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EPA ID: [EPA-HQ-OPP-2002-0262; FRL-8339-5]

NOTICE: NOTICES

ACTION: Pesticides:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Endosulfan Updated Risk Assessments, Notice of Availability, and Solicitation of Usage Information

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

DOCUMENT 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 PostRED 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.

SUMMARY: Risk assessments—; Endosulfan,

SUPPLEMENTAL 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 email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CDROM that you mail to EPA, mark the outside of the disk or CDROM as CBI and then identify electronically within the disk or CDROM 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) (FRL72755 ). 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: MakhteshimAgan 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 intermediateterm 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 restrictedentry 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 [[Page 64626]]
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 inADDRESSES, 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 productspecific data on individual enduse 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.
[FR Doc. E722385 Filed 111507; 8:45 am]
BILLING CODE 656050S

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 204600001; telephone number: (703) 3080128; fax number: (703) 3088005; email address:perry.tracy@epa.gov.