Oxydemeton-Methyl; Final Determination to Terminate Special Review, 64620-64621 [E7-22362]

Download as PDF mstockstill on PROD1PC66 with NOTICES 64620 Federal Register / Vol. 72, No. 221 / Friday, November 16, 2007 / Notices SAB was established by 42 U.S.C. 4365 to provide independent scientific and technical advice to the Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Background: In 2003, EPA issued a draft Report on the Environment describing the status of and trends in the environment and human health. The draft 2003 Report on the Environment was reviewed by the SAB (see http:// www.epa.gov/sab/pdf/sab_05_004.pdf). EPA used advice received from the SAB and comments from stakeholders to develop an improved and updated draft Report on the Environment 2007. The Report on the Environment 2007 consists of: a Science Report (ROE 2007 Science Report) containing detailed scientific and technical information, a Highlights Document written for concerned citizens, and an electronic document facilitating access to material in the reports. The ROE 2007 Science Report asks key questions about the current status of, and trends in, the condition of the environment and human health. These questions are intended to be relevant to EPA’s current regulatory and programmatic activities and mission, and they have been answered using a suite of environmental and human health indicators. EPA’s Office of Research and Development requested that the SAB review the ROE 2007 Science Report. In response to EPA’s request, the SAB Staff Office formed the Panel for the Review of EPA’s 2007 Report on the Environment. Background information on the Panel formation process was provided in a Federal Register notice published on May 25, 2006 (71 FR 30138). The Panel has previously held two teleconferences and a face-to-face meeting (72 FR 29498; 72 FR 56342). Information about the SAB Panel for the Review of EPA’s 2007 Report on the Environment is available on the SAB Web site at: http://www.epa.gov/sab. Availability of Meeting Materials: The draft Report on the Environment 2007: Science Report reviewed by the SAB Panel is available on the following EPA Office of Research and Development Web site: http://cfpub.epa.gov/ncea/ cfm/recordisplay.cfm?deid=140917. The agenda and other material for the upcoming public teleconference will be posted on the SAB Web site at: http:// www.epa.gov/sab in advance of the teleconference. VerDate Aug<31>2005 21:48 Nov 15, 2007 Jkt 214001 Procedures for Providing Public Input: Interested members of the public may submit relevant written or oral information for the SAB Panel to consider during the advisory process. Oral Statements: In general, individuals or groups requesting an oral presentation at a public teleconference will be limited to three minutes per speaker, with no more than a total of 30 minutes for all speakers. Interested parties should contact Dr. Armitage, DFO, in writing (preferably via e-mail) at the contact information noted above, no later than December 3, 2007 to be placed on a list of public speakers for the teleconference. Written Statements: Written statements should be received in the SAB Staff Office by December 3, 2007 so that the information may be made available to the SAB Panel members for their consideration. Written statements should be supplied to the DFO in the following formats: one hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat PDF, WordPerfect, MS Word, MS PowerPoint, or Rich Text files in IBMPC/Windows 98/2000/XP format). Accessibility: For information on access or services for individuals with disabilities, please contact Dr. Armitage at the phone number or e-mail address noted above, preferably at least ten days prior to the meeting to give EPA as much time as possible to process your request. Dated: November 9, 2007. Vanessa T. Vu, Director, EPA Science Advisory Board Staff Office. [FR Doc. E7–22452 Filed 11–15–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2007–0436; FRL–8151–2] Oxydemeton-Methyl; Final Determination to Terminate Special Review Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: On August 8, 2007, EPA proposed to terminate the Special Review of oxydemeton-methyl (ODM) because the risks that were the basis of the Special Review are no longer of concern. The Agency offered an opportunity to provide comment to the proposal. The Agency received no substantive comments in response to the proposal and EPA is announcing its PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 final determination to terminate the Special Review of ODM. FOR FURTHER INFORMATION CONTACT: Richard P. Dumas, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 308– 8015; fax number: (703) 308–8005; email address: dumas.richard@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you as a member of the general public or a stakeholder such as 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. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. 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–2007–0436. 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 (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? On October 5, 1987, EPA initiated a Special Review of oxydemeton-methyl (ODM) because of its potential to adversely affect reproduction of workers who mix, load, and apply products containing ODM. The Agency’s E:\FR\FM\16NON1.SGM 16NON1 mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 221 / Friday, November 16, 2007 / Notices concerns regarding reproductive effects were based primarily on the results of a two-generation rat reproduction study and interim progress reports from an ongoing male rat reproductive toxicity study. Observed reproductive effects were decreased parental body weight, parental testes weight and fertility index, vacuolation of the corpus epididymus, decreased litter size, decreased pup weight and increased pup mortality. Since the initiation of the Special Review, additional data and more comprehensive reviews of potential risks associated with ODM exposure have been completed, including those described in the 2002 Interim Reregistration Eligibility Decision (IRED) for ODM. In addition, during the reregistration process EPA conducted an intensive and public review of whether or not ODM registrations meet the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) standard for registration. In the 2002 IRED and subsequent label amendments, the Agency addressed the occupational risk concerns, including risk associated with potential reproductive effects. There continues to be evidence of reproductive effects; however, there is no evidence that these effects inhibit the ability of organisms to reproduce. Similarly, further data and analysis have addressed the concern for heritable effects. With the label amendments that have been made since the initiation of Special Review, ODM exposure is expected to be below the levels where any reproductive effects occur. Because the risks that were the basis of the Special Review are no longer of concern, the Agency is proposing to terminate the Special Review of ODM. The final risk management decision regarding the risk to workers exposed to ODM was completed with the 2002 IRED. A detailed description of the rationale and supporting documents can be found in http://www.regulations.gov under EPA–HQ–OPP–2005–0281. As described above and in the 2002 IRED, concerns regarding reproductive effects were addressed under FIFRA and no further action is required at this time. As such, on August 8, 2007, EPA announced its proposed decision to terminate the Special Review of ODM. The Agency received one comment to that notice. The commenter offered no substantive information to alter EPA’s understanding of ODM risks. This notice announces EPA’s final determination to terminate the Special Review of ODM. VerDate Aug<31>2005 21:48 Nov 15, 2007 Jkt 214001 B. What is the Agency’s Authority for Taking this Action? A pesticide product may be sold or distributed in the United States only if it is registered or exempt from registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C. 136 et seq.). Before a product can be registered it must be shown that it can be used without causing ‘‘unreasonable adverse effects on the environment,’’ (FIFRA section 3(c)(5)). The term ‘‘unreasonable adverse effects on the environment’’ is defined in FIFRA section 2(bb) as ‘‘any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.’’ The burden of proving that a pesticide meets this standard for registration is, at all times, on the proponent of initial or continued registration. If at any time the Agency determines that a pesticide no longer meets this standard, the Administrator may cancel this registration under section 6 of FIFRA. The Special Review process provides a mechanism to permit public participation in EPA’s deliberations prior to issuance of any Notice of Final Determination describing the regulatory action which the Administrator has selected. The Special Review process, which was previously called the Rebuttable Presumption Against Registration (RPAR), is described in 40 CFR part 154, published in the Federal Register of November 25, 1985 (50 FR 49015). The purpose of this process is to determine whether some or all registrations of a particular active ingredient or ingredients meet the FIFRA standard for registration, or whether amendment of the terms and conditions of registration or cancellation of portions or all of the registrations is appropriate. Prior to formal initiation of a Special Review, a preliminary notification is sent to registrants and applicants for registration pursuant to 40 CFR 154.21 announcing that the Agency is considering commencing a Special Review. Registrants and applicants for registration are allowed 30 days from receipt of the notification to comment on the Agency’s proposal to commence a Special Review. If the Agency determines, after issuance of a notification pursuant to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR 154.23(c) requires the Administrator to publish a Notice of Special Review in the Federal Register. To conclude the Special Review after a Special Review has been initiated, 40 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 64621 CFR 154.31 requires the Administrator to first publish a Notice of Preliminary Determination in the Federal Register. That regulation requires the Administrator to respond to all significant comments received on the Notice of Special Review and, among other things, make a preliminary determination of whether any of the applicable risk criteria have been satisfied. Finally, after receipt and evaluation of comments on the Notice of Preliminary Determination, 40 CFR 154.33 requires that the Administrator publish in the Federal Register a Notice of Final Determination, including the reasons for the determination. This Notice is being issued pursuant to 40 CFR 154.33. List of Subjects Environmental protection, Pesticides, Pests. Dated: November 8, 2007. James Jones, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E7–22362 Filed 11–15–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2007–0435; FRL–8151–3] Ethyl Parathion; Final Determination Not to Initiate Special Review and Tributyltin Antifoulants; Final Determination to Terminate Special Review Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: This notice announces the Agency’s decision not to initiate a Special Review of Ethyl Parathion and its decision to terminate the Special Review of Tributyltin (TBT) used in antifouling paints. The Agency has taken these actions because all pesticide registrations of ethyl parathion and all TBT antifouling paints are canceled. These decisions were proposed in the Federal Register on August 8, 2007 and the Agency received no comments in response to these proposed decisions. FOR FURTHER INFORMATION CONTACT: Richard P. Dumas, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 308– 8015; fax number: (703) 308–8005; email address: dumas.richard@epa.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\16NON1.SGM 16NON1

Agencies

[Federal Register Volume 72, Number 221 (Friday, November 16, 2007)]
[Notices]
[Pages 64620-64621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22362]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0436; FRL-8151-2]


Oxydemeton-Methyl; Final Determination to Terminate Special 
Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: On August 8, 2007, EPA proposed to terminate the Special 
Review of oxydemeton-methyl (ODM) because the risks that were the basis 
of the Special Review are no longer of concern. The Agency offered an 
opportunity to provide comment to the proposal. The Agency received no 
substantive comments in response to the proposal and EPA is announcing 
its final determination to terminate the Special Review of ODM.

FOR FURTHER INFORMATION CONTACT: Richard P. Dumas, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8015; fax 
number: (703) 308-8005; e-mail address: dumas.richard@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you as a member 
of the general public or a stakeholder such as 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. This listing is not intended to be exhaustive, 
but rather provides a guide for readers regarding entities likely to be 
affected by this action. Other types of entities not listed in this 
unit could also be affected. 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-2007-0436. 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 (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?

    On October 5, 1987, EPA initiated a Special Review of oxydemeton-
methyl (ODM) because of its potential to adversely affect reproduction 
of workers who mix, load, and apply products containing ODM. The 
Agency's

[[Page 64621]]

concerns regarding reproductive effects were based primarily on the 
results of a two-generation rat reproduction study and interim progress 
reports from an ongoing male rat reproductive toxicity study. Observed 
reproductive effects were decreased parental body weight, parental 
testes weight and fertility index, vacuolation of the corpus 
epididymus, decreased litter size, decreased pup weight and increased 
pup mortality.
    Since the initiation of the Special Review, additional data and 
more comprehensive reviews of potential risks associated with ODM 
exposure have been completed, including those described in the 2002 
Interim Reregistration Eligibility Decision (IRED) for ODM. In 
addition, during the reregistration process EPA conducted an intensive 
and public review of whether or not ODM registrations meet the Federal 
Insecticide, Fungicide, Rodenticide Act (FIFRA) standard for 
registration. In the 2002 IRED and subsequent label amendments, the 
Agency addressed the occupational risk concerns, including risk 
associated with potential reproductive effects. There continues to be 
evidence of reproductive effects; however, there is no evidence that 
these effects inhibit the ability of organisms to reproduce. Similarly, 
further data and analysis have addressed the concern for heritable 
effects. With the label amendments that have been made since the 
initiation of Special Review, ODM exposure is expected to be below the 
levels where any reproductive effects occur. Because the risks that 
were the basis of the Special Review are no longer of concern, the 
Agency is proposing to terminate the Special Review of ODM.
    The final risk management decision regarding the risk to workers 
exposed to ODM was completed with the 2002 IRED. A detailed description 
of the rationale and supporting documents can be found in http://
www.regulations.gov under EPA-HQ-OPP-2005-0281. As described above and 
in the 2002 IRED, concerns regarding reproductive effects were 
addressed under FIFRA and no further action is required at this time. 
As such, on August 8, 2007, EPA announced its proposed decision to 
terminate the Special Review of ODM. The Agency received one comment to 
that notice. The commenter offered no substantive information to alter 
EPA's understanding of ODM risks. This notice announces EPA's final 
determination to terminate the Special Review of ODM.

B. What is the Agency's Authority for Taking this Action?

    A pesticide product may be sold or distributed in the United States 
only if it is registered or exempt from registration under the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C. 
136 et seq.). Before a product can be registered it must be shown that 
it can be used without causing ``unreasonable adverse effects on the 
environment,'' (FIFRA section 3(c)(5)). The term ``unreasonable adverse 
effects on the environment'' is defined in FIFRA section 2(bb) as ``any 
unreasonable risk to man or the environment, taking into account the 
economic, social, and environmental costs and benefits of the use of 
any pesticide.'' The burden of proving that a pesticide meets this 
standard for registration is, at all times, on the proponent of initial 
or continued registration. If at any time the Agency determines that a 
pesticide no longer meets this standard, the Administrator may cancel 
this registration under section 6 of FIFRA.
    The Special Review process provides a mechanism to permit public 
participation in EPA's deliberations prior to issuance of any Notice of 
Final Determination describing the regulatory action which the 
Administrator has selected. The Special Review process, which was 
previously called the Rebuttable Presumption Against Registration 
(RPAR), is described in 40 CFR part 154, published in the Federal 
Register of November 25, 1985 (50 FR 49015). The purpose of this 
process is to determine whether some or all registrations of a 
particular active ingredient or ingredients meet the FIFRA standard for 
registration, or whether amendment of the terms and conditions of 
registration or cancellation of portions or all of the registrations is 
appropriate.
    Prior to formal initiation of a Special Review, a preliminary 
notification is sent to registrants and applicants for registration 
pursuant to 40 CFR 154.21 announcing that the Agency is considering 
commencing a Special Review. Registrants and applicants for 
registration are allowed 30 days from receipt of the notification to 
comment on the Agency's proposal to commence a Special Review.
    If the Agency determines, after issuance of a notification pursuant 
to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR 
154.23(c) requires the Administrator to publish a Notice of Special 
Review in the Federal Register. To conclude the Special Review after a 
Special Review has been initiated, 40 CFR 154.31 requires the 
Administrator to first publish a Notice of Preliminary Determination in 
the Federal Register.
    That regulation requires the Administrator to respond to all 
significant comments received on the Notice of Special Review and, 
among other things, make a preliminary determination of whether any of 
the applicable risk criteria have been satisfied. Finally, after 
receipt and evaluation of comments on the Notice of Preliminary 
Determination, 40 CFR 154.33 requires that the Administrator publish in 
the Federal Register a Notice of Final Determination, including the 
reasons for the determination. This Notice is being issued pursuant to 
40 CFR 154.33.

List of Subjects

    Environmental protection, Pesticides, Pests.

    Dated: November 8, 2007.
 James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
[FR Doc. E7-22362 Filed 11-15-07; 8:45 am]
BILLING CODE 6560-50-S