[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8390]
ENVIRONMENTAL PROTECTION AGENCY
1,3-Dichloropropene (1,3-D) Revised Human Health Risk Assessment,
Notice of Availability and Solicitation of Risk Reduction Options
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the availability and solicitation of
comments on the EPA's revised human health risk assessment for the soil
fumigant 1,3-Dichloropropene (1,3-D), which is commonly referred to as
telone. In addition, this notice seeks public comment on the risk
reduction options paper and EPA's benefits assessments for the soil
fumigant group. The Agency is also seeking comments on the 1,3-D
ecological risk assessment which, based on public comments in phase 3,
was not revised. Although 1,3-D has undergone reregistration and a
Reregistration Eligibility Decision was published in December 1998, EPA
is concurrently assessing six soil fumigants to ensure that its risk
assessment approaches are consistent, and to ensure that risk tradeoffs
and economic outcomes can be adequately predicted in reaching risk
management decisions for the five other soil fumigants. The Agency is
seeking the same input from the public on these pesticides. EPA has
developed a revised human health risk assessment for 1,3-D and is
seeking comment through a public participation process in order to make
available current and accurate information on this pesticide.
DATES: Comments must be received on or before July 2, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0124, 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 telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0124. 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 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 Building), 2777 S. Crystal Drive, 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
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Andrea Carone, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:703-308-0122; fax number:
(703) 308-8005; e-mail address: email@example.com
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,
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
vi. Provide specific examples to illustrate your concerns and
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
A. What Action is the Agency Taking?
EPA is making available the Agency's revised human health risk
assessment, initially issued for comment through a Federal Register
notice published on July 13, 2005 (70 FR 40342) (FRL-7721-9); a
response to comments; and related documents for 1,3-D. EPA also is
soliciting public comment on the risk reduction options paper and the
benefits assessments for the soil fumigant group. 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).
1,3-D is applied to control root-knot nematodes and certain pests
and diseases in the soil prior to the planting of a variety of food and
feed crops including vegetables, fruits, nuts, and other field and
nursery crops. In addition there is a proposed new use for post-plant
drip irrigation in established vineyards. 1,3-D is also a restricted
use pesticide and as such can only be applied by certified applicators
or those under the supervision of a certified applicator. End-use
product formulations containing 1,3-D may be applied through drip
irrigation or by injection below the soil surface either in rows or
broadcast across an area.
1,3-D was deemed eligible for reregistration in December 1998. The
volatility of 1,3-D in the environment and results of metabolism
studies in plants assure that there is no reasonable expectation of
finite residues to be incurred in/on any raw agricultural commodities
when end-use product formulations containing 1,3-D are applied
according to label directions. Therefore, this fumigant does not
require food tolerances.
EPA is providing an opportunity, through this notice, for
interested parties to provide risk management proposals or otherwise
comment on risk management for the soil fumigant group. A complete list
of the mitigation options can be found in the following document,
``Risk Mitigation Options to Address Bystander and Occupational
Exposures from Soil Fumigant Applications,'' docket number EPA-HQ-OPP-
2005-0124-0048. A Reader's Guide has been created to provide an
organizational structure to the 1,3-D Docket, to allow readers to more
easily access and navigate the various entries contained in the 1,3-D
Docket, and to facilitate public comment. You will find this guide at
EPA-HQ-OPP-2005-0124-0046. 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
Although 1,3-D has undergone reregistration, the Agency plans to
follow a similar public participation process for the human health
revised risk assessment to ensure that the risk assessment approaches
are consistent, and that risk management decisions for the five other
soil fumigants consider the relative risks and benefits of each
chemical. While the Agency does not anticipate making changes to the
decisions made in the 1998 RED, if, at the conclusion of the soil
fumigant assessment and risk management process, EPA determines that it
is appropriate to modify its 1998 risk mitigation decision for 1,3-D
considering the relative risks and benefits of others, EPA may relax
certain measures or consider adding new ones.
All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments and
proposals will become part of the Agency Docket for 1,3-D. 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.''
1,3-D was deemed eligible for reregistration in December 1998. EPA
has developed a revised human health risk assessment for 1,3-D to
assess the proposed post-plant use in established vineyards, and also
in order to make available current and accurate information on this
pesticide which will be considered as EPA assesses risk and develops
risk management decisions for the five other soil fumigants.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: April 19, 2007.
Acting Director, Special Review and Reregistration Division, Office of
[FR Doc. E7-8390 Filed 5-1-07; 8:45 am]
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