[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Notices]
[Pages 42945-42947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-20316]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34192; FRL-6097-9]


Neurotoxic Pesticides; Availability of Data Call-In Notice

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is requiring registrants of neurotoxic pesticides to 
conduct acute, subchronic, and developmental neurotoxicity studies and 
submit the results to EPA. These studies are designed to show the 
effects of a chemical on the nervous system. EPA will issue Data Call-
In Notices to registrants of all neurotoxic pesticides in phases over 
time, beginning with the cholinesterase-inhibiting organophosphates 
because of their known neurotoxicity concerns. EPA expects to receive 
the first studies within 2 years. This Data Call-In program was 
developed with the advice of the Children's Health Advisory Committee 
and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
Scientific Advisory Panel.

DATES: The Data Call-In Notice will be available October 5, 1999.


[[Page 42946]]


ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number OPP-34192 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone numbers: (703) 308-8004 and fax number: (703) 308-8005; e-
mail address: angulo.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

     You may be potentially affected by this notice if you manufacture 
or formulate pesticides. Potentially affected categories and entities 
may include, but are not limited to:


 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            potentially
                                                       affected entities
------------------------------------------------------------------------
Pesticide producers               32532               Pesticide
                                                       manufacturers
                                                      Pesticide
                                                       formulators
------------------------------------------------------------------------


    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 could also be affected. If 
available, the North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this notice affects certain entities. If you have any 
questions regarding the applicability of this announcement to you, 
consult the person listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

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

A. Electronically

     You may obtain electronic copies of this document and other 
related documents 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 obtain electronic copies of the Neurotoxicity Data Call-In 
Notice mentioned in this notice, you can go directly to the Home Page 
for the Office of Pesticide Programs (OPP) at http://www.epa.gov/ pesticides/.

B. In Person

     The Agency has established an official record for this action 
under docket control number OPP-34192. 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 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 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.

III. How Can I Respond to this Action?

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-34192 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division, Office of Pesticide Programs, Environmental 
Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA. The Document Control Office (DCO) is open 8 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 in this unit. 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 5.1/6.1 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPP-34192. Electronic 
comments may also be filed online at many Federal Depository Libraries.

B. How Should I Handle CBI Information 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 listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

IV. What Action is EPA Taking in this Notice?

    EPA is requiring registrants of neurotoxic pesticides to conduct 
acute, subchronic, and developmental neurotoxicity studies and submit 
the results to EPA. These studies are designed to show the effects on 
the nervous system of a chemical with a one-time or very short-term 
dose (acute), with exposure over an extended period of time (sub-
chronic), and before or shortly after birth (developmental). The data 
developed in response to this Data Call-In will help determine whether 
or not differences occur because of age or stage of nervous system 
development. (The differences could be measurable (or quantitative) or 
descriptive (qualitative)). EPA will use these data in making decisions 
in the implementation of certain aspects of the Food Quality Protection 
Act's (FQPA) tolerance-setting process.

[[Page 42947]]

    EPA is implementing the Data Call-In in phases over the next 
several months to ensure that data from the highest priority neurotoxic 
pesticides are called in first and that the laboratory capacity 
available to pesticide registrants is adequate to perform the studies 
within the required timeframes. This program to call in data will apply 
to approximately 140 pesticides. The cholinesterase-inhibiting 
organophosphates have been selected to be the first chemical class to 
be called in, based on their known neurotoxicity concerns. EPA expects 
to receive the first studies within 2 years. This Data Call-In program 
was developed with the advice of the Children's Health Advisory 
Committee and the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) Scientific Advisory Panel.

List of Subjects

     Environmental protection, Chemicals, Pesticides and pests.

    Dated: August 2, 1999.

Lois A. Rossi,

Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

[FR Doc. 99-20316 Filed 8-5-99; 8:45 am]
BILLING CODE 6560-50-F