[Federal Register Volume 65, Number 101 (Wednesday, May 24, 2000)]
[Notices]
[Pages 33542-33543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12960]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00651; FRL-6551-6]


Minimum Risk Pesticides Exempted Under FIFRA Section 25(b); 
Clarification of Issues; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice clarifies several aspects of the exemption for 
minimum risk pesticides by the FIFRA section 25(b) rule, including 
composition, labeling, food tolerances, and state regulation. It is 
being issued to answer questions frequently asked of EPA about such 
products. Registration (PR) Notice 2000-6, Entitled ``Minimum Risk 
Pesticides Exempted under FIFRA Section 25(b); Clarification of 
Issues,'' provides guidance to the registrant concerning frequently 
asked questions regarding section 25(b) and is effective now but 
comments will be accepted for 30 days, after which the Agency may 
revise the notice.

DATES: Comments, identified by docket control number OPP-00651, must be 
received on or before June 23, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00651 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Brian Steinwand (7511C), Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-7973; fax number: 
(703) 308-7026; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. 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 
interested in section 25(b) exempted products. 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.

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 the PR Notice from the Office of Pesticide Programs' Home 
Page at http://www.epa.gov/pesticides/. You can also go directly to the 
listings from the EPA Internet 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 PR Notice 
Entitled ``Minimum Risk Pesticides Exempted under FIFRA Section 25(b); 
Clarification of Issues,'' by using a faxphone to call (202) 401-0527 
and selecting item 6130. 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-00651. 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

[[Page 33543]]

available for inspection in the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson 
Davis Highway, 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.

C. 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-00651 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, Environmental Protection Agency, 
Ariel Rios Bldg., 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, 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB 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-00651. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. 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. 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.

E. 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.

II. Background

A. What Guidance Does This PR Notice Provide?

    Except in very limited circumstances, any substance that makes a 
pesticidal claim must be registered by EPA before it can be legally 
sold or distributed. One such exemption to the registration requirement 
is for those pesticides under section 25(b) of FIFRA. In 1996, EPA 
exempted certain minimum risk pesticides from FIFRA requirements if 
they satisfy certain conditions. EPA exempted the products described in 
40 CFR 152.25(g) in part to reduce the cost and regulatory burdens on 
businesses as well as the public for pesticides posing little or no 
risk, and to focus EPA's limited resources on pesticides which pose 
greater risk to humans and the environment. To qualify for an exemption 
as a minimum risk pesticide, each active ingredient in the pesticide 
product must be listed in 40 CFR 152.25(g)(1). In addition, 40 CFR 
152.25(g)(2) provides that these pesticide products may only contain 
minimal risk inert ingredients listed in List 4A. The PR Notice is 
intended to answer frequently asked questions regarding composition, 
labeling, food tolerances, and state regulation.

B. Why Is a PR Notice Guidance and Not a Rule?

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and decision-makers, and to the public. As a 
guidance document and not a rule, this policy is not binding on either 
EPA or any outside parties. Although this guidance document provides a 
starting point for EPA decisions, EPA will depart from this policy 
where the facts or circumstances warrant. In such cases, EPA will 
explain why a different course was taken. Similarly, outside parties 
remain free to assert that this policy is not appropriate for a 
specific pesticide or that the specific circumstances demonstrate that 
this policy should be abandoned.
    EPA has stated in this notice that it will make available revised 
guidance after consideration of public comment, if mecessary. Public 
comment is not being solicited for the purpose of converting this 
guidance document into a binding rule. EPA will not be codifying this 
policy in the Code of Federal Regulations. EPA is allowing comment so 
that it can make fully informed decisions regarding the content of this 
guidance.
    The ``revised'' guidance will not be an unalterable document. Once 
a ``revised'' guidance document is issued, EPA will continue to treat 
it as guidance, not a rule. Accordingly, on a case-by-case basis EPA 
will decide whether it is appropriate to depart from the guidance or to 
modify the overall approach in the guidance. In the course of 
commenting on this guidance document, EPA would welcome comments that 
specifically address how the guidance document can be structured so 
that it provides meaningful guidance without imposing binding 
requirements.

List of Subjects

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

    Dated: May 5, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-12960 Filed 5-23-00; 8:45 am]
BILLING CODE 6560-50-F