E7-22385. Endosulfan Updated Risk Assessments, Notice of Availability, and Solicitation of Usage Information

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's updated human health and ecological effects risk assessments for the organochlorine pesticide endosulfan, based in part on data recently submitted by endosulfan registrants as required in the 2002 Reregistration Eligibility Decision (RED). The Agency is seeking comment on these updated risk assessments as part of EPA's Post-RED process regarding endosulfan (see Note to Reader in the endosulfan docket for more detail). In addition, this notice solicits public comment on EPA's analysis of endosulfan usage information since the 2002 RED, and its preliminary determinations regarding endosulfan's importance to growers and availability of alternatives.

DATES:

Comments must be received on or before January 16, 2008.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2002-0262, 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 Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2002-0262. 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 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 website 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Tracy L. Perry, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; 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 updated risk assessments for endosulfan, last issued for comment through a Federal Register notice announcing the availability of the 2002 Reregistration Eligibility Decision (RED) published on November 6, 2002 (67 FR 67617) (FRL-7275-5 ). EPA also is soliciting public comment on the Agency's analysis of endosulfan usage information since the 2002 RED, and its preliminary determinations regarding endosulfan's importance to growers and availability of alternatives.

Endosulfan is a broad spectrum contact insecticide and acaricide registered for use on a wide variety of vegetables, fruits, cereal grains, and cotton, as well as ornamental shrubs, trees, vines, and ornamentals for use in commercial agricultural settings. Endosulfan is formulated as a liquid emulsifiable concentrate and a wettable powder. There are currently three endosulfan registrants: Makhteshim-Agan of North America, Makheteshim Chemical Works, Ltd., and Drexel Chemical Company. Bayer CropScience recently canceled all U.S. registrations of endosulfan products, effective July 16, 2007.

In its 2002 RED, EPA identified use of endosulfan to pose dietary, occupational, and ecological risks of concern. However, the Agency determined that these risks could likely be mitigated to levels below concern through the deletion of use on five crops and changes to pesticide labeling and formulation. Accordingly, EPA concluded that endosulfan was eligible for reregistration provided that: (1) Additional required data were submitted by the registrants confirming this decision; and (2) the risk mitigation measures outlined in the RED were adopted, and label amendments made to reflect these measures.

EPA's updated assessment of the potential human health effects of endosulfan is based on the review of a recently submitted developmental neurotoxicity (DNT) study, which was required in the reregistration eligibility decision for endosulfan. Based on the toxicological effects observed in the DNT, the Agency selected a different endpoint than used in the 2002 RED assessment to evaluate short- and intermediate-term dermal exposure for occupational handlers. Using the revised dermal endpoint, many of the occupational handler scenarios exceed the Agency's level of concern even with maximum Personal Protective Equipment (PPE) and engineering controls. In addition, for many of the occupational postapplication scenarios, the restricted-entry interval (REI) would be several to multiple days longer than the REIs required in the 2002 RED.

In addition, EPA has updated the ecological effects assessment for endosulfan based on studies required in the 2002 RED and on additional information drawn from the published literature on endosulfan bioaccumulation, monitoring and transport, and ecological incidence. In general, although preliminary, the new information suggests that parent endosulfan and its sulfate degradate may pose greater risks than the 2002 RED outlined. While the parent may readily undergo degradation under some environmental conditions, the sulfate degradate is persistent and represents a source for endosulfan to enter aquatic and terrestrial food chains. While endosulfan is not expected to biomagnify appreciably in aquatic food webs, the compound does bioconcentrate in aquatic organisms to a significant extent. Also, there is direct evidence (measured residues) that endosulfan bioaccumulates in terrestrial systems and indirect evidence (modeling) that endosulfan has a significant potential to biomagnify in certain terrestrial food webs. In addition, EPA continues to be concerned about endosulfan's volatility and its ability to migrate to sites distant from use areas, such as the Arctic, through various environmental media (air, water, and sediment).

EPA is providing an opportunity, through this notice, for interested parties to comment on the Agency's updated human health and ecological effects assessments for endosulfan. Risks of concern associated with the use of endosulfan are: (1) Occupational handler risks for many use scenarios, even with maximum PPE and engineering controls; (2) risk to aquatic and terrestrial organisms; and (3) potential for significant adverse effects to vulnerable populations and ecosystems, based on the ability for endosulfan and its sulfate degradate to migrate to sites distant from use areas. In addition, the Agency is soliciting public comment on EPA's analysis of endosulfan usage information since the 2002 RED, and its preliminary determinations regarding endosulfan's importance to growers and availability of alternatives.

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 endosulfan. 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.”

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: November 8, 2007.

Peter Caulkins,

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