E8-11395. Nicotine Reregistration Eligibility Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's Reregistration Eligibility Decision (RED) for the pesticide nicotine. The Agency's risk assessments and other related documents are available in the nicotine Docket. The sole remaining nicotine registration, a restricted use insecticide registered for use only on greenhouse ornamentals and effective against adult whiteflies, aphids, and thrips, is being voluntarily cancelled by the registrant. EPA has reviewed nicotine through the reregistration eligibility decision-making process, which is used by the Agency to ensure that all pesticides meet current health and safety standards.

FOR FURTHER INFORMATION CONTACT:

Jill Bloom, 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

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.

II. Background

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 RED for the pesticide nicotine under section 4(g)(2)(A) of FIFRA. The sole remaining nicotine registration is a restricted use insecticide registered for use only on greenhouse ornamentals and effective against adult whiteflies, aphids, and thrips. It is not registered for use on food.

EPA has determined that the data base to support nicotine is incomplete. The Agency has relied primarily on information available from the open literature to assess the risks associated with the use of nicotine. Although there is considerable information, particularly toxicity information, available in the literature, very little of it is appropriate for the routes of exposure relevant to the pesticidal use of nicotine, and much of it relates to derivatives of nicotine not present in the pesticide. Data on worker and residential exposures are also very limited. The data gaps create a substantial amount of uncertainty in the Agency's risk assessment, and risk estimates derived from the available data exceed the Agency's level of concern in certain areas. The RED identifies data that would be needed to refine the risk assessment for nicotine. Rather than develop the data needed to refine the assessment, the registrant has requested the cancellation of its nicotine registration, effective December 31, 2013.

The Agency has made its risk management decision for nicotine, and has determined that the phase-out as requested by the registrant is warranted due to the extremely low volume of nicotine use and the benefits associated with its use in production of greenhouse ornamentals. In light of the risk estimates derived from the available data, the Agency is requiring implementation of label amendments designed to reduce the potential for exposure and reduce risk during the phase-out period, including prohibiting the use of nicotine on plants grown for cut flowers, prohibiting use in non-commercial greenhouses, and restricting consumers' access to treated greenhouses for 24 hours following the last application of the nicotine product and until ventilation criteria have been met.

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: May 8, 2008.

Peter Caulkins,

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