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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: May 24, 2000 (Volume 65, Number 101)]
[Notices]
[Page 33542-33543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my00-49]

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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: steinwand.brian@epa.gov.

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: ``opp-docket@epa.gov,'' 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
Minimum Risk Pesticides Exempted Under FIFRA Section 25(b); Clarification of Issues; Notice of Availability

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