[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Notices]
[Page 20629-20631]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap08-48]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0248; FRL-8361-5]
Creosote Revised Risk Assessments and Qualitative Economic
Analysis of the Alternatives; Notice of Availability and Solicitation
of Risk Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's revised risk
assessments for the pesticide creosote. In addition, this notice
solicits public comment on risk reduction options for creosote as well
as solicits comments on the qualitative economic impacts analysis,
(Phase 5 of 6-Phase Process). EPA is developing a Reregistration
Eligibility Decision (RED) for creosote through the full, 6-Phase
public participation process that the Agency uses to involve the public
in developing pesticide reregistration and tolerance reassessment
decisions. Through these programs, EPA is ensuring that all pesticides
meet current health and safety standards.
DATES: Comments must be received on or before June 16, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0248, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0248. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although, listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. 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 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.
FOR FURTHER INFORMATION CONTACT: Jacqueline Cambpell-McFarlane,
Antimicrobials Division (7510P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-
[[Page 20630]]
0001; telephone number: (703) 308-6416; fax number: (703) 308-6467; e-
mail address: campbell-mcfarlane.jacqueline@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. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is making available the Agency's revised risk assessments,
initially issued for comment through a Federal Register notice
published on December 5, 2003 (68 FR 68042) (FRL-7318-6); a response to
comments; and related documents for creosote. EPA is also soliciting
public comment on risk reduction options for creosote and comments on
the qualitative economic impacts analysis. EPA developed the risk
assessments for creosote as part of its public process for making
pesticide reregistration eligibility and tolerance reassessment
decisions. Through these programs, EPA is ensuring that pesticides meet
current standards under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
Creosote, a restricted use pesticide, is a ``heavy duty wood
preservative'' that was first registered in the United States in 1948.
Presently, 13 products are registered as industrial wood preservatives
for above and ground wood protection treatments, as well as wood used
in marine environments. Creosote wood preservatives are used primarily
in the pressure treatment of railroad ties/crossties (about 70%
creosote use), utility poles/cross-arms (about 16% of all creosote
use), and marine piles (> 4% creosote use. Assorted creosote-treated
lumber products (e.g., timbers, poles, posts, and ground-line support
structures) account for the remaining uses of this wood preservative.
EPA issued cancellation orders in August 2004 that accepted the
voluntary use termination request/product cancellation requests to
either amend current label language to delete non-pressure treatment
uses of creosote or to cancel the affected products (September 15,2007;
69 FR 55623; FRL-7682). This action canceled three pesticide
registrations and terminated certain uses of seven pesticide
registrations as of December 31, 2004.
EPA is providing an opportunity, through this notice, for
interested parties to provide risk management proposals or otherwise
comment on risk management for creosote. Risks of concern associated
with the use of creosote are: Short-term, intermediate-term, and long-
term non-cancer risks; and cancer risks for occupational handlers.
Approximately one third of the dermal non-cancer scenarios indicate
potential risks of concern. The non-cancer inhalation MOEs for
occupational exposure to naphthalene (detected in 100% of the
inhalation exposure samples when applying creosote) range from 23-1,900
with the inhalation MOEs for 16 of the 19 job functions being below the
target MOE of 300. All of the cancer risks exceed the Agency's level of
concern of 1 x 10-6 but only 4 of the scenarios had risks
exceeding 1 x 10-4 (i.e., risks range from 1.6E-3 to 9.5E-
6). In targeting these risks of concern, the Agency solicits
information on effective and practical risk reduction measures.
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, creosote is being reviewed
through the full 6-Phase public participation process.
All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments and
proposals will become part of the Agency Docket for creosote. Comments
received after the close of the comment period will be marked ``late''.
EPA is not required to consider these late comments.
After considering comments received, EPA will develop and issue for
comment the creosote RED.
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
[[Page 20631]]
products or taking other ``appropriate regulatory action.''
List of Subjects
Environmental protection, Pesticides and pests, antimicrobials,
creosote.
Dated: April 11, 2008.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E8-8169 Filed 4-15-08; 8:45 .am.]
BILLING CODE 6560-50-S