[Federal Register Volume 70, Number 12 (Wednesday, January 19, 2005)]
[Notices]
[Pages 3022-3024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1026]



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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0335; FRL-7685-7]


D-Limonene; Reregistration Eligibility Decision for Low Risk 
Pesticide; Notice of Availability

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the availability of EPA's 
Reregistration Eligibility Decision (RED) for the pesticide D-Limonene, 
and opens a public comment period on this document, related risk 
assessments, and other support documents. EPA has reviewed the low risk 
pesticide D-Limonene through a modified, streamlined version of the 
public participation process that the Agency uses to involve the public 
in developing pesticide reregistration and tolerance reassessment 
decisions. Through these programs, EPA is ensuring that all pesticides 
meet current health and safety standards.

DATES:  Comments, identified by docket ID number OPP-2004-0335, must be 
received on or before March 21, 2005.

ADDRESSES:  Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Mark Perry, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8024; fax 
number: (703) 308-8024; 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, and may be of 
interest to a wide range of stakeholders including environmental, human 
health, and agricultural advocates; the chemical industry; pesticide 
users; and members of the public interested in the sale, distribution, 
or use of pesticides. Since others also may 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 
applicability of this action to a particular entity, consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2004-0333. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although, a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although, not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B.1. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the

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comment and allows EPA to contact you in case EPA cannot read your 
comment due to technical difficulties or needs further information on 
the substance of your comment. EPA's policy is that EPA will not edit 
your comment, and any identifying or contact information provided in 
the body of a comment will be included as part of the comment that is 
placed in the official public docket, and made available in EPA's 
electronic public docket. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0333. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to opp-epa.gov, 
Attention: Docket ID number OPP-2004-0335. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0335.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0335. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit the 
copy that does not contain CBI on disk or CD ROM, mark the outside of 
the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed 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 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 your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline 
identified.
    8. To ensure proper receipt by EPA, identify the appropriate docket 
ID number in the subject line on the first page of your response. It 
would also be helpful if you provided the name, date, and Federal 
Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

     Under section 4 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to 
ensure that they meet current scientific and regulatory standards. 
Using a modified, streamlined version of its public participation 
process, EPA has completed a RED for the low risk pesticide, D-Limonene 
under section 4(g)(2)(A) of FIFRA. EPA has determined that the data 
base to support reregistration is substantially complete and that 
products containing D-Limonene will be eligible for reregistration, 
provided the risks are mitigated either in the manner described in the 
RED or by another means that achieves equivalent risk reduction. Upon 
submission of any required product-specific data under section 
4(g)(2)(B) and any necessary changes to the registration and labeling 
(either to address any concerns identified in the RED or as a result of 
product specific data), EPA will make a final reregistration decision 
under section 4(g)(2)(C) for products containing D-Limonene.
     D-limonene has a lemon-like flavor and smell, and occurs naturally 
in citrus and certain fruits, vegetables, meats and spices. D-limonene 
is used as both an active and inert ingredient in pesticide products, 
and as an ingredient in food products, soaps and perfumes. As an active 
ingredient, it is used as an insecticide, insect repellant, and animal 
(dog and cat) repellent. As a pesticide inert ingredient it is used as 
a solvent or fragrance. It is also found in consumer products such as 
certain foods, soaps, and perfumes. The Food and Drug Administration 
(FDA) considers D-limonene to be generally recognized as safe (GRAS) as 
a food additive when used as a synthetic flavoring substance and 
adjuvant (21 CFR 182.60). D-limonene is not registered for food or feed 
crop uses as an active ingredient, but can be used on compost and 
manure.
     EPA must review tolerances and tolerance exemptions that were in 
effect when the Food Quality Protection Act (FQPA) was enacted in 
August 1996, to ensure that these existing pesticide residue limits for 
food and feed commodities meet the safety standard established by the 
new law. Tolerances are considered reassessed once the safety finding 
has been made or a revocation occurs. EPA has reviewed and made the 
requisite safety finding for the D-Limonene tolerances included in this 
notice.

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     EPA is applying the principles of public participation to all 
pesticides undergoing reregistration and tolerance reassessment. The 
Agency's Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process, published in the Federal Register on May 14, 
2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these 
programs, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
issues, and degree of public concern associated with each pesticide. 
EPA can expeditiously reach decisions for pesticides like D-Limonene, 
which pose no risk concerns, have low use, affect few if any 
stakeholders, and require no risk mitigation. Once EPA assesses uses 
and risks for such pesticides, the Agency may go directly to a decision 
and prepare a document summarizing its findings. The Agency therefore 
is issuing the low risk D-Limonene RED, risk assessments, and related 
documents simultaneously for public comment.
     The reregistration program is being conducted under 
Congressionally mandated time frames, and EPA recognizes the need both 
to make timely decisions and to involve the public in finding ways to 
effectively mitigate pesticide risks. D-Limonene, however, poses no 
risks that require mitigation. The Agency, therefore, is issuing the D-
Limonene RED, its risk assessments, and related support materials 
simultaneously for public comment. The comment period is intended to 
provide an opportunity for public input and a mechanism for initiating 
any necessary amendments to the RED. All comments should be submitted 
using the methods in Unit I. of the SUPPLEMENTARY INFORMATION, and must 
be received by EPA on or before the closing date. These comments will 
become part of the Agency Docket for D-Limonene. Comments received 
after the close of the comment period will be marked ``late.'' EPA is 
not required to consider these late comments.
     EPA will carefully consider all comments received by the closing 
date and will provide a Response to Comments Memorandum in the Docket 
and electronic Edocket. If any comment significantly affects the 
document, EPA will also, publish an amendment to the RED in the Federal 
Register. In the absence of substantive comments requiring changes, the 
D-Limonene RED will be implemented as it is now presented.

B. What is the Agency's Authority for Taking this Action?

     Section 4(g)(2) of FIFRA as amended directs that, after submission 
of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in 
product-specific data on individual end-use products and either 
reregistering products or taking other ``appropriate regulatory 
action.''
     Section 408(q) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(q), requires EPA to review tolerances and 
exemptions for pesticide residues in effect as of August 2, 1996, to 
determine whether the tolerance or exemption meets the requirements of 
section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by 
August 3, 2006.

List of Subjects

     Environmental protection, Pesticides and pests.

    Dated: December 17, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-1026 Filed 1-18-05; 8:45 am]
BILLING CODE 6560-50-S