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Bioban P-1487 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: July 6, 2007 (Volume 72, Number 129)]
[Notices]
[Page 37006-37008]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy07-63]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0402; FRL-8136-8]
Bioban P-1487 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
assessments, and related documents for the pesticide Bioban P-1487, and
opens a public comment period on these documents. 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 Bioban P-1487 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 September 4, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0402, 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-
2007-0402. 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 Federal 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
[[Page 37007]]
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 web
site 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: Michelle Centra, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-2476; fax number: (703) 305-5620; e-
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 Bioban P-1487, an antimicrobial pesticide, and soliciting public
comment on risk management ideas or proposals. Bioban P-1487, a mixture
of the two active ingredients morpholine and dimorpholine, is currently
registered for indoor non-food and non-feed use as an antimicrobial
agent (inhibition of microbial growth and materials preservative) for
the control of slime-forming fungi and bacteria. EPA developed the risk
assessment and risk characterization for Bioban P-1487 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).
For inhibition of microorganism growth, Bioban P-1487 containing
products are approved for use in industrial processes and water systems
such as metalworking fluids; oil storage tank bottom water, fuel
storage tank bottom water; and diesel oil, fuel oil, gasoline, and
kerosene (hydrocarbon preservation). Bioban P-1487 is also used as a
materials preservative in die cast lubricants, corrosion inhibiting
metal coatings, mold-release agents (manufacture of plastics), and
diesel engines (fuel conditioner).
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessment for Bioban P-1487. Such comments and input could address,
for example, the availability of additional data to further refine the
risk assessments, such as an acute inhalation toxicity study, a 90-day
inhalation toxicity study, a 90-day subchronic dermal toxicity study
conducted in the rabbit, a two-generational reproductive toxicity
study, a combined chronic toxicity/carcinogenicity study, acute
toxicity testing of rainbow trout, acute toxicity testing of Daphnid,
algal growth testing using freshwater green algae, application and/or
treatment rates for occupational uses of metalworking fluids and fuels,
and monitoring data to confirm the estimated (CMA and/or PHED) dermal
and inhalation unit exposure values, or could address 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
[[Page 37008]]
proposals or otherwise comment on risk management for Bioban P-1487.
The risk of concern associated with the use of Bioban P-1487 is:
Occupational handler (machinist) dermal exposure to metalworking
fluids. 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 Bioban P-1487, 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 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 Bioban P-1487, a modified, 4-Phase process with 1
comment period and ample opportunity for public consultation seems
appropriate in view of its refined risk assessment, limited use, small
number of users, few complex issues, and few affected stakeholders.
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 Bioban P-1487. 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.''
Section 408(q) of the 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
was completed by August 3, 2006.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 25, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E7-12738 Filed 7-5-07; 8:45 am]
BILLING CODE 6560-50-S