Document ID: EPA-HQ-OPP-2006-0202-0001
Agency: epa
Document Type: Notice
Title: Chloroacetanilide Cumulative Risk Assessment; Notice of Availability
Posted Date: 2006-03-29T13:26:04Z

[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]

BILLING CODE 6560-50-S