E9-12413. Iodine and Iodophors Reregistration Eligibility Decision

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's Reregistration Eligibility Decision (RED) and supporting science documents for the pesticide iodine and iodophor complexes. The Reregistration Eligibility Decision document for iodine and iodophor complexes was signed on July 27, 2006 with additional revisions described in a March 17, 2009 amendment.

FOR FURTHER INFORMATION CONTACT:

Heather Garvie, Antimicrobials Division (7510P), 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, farm worker 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. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0599. 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 Office of Pesticide Programs (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].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. Background

A. What Action is the Agency Taking?

Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) directs EPA to reevaluate existing pesticides to ensure that they meet current scientific and regulatory standards. In 2006, EPA signed a RED for iodine and iodophor complexes under section 4(g)(2)(A) of FIFRA. An additional amendment was signed on March 17, 2009.

Taking into consideration all available information on iodine, including its relatively low acute toxicity, the reversibility of subclinical hypothyroidism, the low toxicity of the iodophor complexes, the Food and Drug Administration's designation of iodide as a “Generally Recognized As Safe (GRAS)” chemical, the presence of iodine in food products, and the sporadic and short-term nature of the antimicrobial uses, the Agency concludes that exposure to iodine and iodophor complexes from the EPA-registered uses present no risk of concern. No mitigation measures are necessary at this time. The March 17, 2009 amendment to the Iodine and Iodophor Complexes RED is inclusive of a Labeling Changes Summary Table and a revised Appendix A. The label table incorporated into the Iodine and Iodophor Complexes March 17, 2009 RED amendment includes modifications which specify label language for emergency human drinking water use. Appendix A is inclusive of the current EPA-registered products containing iodine or an iodophor complex as an active ingredient.

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
• Antimicrobials
• Iodine
• Iodophor complexes

Dated: May 8, 2009.

Betty Shackleford,

Acting Director, Antimicrobials Division, Office of Pesticide Programs.