Chloroacetanilide Cumulative Risk Assessment; Notice of Availability
[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]
[Page 15726-15728]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-74]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0202; FRL-7770-5]
Chloroacetanilide Cumulative Risk Assessment; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's cumulative
risk assessment for the chloroacetanilide group of pesticides and opens
a public comment period on these documents. As required by the Food
Quality Protection Act (FQPA), a cumulative risk assessment, which
evaluates exposures based on a common mechanism of toxicity, was
conducted to evaluate the risk from food, drinking water, and non-
occupational exposure resulting from all registered uses of
chloroacetanilide pesticides. The chloroacetanilides group includes the
pesticides acetochlor, alachlor and butachlor; however, butachlor was
not incorporated into the cumulative assessment because there are no
U.S. registrations or established tolerances. The Agency is also
releasing the Report on FQPA Tolerance Reassessment Progress and Risk
Management Decision (TRED) for Acetochlor concurrent with the release
of the chloroacetanilide cumulative assessment. See EPA-HQ-OPP-2005-
0227 in the Notice section of this issue of the Federal Register.
DATES: Comments must be received on or before May 30, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0202, by one of the following methods:
? http://www.regulations.gov/ 
Follow the on-line
instructions for submitting comments.
? Mail. Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
? Hand Delivery. Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2006-0202. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is (703) 305-5805. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions. Direct your comments to docket ID number EPA -HQ-OPP-
2006-0202. EPA's policy is that all comments received will be included
in the public 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 captured automatically and included as part
of the comment that is placed in the public 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm.
Docket. All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as
[[Page 15727]]
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov/ or in hard copy at the
Public Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the docket facility
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Felicia Fort, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-7478; fax
number: (703) 308-8005; e-mail address: fort.felicia@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
http://www.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 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 completed cumulative risk assessment
for the chloroacetanilide pesticides. The chloroacetanilides group
includes the pesticides, acetochlor, alachlor and butachlor; however,
butachlor was not incorporated into the cumulative assessment because
there are no U.S. registrations or established tolerances. The Agency
developed this risk assessment 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 FQPA.
A chloroacetanilide cumulative risk assessment was conducted for
acetochlor and alachlor exposures based on a common mechanism of
toxicity, their ability to cause nasal turbinate tumors. This
determination can be found in the chloroacetanilides decision document
published in 2001 entitled ``The Grouping of a Series of
Chloroacetanilide Pesticides Based on a Common Mechanism of Toxicity''
(http://www.epa.gov/oppfod01/cb/csb_page/updates/commechs.htm).
The Agency has concluded that the cumulative risk associated with
chloroacetanilide pesticides is below the Agency's level of concern.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's
completed cumulative risk assessment for the chloracetanilides. Such
comments and input could address the Agency's risk assessment
methodologies and assumptions as applied to this cumulative assessment.
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 chloroacetanilide pesticides,
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, 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.
Comments should be limited to issues raised within the risk
assessment and associated documents. Failure to comment on any such
issues as part of this opportunity will not limit a commenter's
opportunity to participate in any later notice and comment processes on
this matter. 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 the
chloroacetanilide cumulative risk assessment. 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)(A) of FIFRA, as amended, requires the Administrator
to make ``a determination as to the eligibility for reregistration (i)
for all
[[Page 15728]]
active ingredients subject to reregistration under this section for
which tolerances or exemptions from tolerances are required under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not later
than the last date for tolerance reassessment established under section
408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)) * * *''
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. A tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2), respectively, if ``the
Administrator determines the pesticide chemical residue is safe,''
i.e., ``that there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' 21 U.S.C. 346a(b)(2)(A), (c)(2)(A). In
making this safety finding, FFDCA requires the Administrator to
consider, among other factors, ``available information concerning the
cumulative effects of such residues and other substances that have a
common mechanism of toxicity * * *'' 21 U.S.C. 346a(b)(2)(D)(v), (c)(2)(B).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: March 21, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-4505 Filed 3-28-06; 8:45 am]
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