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Busan 77 Risk Assessment; Notice of Availability and Risk Reduction Options
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55202-55204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se07-85]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0834; FRL-8150-2]
Busan 77 Risk Assessment; Notice of Availability and Risk
Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's risk
assessment, and related documents for the pesticide Busan 77 and opens
a public comment period on these documents (Phase 3 of 4-Phase
Process). The public is encouraged to suggest risk management ideas or
proposals to address the risks identified. EPA is developing a
Reregistration Eligibility Decision (RED) for Busan 77 through a
modified, 4-Phase public participation process that the Agency uses to
involve the public in developing pesticide reregistration decisions.
Through this program, EPA is ensuring that all pesticides meet current
health and safety standards.
DATES: Comments must be received on or before November 27, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0834, 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-
2007-0834. 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
[[Page 55203]]
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: ShaRon Carlisle, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-6427; fax number: (703) 308-6467; e-
mail address: carlisle.sharon@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 releasing for public comment its human health and
environmental fate and effects risk assessment and related documents
for Busan 77 and soliciting public comment on risk management ideas or
proposals. Busan 77 is currently registered as an antimicrobial agent
for use in the manufacture of a variety of products used in swimming
pools, metal working fluids, cooling water towers, paper mill process
water, ornamental ponds and various sorts of fabrics. EPA developed the
risk assessment and risk characterization for Busan 77 through a
modified version 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).
This active ingredient is found in products that can be used in
swimming pools, spas whirlpools, hot tubs, metalworking fluids, fire
water protection systems, cooling water towers, petroleum secondary
recovery systems, paper mill process water, air washer water systems,
ornamental ponds and aquariums. In addition, various fibers can be
preserved with Busan 77.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessment(s) for Busan 77. Such comments and input could address, for
example, the availability of additional data to further refine the risk
assessments, such as an acute freshwater and marine invertebrate
studies, and a textile residue study to evaluate the amount of Busan 77
remaining in textiles after treatment. This information could refine
the Agency's risk assessment methodologies and assumptions as applied
to this specific pesticide.
Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for Busan 77. There are risks of concern
associated with the use of Busan 77 in residential settings from
treating aquatic areas (dermal and inhalation); occupational exposure
for machinist using biocide treated metalworking fluids; and ecological
risk to freshwater fish, freshwater invertebrates and marine
invertebrates because of the once-through cooling water use. In
targeting these risks of concern, the Agency solicits information on
effective and practical risk reduction measures.
EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to Busan 77 compared to the
general population.
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
[[Page 55204]]
Process, published in the Federal Register on May 14, 2004 (69 FR 26819)
(FRL-7357-9), explains that in conducting these programs, the
Agency is tailoring its public participation process to be commensurate
with the level of risk, extent of use, complexity of the issues, and
degree of public concern associated with each pesticide. For Busan 77 a
modified, 4-Phase process with 1 comment period and ample opportunity
for public consultation seems appropriate in view of its refined risk
assessment and/or other factors. However, if as a result of comments
received during this comment period EPA finds that additional issues
warranting further discussion are raised, the Agency may lengthen the
process and include a second comment period, as needed.
All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments
will become part of the Agency Docket for Busan 77. Comments received
after the close of the comment period will be marked ``late.'' EPA is
not required to consider these late comments.
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.''
List of Subjects
Environmental protection, Pesticides and pests.
Dated: September 20, 2007.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E7-19236 Filed 9-27-07; 8:45 am]
BILLING CODE 6560-50-S