Document ID: EPA-HQ-OPP-2006-0038-0001
Agency: epa
Document Type: Notice
Title: Triadimenol Risk Assessments; Notice of Availability and Risk Reduction Options
Posted Date: 2006-02-15T14:54:39Z

[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]               
[Page 7947-7949]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe06-56]                         

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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: pates.john@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 
http://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]

BILLING CODE 6560-50-S