[Federal Register Volume 70, Number 133 (Wednesday, July 13, 2005)]
[Notices]
[Pages 40333-40336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13345]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0125; FRL-7722-1]


Metam Sodium 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 human health 
risk assessment and related documents for the pesticide metam sodium, 
and opens a public comment period on these documents. EPA is developing 
a Reregistration Eligibility Decision (RED) for metam sodium through 
the full, 6-Phase public participation process that the Agency uses to 
involve the public in developing pesticide reregistration and tolerance 
reassessment decisions. EPA also is concurrently assessing the risks of 
five other soil fumigant pesticides to ensure that its assessment 
approaches are consistent and to ensure that risk trade offs and 
economic outcomes can be adequately predicted in reaching risk 
management decisions. Through these programs, EPA is ensuring that all 
pesticides meet current health and safety standards.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0125, must be received on or before September 12, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mark Seaton, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 306-0469; fax 
number: (703) 308-8041; e-mail address:[email protected].

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. How Can I Get Copies of this Document and Other Related Information?

     1. Docket. EPA has established an official public docket for this 
action under Docket ID Number OPP-2005-0125. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    Additional support documents can viewed at EPA's electronic public 
docket under Docket ID Number OPP-2004-0159. On June 2, 2004, the 
Agency previously opened a docket announcing the availability of the 
human health and environmental fate and effects risk assessments for 
metam sodium. You may wish to review these additional support 
documents, but the Agency is not asking for comments on these 
documents, nor accepting comments under Docket ID Number OPP-2004-0159. 
The Agency is making available an updated human health risk assessment 
under Docket ID Number OPP-2005-0125 and is seeking comments on this 
risk assessment.
     2. Electronic access. You may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr/.

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     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B.1. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
     1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
     i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in Docket ID Number 
OPP-2005-0125. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
     ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2005-0125. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
     iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
     2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0125.
     3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0125. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does

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 not contain CBI on disk or CD ROM, mark the outside of the disk or CD 
ROM clearly that it does not contain CBI. Information not marked as CBI 
will be included in the public docket and EPA's electronic public 
docket without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
     1. Explain your views as clearly as possible.
     2. Describe any assumptions that you used.
     3. Provide any technical information and/or data you used that 
support your views.
     4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
     5. Provide specific examples to illustrate your concerns.
     6. Offer alternatives.
     7. Make sure to submit your comments by the comment period 
deadline identified.
     8. To ensure proper receipt by EPA, identify the appropriate 
docket ID number in the subject line on the first page of your 
response. It would also be helpful if you provided the name, date, and 
Federal Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

     EPA is making available the human health risk assessment for metam 
sodium, and metam potassium. They are non-selective pre-plant soil 
fumigants with fungicidal, herbicidal, insecticidal, and nematicidal 
properties. Metam sodium is one of the most widely used agricultural 
pesticides in the U.S. and is presently registered on a wide variety of 
crop groups including: root and tuber vegetables; bulb vegetables; 
leafy vegetables; Brassica (cole) leafy vegetables; legume vegetables; 
fruiting vegetables; cucurbit vegetables; citrus fruits; pome fruits; 
stone fruits; berries; tree nuts; cereal grains; nongrass livestock 
feeds; and herbs and spices. Metam sodium may be applied to plant beds 
as a soil drench treatment. It may also be applied to field or row 
crops during pre-plant and postharvest stages via chemigation, soil 
broadcast treatment, soil band treatment, soil-incorporated treatment, 
and soil-injection treatment. An estimated 51 million pounds of metam 
sodium is applied annually. Lesser amounts of metam potassium are used 
in the U.S.; unless further qualified or specified, use of the term 
``metam sodium'' should be assumed to also include ``metam potassium.''
    Metam sodium and metam potassium are converted to methyl 
isothiocyanate (MITC) in the environment, particularly in the presence 
of moisture (such as in soil after application). It is MITC that 
performs the fumigating activity.
    The volatility of metam sodium in the environment and results of 
metabolism studies in plants assure that there is no reasonable 
expectation of finite residues to be incurred in/on any raw 
agricultural commodity when these products are applied according to 
label directions. Therefore, this fumigant does not require food 
tolerances.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessment for metam sodium. Such comments and input could address, for 
example, the availability of additional data to further refine the risk 
assessments, or information about specific use practices for crops that 
are produced using metam sodium. For example, the following information 
would be helpful to EPA in characterizing regional and crop differences 
in use practices and possible effects on potential risk. When providing 
information to the Agency, consider providing pictures or video footage 
to help clarify your comment:
     Crop.
     Fumigant use.
     Average acres grown per enterprise.
     Maximum acres fumigated per day.
     Percent of the acres grown that are fumigated.
     Typical application rate (lb a.i./acre).
     Minimum application rate used (lb a.i./acre)(for high pest 
pressure situations).
     Time of year that soil is fumigated.
     Fumigation cycle (every crop cycle, 1 time/year, 1 time/2 
years).
     Target pests (by category or specific pests).
     Method of application (e.g., chemigation, soil injection, 
specific equipment used, etc.)
     Methods or actions taken to reduce emissions (e.g., 
polyethylene tarps, water seal, or soil cap).
     Could high-density polyethylene (HDPE) or high barrier 
tarps be used on this crop?
     Time between treatment and next production activity (e.g., 
time until planting).
     Typical crops following the fumigated crop (only if they 
benefit from the fumigation).
     Regulatory restrictions in your area on this fumigant or 
an alternative fumigant (such as weather restrictions).
     Soil restrictions on this fumigant or an alternative 
fumigant.
     Any restrictions or concerns about minimum soil 
temperature, hilly terrain, etc.
     Best available alternative (another fumigant or strategy 
such as leaving land fallow, etc.)
     Could the use of different fumigants be alternated to 
achieve similar efficacy (e.g., metam sodium followed by 1,3-D)? 
Specify how.
     Yield or quality impacts that are likely to result from 
moving to the next best available alternative (i.e., change in 
commodity price or grade).
     Would moving to the next best alternative impact key 
market windows? How?
     Cost per acre of active ingredient.
     Cost per acre of other fumigation inputs (e.g., irrigation 
and equipment).
     Is there a crop budget available for your area and crop?
     Do you know of any other contacts or other sources of 
information for this crop that could provide information on acreage, 
prices, pests, etc.?
     Are there non-chemical alternatives that can be used in 
place of fumigants? Describe use.
     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 metam sodium, 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. 
EPA plans to

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review metam sodium through the full, 6-Phase public participation 
process.
     Comments should be limited to issues raised within the 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 Unit 
I. of the SUPPLEMENTARY INFORMATION, and must be received by EPA on or 
before the closing date. Comments will become part of the Agency Docket 
for metam sodium. 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: June 29, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-13345 Filed 7-12-05; 8:45 am]
BILLING CODE 6560-50-S