[Federal Register Volume 67, Number 60 (Thursday, March 28, 2002)]
[Notices]
[Pages 14941-14943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7495]



[[Page 14941]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP- 00745; FRL-6809 -9]


Pesticides; Draft Guidance for Pesticide Registrants on False or 
Misleading Pesticide Product Brand Names

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency is announcing the availability of and seeking 
public comment on a draft Pesticide Registration (PR) Notice entitled 
``False or Misleading Pesticide Product Brand Names.'' PR Notices are 
issued by the Office of Pesticide Programs (OPP) to inform pesticide 
registrants and other interested persons about important policies, 
procedures, and registration related decisions, and serve to provide 
guidance to pesticide registrants and OPP personnel. This particular 
draft PR Notice provides guidance to registrants, applicants and the 
public as to what product brand names may be false or misleading, 
either by themselves or in association with company names or 
trademarks.

DATES: Comments, identified by docket control number OPP-00745, must be 
received on or before May 28, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit V.A. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00745 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobial Division, 
(7510C). Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-5448; fax number: (703) 308-6467; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons who are required 
to register pesticides. 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 
information in this notice, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

II. What Guidance Does this PR Notice Provide?

    This draft PR Notice provides guidance to registrants and 
distributors concerning pesticide product brand names that may be false 
or misleading, either by themselves or in association with particular 
company names or trademarks. Occasionally, some registrants and 
distributors have considered or adopted product brand names (or placed 
company names or trademarks within or in close proximity to product 
brand names) that conflict with current Agency regulations concerning 
false or misleading claims [40 CFR 156.10(a)(5) and (b)(2)] and with 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
sections 12(a)(1)(e) and 2(q)(1)(A). Under these regulations, products 
with brand names (or any other statements) that state or imply safety, 
efficacy, or comparative claims, or are false or misleading in any 
particular. are considered to be misbranded. To address this problem as 
it specifically relates to pesticide product brand names, the Agency is 
proposing to clarify the applicability of its regulations as follows:
     These regulations (40 CFR 156.10(a)(5) and 156.10(b)(2)) 
require that a pesticide product brand name, either by itself or 
containing or located in close proximity to a company name or 
trademark, not be false or misleading. Examples of potentially false or 
misleading product brand names are provided in Table 1 in the draft PR 
Notice. In addition, the guidance provided by Section III.4. of PR 
Notice 93-6 (pertaining to the use of ``Brand'' to qualify superlative 
terms) would be superseded by this notice.
     When the draft PR Notice is formally issued, following 
this notice and comment, the Agency would be applying these regulations 
as clarified in the notice when evaluating applications for new 
products or brand names, or notifications for alternate or changed 
brand names, for registration or reregistration. Registrants would 
review their product names in light of the notice, and, if warranted, 
take corrective action before October 1, 2003. It is proposed that as 
of that date, EPA would use this guidance when determining whether a 
product is misbranded under FIFRA section 12.
    Because of the growing potential for product brand names (either by 
themselves or in association with company names or trademarks) that 
appear not to comply with FIFRA and the regulations, the Agency 
believes that additional guidance is needed so that registrants can 
better understand the circumstances under which product brand names are 
potentially false or misleading and what kinds of corrective actions 
are needed for registered products already bearing such brand names.
    The Agency's policy as set forth in the draft PR Notice concludes 
that a pesticide product brand name, either by itself or in connection 
with a company name or trademark must not be false or misleading in any 
particular. EPA's regulations (40 CFR 156.10(a)(5) and (b)(2)) and 
FIFRA give the regulatory foundation for this position.
    The draft PR notice is intended to aid registrants in bringing 
their product brand names into compliance with those regulatory 
requirements. Specifically, that draft document provides clarifying 
guidance to help registrants determine whether their product brand 
names, alone or through association with their company names or 
trademarks, comply with the regulations cited above. To ensure that a 
product's name is consistent with those regulations, a registrant would 
review the brand names of its products in light of the regulations and 
guidance in this notice and take corrective action, if warranted. 
Examples of words, terms, or phrases that might cause product brand 
names to be false or misleading are listed in the draft PR Notice. By 
examining these examples as well as other terms listed in the 
regulations cited above, registrants could determine whether they need 
to take corrective steps.
    If a Federal registrant or distributor of a product were to have a 
product bearing a false or misleading product brand name, then the 
draft PR Notice would provide two basic options for bringing that 
product label into compliance, depending on the specific circumstances:
    (1) Change or delete words, phrases, company names or trademarks in 
the product brand name, and/or
    (2) use an appropriate qualifier or disclaimer.
    The draft PR notice proposes implementation steps for assuring that 
all products are brought into compliance with the applicable 
regulations. When the PR Notice is signed and formally issued, EPA 
would review all applications for new pesticide product registrations, 
for amendments to registered products, and for reregistration of 
registered products using this guidance. It is proposed that as of 
October 1, 2003, the Agency would monitor registered products using 
this guidance to determine whether their

[[Page 14942]]

labeling is consistent with (40 CFR 156.10(a)(5) and 156.10(b)(2)) and 
FIFRA. Pesticide products that are released for shipment by registrants 
or distributors on or after that date and that bear product brand names 
or trademarks that EPA determines are false or misleading would risk 
being considered in violation of FIFRA.
    To give sufficient time for pesticide products in the channels of 
trade to be distributed or sold to users or otherwise disposed of, the 
Agency would provide a period of time for companies to comply with 
those labeling elements that have been clarified by this notice. 
Therefore, pesticide products released for shipment prior to October 1, 
2003, would be considered existing stocks in the channels of trade that 
may be sold, used or otherwise disposed of until exhausted. Registrants 
and distributors would need to take corrective measures as soon as 
possible to assure that their product brand names are in compliance 
with FIFRA and its implementing regulations. Registrants who would want 
to modify their product labels to ensure compliance with FIFRA would 
submit revised labeling using the notification or amendment application 
process, as applicable.
    The Agency is aware of certain Constitutional considerations that 
are applicable to commercial speech such as use of a corporate or 
product name or other statements in connection with a product's 
features or claims. It is the Agency's intent to address such 
considerations in this proposed PR Notice so as to promote the exercise 
of commercial speech in a way that does not run afoul of statutory and 
regulatory prohibitions against false or misleading statements in 
connection with sale or distribution of pesticide products. This 
proposed PR Notice deals with inherently false or misleading statements 
or claims and potentially false or misleading statements or claims--in 
particular, those that occur in names that appear on products. Rather 
than attempting to prohibit product names or claims where they may 
seemingly be false or misleading, the PR Notice incorporates an 
approach where the remedy is tailored to the situation. As such, the 
Agency recognizes that there may be instances where full prohibition 
may not be warranted and that some remedy short of prohibition might be 
employed such as the use of qualifiers or different placement of the 
statement or name on the product label. This proposed PR Notice seeks 
to employ such an approach.

III. Do PR Notices Contain Binding Requirements?

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and decision-makers and to pesticide 
registrants. While the requirements in the statutes and Agency 
regulations described here are binding on EPA and the applicants, this 
PR Notice itself is not binding on either EPA or pesticide registrants, 
and EPA may depart from the guidance where circumstances warrant and 
without prior notice. Likewise, pesticide registrants may assert that 
the guidance is not appropriate generally or not applicable to a 
specific pesticide or situation.

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

    1. Electronically. You may obtain an electronic copy of this 
Federal Register document using the date of publication from the 
listing of EPA Federal Register documents at http://www.epa.govlfedrgstr/. You may obtain an electronic copy of this PR-
Notice, as well as other PR-Notices, both final and draft, at http://www.epa.gov/PR_Notices/.
    2. Fax-on-demand. You may request a faxed copy of the draft 
Pesticide Registration (PR) Notice entitled ``False or Misleading 
Pesticide Product Brand Names,'' by using a faxphone to call (202) 401-
0527 and selecting item 6146. You may also follow the automated menu.
    3. In person. The Agency has established an official record for 
this action under docket control number OPP-00745. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period and other 
information related to this action, including any information claimed 
as Confidential Business Information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

V. How Do I Submit Comments?

A. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00745 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRlB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-00745. Electronic comments may 
also be filed online at many Federal Depository Libraries.

B. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record.

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Information not marked confidential will be included in the public 
version of the official record without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person identified under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

D. Issues for Comment

    Following are several key issues that you may wish to comment on. 
While the Agency has identified these three issues, it does not intend 
to limit the issues upon which you may provide comments should you 
believe the Agency needs to consider other issues.
    1. Does the draft PR Notice provide a reasonable approach to 
qualifying or disclaiming product names that might otherwise appear to 
conflict with EPA's regulations concerning false or misleading claims?
    2. Could some claims in product names be so egregious that they 
could not be adequately qualified or disclaimed (e.g., ``Safe As Water 
Insecticide'')?
    3. Does the Agency's proposed approach adequately balance 
commercial speech considerations and protection of the public against 
false or misleading claims in connection with the sale or distribution 
of pesticide products?

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

    Dated: March 14, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 02-7495 Filed 3-27-02; 8:45 a.m.]
BILLING CODE 6560-50-S