E7-8390. 1,3-Dichloropropene (1,3-D) Revised Human Health Risk Assessment, Notice of Availability and Solicitation of Risk Reduction Options

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability and solicitation of comments on the EPA's revised human health risk assessment for the soil fumigant 1,3-Dichloropropene (1,3-D), which is commonly referred to as telone. In addition, this notice seeks public comment on the risk reduction options paper and EPA's benefits assessments for the soil fumigant group. The Agency is also seeking comments on the 1,3-D ecological risk assessment which, based on public comments in phase 3, was not revised. Although 1,3-D has undergone reregistration and a Reregistration Eligibility Decision was published in December 1998, EPA is concurrently assessing six soil fumigants to ensure that its risk assessment approaches are consistent, and to ensure that risk tradeoffs and economic outcomes can be adequately predicted in reaching risk management decisions for the five other soil fumigants. The Agency is seeking the same input from the public on these pesticides. EPA has developed a revised human health risk assessment for 1,3-D and is seeking comment through a public participation process in order to make available current and accurate information on this pesticide.

DATES:

Comments must be received on or before July 2, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0124, 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 Bldg.), 2777 S. Crystal Dr., 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 [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2005-0124. 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 available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. 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 [phone].

FOR FURTHER INFORMATION CONTACT:

Andrea Carone, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:703-308-0122; fax number: [phone]; e-mail address: [e-mail]

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 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 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 deadline identified.

II. Background

A. What Action is the Agency Taking?

EPA is making available the Agency's revised human health risk assessment, initially issued for comment through a Federal Register notice published on July 13, 2005 (70 FR 40342) (FRL-7721-9); a response to comments; and related documents for 1,3-D. EPA also is soliciting public comment on the risk reduction options paper and the benefits assessments for the soil fumigant group. 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).

1,3-D is applied to control root-knot nematodes and certain pests and diseases in the soil prior to the planting of a variety of food and feed crops including vegetables, fruits, nuts, and other field and nursery crops. In addition there is a proposed new use for post-plant drip irrigation in established vineyards. 1,3-D is also a restricted use pesticide and as such can only be applied by certified applicators or those under the supervision of a certified applicator. End-use product formulations containing 1,3-D may be applied through drip irrigation or by injection below the soil surface either in rows or broadcast across an area.

1,3-D was deemed eligible for reregistration in December 1998. The volatility of 1,3-D in the environment and results of metabolism studies in plants assure that there is no reasonable expectation of finite residues to be incurred in/on any raw agricultural commodities when end-use product formulations containing 1,3-D are applied according to label directions. Therefore, this fumigant does not require food tolerances.

EPA is providing an opportunity, through this notice, for interested parties to provide risk management proposals or otherwise comment on risk management for the soil fumigant group. A complete list of the mitigation options can be found in the following document, “Risk Mitigation Options to Address Bystander and Occupational Exposures from Soil Fumigant Applications,” docket number EPA-HQ-OPP-2005-0124-0048. A Reader's Guide has been created to provide an organizational structure to the 1,3-D Docket, to allow readers to more easily access and navigate the various entries contained in the 1,3-D Docket, and to facilitate public comment. You will find this guide at EPA-HQ-OPP-2005-0124-0046. 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, 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.

Although 1,3-D has undergone reregistration, the Agency plans to follow a similar public participation process for the human health revised risk assessment to ensure that the risk assessment approaches are consistent, and that risk management decisions for the five other soil fumigants consider the relative risks and benefits of each chemical. While the Agency does not anticipate making changes to the decisions made in the 1998 RED, if, at the conclusion of the soil fumigant assessment and risk management process, EPA determines that it is appropriate to modify its 1998 risk mitigation decision for 1,3-D considering the relative risks and benefits of others, EPA may relax certain measures or consider adding new ones.

All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. Comments and proposals will become part of the Agency Docket for 1,3-D. 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.”

1,3-D was deemed eligible for reregistration in December 1998. EPA has developed a revised human health risk assessment for 1,3-D to assess the proposed post-plant use in established vineyards, and also in order to make available current and accurate information on this pesticide which will be considered as EPA assesses risk and develops risk management decisions for the five other soil fumigants.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: April 19, 2007.

Peter Caulkins,

Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs.