environmental Protection Agency (EPA)
ACTION: Notice of availability.
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(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- firstname.lastname@example.org. 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: email@example.com.
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.
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.
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.
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 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.
"Antibacterial properties are built-in to inhibit the growth of bacteria that may affect this product. The antibacterial properties do 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.
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: firstname.lastname@example.org
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.
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 SubjectsEnvironmental 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
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