Aldicarb Risk Assessment; Notice of Availability and Risk Reduction Options
[Federal Register: May 17, 2006 (Volume 71, Number 95)]
[Notices]
[Page 28693-28695]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my06-54]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0163; FRL-8064-8]
Aldicarb Risk Assessment; Notice of Availability and Risk Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's Health Effects
risk assessment, and related documents for the carbamate pesticide
aldicarb, and opens a public comment period on these documents. EPA's
Environmental Risk assessment has previously been released for public
comment. The public is encouraged to suggest risk management ideas or
proposals to address the risks identified. EPA is developing a
Reregistration Eligibility Decision (RED) for aldicarb through a
modified, 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 July 17, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0163[insert number], 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
Building); 2777 S. Crystal Drive, 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-
2005-0163[insert number]. 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.
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
[[Page 28694]]
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 in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. 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: Sherrie Kinard, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-0563; fax
number: (703) 308-8005; e-mail address: sherrie.kinard@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 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 risk
assessment and related documents for aldicarb, a carbamate pesticide,
and soliciting public comment on risk management ideas or proposals.
Aldicarb is registered for use as a systemic insecticide, acaricide and
nematicide on agricultural crops including citrus, cotton, dry beans,
peanuts, pecans, potatoes, sorghum, soybeans, sugar beets, sugarcane,
sweet potatoes, and seed alfalfa (CA). In addition, aldicarb may be
applied to field grown ornamentals (CA) and tobacco, and on coffee
grown in Puerto Rico. The types of plant pests controlled by aldicarb
include leaf phylloxera, bud moth, citrus nematode, aphids, mites
(citrus red, citrus rust, Texas citrus), white flies, thrips,
fleahoppers, leafminers, leafhoppers, overwintering boll weevil (adults
feeding on foliage), lygus, nematodes, cotton leaf perforator, seedcorn
maggot, Mexican bean beetle, flea beetles, Colorado potato beetle,
greenbug, chinch bug, three cornered alfalfa hopper (suppression), and
sugar beet root maggot.
The largest uses of aldicarb are peanuts, sweet potatoes, cotton,
potatoes, and citrus. Aldicarb is a restricted use pesticide (RUP), and
may be applied only in occupational settings by certified applicators.
There are no products containing the active ingredient aldicarb which
are intended for sale to homeowners or for occupational use in non-
occupational settings (e.g., turf or golf course). EPA developed the
risk assessment and risk characterization for aldicarb 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).
Aldicarb is formulated and marketed solely as a granular pesticide.
Aldicarb in a vinyl binder coating is adhered to either a corn cob grit
or gypsum substrate; these two substrates produce less dust than
typical clay substrates used for granular pesticides. Only the gypsum
granular is available in closed loading systems. The formulations
consist of 5, 10 and 15% granular, which are applied early in the
growing season, either pre-plant, at-planting, or early post-emergent,
using ground application equipment. Labels specify use of positive
displacement application equipment and immediate soil incorporation.
For most crops, only one aldicarb application per season is
allowed, but 2 or 3 split applications are permitted on sugar beets.
The pre-harvest intervals (PHIs) are generally long due to the early
application timing, ranging from 80 to 150 days when specified.
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for aldicarb. Such comments and input could address, for
example, the availability of additional data to further refine the risk
assessments, such as, additional toxicological data, worker exposure
data, and usage information, or could address the Agency's risk assessment
methodologies and assumptions as applied to this specific pesticide.
Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals for aldicarb.
Risks of concern associated with the use of aldicarb are: acute dietary
risk estimates for the general U.S. population and all population
subgroups at the 99.9th percentile of exposure; acute
aggregate food and water risk estimates for adults and children; and
worker risk estimates for most mixers, loaders and
[[Page 28695]]
applicators. In addition, EPA is providing interested parties an
opportunity to submit risk management proposals for ecological risks of
concern including those to birds, mammals, fresh water and marine fish
and invertebrates. In targeting these risks of concern, the Agency
solicits information on effective and practical risk reduction measures.
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 aldicarb, 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 aldicarb, a modified, 4-Phase process with one comment
period and ample opportunity for public consultation seems appropriate
in view of its refined risk assessment. 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,
the decisions presented in the RED may be supplemented by further risk
mitigation measures when EPA considers its cumulative assessment of the
carbamate pesticides.
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 aldicarb. 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: May 11, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-7496 Filed 5-16-06; 8:45 am]
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