Document ID: EPA-HQ-OPP-2006-0339-0001
Agency: epa
Document Type: Notice
Title: Alkyl Dimethyl Ammonium Chloride Risk Assessments and Preliminary Risk Reduction Options; Notice of Availability
Posted Date: 2006-04-26T12:59:15Z

[Federal Register: April 26, 2006 (Volume 71, Number 80)]
[Notices]               
[Page 24675-24677]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap06-70]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0339; FRL-8061-3]

 
Alkyl 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 II Quat Clustr of structurally similar quaternary 
ammonium compounds known as alkyl dimethyl ammonium chloride (ADBAC), 
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 ADBAC 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.

DATES: Comments must be received on or before June 26, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0339, 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 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

[[Page 24676]]

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-
2006-0339. 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: Jacqueline McFarlane, Antimicrobials 
Division (7510C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-6416; fax number: (703) 308-6416; 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 releasing for public comment its human health and 
environmental fate and effects risk assessments, preliminary risk 
reduction options, and related documents for ADBAC 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 ADBAC 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).
    ADBAC is an active ingredient in numerous types of products. These 
products are mainly disinfectants, food and non-food contact 
sanitizers, wood preservatives, bacteriocide/bacteriostat, 
microbiocide/microbiostats, fungicide/fungistats, algaecides, and 
virucides. These products are used in agricultural, food handling, 
commercial, institutional/industrial, residential, and public access, 
and medical settings. Examples of registered uses for ADBAC 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 shell, 
shoes, milking equipment and udders, humidifiers, RV

[[Page 24677]]

tanks, medical instruments, human remains, ultrasonic tanks, reverse 
osmosis units, and water storage tanks. There are products that are 
used in residential and commercial swimming pools, aquatic areas such 
as decorative ponds, decorative fountains, and agricultural watering 
lines, and industrial process and water systems such as once through 
and recirculating cooling water systems, cooling water towers, 
evaporative condensers, pasteurizers, drilling mud and packer fluids, 
oil well injection and wastewater systems, pulp and paper products, 
water, and chemicals. Additionally, these products are used in wood 
preservation through non-pressure and pressure treatment methods. There 
are a number of methods for applying these products such as fogging in 
both occupational and residential settings. The Agency's risk 
assessment identified residential, occupational, and ecological risks 
of concern for some exposure scenarios. Due to limited information for 
some exposure scenarios, conservative assumptions were used in this 
assessment. The Agency is interested in receiving any information.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessments for ADBAC. Such comments and input could address, for 
example, the availability of additional data to further refine the risk 
assessments, such as higher tier modeling to assess degradation for 
once-through cooling towers, a leaching study to address the liquid 
availability from ADBAC treated wood, refinement of the percent active 
ingredient in solution for pressure treatment of lumber, detailed 
description of the application/spray equipment used on hard surfaces 
and wood, detailed use information, confirmatory exposure data to 
support the using the 10% transfer rate in the dietary assessment, 
confirmatory exposure data to support the occupational scenarios, 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 ADBAC, 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 ADBAC, 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 ADBAC, 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 ADBAC. 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. E6-6299 Filed 4-25-06; 8:45 am]

BILLING CODE 6560-50-S