[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7947-7949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2152]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0038; FRL-7761-7]
Triadimenol Risk Assessments; Notice of Availability and Risk
Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's risk
assessment, and related documents for the triazole fungicide
triadimenol and for its free triazole metabolites, and opens a public
comment period on these documents. The triazole fungicides, which
include triadimenol, triadimefon, and propiconazole, and others, share
the common metabolites 1,2,4-triazole, triazole alanine, and triazole
acetic acid (also known as free triazoles). EPA has conducted an
aggregate risk assessment for the free triazole metabolites to ensure
that aggregate exposure and risk from these common metabolites meet the
current safety standards. he public is encouraged to suggest risk
management ideas or proposals to address the risks identified. EPA is
developing a tolerance reassessment decision (TRED) for triadimenol
through a modified, 4-Phase 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 must be received on or before April 17, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0038, by one of the following methods:
http://www.regulations.gov/. Follow the on-line
instructions for submitting comments.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2006-0038. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is (703) 305-5805. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0038. EPA's policy is that all comments received will be included
in the public 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 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 captured automatically and included as part
of the comment that is placed in the public 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm/.
Docket: All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public Information
and Records
[[Page 7948]]
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA. The docket facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the docket facility is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8195; fax
number: (703) 308-8041; 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
www.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?
EPA is releasing for public comment its human health risk
assessment and related documents for triadimenol, a triazole fungicide,
and an aggregate risk assessment for the free triazole metabolites, and
encouraging the public to suggest risk management ideas or proposals.
Triadimenol is a systemic fungicide used as a seed treatment for
barley, corn, cotton, oats, rye, sorghum, and wheat. In addition, other
triazole fungicides, which may metabolize to triazole conjugates, are
formulated into pharmaceutical products which are approved for use by
the Food and Drug Administration (FDA).
Additionally, an import tolerance on bananas has been established.
Tolerances are established for residues of triadimenol and its
butanediol metabolite in/on various plant commodities and are regulated
as metabolites of the fungicide triadimefon. EPA developed the risk
assessment and risk characterization for triadimenol through a modified
version of its public process for making pesticide reregistration
eligibility and tolerance reassessment decisions. Through these
programs, EPA is ensuring that pesticides meet current standards under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessment for triadimenol and for the free triazole metabolites 1,2,4-
triazoleole alanine, and triazole acetic acid. Such comments and input
could address, for example, the availability of additional data to
further refine the risk assessments, such as both acute and subchronic
neurotoxicity studies, a Developmental Neurotoxicity (DNT) study,
information on potential exposure to triazole conjugates from
pharmaceutical products, and separate metabolism studies (seed
treatment) to confirm residues of concern, or could address the
Agency's risk assessment methodologies and assumptions as applied to
this specific pesticide.
Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for triadimenol. As there are no residential
uses associated with triadimenol, the aggregate risk assessment
includes exposure from food and drinking water only. Acute and chronic
aggregate risks (food and drinking water) are below the Agency's level
of concern for all population subgroups. The current risk assessment
only addresses risks associated with residues of triadimenol resulting
from the use of triadimenol as an active ingredient. There are
additional exposures to triadimenol residues that result from the use
of the active ingredient triadimefon, because triadimefon degrades to
triadimenol, but those exposures have not been aggregated with
exposures from the use of triadimenol alone because the risks
associated with the active ingredient triadimefon are currently
unacceptable. However, once the triadimefon risks have been refined or
mitigated, EPA will conduct an aggregate assessment of the risks
associated with triadimenol residues that result from the use of both
active ingredients, triadimenol and triadimefon. In targeting these
potential risks of concern, the Agency solicits comments on assumptions
used in the current risk assessment as well as information on effective
and practical risk reduction measures.
EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to
[[Page 7949]]
triadimenol or its free triazole metabolites, compared to the general
population.
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
the issues, and degree of public concern associated with each
pesticide. For triadimenol, a modified, 4-Phase process with one
comment period and ample opportunity for public consultation seems
appropriate in view of its refined risk assessment and other factors.
However, if as a result of comments received during this comment period
EPA finds that additional issues warranting further discussion are
raised, the Agency may lengthen the process and include a second
comment period, as needed. The decisions presented in the TRED may be
supplemented by further risk mitigation measures when EPA considers
whether a cumulative assessment is necessary for the triazole group of
pesticides.
All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments
will become part of the Agency Docket for Triadimenol. Comments
received after the close of the comment period will be marked ``late.''
EPA is not required to consider these late comments.
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 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, Triadimenol; Triazole Fungicides,
Pesticides and pests.
Dated: February 8, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-2152 Filed 2-14-06; 8:45 am]
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