Document ID: EPA-HQ-OPP-2007-0632-0001
Agency: epa
Document Type: Notice
Title: Explanatory Document to the September 2005 Draft North American Free Trade Agreement Standard Operating Procedure for Determining Pesticide Maximum Residue Limits; Notice of Availability
Posted Date: 2007-08-01T04:00Z

[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Notices]               
[Page 42081-42082]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au07-59]                         

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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: 
villanueva.philip@epa.gov.

[[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