Formetanate Hydrochloride; Modification and Closure of Interim Reregistration Eligibility Decision; Notice

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's intention to modify certain risk mitigation measures that were imposed as a result of the 2006 Interim Reregistration Eligibility Decision (IRED) for the pesticide formetanate hydrochloride (HCl). EPA conducted this reassessment of the formetanate HCl IRED in response to comments received regarding endpoints chosen for the assessment. The Agency agreed that the toxicity endpoints fo human health risk assessment should be re-evaluated. Hence, the resulting assessment modified the mitigation listed in the IRED. Therefore, on formetanate HCl labels, there will be no requirement for closed cabs for applicators using air-blast sprayers on orchard fruit and the Restricted Entry Intervals are modified for alfalfa (from 9 to 4 days), pome and stone fruit (from 8 to 5 days) and citrus fruit (from 10 to 9 days).

FOR FURTHER INFORMATION CONTACT:

James Parker, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 306-0469; fax number: (703) 308-7070; e-mail address: parker.james@epa.gov.

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. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2004-0032. 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 telephone number is (703) 305-5805.

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?

In 2006, EPA issued an IRED for formetanate HCl under section 4(g)(2)(A) of FIFRA. Subsequent to publication of this IRED, the technical registrant submitted additional information and comments regarding the risk assessments. After reviewing comments received from the registrant (Gowan Company), regarding the use of bench mark dose (BMD) modeling as an appropriate method for selecting the inhalation toxicity endpoint and concerns for the dermal endpoint selected, the Agency reassessed and consequently modified its original dermal and inhalation points of departure of 0.1 mg/kg for inhalation and 10 mg/kg for dermal to 0.18 mg/kg for the inhalation endpoint and 15 mg/kg for dermal. This change in endpoint selection resulted in acceptable Margins of Exposure (MOEs) for orchard air-blast applications when using double layer Personal Protective Equipment (PPE). Furthermore, the Restricted Entry Intervals (REIs) were reduced (from 9 to 4 days for alfalfa, 8 to 5 days for pome and stone fruit and 10 to 9 days for citrus fruit). The Agency has also updated the formetanate HCl IRED including a Response to Comments memorandum and an updated label table.

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. Due to its uses, risks, and other factors, formetanate HCl was reviewed through the modified 4-Phase public participation process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for formetanate HCl.

There were already two public comment periods for formetanate HCl and this updated IRED document addresses all issues which were raised during earlier comment periods. The Agency therefore is issuing the updated IRED for formetanate HCl without an additional comment period.

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.”

Section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

• Environmental protection
• Pesticides and pests