Pesticide programs: Risk assessments Propazine,
[Federal Register: June 21, 2006 (Volume 71, Number 119)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Propazine; Tolerance Reassessment Progress and Risk Management Decision for Low Risk Pesticide; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the availability of EPA'sTolerance Reassessment Progress and Risk Management Decision (TRED) for the chlorinated triazine pesticide propazine, and opens a public comment period on this document, related risk assessments, and other support documents. EPA has reviewed the low risk pesticide propazine through a modified, streamlined version of the public participation process that the Agency uses to involve the public in developing pesticide tolerance reassessment and reregistration decisions. Through the tolerance reassessment program, EPA is ensuring that all pesticides meet current health and food safety standards. The Agency is concurrently issuing for public comment the Triazine Cumulative Risk Assessment; see EPA-HQ- OPP-2005-0481 in the Notices section of this issue of the Federal Register.
DATES: Comments must be received on or before August 21, 2006.
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0496, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2005-0496. EPA's policy is that all comments received will be included in the 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 Federal 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 automatically captured and included as part of the comment that is placed in the 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.
Docket: All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov ,or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Diane Sherman,Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0128; fax number: (703) 308-8005; e-mail address:firstname.lastname@example.org.
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.
What Should I Consider as I Prepare My Comments for EPA?
Submitting CBI. Do not submit this information to EPA through 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.
Tips for preparing your comments. When submitting comments, remember to:
i. Identify the document by docket ID 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 deadlineidentified.
What Action is the Agency Taking?
EPA has reassessed the uses of propazine, reassessed four existing tolerances or legal residue limits, and on April 6, 2006, reached a tolerance reassessment decision for this low risk chlorinated triazine pesticide. The Agency is now issuing for comment the resulting Report onFood Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision for propazine, known as a TRED, as well as related risk assessments and technical support documents. Propazine is a systemic herbicide that is usually applied to the soil, absorbed through leaves and roots, and acts by inhibiting photosynthesis within the targeted plant. It isused as a selective herbicide to control most annual grasses and broadleaf weeds before the weeds emerge or after removal of weed growth. Propazine is formulated as a flowable concentrate, is registered for use on container grown ornamentals in greenhouses, and is to be applied through flood or drench nozzles only. The Agency has received a new use petition forsorhgum from the Griffin Corporation (PP 7F4837 as announced in a Federal Register Notice published on June 22, 2005, 70 FR 36159), and potential risks resulting from this use will be assessed when the petition is considered.
EPA developed the propazine TRED through a modified, streamlined version of its public process for making tolerance reassessment and reregistration eligibility decisions. Through these programs, the Agency is ensuring that pesticides meet current standards under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, andRodenticide Act (FIFRA), as amended by FQPA. EPA must review tolerances and tolerance exemptions that were in effect when FQPA was enacted, 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 propazine tolerances included in this notice. EPA has determined that the data base to support propazine tolerance reassessment is substantially complete and that propazine tolerances meet the FFDCA safety standard. The propazine TRED presents the Agency's tolerance reassessment conclusions for propazine alone; however, section 408(b)(2)(D)(v) of FFDCA directs the Agency also to consider available information on the cumulative risk from substances sharing a common mechanism of toxicity. Propazine shares a neuroendocrine mechanism of toxicity, which results in both reproductive and developmental consequences, with the structurally-related chlorinated triazine pesticides atrazine and simazine. Because these chlorinated triazine pesticides share a common mechanism of toxicity, the Agency evaluated the cumulative risk posed by this group while making final tolerance reassessment decisions on individual chlorinated triazines. However, propazine was not incorporated into the cumulative risk assessment because no dietary, drinking water, or residential human exposure to propazine is anticipated from any of the currently registered uses. 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, the Agency 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. EPA can expeditiously reach decisions for pesticides like propazine, which pose no risk concerns, have low use, affect few stakeholders, and require no risk mitigation. Once EPA assesses uses and risks for such low risk pesticides, the Agency may go directly to a decision and prepare a document summarizing its findings, such as the propazine TRED.
The tolerance reassessment program is being conducted under Congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public in finding ways to effectively mitigate pesticide risks. Propazine, however, poses no risks that require mitigation. The Agency therefore is issuing the propazine TRED, its risk assessments, and related support documents simultaneously for public comment. The commentperiod is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the TRED. All comments should be submitted using the methods in Unit I. of the SUPPLEMENTARY INFORMATION, and must be received by EPA on or before the closing date. These comments will become part of the Agency Docket for propazine. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments.
EPA will carefully consider all comments received by the closing date and will provide a Response to Comments Memorandum in the Docket and regulations.gov. If any comment significantly affects the document, EPA also will publish an amendment to the TRED in the Federal Register. In the absence of substantive comments requiring changes, the decisions reflected in the TRED will be implemented as presented.
What is the Agency's Authority for Taking this 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. A tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2), respectively, if ``the Administrator determines
[the pesticide chemical residue] is safe,'' i.e., ``that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' 21 U.S.C.346a(b)(2)(A), and (c)(2)(A). In making this safety finding, FFDCA requires the Administrator to consider, among other factors, ``available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity . . . '' 21 U.S.C.346a(b)(2)(D)(v), and (c)(2)(B).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 9, 2006. Debra Edwards, Director, Special Review and Reregistration Division, Office of Pesticide Programs.
[FR Doc. E6-9470 Filed 6-20-06; 8:45 am]
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