[Federal Register Volume 64, Number 191 (Monday, October 4, 1999)]
[Notices]
[Pages 53676-53678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25714]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-30414A; FRL-6385-1]
Pesticide Product Registrations; Conditional Approval
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces Agency approval of applications
submitted by Novartis Crop Protection Inc., to conditionally register
the pesticide products Emamectin Benzoate Technical, Denim Insecticide,
and Proclaim Insecticide, products containing a new active ingredient
not included in any previously registered products pursuant to the
provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended.
FOR FURTHER INFORMATION CONTACT: By mail: Linda Arrington, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: 703-305-5446; and e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
[[Page 53677]]
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``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 certain other related documents that might be available
electronically, 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/.
To access a fact sheet which provides more detail on this
registration, go to the home page for the Office of Pesticide Programs
at http://www.epa.gov/pesticides/, and select ``factsheet.''
2. In person. The Agency has established an official record for
this action under docket control number OPP-30414A. 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.
In accordance with section 3(c)(2) of FIFRA, a copy of the approved
label, the list of data references, the data and other scientific
information used to support registration, except for material
specifically protected by section 10 of FIFRA, are available for public
inspection in the Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal
Mall #2, Arlington, VA ((703) 305-5805). Requests for data must be made
in accordance with the provisions of the Freedom of Information Act and
must be addressed to the Freedom of Information Office (A-101), 401 M
St., SW., Washington, DC 20460. Such requests should: Identify the
product name and registration number and specify the data or
information desired.
A paper copy of the fact sheet, which provides more detail on this
registration, may be obtained from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161.
II. Did EPA Conditionally Approve the Application(s)?
A conditional registration may be granted under section 3(c)(7)(C)
of FIFRA for a new active ingredient where certain data are lacking, on
condition that such data are received by the end of the conditional
registration period and do not meet or exceed the risk criteria set
forth in 40 CFR 154.7; that use of the pesticide during the conditional
registration period will not cause unreasonable adverse effects; and
that use of the pesticide is in the public interest. The Agency has
considered the available data on the risks associated with the proposed
use of emamectin benzoate, and information on social, economic, and
environmental benefits to be derived from such use. Specifically, the
Agency has considered the nature and its pattern of use, application
methods and rates, and level and extent of potential exposure. Based on
these reviews, the Agency was able to make basic health and safety
determinations which show that use of emamectin benzoate during the
period of conditional registration will not cause any unreasonable
adverse effect on the environment, and that use of the pesticide is, in
the public interest.
Consistent with section 3(c)(7)(C) of FIFRA, the Agency has
determined that these conditional registrations are in the public
interest. Use of the pesticides are of significance to the user
community, and appropriate labeling, use directions, and other measures
have been taken to ensure that use of the pesticides will not result in
unreasonable adverse effects to man and the environment.
III. Conditionally Approved Registrations
EPA issued a notice, published in the Federal Register of July 10,
1996 (61 FR 36372)(FRL-5377-9), which announced that Merck Research
Laboratories, P.O. Box 450 Hillsborough Rd., Three Bridges, NJ 0887-
0450, had submitted applications to register the products Emamectin
Benzoate Technical, Proclaim 0.26 EC Insecticide, and Proclaim 5 SG
Insecticide (EPA File Symbols 618-RNI, 618-RNT, and 618-RNA) containing
the active ingredient emamectin benzoate 4''-epi-methylamino-4''-
deoxavermectin B1 benzoate [A mixture of a minimum of 90''-
epi-methylamino-4''-deoxyavermectin B1 and a maximum of
10''-epi-methylamino-4''-deoxyavermectin B1 benzoate at 95%,
2.15%, and 5% respectively. The technical product is the only one
containing emamectin benzoate and 4% of related compounds. These
products were not previously registered.
These products were subsequently transferred to Novartis Crop
Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300, and were
asssigned new EPA Registration Numbers.
The applications were approved on May 19, 1999, for one technical
and two end-use products:
1. Emamectin Benzoate Technical for formulation use only (EPA
Registration Number 100-902.
2. Denim Insecticide (formerly Proclaim 0.16 EC) for use on cavalo
broccolo (EPA Registration Number 100-903).
3. Proclaim Insecticide for control of certain lepidopteran pests
on head and stem Brassica vegetables, celery, and lettuce (EPA
Registration Number 100-904).
Authority: 7 U.S.C. 136.
List of Subjects
Environmental protection, Pesticides and pests.
[[Page 53678]]
Dated: September 23, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 99-25714 Filed 10-1-99; 8:45 am]
BILLING CODE 6560-50-F