Date: Feb 18, 2000
In the February 11, 2000 Federal Register (65 Fed. Reg.7007), EPA announced the availability of the final version of Pesticide Registration (PR) Notice 2000-1 regarding the treated articles exemption under 40 C.F.R. § 152.25(a). The Notice provides guidance on the types of claims deemed acceptable for products within the treated articles exemption and on the requirement that the pesticide in a treated article be "registered for such use." EPA announced the draft version of the PR Notice on April 17, 1998 in the Federal Register. (63 Fed. Reg. 19256). Since then, EPA has negotiated with a number of parties to develop this final version. Although there are a few remaining issues to be addressed, generally, EPA has followed many of the recommendations that we provided.
Generally, no public health claims may be made on treated articles. Claims limited in accordance with the PR Notices will be allowed for unregistered products. The highlights of the anticipated PR Notice are listed below.
The Notice will go into effect one year from the date of issuance (February 11, 2001).
Use of the words "antibacterial," "bactericidal," "germicidal," or any references to activity against germs or human pathogens are considered per se public health claims outside the scope of the exemption.
Use of "antimicrobial," "fungistatic," "mildew-resistant," and "preservative" are acceptable for treated articles as long as the claims are properly and clearly qualified and not part of the name of the product. References to the pesticidal properties and the qualifying statements should be located together, in the same prominence - type-size, style, color. The claims should not be given any greater prominence than other product features described on the label.
Claims made to inhibit offensive odors in the article are considered non-public health claims acceptable for treated articles.
Non-public health claims for microbial odor control and mold and mildew claims associated with deterioration, discoloration, and staining when properly and clearly qualified are acceptable for treated articles.
EPA may determine that use of trademarked product names for the treated article, or references to trademarked names of registered pesticides, constitutes public health claims.
The Notice provides a list of examples of claims that the agency would likely consider unacceptable.
The Notice also lists examples of claims likely to be acceptable for mold and mildew resistance and odor resistance.
The registration and labeling of the antimicrobial pesticide incorporated into treated articles needs to include specific listings of the articles or substances that may be treated. EPA does not permit broad general use patterns.
In general, the PR Notice admits that flexibility is available in describing the benefits to a treated article of an antimicrobial that has been used to protect the article. Some flexibility is also admitted with regard to disclaimers of public health benefits that might otherwise be inferred or implied. However, the examples provided by EPA imply that the amount of flexibility may be limited. Moreover, EPA's position that the use of certain words, e.g, bactericidal, is completely prohibited under the treated article exemption suggests that EPA has not really taken to heart the comments that restrictions on commercial free speech must be carefully limited to avoid infringing rights granted under the First Amendment of the U.S. Constitution. We do not believe EPA has adequately established that the prohibited words are so likely to be misleading that there is no less burdensome alternative than to prohibit their use completely.
Please click here to view a PDF version of the PR Notice.
We are preparing a brief memorandum describing the remaining issues which need to be addressed to be placed on this Web site shortly. Please feel free to contact <ahref="index.cfm?fuseaction=biographies.showbiodetail&id=174&lastname=sarvadi&firstname=david&initial=g.&sarvadi">David Sarvadi at (202) 434-4249 or via e-mail at <ahref="mailto:email@example.com">firstname.lastname@example.org if you have any questions.</ahref="mailto:email@example.com"></ahref="index.cfm?fuseaction=biographies.showbiodetail&id=174&lastname=sarvadi&firstname=david&initial=g.&sarvadi">