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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 
[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

 
 

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