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Didecyl Dimethyl Ammonium Chloride Risk Assessments and Preliminary Risk Reduction Options; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: April 26, 2006 (Volume 71, Number 80)]
[Notices]
[Page 24679-24681]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap06-72]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0338; FRL-8061-2]
Didecyl Dimethyl Ammonium Chloride Risk Assessments and
Preliminary Risk Reduction Options; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's risk
assessments, preliminary risk reduction options, and related documents
for the Group 1 Quat Cluster pesticide didecyl dimethyl ammonium
chloride, and opens a public comment period on these documents. The
public also is encouraged to suggest risk management ideas or proposals
to address the risks identified. EPA is developing a Reregistration
Eligibility Decision (RED), for didecyl dimethyl ammonium chloride
through a modified, 4-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.
DATED: Comments must be received on or before June 26, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0338, 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 (7502C), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Hand Delivery: OPP Regulatory Public Docket, Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St.,
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
[[Page 24680]]
Docket telephone number is (703) 305-5805.
? Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall #2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number and hours of operation
will remain the same after the move.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0338. 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 Web site 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.
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 in the electronic docket at http://www.regulations.gov,
or, if only available in hard copy, at the OPP Regulatory Public Docket at
the location identified under ``Delivery'' and ``Important Note.'' The
hours of operation for 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.
FOR FURTHER INFORMATION CONTACT: Tracy Lantz, Antimicrobials Division,
(7510C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-6415; fax number: (703) 308-8481; e-mail address:
lantz.tracy@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 assessments, preliminary risk
reduction options, and related documents for didecyl dimethyl ammonium
chloride, and encouraging the public to suggest risk management ideas
or proposals. This chemical is an antimicrobial pesticide used in
agricultural, food handling, commercial, institutional/industrial,
residential and public access, and medical settings. EPA developed the
risk assessments and preliminary risk reduction options for didecyl
dimethyl ammonium chloride 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
(FQPA) of 1996.
Products containing this chemical are used as disinfectants, food
and non-food contact sanitizers, wood preservatives, bacteriocide/
bacteriostats, microbiocide/microbiostats, fungicide/fungistats,
algaecides and virucides. These products are used in agricultural, food
handling, commercial,
[[Page 24681]]
institutional/industrial, residential and public access, and medical
settings. Examples of registered uses in these settings include
application to indoor and outdoor hard surfaces (e.g., walls, floors,
tables, toilets, and other similar surfaces), eating utensils, laundry,
carpets, agricultural tools and vehicles, egg shells, shoes, milking
equipment and udders, humidifiers, medical instruments, human remains,
ultrasonic tanks, reverse osmosis units, and water storage tanks. These
products are also used in residential and commercial swimming pools,
aquatic areas such as decorative ponds and decorative fountains, and
industrial process and water systems such as re-circulating cooling
water systems, drilling muds and packer fluids, oil well injections and
wastewater systems. Additionally, these products are used for wood
preservation through non-pressure and pressure-treatment methods. There
are application methods of concern such as fogging in occupational
settings. The Agency's risk assessment identified residential,
ecological, and occupational risks of concern for some exposure
scenarios. Due to limited information for some exposure scenarios,
conservative assumptions were used in the risk assessment. The Agency
is interested in receiving any information that could assist in
refining the risk assessment.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for didecyl dimethyl ammonium chloride. Such comments and
input could address, for example, the availability of additional data
to further refine the risk assessments, such as higher tier modeling
for once-through cooling towers, refinement of percent active
ingredient in solution for pressure treatment of lumber, detailed use
information (encompasses the information requested on secondary oil
field recovery and food processing plants), confirmatory studies to
support occupational scenarios, confirmatory data to establish the
reliability of using the 10% transfer rate in the dietary assessment,
wipe data to assess the children's dermal contact to treated decks and
play sets, non-target plant phytotoxicity testing, acute sheepshead
minnow testing, acute eastern oyster embryo larvae testing, chronic
Daphnis manga testing, or could address the Agency's risk assessment
methodologies and assumptions as applied to this specific pesticide.
Through this notice, EPA also is releasing for public comment its
preliminary risk reduction options for didecyl dimethyl ammonium
chloride, and is providing an opportunity for interested parties to
provide risk management proposals or otherwise comment on risk management.
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 didecyl dimethyl ammonium
chloride, 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 didecyl dimethyl ammonium chloride, a modified, 4-Phase
process with one comment period and ample opportunity for public
consultation seems appropriate in view of its refined risk assessments
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 didecyl dimethyl ammonium
chloride. 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
is to be completed by August 3, 2006.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: April 19, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E6-6301 Filed 4-25-06; 8:45 am]
BILLING CODE 6560-50-S