Document ID: EPA-HQ-OPP-2004-0032-0042
Agency: epa
Document Type: Notice
Title: Formetanate Hydrochloride; Modification and Closure of Interim Reregistration Eligibility Decision; Notice
Posted Date: 2007-04-25T04:00Z

[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Notices]               
[Page 20543-20544]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap07-77]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2004-0032; FRL-8124-3]

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

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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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.''

[[Page 20544]]

    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.

    Dated: April 12, 2007.
 Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E7-7766 Filed 4-24-07; 8:45 am]

BILLING CODE 6560-50-S