Environmental Protection Agency (EPA).
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 Start Printed Page 9318through 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.Start Further Info
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: doty.craig.@epa.gov.End Further Info End Preamble Start Supplemental 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 at http://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.
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 Start Printed Page 9319high 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.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: February 16, 2005.
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