Document ID: EPA-HQ-OPP-2005-0258-0001
Agency: epa
Document Type: Notice
Title: Triadimefon Risk Assessments; Notice of Availability and Risk Reduction Options
Posted Date: 2006-02-15T14:26:27Z

[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]               
[Page 7945-7947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe06-55]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0258; FRL-7761-8]

 
Triadimefon 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 
assessments, and related documents for the triazole fungicide 
triadimefon and for its free triazole metabolites, and opens a public 
comment period on these documents. The triazole fungicides, which 
include triadimefon, triadimenol, 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. The public is encouraged to suggest risk 
management ideas or proposals to address the risks identified. EPA is 
developing a Reregistration Eligibility Decision (RED) for triadimefon 
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-2005-0258; 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-
2005-0258. 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-2005-0258. 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 athttp://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 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

[[Page 7946]]

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 and 
environmental fate and effects risk assessments and related documents 
for triadimefon, a triazole fungicide, and an aggregate risk assessment 
for the free triazole metabolites, and encouraging the public to 
suggest risk management ideas or proposals. Triadimefon is a systemic 
fungicide used to control rust and mildew on apples, grapes, pears, 
pineapple, and raspberries. Non-food uses include pine seedlings, 
Christmas trees, residential and commercial turf, ornamentals, and 
landscapes. EPA developed the risk assessments and risk 
characterization for triadimefon 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).
    Triadimefon is a triazole fungicide. It is used as a preharvest 
foliar treatment on apples, pears, grapes, raspberries, Christmas 
trees, and pine seedlings as well as a pre-/post-harvest treatment for 
pineapple and a pre-plant soak/treatment for pine seeds. Triadimefon 
products are marketed for homeowner use on residential lawns, landscape 
ornamentals, trees, fruit trees, and grapes. Triadimefon-containing 
products are also marketed for use by professional applicators on 
residential turf, golf courses, other turf such as recreational/
commercial areas, and on ornamental plantings. 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).
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessments for triadimefon and for the free triazole metabolites 
1,2,4-triazole, triazole 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 the 
need for a Developmental Neurotoxicity (DNT) study, information on 
potential exposure to triazole conjugates from pharmaceutical products, 
data on actual use patterns including rates, timing, and the kinds of 
tasks that are required to produce agricultural commodities and other 
products, as well as triadimefon-specific turf transferrable residue or 
dislodgeable foliar residue data to help refine exposure and risk 
estimates, 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 triadimefon. Risks of concern associated 
with the use of triadimefon include acute and chronic dietary risks, 
ecological, residential and worker risks associated with the use on 
turf, post-application risk to adults (mowing and gardening) and 
youths/toddlers following application to turf, and worker risk due to 
inhalation exposure for pine seed treatment. In targeting these risks 
of concern, the Agency solicits 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 triadimefon 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

[[Page 7947]]

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 triadimefon, a modified, 4-Phase 
process with one comment period and ample opportunity for public 
consultation seems appropriate in view of its refined risk assessments 
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 RED 
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 Triadimefon. 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, Triadimefon; Triazole Fungicides, 
Pesticides and pests.

    Dated: February 8, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E6-2151 Filed 2-14-06; 8:45 am]

BILLING CODE 6560-50-S