N-methyl Carbamate Revised Cumulative Risk Assessment; Notice of
Availability
[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Notices]
[Page 54656-54658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se07-64]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0935; FRL-8149-1]
N-methyl Carbamate Revised 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 revised
cumulative risk assessment for the N-methyl carbamate 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 N-methyl carbamate
pesticides. The N-methyl carbamate group includes aldicarb, carbaryl,
carbofuran, formetanate HCl, methiocarb, methomyl, oxamyl, pirimicarb,
propoxur, and thiodicarb.
DATES: Comments must be received on or before November 26, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0935, 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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0935. 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
[[Page 54657]]
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
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
website 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 Bldg.),
2777 S. Crystal Dr., 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 Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Neil Anderson, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8187; fax
number: (703) 308-8005; e-mail address: anderson.neil@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 N-methyl carbamate 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 2004 that the N-
methyl carbamate pesticides share a common mechanism of toxicity,
cholinesterase inhibition. The N-methyl carbamates have been among
EPA's highest priority pesticides for review under FQPA.
In developing the N-methyl carbamate cumulative risk assessment,
EPA employed the methodologies utilized in earlier cumulative risk
assessments (i.e., the organophosphate pesticides) and 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 Estimation of Cumulative Risk from N-methyl Carbamate
Pesticides: Preliminary Assessment in August 2005. The N-methyl
Carbamate Revised Cumulative Risk Assessment is considered an addendum
to the August 2005 assessment, and includes improvements and
refinements in assessing the cumulative risks of the N-methyl carbamate
pesticides. The previous versions of the N-methyl carbamate cumulative
risk assessment may be accessed on the EPA website at
[[Page 54658]]
http://www.epa.gov/pesticides/cumulative.
EPA has concluded that, with the adoption of the risk mitigation
measures evaluated in the N-methyl carbamate cumulative risk
assessment, all of the N-methyl carbamate pesticide tolerances assessed
in this risk assessment meet the safety standard set forth in section
408(b)(2)(a) of the FFDCA. For those tolerances, this conclusion
terminates the tolerance reassessment process under section 408(q) of
the FFDCA. For all of the chemicals, to the extent that the safety
determination for these uses based on the cumulative risk assessment
was the only remaining issue to complete the reregistration eligibility
determination for a particular chemical under section 4(g)(2)(A) of
FIFRA, the Agency now considers that determination (consistent with the
risk mitigation measures described in the cumulative assessment) to be
complete. As noted in the Introduction to the cumulative risk
assessment, certain tolerances and uses were omitted from the risk
assessment because EPA had previously determined that these uses or
tolerances did not meet the safety standards based on their individual,
aggregate risks or should be canceled for other reasons. These
tolerances and uses are identified in Appendix II.A of the cumulative
risk assessment. The cumulative assessment does not change the Agency's
determination with respect to those uses. Should any risk mitigation
measures identified in the assessment not subsequently be implemented,
EPA will revise the assessment as necessary to take those residues into
account.
In June 2006, the Agency determined that 144 of the N-methyl
carbamate tolerances were insignificant contributors to the overall
dietary exposure to the N-methyl carbamates. The uses associated with
these 144 tolerances make an insignificant contribution to the overall
N-methyl carbamate cumulative risk. Therefore, EPA counted these
tolerances as reassessed before the final N-methyl carbamate cumulative
assessment was issued. That determination is not changed by the
assessment the Agency is now issuing. As noted in the previous
paragraph above, EPA has now determined that those tolerances assessed
in the N-methyl carbamate cumulative risk assessment meet the FFDCA
safety standard and that no further dietary risk mitigation is
necessary for any of the pesticides involved in the cumulative risk
assessment other than the mitigation measures identified in the
individual chemical or cumulative assessments.
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 N-methyl carbamate
pesticides. 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 N-methyl carbamate 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, andpolicies. 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 N-methyl carbamate
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 N-methyl carbamate 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 N-methyl
carbamate 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 N-methyl carbamate 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) 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), 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: September 19, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-18860 Filed 9-25-07; 8:45 am]
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