[Federal Register Volume 70, Number 37 (Friday, February 25, 2005)]
[Notices]
[Pages 9317-9319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3535]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0183; FRL-7696-6]


Thiram Reregistration Eligibility Decision

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 thiram. The Agency's risk 
assessments and other related documents also are available in the 
thiram docket. EPA has reviewed thiram

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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.

FOR FURTHER INFORMATION CONTACT:  Craig Doty, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0122; 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. 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-2004-0183. 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 athttp://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 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. 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. 
Once in the system, select ``search,'' then key in the appropriate 
docket ID number.

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 
pesticide, thiram 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 thiram are eligible for reregistration 
depending on their specific uses, provided the risks are mitigated 
either in the manner described in the RED.
    Thiram is a member of the dithiocarbamate class of non-systemic 
fungicides. It is used as a fungicide to prevent crop damage in the 
field and to protect harvested crops (apples, peaches, and 
strawberries) from deterioration in storage or transport. It is also 
used as a seed protectant (e.g., small seeded vegetables, large seeded 
vegetables, cereal grains and other seeds, coniferous seeds, cotton 
seed, ornamental seeds, and soybeans) and to protect turf from fungal 
diseases. In addition, thiram is used as an animal repellent to protect 
crops from damage by rabbits, rodents, and deer. Thiram is available in 
a variety of formulations including dust, wettable powder, water 
dispersable granule, flowable concentrate, dry flowable, soluble 
concentrate, and ready-to-use liquid. Thiram is applied both by 
commercial seed treaters and on-farm applicators.
    An aggregate risk assessment looks at the combined risk from 
dietary exposure (food and drinking water pathways) as well as 
exposures from non-occupational sources (e.g., residential uses). Acute 
risks from aggregate exposures are not of concern, due to removal of 
strawberries from the label, a voluntary request for cancellation of 
apple uses, and requests for voluntary cancellation of most residential 
uses. Short-term aggregate risks are not of concern. The Agency 
concludes with reasonable certainty that aggregate exposure to food and 
drinking water will not result in an unacceptable chronic risk. The 
Agency's human heath risk assessment indicates no risks of concern. 
Thiram will no longer be available for sale or use by homeowner 
applicators. As such, all residential risks were calculated related to 
the non-residential turf uses that include golfing for adults and 
toddler exposures in areas that can be treated with thiram by certified 
pesticide applicators. No risk mitigation measures are required to 
address this scenario.
    To protect children from scenarios of concern for exposure to 
thiram-treated turf and to further protect from exposure to ornamentals 
treated with thiram as a deer repellent, the Agency is requiring label 
modifications as outlined in the RED.
    The Agency calculated the potential exposure and risk to pesticide 
handlers from 28 major occupational exposure scenarios based on the 
types of equipment and techniques that potentially can be used for 
thiram applications. For the most part, current label requirements (for 
personal protection single layer clothing, gloves, and no respirator) 
appear to be generally adequate. To reduce worker exposure, the Agency 
has determined that the following measures for specific scenarios are 
appropriate and required for reregistration eligibility:
     Comply with label changes with updated Worker Protection 
Standard and other regulations.
     Cancellation of the aerial and hand/spoon applications of 
granular formulations.
     Require water soluble bags be instituted for all wettable 
powder formulations.
     Cancellation of on-farm seed treatment for peanuts.
    Workers can also be exposed to thiram residues by entering 
previously treated areas to perform activities. The Restricted Entry 
Interval (REI) is used by the Agency to manage risks for post-
application workers doing activities that require contact with treated 
surfaces. The REI is the amount of time required after application 
before residues decline to a level so entry into the treated area and 
engaging in any task or activity would not result in exposures which 
are of concern. Current REIs are protective for most crops; however, 
risks for re-entry workers are of concern for very

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high exposure activities. The following mitigation addresses the risks 
of concern for high exposure activities associated with apples and sod:
     Cancellation of all turf applications for turf grown for 
sale or other commercial use such as sod.
     Cancellation of all apple uses.
    The ecological risk assessment for birds shows risks for 
reproductive effects to birds. There is a chronic effect to mammals 
including endangered species. The Agency's assessment suggested that a 
number of endangered species may potentially be impacted by thiram; 
however, this RED includes only risk mitigation for the Attwater's 
Prairie Chicken (Tympanuchus cupido attwateri). The RED outlines 
mitigation measures that address the Agency's ecological risks of 
concern.
    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 thiram 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 uses, risks, and other factors, thiram was reviewed through 
the full 6-phase public participation process. Through this process, 
EPA worked extensively with stakeholders and the public to reach the 
regulatory decisions for thiram. Tolerances for residues in/on food and 
feed commodities are currently expressed in terms of residues of thiram 
(40 CFR 180.132) per se and are established at 7 parts per million for 
apples, peaches, and strawberries. Seed treatments are considered to be 
non-food uses and therefore do not require a tolerance.
    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. All issues related to this 
pesticide were resolved through consultations with stakeholders. The 
Agency therefore is issuing the Thiram RED without a comment period.

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

    Section 4(g)(2) of FIFRA as amended, directs that, after submission 
of alldata 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: February 16, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

[FR Doc. 05-3535 Filed 2-24-05; 8:45 am]
BILLING CODE 6560-50-S