[Federal Register Volume 72, Number 147 (Wednesday, August 1, 2007)]
[Notices]
[Pages 42081-42082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14889]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0632; FRL-8142-7]
Explanatory Document to the September 2005 Draft North American
Free Trade Agreement Standard Operating Procedure for Determining
Pesticide Maximum Residue Limits; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is seeking public comment on the document entitled
Statistical Basis of the NAFTA Method for Calculating Pesticide Maximum
Residue Limits from Field Trial Data available at http://www.pmra-arla.gc.ca/english/pdf/nafta/docs/nafta_mrls-e.pdf. Although Canada's
Management Regulatory Agency (PMRA) is also accepting comments, EPA and
PMRA will be jointly responding to comments submitted to either agency.
The document was prepared by the NAFTA MRL Harmonization Working Group
(a group comprised of United States and Canadian governments, created
to develop a coordinated pesticides regulatory framework among North
American Free Trade Agreement (NAFTA) partners). The document provides
additional technical and explanatory material for a standard operating
procedure (SOP) previously released by Canada's PMRA for public comment
in September 2005. The document currently open for public comment
supports the September 2005 draft SOP that is intended for use by
residue chemistry reviewers in the United States and Canada to ensure
that the same or similar residue chemistry data sets will result in the
same or similar recommendation for maximum residue limit (MRL) levels
for pesticide residues on food and feed commodities by each agency. The
goal for this method is to minimize trade barriers of pesticide treated
commodities between the United States and Canada.
DATES: Comments must be received on or before August 31, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0632, 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-
2007-0632. 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 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: Philip Villanueva, Health Effects
Division (7509P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8665; e-mail address:
[email protected].
[[Page 42082]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are engaged
in pesticide and other agricultural chemical manufacturing. Potentially
affected entities may include, but are not limited to:
Pesticide and other agricultural chemical manufacturing
(NAICS code 325320) e.g., individuals or entities engaged in activities
related to the registration of a pesticide product.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What Action is the Agency Taking?
EPA is seeking public comment on the document entitled Statistical
Basis of the NAFTA Method for Calculating Pesticide Maximum Residue
Limits from Field Trial Data. The document, prepared by the NAFTA MRL
Harmonization Working Group, serves as an added explanatory document to
Canada's PMRA and EPA's OPP September 2005 draft document entitled
Guidance for Setting Pesticide Maximum Residue Limits Based on Field
Trial Data which is available at http://www.pmra-arla.gc.ca/english/pdf/pro/pro2005-04-e.pdf. The SOP includes procedures for using the
companion ``NAFTA MRL calculator,'' the Microsoft Excel[reg]
spreadsheet that incorporates the decision algorithm and automates the
statistical calculations as outlined by the SOP. The NAFTA MRL
calculator can be downloaded from the PMRA website (http://www.pmra-arla.gc.ca/english/pdf/mrl/method_calc.xls). The September 2005 draft
SOP is intended for use by residue chemistry reviewers in the United
States and Canada to ensure that the same or similar data sets will
result in the same or similar recommendation for MRL levels in each
regulatory program. A 60-day comment period was opened for this by PMRA
in September 2005 and is now closed. The comments received by PMRA were
shared with EPA.
Upon the September 2005 release of the draft SOP, PMRA and EPA
announced that an additional explanatory document would be published at
a future date. This document is now available on the PMRA website (see
http://www.pmra-arla.gc.ca/english/pdf/nafta/docs/nafta_mrls-e.pdf)
and EPA is seeking comment on the statistical (and non-statistical)
basis of the selected procedures and algorithms. More detailed
statistical, simulation, and other support for the methods described in
the September 2005 draft SOP are provided in this follow-on document
which is intended to provide a permanent and enduring record of the
rationale, reasoning, historical context, and technical/statistical
support for the MRL estimation methodologies described and discussed in
the September 2005 SOP.
Once the public comment period closes for this document, the
statistical support document, the SOP and the associated MRL calculator
will be modified as appropriate to address the comments from this
current public comment period and the previous PMRA comment period for
the draft SOP, and then reissued. We anticipate these documents will be
released in final form in December 2007.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, North American Free Trade Agreement (NAFTA),
Pesticides and pests.
Dated: July 26, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-14889 Filed 7-31-07; 8:45 am]
BILLING CODE 6560-50-S