Organophosphate Cumulative Risk Assessment; Notice of Availability
[Federal Register: August 2, 2006 (Volume 71, Number 148)]
[Notices]
[Page 43740-43742]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au06-67]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0618; FRL-8082-5]
Organophosphate Cumulative Risk Assessment; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's cumulative
risk assessment for the organophosphate group of pesticides and opens a
public comment period on this document and other support 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,
residential, and other non-occupational exposures resulting from
registered uses of organophosphate pesticides. The organophosphate
group includes over 30 pesticides including acephate, azinphos-methyl
(AZM), bensulide, chlorethoxyfos, chlorpyrifos, chlorpyriphos-methyl,
diazinon, dichlorvos (DDVP), dicrotophos, dimethoate, disulfoton,
ethoprop, fenamiphos, fenthion, fosthiazate, malathion, methamidophos,
methidathion, methyl-parathion, mevinphos, naled, omethoate,
oxydemeton-methyl, phorate, phosalone, phosmet, phostebupirim,
pirimiphos-methyl, profenofos, terbufos, tetrachlorvinphos, tribufos,
and trichlorfon. Several organophosphate pesticides, however, were not
incorporated into the cumulative risk assessment because no dietary,
drinking water, or residential human exposure to these pesticides is
anticipated from any of the currently registered uses.
DATES: Comments must be received on or before October 2, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0618, 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-
2006-0618. 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 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.
[[Page 43741]]
FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-8401; fax
number: (703) 308-8005; e-mail address: sherman.kelly@epa.gov; or
Kendra Tyler, Special Review and Reregistration Division (7508P);
telephone number: (703) 308-0125; e-mail address: tyler.kendra@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 making available the completed cumulative risk assessment
for the organophosphate pesticides. The Agency developed this risk
assessment as part of its ongoing 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 FQPA.
Section 408(b)(2)(D)(v) of the FFDCA directs the Agency to consider
available information on the cumulative risk from substances sharing a
common mechanism of toxicity. The Agency determined in 1999 that the
organophosphate pesticides share a common mechanism of toxicity,
cholinesterase inhibition. The organophosphates have been among EPA's
highest priority pesticides for review under FQPA.
In developing the organophosphate cumulative risk assessment and
underlying methodologies, EPA consulted with the FIFRA Scientific
Advisory Panel numerous times, seeking expert review, advice, and
recommendations at each major step of the process. The Agency also met
with several of its advisory committees to obtain input from a broad
spectrum of stakeholders representing the pesticide industry,
environmental and public interest groups, growers, academia, and
others, including other federal and state regulatory agencies. EPA
issued the Preliminary Organophosphate Cumulative Risk Assessment for
public comment in December 2001, and presented the cumulative
assessment at a Technical Briefing for the public in January 2002. The
Agency released the Revised Organophosphate Cumulative Risk Assessment
for public comment in June 2002. The Organophosphate Cumulative Risk
Assessment (2006 update) is considered an addendum to the June 2002
assessment, and includes improvements and refinements in assessing the
cumulative risks of the organophosphate pesticides. The previous
versions of the Organophosphate Cumulative Assessment may be accessed
on the EPA website at http://www.epa.gov/pesticides/cumulative.
EPA has concluded that the cumulative risks associated with the
remaining uses of the organophosphate pesticides are below the Agency's
level of concern. While completing reregistration eligibility and
tolerance reassessment decisions for individual organophosphates, the
Agency also evaluated the cumulative risk posed by this group. Although
individual risk assessments were conducted for each of the
organophosphate pesticides, several were not incorporated into the
cumulative risk assessment because no dietary, drinking water, or
residential human exposure is anticipated from any of the currently
registered uses of these pesticides.
The Interim Reregistration Eligibility Decisions (IREDs) previously
issued for a number of organophosphate pesticides are now considered
final; the tolerance reassessment and reregistration eligibility
process for these pesticides is complete. EPA has determined that the
remaining/reassessed tolerances for these pesticides meet the FFDCA
safety standard and that no further risk mitigation is necessary as a
result of the organophosphate cumulative risk assessment.
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 organophosphates. Such
comments and input could address the Agency's risk assessment
methodologies and assumptions as applied to this cumulative assessment.
The Agency will consider all comments received, and make changes, if
appropriate, to the organophosphate cumulative risk 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
[[Page 43742]]
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 organophosphate
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.
The organophosphate pesticides have had extensive opportunities for
public comment as part of their reregistration and tolerance
reassessment process.
Comments should be limited to issues raised within the
organophosphate cumulative 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 organophosphate 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 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) of (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), and
(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), and (c)(2)(B).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: July 20, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12343 Filed 8-1-06; 8:45 am]
BILLING CODE 6560-50-S
![[logo] US EPA](https://webarchive.library.unt.edu/eot2008/20090514030840im_/http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}