[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35669-35671]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn06-103]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0151; FRL-8065-2]
Simazine; Reregistration Eligibility Decision; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) for the chlorinated triazine pesticide
simazine, and opens a public comment period on this document, related
risk assessments, and other support documents. Simazine is a systemic
herbicide that is usually applied to soil, absorbed through leaves and
roots, and acts by inhibiting photosynthesis within the targeted plant.
It is widely used as a selective herbicide to control most annual
grasses and broadleaf weeds before they emerge or after removal of weed
growth. EPA has reviewed simazine through 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.
The Agency is concurrently issuing for public comment the Triazine
Cumulative Risk Assessment; see EPA-HQ-OPP-2005-0481 in the Notice
section of this issue of the Federal Register.
DATES: Comments must be received on or before August 21, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0151, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P),
[[Page 35670]]
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0151. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
,or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Diane Sherman, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0128; fax
number: (703) 308-8005; e-mail address: sherman.diane@epa.gov.
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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
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. EPA
has completed a Reregistration Eligibility Decision (RED) for the
chlorinated triazine pesticide, simazine, under section 4(g)(2)(A) of
FIFRA. Simazine is widely used as a selective herbicide and registered
for use on a variety of food and feed crops, including, but not limited
to, fruit and nut crops in addition to corn. Simazine can also be
applied at forestry sites and on turfgrass grown commercially for sod.
Simazine is registered for residential use on turfgrass including both
commercial use on recreational lawns such as golf courses and
commercial or homeowner use on lawns. An algaeicide use exists for
ornamental ponds and aquariums of 1,000 gallons or less. End-use
products containing simazine are formulated as pellets/tablets, dry
flowables, emulsifiable concentrates, flowable concentrates, and ready-
to-use liquids. These product formulations may be applied on the ground
by broadcast across an area, as a spot treatment, or in rows, which is
also referred to as band treatment.
The simazine RED presents the Agency's conclusions on the risks
posed by exposure to simazine alone; however, section 408(b)(2)(D)(v)
of the Federal Food, Drug and Cosmetic Act (FFDCA) directs the Agency
also to consider available information on the cumulative risk from
substances sharing a common
[[Page 35671]]
mechanism of toxicity. Simazine shares a neuroendocrine mechanism of
toxicity, which results in both reproductive and developmental
consequences, with the structurally-related chlorinated triazine
pesticides atrazine and propazine. Because these chlorinated triazine
pesticides share a common mechanism of toxicity, the Agency evaluated
the cumulative risk posed by this group while making final
reregistration eligibility decisions on individual chlorinated
triazines.
EPA has determined that the data base to support reregistration is
substantially complete and that products containing simazine are
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 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 simazine.
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 simazine tolerances included in this
notice.
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 of May 14,
2004, (69 FR 26819)(FRL-7357-9) explains that in conducting these
programs, EPA 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.
Due to its refined risk assessment and the relatively limited risk
management issues associated with this pesticide, simazine was reviewed
through the modified four-phase process. Through this process, EPA
worked extensively with stakeholders and the public to reach the
regulatory decisions for simazine.
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. The Agency is issuing the simazine
RED for public comment. This comment period is intended to provide an
additional opportunity for public input and a mechanism for initiating
any necessary amendments to the RED. All comments should be submitted
using the methods in ADDRESSES, and must be received by EPA on or
before the closing date. These comments will become part of the Agency
Docket for simazine. Comments received after the close of the comment
period will be marked ``late.'' EPA is not required to consider these
late comments.
The Agency will carefully consider all comments received by the
closing date and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. 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
simanzine RED will be implemented as it is now presented.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2)(A) of FIFRA, as amended, requires the Aministrator
to make ``a determination as to the eligibility for reregistration (i)
for all active ingredients subject to reregistration under this section
for which tolerances or exemptions from tolerances are required under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not
later than the last date for tolerance reassessment established under
section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)) . . . .''
Section 408(q) of the 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. A tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2), respectively, if ``the
Administrator determines [the pesticide chemical residue] is safe'',
i.e., ``that there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' 21 U.S.C. 346a(b)(2)(A), (c)(2)(A). In
making this safety finding, FFDCA requires the Administrator to
consider, among other factors, ``available information concerning the
cumulative effects of such residues and other substances that have a
common mechanism of toxicity . . . .'' 21 U.S.C. 346a(b)(2)(D)(v),
(c)(2)(B).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 9, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-9462 Filed 6-20-06; 8:45 am]
BILLING CODE 6560-50-S