[Federal Register: December 12, 2007 (Volume 72, Number 238)]
[Notices]
[Page 70593-70595]
[DOCID:fr12de07-42]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1140; FRL-8341-5]

Sodium Metasilicate; Notice of Receipt of Request to Voluntarily
Cancel Uses of Sodium Metasilicate Pesticide Registration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of a request by the registrant to voluntarily cancel
their registration for Misty Quat-22, (EPA Reg. No. 10807-106) product
containing the pesticide sodium metasilicate. The request would
terminate sodium metasilicate use in or on floors, walls, counter tops
in homes, schools, restaurants, hospitals, nursing homes, public rooms,
food processing plants, and in other places where efficient cleaning
and antimicrobial action is desired. The request would not terminate
the last sodium metasilicate product registered for use in the United
States. EPA intends to grant this request at the close of the comment
period for this announcement unless the Agency receives substantive
comments within the comment period that would merit its further review
of the request, or unless the registrant withdraws their request within
this period. Upon acceptance of this request, any sale, distribution,
or use of products listed in this notice will be permitted only if such
sale, distribution, or use is consistent with the terms as described in
the final order.

DATES: Comments must be received on or before January 11, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1140, 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<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1140. 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: James Parker, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 on the Receipt of Requests to Cancel and/or Amend
Registrations to Delete Uses

    This notice announces receipt by EPA of a request from registrant
Amreps, Inc. to cancel registration for a product (Reg. No. 10807-106)
. In an email dated October 24, 2007 Amreps, Inc. requested EPA to
cancel the affected product registration identified in this notice
(Table 1). Misty Quat-22 (Reg. No 10807-106) is the last pesticide
product registered in the United States for these uses; therefore, this
request is also to terminate these uses for sodium metasilicate.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of a request from a registrant
to cancel and terminate uses of Misty Quat-22 (EPA Reg. No 10807-106)
product registration. The affected product and the registrant making
the request is identified in Table 1 of this unit.
    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that their pesticide registrations be canceled or amended to
terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA
requires that before acting on a request for voluntary cancellation,
EPA must provide a 30-day public comment period on the request for
voluntary cancellation or use termination. In addition, section
6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period
on a request for voluntary cancellation or termination of any minor
agricultural use before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
    The Amreps, Inc. registrants have requested that EPA waive the 180-
day comment period. EPA will provide a 30-day comment period on the
proposed requests.
    Unless a request is withdrawn by the registrant within 30 days of
publication of this notice, or if the Agency determines that there are
substantive comments that warrant further review of this request, an
order will be issued canceling the affected registration.

    Table 1.--Sodium Metasilicate Product Registrations with Pending
                        Requests for Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name           Company
------------------------------------------------------------------------
10807-106                         Misty Quat-22.....  Amreps, Inc.
------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the product listed in Table 1 of this unit.

     Table 2.--Registrants Requesting Voluntary Cancellation and/or
                               Amendments
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
10807.....................................  Amreps, Inc., 990 Industrial
                                             Park Dr. Marietta, GA 30062
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may

at any time request that any of its pesticide registrations be canceled
or amended to terminate one or more uses. FIFRA further provides that,
before acting on the request, EPA must publish a notice of receipt of
any such request in the Federal Register. Thereafter, following the
public comment period, the Administrator may approve such a request.

V. Procedures for Withdrawal of Request and Considerations for
Reregistration of Sodium Metasilicate

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT, postmarked before January 11, 2008. This
written withdrawal of the request for cancellation will apply only to
the applicable FIFRA section 6(f)(1) request listed in this notice. If
the products(s) have been subject to a previous cancellation action,
the effective date of cancellation and all other provisions of any
earlier cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action.
    If the request for voluntary cancellation and use termination is
granted as discussed in this unit, the Agency intends to issue a
cancellation order that will allow persons other than the registrant to
continue to sell and/or use existing stocks of cancelled products until
such stocks are exhausted, provided that such use is consistent with
the terms of the previously approved labeling on, or that accompanied,
the cancelled product. The order will specifically prohibit any use of
existing stocks that is not consistent with such previously approved
labeling. If, as the Agency currently intends, the final cancellation
order contains the existing stocks provision just described, the order
will be sent only to the affected registrants of the cancelled
products. If the Agency determines that the final cancellation order
should contain existing stocks provisions different than the ones just
described, the Agency will publish the cancellation order in the
Federal Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: November 29, 2007.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.

[FR Doc. E7-23901 Filed 12-11-07; 8:45 am]

BILLING CODE 6560-50-S


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="Guidance for Prospective">
<META name="creation-date" content="13/01/2010 10:32:39 ">
<TITLE>Guidance for Prospective</TITLE>

United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7101)
EPA 712-B-10-001
August 25, 2008
Fate, Transport and
Transformation Test
Guidelines
OPPTS 835.7100:
Guidance for Prospective
Ground-Water
Monitoring Studies

NOTICE
This guideline is one of a series of test guidelines established by the Office of Prevention, Pesticides
and Toxic Substances (OPPTS), United States Environmental Protection Agency for use in testing
pesticides and chemical substances to develop data for submission to the Agency under the Toxic
Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and
Cosmetic (FFDCA) (21 U.S.C. 346a).
The OPPTS test guidelines serve as a compendium of accepted scientific methodologies and
protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA,
and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA,
the public, and the companies that are subject to data submission requirements under TSCA, FIFRA
and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any
outside parties, and the EPA may depart from the guidelines where circumstances warrant and
without prior notice.  The procedures contained in this guideline are strongly recommended for
generating the data that are the subject of the guideline, but EPA recognizes that departures may be
appropriate in specific situations. You may propose alternatives to the recommendations described in
these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.
For additional information about OPPTS harmonized test guidelines and to access the
guidelines electronically, please go to http://www.epa.gov/oppts and select “Test Methods &
Guidelines” on the left side navigation menu.  You may also access the guidelines in
http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150
through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

2
CHAPTER 1 - INTRODUCTION.................................................................................................. 7
1.1 ENVIRONMENTAL EXPOSURE CHARACTERIZATION ..................................... 8
1.11  Fate and Transport Studies............................................................................. 9
1.12  Conceptual Model........................................................................................ 11
1.2 GROUND WATER EXPOSURE AND ESTIMATING RISK................................. 13
1.21  Evaluation of Registered or Proposed Uses................................................. 13
1.22  Available Monitoring Data .......................................................................... 14
1.23  Modeling Ground Water Exposure.............................................................. 14
1.24  Consideration of Risk .................................................................................. 15
1.3  CASE STUDY........................................................................................................... 15
1.31  Exposure Characterization........................................................................... 15
1.32  Monitoring ................................................................................................... 16
1.33  Modeling...................................................................................................... 17
1.34  Data Evaluation............................................................................................ 17
1.4  STUDY COMPONENTS .......................................................................................... 18
1.5  STUDY RESULTS.................................................................................................... 19
CHAPTER 2 - SITE SELECTION............................................................................................... 19
2.1  STUDY SCOPE......................................................................................................... 20
2.11 Definition...................................................................................................... 20
2.12  Compounds of Interest and Analytical Methods.......................................... 22
2.2  A SET OF CANDIDATE SITES............................................................................... 23
2.21  Unconfined Aquifer ..................................................................................... 24
2.22  Shallow Depth.............................................................................................. 24
2.23  No Flow Restrictive Layers ......................................................................... 24
2.24 Preferential Flow.......................................................................................... 25
2.25  Tile Drains ................................................................................................... 25
2.26  Single Soil Series Mapping Unit.................................................................. 25
2.27  Low Topographic Slope............................................................................... 26
2.28  Stable Hydraulic Gradient............................................................................ 27
2.3  COOPERATOR INTERVIEW.................................................................................. 27
2.31  No Prior History of Test Pesticide Use........................................................ 27
2.32  Long-Term Availability of Study Site ......................................................... 27
2.4  PRELIMINARY SITE CHARACTERIZATION...................................................... 28
2.41  Absence of Dominant Fracture Flow........................................................... 29
CHAPTER 3 - SITE CHARACTERIZATION AND CONCEPTUAL MODEL ........................ 30
3.1  EXISTING LOCAL DATA AND BASE MAP......................................................... 30
3.11  Compile Existing Local Data....................................................................... 31
3.12  Develop a Base Map .................................................................................... 31
3.13  Information Sources..................................................................................... 32
3.2  SOIL AND VADOSE ZONE INVESTIGATION..................................................... 32
3.21  Exploratory Coring Program and Field Testing........................................... 33
3.22  Number and Locations of Soil Cores........................................................... 34
3.23 Field Testing ................................................................................................. 35

3
3.24  Preservation and Transportation of Formation Samples.............................. 35
3.25  Quality Assurance and Quality Control Procedures .................................... 36
3.26  Test Pit Excavation ...................................................................................... 36
3.27  Abandonment of Soil Core Holes................................................................ 37
3.3  SATURATED ZONE INVESTIGATION................................................................. 37
3.31  Hydraulic Head ............................................................................................ 37
3.32  Direction of Ground-Water Flow and Hydraulic Gradient .......................... 38
3.33  Hydraulic Conductivity................................................................................ 38
3.34  Background Water Quality .......................................................................... 38
3.4  CONCEPTUAL MODEL.......................................................................................... 39
3.41  Soils and the Vadose Zone........................................................................... 39
3.42  Saturated Zone and Water Quality............................................................... 40
CHAPTER 4 - MONITORING PLAN DESIGN ......................................................................... 41
4.1  SETTING UP............................................................................................................. 41
4.11  Agricultural Management Practices............................................................. 41
4.12  Irrigation....................................................................................................... 42
4.13  Initial Post-Pesticide Application Irrigation Event ...................................... 43
4.14  Irrigation After Initial Event ........................................................................ 43
4.15  Mixing and Loading Area............................................................................ 44
4.16  Control Plot.................................................................................................. 44
4.17  Decontamination Area ................................................................................. 44
4.18  Weather Station............................................................................................ 44
4.2  APPLICATION OF PESTICIDE AND TRACER .................................................... 45
4.21  Pesticide....................................................................................................... 45
4.22  Tracer ........................................................................................................... 45
4.3  SOIL MONITORING PLAN..................................................................................... 45
4.31  Soil Sampling Methods and Instrumentation............................................... 46
4.32  Number and Location of Soil Cores ............................................................ 46
4.33  Soil Sampling Timing and Frequency.......................................................... 46
4.4  SOIL-WATER MONITORING PLAN ..................................................................... 46
4.41  Soil Water Content Measurements .............................................................. 47
4.42  Instrumentation ............................................................................................ 47
4.43  Location and Frequency of Sampling .......................................................... 47
4.44  Soil water Sampling..................................................................................... 47
4.45  Instrumentation ............................................................................................ 48
4.46   Depth and Number of Lysimeters............................................................... 48
4.47  Time of Emplacement.................................................................................. 48
4.48  Sampling Frequency..................................................................................... 48
4.5  GROUND-WATER MONITORING PLAN............................................................. 49
4.51  Monitoring Well Design .............................................................................. 49
4.52  Number, Emplacement, and Screen Lengths of Wells Within a Cluster..... 50
4.53  Number and Location of Monitoring Well Clusters .................................... 50
4.54  Time of Emplacement.................................................................................. 50
4.55  Sampling Frequency..................................................................................... 51

4
4.56  Instrumentation ............................................................................................ 52
4.57  Sampling Methods ....................................................................................... 52
4.58  Integrated Sampling Schedule...................................................................... 52
CHAPTER 5 - SITE CHARACTERIZATION AND MONITORING PLAN DESIGN REPORTS
........................................................................................................................................... 56
5.1  SITE CHARACTERIZATION REPORT.................................................................. 56
5.11  Site Base Map .............................................................................................. 57
5.12  Surficial Soil Characteristics........................................................................ 57
5.13  Field Testing Methods and Results.............................................................. 57
5.14  Historical Water Needs and Net Recharge................................................... 57
5.15  Test Pit Excavation ...................................................................................... 58
5.16  Exploratory Boring Program........................................................................ 58
5.17  Saturated Zone Investigations...................................................................... 58
5.18  Background Water Quality .......................................................................... 58
5.19  Conceptual Model........................................................................................ 58
5.2  MONITORING PLAN DESIGN REPORT (PROTOCOL)...................................... 59
CHAPTER 6 - MONITORING PLAN IMPLEMENTATION..................................................... 62
6.1  APPLICATION OF PESTICIDE AND TRACER .................................................... 63
6.2  IRRIGATION ............................................................................................................ 63
6.3  SOIL MONITORING ................................................................................................ 64
6.31  Decontamination of Sampling Equipment................................................... 64
6.32  Soil Sample Collection and Handling.......................................................... 64
6.4  PORE-WATER MONITORING ............................................................................... 65
6.41  Instrumentation ............................................................................................ 65
6.42  Decontamination.......................................................................................... 66
6.43  Sample Collection........................................................................................ 66
6.5  GROUND-WATER MONITORING ........................................................................ 67
6.51  Instrumentation ............................................................................................ 67
6.52  Well Development ....................................................................................... 68
6.53  Decontamination.......................................................................................... 69
6.54  Sample Collection........................................................................................ 69
6.6  SAMPLE HANDLING AND TRACKING............................................................... 70
CHAPTER 7 - REPORTING........................................................................................................ 72
7.1  QUARTERLY REPORTS......................................................................................... 72
7.11  Summary of Site Activities.......................................................................... 73
7.12  Mass Balance ............................................................................................... 73
7.13  Protocol Deviations...................................................................................... 73
7.14  Analytical Results ........................................................................................ 73
7.2  STUDY TERMINATION REPORT ......................................................................... 74
7.3  FINAL REPORT........................................................................................................ 74
7.31  Field Practices.............................................................................................. 75
7.32  Sampling Activities...................................................................................... 75
7.33  Analytical Results and Discussion of Findings............................................ 75
7.34  Quality Assurance........................................................................................ 75

5
7.4  ELECTRONIC DATA REPORTING GUIDELINES............................................... 76
7.41  Study Area and Conceptual Site Model....................................................... 77
7.42  Application of pesticide and tracer .............................................................. 77
7.43  Crop information.......................................................................................... 78
7.44  Soil properties.............................................................................................. 78
7.45  Ground-water data........................................................................................ 79
7.46  Weather data ................................................................................................ 79
7.47  Irrigation input ............................................................................................. 80
7.48  Chemical monitoring results........................................................................ 80
CHAPTER 8.0 - REFERENCES.................................................................................................. 81

6
ACKNOWLEDGEMENT
Many scientists in the Environmental Fate and Effects Division deserve thanks for their roles in
the design of these studies and development of this Guidance.  We would like to acknowledge
Michael Barrett, Elizabeth Behl, Kevin Costello, and James Wolf, who developed the design of
the field study described in this document and who wrote substantial sections of the document.
Other scientists provided significant technical input and editing of the guidance and/or
participated in the public workshop and Scientific Advisory Panel meetings were Jonathan
Angier, Mark Corbin, R. David Jones, Robert Matzner, Laurence Libello, David Wells and Amy
McKinnon.  Finally, the original concept of designing a prospective ground-water monitoring
study for pesticides was developed by Stuart Z. Cohen and Catherine Eiden.

7
CHAPTER 1 - INTRODUCTION
This document provides guidance for conducting a Prospective Ground-Water (,!2D
monitoring study /'& *Y) &)5%1*&+*%'# '/ N)1*%0%.)1 %# *Y) 6#%*). 8*+*)1 `,%1*). +1 5;%.),%#)
number 166-1 in 40 CFR 158.29).  The PGW study, which is required on a case-by-case basis, is
conducted in a controlled setting and provides the Agency with data for evaluating the impact of
legal pesticide use on ground water quality.  After assessing the overall environmental fate of a
pesticide, the Agency may require the pesticide manufacturer (registrant) to conduct a PGW
study, with input from EPA on key aspects of the study design.  The Agency’s assessment is
based on a review of laboratory data on mobility and persistence of the compound, estimates of
potential exposure, available monitoring and modeling information, and a consideration of the
potential for risk from drinking water exposure. Data generated from these field studies have
proven valuable to EPA scientists and risk managers as they are specifically designed to relate
pesticide use specified on the label to measurements of the pesticide and its degradates in ground
water used as a source of drinking water.  This document provides guidance on how to conduct a
PGW monitoring study, describes milestones for consulting with EPA, and describes how results
should be reported to EPA.
EPA uses the results of PGW monitoring studies to help answer questions such as: (1) Will the
pesticide leach in portions of the pesticide use area that are similar to the study area? (2) How do
pesticide residues change over time? (3) What measures might be effective in mitigating the
pesticide leaching?  Monitoring data generated in these studies provide a time-series of
concentrations that can be used in exposure and risk assessments as a reasonable surrogate for
pesticide concentrations in drinking water drawn from shallow private wells in agricultural areas.
PGW studies have been used to test alternative mitigation strategies for pesticides that have
adversely affected ground water quality to determine, for example, if a reduction in application
rate or specific irrigation technology will reduce or eliminate the impact.  Data from these studies
also have been used to develop the EPA regression screening model SCI-GROW,
(http://www.epa.gov/oppefed1/models/water/models4.htm#scigrow ; see also ILSI, 1998), which
is used to estimate screening-level pesticide concentrations in ground water used as a source of
drinking water.  Currently, the results of these studies are being used to evaluate models of
subsurface pesticide transport, and as a basis for model scenarios for estimating pesticide
concentrations in shallow ground water.
In the past, the Agency has required both retrospective and PGW studies on a case-by-case basis.
The prospective study was designed to eliminate factors that confound the interpretation of
retrospective monitoring studies.  For example, in the site selection process, sites with prior use
of the pesticide or with point sources of contamination are not selected for study.  Also, since the
pesticide is applied according to a current or proposed label, concentrations observed during the
study can be directly linked to a known and current labeled use. The PGW studies are conducted
at a field scale rather than a larger scale to ensure that adequate field quality assurance/quality
control (QA/QC), collection of ancillary data (climatic data, soil characteristics), and level of

8
instrumentation can be implemented at a reasonable cost, while maintaining a scale that captures
the natural variability in soils, hydrology, and other environmental factors, and under which
standard agronomic practices can be implemented.
The original draft guidance for PGW monitoring studies was developed primarily in the early
1990s and has been subjected to substantial public review and comment, including a public
workshop sponsored by EPA in 1995 and a Scientific Advisory Panel (SAP) review in 1998.
The comments received during the workshop and SAP meeting provided valuable suggestions
from both a technical and practical perspective and were used to revise this guidance and to
address other issues identified in the Agency’s review of studies conducted for the registration of
over 50 pesticides.  The recommendations in this guidance document also represent the Agency’s
substantial experience, over the last decade, in developing and articulating effective procedures
for collecting high quality data on pesticide movement into ground water.
1.1 ENVIRONMENTAL EXPOSURE CHARACTERIZATION
PGW studies may be required on a case-by-case basis, depending on an assessment of the
pesticide’s potential to impact ground water and the Agency’s consideration of risk.  Before a
pesticide can be sold in the United States, EPA evaluates its safety to humans and to terrestrial
and aquatic animals and plants, based on a wide range of laboratory and field studies. The
environmental studies examine both the ecological effects (toxicity) of a pesticide and its
chemical fate and transport.  After EPA scientists review all the available information on
toxicity, chemical fate and transport, and proposed use of a pesticide, they develop an
environmental exposure characterization, which includes an exposure profile and conceptual
model.  The exposure characterization estimates the potential exposure of plants, animals, and
water resources to pesticide residues in water, food, and air.  The exposure profile describes:
·
Degradation of the pesticide active ingredient (how fast and by what means it is degraded
in the environment) and how persistent it is in the environment;
·
Breakdown products or degradates that result from the degradation processes;
·
Mobility of the pesticide active ingredient and its degradates and how these chemicals
may be transported from the application site (!"#" volatilize into the atmosphere, move
into ground or surface waters, or bind to the soil); and
·
Accumulation of the pesticide and it’s degradates in the environment.
These environmental fate studies are designed to help identify which dissipation processes are
likely to occur when a pesticide is released into the environment and to characterize the
breakdown products that are likely to result from these degradation processes. The diagram
below illustrates the potential dissipation pathways for a pesticide after it is applied.

9
Figure 1.  Pesticide Dissipation Pathways
Based upon results of environmental fate and transport studies, EPA develops a preliminary,
qualitative exposure assessment. This, in turn, may be used to design or trigger additional
conditional field studies, such as the PGW study.
1.11 Fate and Transport Studies
EPA reviews many laboratory and field studies to determine the fate of pesticides in the
environment. The types of studies required depend on the use of the pesticide. Certain laboratory
studies (!"#", hydrolysis, photolysis, and soil metabolism) are routinely conducted for all outdoor-
use pesticides. Other conditional studies (!"#", PGW studies, photo-degradation in air, and field
volatility) may be triggered by data from the initially required laboratory studies and/or use or
application patterns and basic product chemistry data. The basic studies provide the following
critical information for a pesticide active ingredient and its major degradates:
·
Half-life of the parent (persistence)
·
Identity of degradates
·
Rates of formation and decline of degradates
·
Bioconcentration potential
·
Mobility of the parent and degradates
The Agency regulations found in 40 CFR 158.29 describe the types and amounts of data that the
Agency needs for assessing the environmental fate of a pesticide active ingredient. These
controlled laboratory and field studies, which are conducted under approved Guidelines and
Good Laboratory Practices, are used to determine the persistence, mobility, and bioconcentration
potential of a pesticide active ingredient and its major degradates.  Generally, degradates formed
at greater than or equal to 10% of the amount of applied pesticide are considered significant ($"!",

10
major degradate) and should be identified in the study.  In addition, degradates of known
toxicological or ecotoxicological concern should be quantified and identified, even when present
at less than 10% of the applied pesticide.
·
Physicochemical Degradation: CY%1 %#0,;.)1 Y:.&',:1%1 +#. NY'*'E.)5&+.+*%'# %#
water, soil, and air. Hydrolysis studies determine the potential of the parent pesticide to
degrade in water, while photo-degradation studies determine the potential of the parent
pesticide to degrade in water, soil or air when exposed to sunlight. During these studies,
data are also collected concerning the identity, formation and persistence of degradates.
·
Biological Degradation: CY)1) 1*;.%)1 %#0,;.) +)&'T%0 +#. +#+)&'T%0 1'%, ()*+T',%1(>
and aerobic and anaerobic aquatic metabolism. The soil metabolism studies determine the
persistence of the parent pesticide when it interacts with soil microorganisms living under
aerobic and anaerobic conditions. The aquatic metabolism studies produce similar data
that are generated by pesticide interaction with microorganisms in a water/sediment
system. These studies also identify degradates that result from biological metabolism.
·
Mobility: CY)1) 1*;.%)1 %#0,;.) ,)+0Y%#5 +#. +.1'&N*%'#c.)1'&N*%'#> ,+T'&+*'&:
volatility, and field volatility. The leaching study assesses the mobility of the parent
pesticide and its’ degradates through columns packed with various soils. The
adsorption/desorption study determines the potential of the parent pesticide and its’
degradates to bind to soils of different types. The potential mobility of the parent
pesticide and each degradate is determined by examining the data from both of these
studies and may range from immobile to highly mobile.
·
Bioconcentration: CY)1) 1*;.%)1 ;1) +\;+*%0 '&5+#%1(1 *' )1*%(+*) *Y) N'*)#*%+, '/ +
pesticide, under controlled laboratory conditions, to partition to the organisms from
respiratory and dermal exposures. These studies also provide information on the degree a
pesticide or degradate can be depurated should levels of the pesticide in the surrounding
aquatic environment be reduced.
·
Field dissipation: CY)1) 1*;.%)1 *&+0W *Y) .%11%N+*%'# '/ + N)1*%0%.) /&'( *Y) 1;&/+0) 1'%,
layer, and the formation and dissipation of degradates.  While laboratory environmental
fate studies are designed to assess one dissipation process at a time, field dissipation
studies assess pesticide loss as a combined result of chemical and biological processes
(!"#", hydrolysis, photolysis, microbial transformation) and offsite transport (!"#",
volatilization, leaching, runoff) as well as loss from plant uptake. These studies provide a
field dissipation half-life, a lumped parameter that takes all routes of dissipation into
account.  Several field studies are usually conducted for each pesticide in typical use
areas.
EPA’s assessment may also identify whether pesticide mobility or persistence is affected by pH,
temperature, or other factors.  The exposure profile, combined with an evaluation of use and
consideration of risk may trigger a PGW monitoring study.

11
1.12 Conceptual Model
The potential for pesticide movement to ground water depends on a variety of factors, including
hydrologic properties of the overlying soil and vadose zone that affect downward movement of
water and chemicals, travel time through the unsaturated zone to ground water, aquifer properties
(conductivity, porosity, depth, type, location of recharge area), leaching potential of the pesticide
(persistence and mobility), and type of well drawing water for drinking purposes (Focazio et al,
2002).  These factors can vary significantly throughout the use area of a pesticide. While
pesticide persistence and mobility parameters derived from laboratory studies are useful as a
starting point for assessment, these parameters are not always sufficient to adequately
characterize leaching of chemicals under actual field conditions.  Data collected in PGW
monitoring studies represent the integration of effects of multiple environmental and agronomic
practices at a site where a specific crop is grown.  The term %&'(%!)*$+! is based on a key aspect
of the study design, namely, the pesticide has not been used previously at the site.  If the pesticide
is detected, then it is the result of the application during the study rather than a prior application
(!"#", at a different label rate) or mishandling of the pesticide during mixing, loading, or disposal
activities.
A PGW monitoring study begins with the application of a pesticide and a mobile tracer
compound to a site that has been instrumented (i.e. wells and other monitoring equipment has
been installed) and where the crop is (or will be) planted.  The crop is grown in a field during the
study, following standard agronomic practices (!"#", tillage, irrigation, crop cultivation).  Figure 2
below depicts a generic conceptual model for pesticide transport to shallow, private rural wells in
an agricultural area.  Following pesticide application, residues can be washed off plant surfaces
by precipitation or irrigation.  They may adsorb to soils to varying degrees and may degrade as a
result of chemical or biological processes.  As water infiltrates through the vadose zone to the
water table, pesticide residues can be transported to the subsurface and can adsorb and degrade
further.  Pesticides can be transported from a field in runoff after precipitation or irrigation,
adsorbed to eroded soil, or volatilized in air.  Pesticides also can be taken up to a varying extent
by plants.  A PGW study is designed to minimize the effect of some of these transport processes
(i.e., runoff or the impacts of artificial drainage) in the site selection process and to track the
overall impact of other processes on water quality.

12
Figure 2.  Conceptual Model for Pesticide Transport to Shallow, Private Rural Wells.
The vadose and saturated zones under the field are monitored over time (usually at least two
years) for residues of the pesticide, significant degradates, and a conservative tracer.  The tracer
identifies the depth to which recharge has moved following the application of the pesticide.
Weather data is also collected during the study.  The pesticide and tracer are only applied one
time, to enable the movement of the pesticide and the tracer to be tracked without interference.
These studies track the movement of the pesticide, degradate, and applied water (using a tracer
compound) through the soil into the water table and produce a time-series of concentrations over
a period of several years.  Adequate ancillary data are collected (!"#", climate, timing and mass of
pesticide applied, irrigation, soil characteristics) to enable the results to be interpreted.  Study
results should be evaluated, and concentrations adjusted accordingly to take into consideration
the numbers and frequencies of application allowed on the label.  The goal of the study is to
determine whether a pesticide will move to ground water in some locations where it can be
applied, and to determine the time-course concentrations in ground water of the pesticide, major
degradates, and degradates of toxicological concern.


[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Notices]
[Page 74488-74493]
[DOCID:fr08de08-51]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2008-0758; FRL-8393-6]

U.S. Government's Process for Obtaining Stakeholder Information
for Chemicals Proposed for Addition to the Stockholm Convention on
Persistent Organic Pollutants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On behalf of the U.S. government agencies comprising the
Interagency Working Group (IWG) on Persistent Organic Pollutants (POPs)
(hereafter USG), EPA is issuing this notice to promote transparency,
increase awareness of the proposals concerning chemicals for addition
to the Stockholm Convention on Persistent Organic Pollutants (hereafter
Convention), to make interested persons aware of the process for adding
chemicals to the Convention, to indicate at which steps receiving
comments or information from interested persons would be useful to the
interagency process, and to indicate for those steps the type of
information to be submitted and the due date. EPA is issuing this
notice to ensure that the process for the review of chemicals proposed
for addition to the Convention allows sufficient time for the
submission and consideration of public comments on chemicals proposed
for addition to the Convention. EPA, on behalf of USG, intends to issue
future notices that alert interested persons to additional chemicals
proposed for addition to the Convention and for which the approach to
commenting described in this notice will be applied. EPA's
responsibility with respect to this process will be to ensure that
comments received are considered by the Agency as part of its internal
process and to ensure that comments received are made available to USG
for their consideration.

DATES: All comments must be received no later than November 30, 2009.
However, specific due dates for earlier responses can be found in Unit
II.G.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0758, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2008-0758. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0758. 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. 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 OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    For technical information contact: Amy Breedlove, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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
particular interest to chemical substance and pesticide manufacturers,
importers, and processors. Since other entities may also 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
technical 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
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. Procedures for preparing CBI. Procedures for preparing CBI
information related to pesticides and industrial chemicals are in Unit
I.B.1. Send CBI information about industrial chemicals using the
submission procedures under ADDRESSES. Send CBI information about
pesticides to: Kristen Hendricks, Field and External Affairs Division
(7506P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or hand
delivered Monday-Friday, excluding Federal holidays, between 9 a.m. and
5 p.m. to: Kristen Hendricks, Government and International Services
Branch, Field and External Affairs Division, Office of Pesticide
Programs, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Rm.
S11336, Arlington, VA 22202.
    3. CBI to remain in the United States. Commenters should note that
none of the CBI information received by EPA will be forwarded to the
Secretariat of the Convention. Information from submissions containing
CBI may be considered by relevant agencies in the development of the
U.S. response. If commenters wish for USG to consider incorporating
information in documents with CBI as part of the U.S. response,
commenters should provide a sanitized copy of the documents. Sanitized
copies must be complete, except that all information claimed as CBI
must be deleted. EPA will place sanitized copies in the public docket.
    4. 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?

    Although the United States has not ratified the Convention, it has
an opportunity, as an observer, to provide submissions for review. The
Agency is issuing this notice on behalf of USG to increase awareness of
the proposals concerning chemicals for addition to the Convention, to
make interested persons aware of the process for adding chemicals to
the Convention, to indicate at which steps receiving comments or
information from interested parties would be useful to USG, and to
indicate for those steps the type of information sought and the due
date. EPA is issuing this notice in order to improve the process used
for soliciting comments on chemicals being reviewed for addition to the
Convention.
    In the future, EPA, on behalf of USG, intends to issue a Federal
Register notice when a chemical is first proposed by a nominating Party
to alert interested persons and to solicit comments from interested
persons at the intervals described in this notice. Since several months
often elapse between steps in the nomination process, EPA will make a
good faith effort to issue e-mail reminders of upcoming due dates to
interested parties. Parties interested in receiving such e-mails should
send an e-mail with their preferred e-mail address to the technical
person listed under FOR FURTHER INFORMATION CONTACT. Persons interested
in contacting EPA directly to discuss POPs related subject matter,
should contact Karissa Taylor Kovner, Senior Policy Advisor for
International Affairs (7101M), Office of the Assistant Administrator
for Prevention, Pesticides and Toxic Substances, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. What is the Agency's Authority for Taking this Action?

    On behalf of USG, EPA is requesting comment and information under
the authority of section 102(2)(F) of the National Environmental Policy
Act, 42 U.S.C. 4321 et seq., which directs all agencies of the Federal
Government to ``[r]ecognize the worldwide and long-range character of
environmental problems and, where consistent with the foreign policy of
the United States, lend appropriate support to initiatives, resolutions
and programs designed to maximize cooperation in anticipating and
preventing a decline in the quality of mankind's world environment.''
Section 17(d)(1) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA) also provides additional support in that it directs the
Administrator of EPA ``in cooperation with the Department of State and
any other appropriate Federal agency, [to] participate and cooperate in
any international efforts to develop improved pesticide research and
regulations.''

C. What is the Stockholm Convention Chemical Listing Process?

    The United States signed the Convention in May of 2001 but has not
yet ratified it (and thus is not a Party to the Convention). The United
States currently participates as an observer in Convention activities.
The Convention, which went into force in May of 2004, requires the
Parties to reduce or eliminate the production and use of a number of
intentionally produced POPs, i.e., those listed in Annex A or B. The
Convention also calls upon Parties to take certain specified measures
to reduce releases of unintentionally produced POPs listed in Annex C
with the goal of their continuing minimization and, where feasible,
ultimate elimination. The Convention also imposes controls on the
handling of POPs wastes and on trade in POPs chemicals.
    In addition, there are certain procedures and science-based
criteria that Parties to the Convention use when considering the
addition of new chemicals to the Convention's Annexes. Article 8 of the
Convention provides the process to be followed for listing new
chemicals in Annexes A, B, and/or C, and is described in summary in
this unit:

    1. A Party to the Convention may submit a proposal to the
Secretariat for listing a chemical in Annexes A, B, and/or C. The
proposal shall contain the information specified in Annex D of the
Convention (``Information Requirements and Screening Criteria'').
    2. The Secretariat verifies that the proposal contains the
information specified in Annex D, and if the Secretariat is satisfied,
the proposal is forwarded to the POPs Review Committee (hereafter
POPRC).
    3. POPRC examines the proposal, applies the Annex D screening
criteria, and determines whether the screening criteria have been
fulfilled.
    4. If POPRC is satisfied that the criteria have been fulfilled,
POPRC, through the Secretariat, will make the proposal and the POPRC's
evaluation available to all Parties and observers and invite them to
submit the information specified in Annex E (``Information Requirements
for the Risk Profiles'').
    5. A draft risk profile is prepared by an ad hoc working group
under POPRC in accordance with Annex E for consideration by POPRC and
made available to all Parties and observers to collect technical
comments. The penultimate final draft is distributed to obtain public
comment from Parties and observers. The outline to be used in
developing the risk profile can be found on the Convention website
(http://www.pops.int).
    6. POPRC reviews the final draft risk profile and technical
comments, finalizes the risk profile, includes a determination as to
whether the chemical is likely, as a result of its long-range
environmental transport, to lead to significant adverse human health
and/or environmental effects, such that global action is warranted.
    7. If POPRC decides that the chemical is likely as a result of its
long-range environmental transport to lead to significant adverse human
health and/or environmental effects such that global action is
warranted, then POPRC, through the Secretariat, will ask Parties and
observers to provide information specified in Annex F (``Information on
Socio-Economic Considerations'') to aid in the development of risk
management evaluations (that include an analysis of possible control
measures).
    8. A draft risk management evaluation is prepared by an ad hoc
working group under POPRC in accordance with Annex F for consideration
by POPRC and made available to Parties and observers to collect
technical comments. The penultimate final draft is distributed to
obtain public comment from Parties and observers. The outline to be
used in developing the risk management evaluation can be found on the
Convention website.
    9. POPRC reviews the draft risk management evaluation prepared by
the ad hoc working group and finalizes it.
    10. On the basis of the risk profile and risk management evaluation
for each chemical, POPRC recommends whether the chemical should be
considered by the Conference of the Parties (COP) for listing in
Annexes A, B, and/or C, depending on the control measures.
    11. Parties may be asked by the Secretariat, prior to the COP
meeting, to provide any specific concerns they have regarding listing a
chemical in a particular annex.
    12. COP makes the final decision whether to list the chemical in
Annexes A, B, and/or C.

D. What is the Purpose and Content of a Risk Profile?

    Risk profiles, as noted in Annex E of the Convention, ``evaluate
whether the chemical is likely, as a result of its long-range
environmental transport, to lead to significant adverse human health
and/or environmental effects, such that global action is warranted.''
The risk profile also further evaluates and elaborates on the
information referred to in Annex D of the Convention and includes, as
far as possible, the information listed in Annex E.

E. What is the Purpose and Content of a Risk Management Evaluation?

    Risk management evaluations include an analysis of possible control
measures, which in accordance with Annex F of the Convention
(``Information on Socio-Economic Considerations'') should encompass
``the full range of options, including management and elimination.''
The risk management evaluation includes socio-economic considerations
associated with possible control measures and reflects due regard for
the differing capabilities and conditions among the Parties.
Additionally, the document should discuss any specific exemptions or
acceptable purposes being considered.

F. Where can Information on the Convention's Activities be Found?

    1. Previous Federal Register notices used to notify interested
parties of Convention activities and solicit comments, draft documents
for comment, and stakeholder comments can be found in docket EPA-HQ-
OPPT-2006-0794.
    2. The Convention website is the location of all the chemical
proposals, risk profiles, risk management evaluations, information and
comments submitted by Parties and observers, meeting documents, etc.
    i. Information such as the Secretariat's invitation letters,
requests for information, and outlines for the risk profiles and risk
management evaluations, can be found on the Convention website by
selecting the tab for Convention, selecting POPRC, and then selecting
Information Requests.
    ii. Meeting documents can be found by selecting:
    a. The Convention tab.
    b. POPRC (or COP).
    c. Meetings.
    d. The particular meeting needed.
    iii. Submissions from Parties and observers of Annex E information,
etc., can be found by selecting:
    a. Convention.
    b. POPRC.
    c. Submissions (yr).
    d. The type of information being looked for.
    iv. Copies of the risk profiles, risk management evaluations, and
new proposals can be found by selecting:
    a. Convention.
    b. POPRC.
    c. Chemicals under review.

G. At What Stages Would Input or Comments be Useful to USG?

    1. Annex E and F related information solicitation stage. Typically,
several weeks after the Fall POPRC meeting, the Secretariat invites
Parties and observers to submit to POPRC (via the Secretariat)
information specified in Annex E and/or Annex F of the Convention, and
other relevant information for the chemicals proposed for addition to
the Convention. The Secretariat has posted the request for Annex E
information, in follow-up to the meeting of POPRC 4 in October 2008, on
the website with a due date of January 9, 2009. The information
collected will be considered by POPRC in its development of the risk
profile and/or risk management evaluation for each chemical. Some
Secretariat invitations to submit information are directed only to
Parties, other invitations are open to Parties and observers. Often the
information being requested by the Secretariat is not readily available
to EPA or other relevant agencies, and therefore stakeholder input can
be quite useful. USG will consider the information it receives for
Annex E and Annex F and use it to inform the U.S. submission to the
Secretariat as appropriate, as well as during the review of the
resulting draft risk profiles and risk management evaluations. EPA
requests that any information be submitted to USG using the
instructions in Unit I no later than

20 calendar days prior to the Secretariat's posted due date in order to
meet POPRC's deadline for the submission of Annex E/F and related
information. Individuals or organizations that wish to submit
information directly to POPRC via the Secretariat should work through
their respective observer organizations, if any.
    2. Draft risk profile/risk management evaluation stage. The
Secretariat typically posts draft risk profiles and draft risk
management evaluations for comment by Parties and observers on the
Convention website in April, and invites comments to be submitted
within 5-6 weeks of the posting date. In 2009, the Secretariat plans to
make the draft documents available on the website in early-to-mid April
with comments due back to the Secretariat no later than late May. The
risk profile and risk management evaluation documents should contain
specifics about production, uses, releases, monitoring data, technical
feasibility of alternatives, costs, etc.; consequently, USG finds value
in comments from interested persons who can provide, or assess, such
information. Also useful are stakeholder comments on the synthesis and
conclusion sections of the document. EPA requests that comments or
information be submitted through this process no later than 15 calendar
days prior to the Secretariat's posted deadline in order to provide
time for the relevant agencies to consider the comments before the U.S.
government provides its response to the Secretariat.
    3. Prior to POPRC/COP meetings. The Secretariat posts documents,
including the final draft risk profiles and risk management
evaluations, on the Convention website to be discussed at upcoming
POPRC or COP meetings typically 1-2 months prior to the meeting. In
2009, the Secretariat plans to post documents for POPRC 5 on the
website by the end of August. If interested parties wish to submit any
written comments regarding those documents to USG, comments should be
received by EPA no later than 20 calendar days prior to the meeting.
Any comments received will be used to inform the U.S. position on
issues to be discussed at the meeting. Separate from the risk profile/
risk management evaluation process, EPA expects the Secretariat to post
meeting documents for COP 4 by early April 2009.

H. What Information is Needed for Chemicals Entering the Annex E Stage?

    1. USG seeks information that is supplementary to the information
in the proposals and POPRC's evaluation of the proposals against the
Annex D screening criteria. The proposals and the evaluations are
available on the Convention website.
    2. Commenters are invited to provide information they deem relevant
to POPRC's development of risk profiles, such as that specified in
Annex E of the Convention and other related information, as described
in paragraphs i. through v. of this unit:
    i. Sources, including as appropriate:
    a. Production data, including quantity and location.
    b. Uses.
    c. Releases, such as discharges, losses, and emissions.
    ii. Hazard assessment for the endpoint or endpoints of concern (as
identified in the proposals and/or POPRC's evaluation of the proposals
against the screening criteria of Annex D), including a consideration
of toxicological interactions involving multiple chemicals.
    iii. Environmental fate, including data and information on the
chemical and physical properties of a chemical as well as its
persistence and how they are linked to its environmental transport,
transfer within and between environmental compartments, degradation,
and transformation to other chemicals. (POPRC is to make a
determination of the bioconcentration factor or bio-accumulation
factor, based on measured values, available, except when monitoring
data are judged to meet this need.)
    iv. Monitoring data.
    v. Exposure in local areas and, in particular, as a result of long-
range environmental transport, and including information regarding bio-
availability.

I. What Information is Needed for Chemicals Entering the Annex F Stage?

    1. For the chemicals entering the risk management stage, USG seeks
information that is supplementary to the information provided during
previous stages in the review process; i.e., information relevant to
Convention Annexes D and E; the proposals, evaluations and risk
profiles. These documents, as well as the Secretariat's letter
soliciting information, can be found on the Convention website.
    2. When providing information, keep in mind that the possible
control measures under the Convention include, among others, the
prohibition or severe restriction of production and use. The provision
of accurate, high quality information is a priority for POPRC's
evaluation.
    3. Commenters are invited to provide information they deem relevant
to POPRC's development of the risk management evaluation, such as that
specified in Annex F of the Convention and other related information,
as described in paragraphs i. through viii. of this unit. Summary
information and relevant references should be provided for:
    i. Efficacy and efficiency of possible control measures in meeting
risk reduction goals:
    a. Describe possible control measures.
    b. Technical feasibility.
    c. Costs, including environmental and health costs.
    ii. Alternatives (products and processes):
    a. Describe alternatives.
    b. Technical feasibility.
    c. Costs, including environmental and health costs.
    d. Efficacy.
    e. Risk.
    f. Availability.
    g. Accessibility.
    iii. Positive and/or negative impacts on society of implementing
possible control measures:
    a. Health, including public, environmental and occupational health.
    b. Agriculture, including aquaculture and forestry.
    c. Biota (biodiversity).
    d. Economic aspects.
    e. Movement towards sustainable development.
    f. Social costs.
    iv. Waste and disposal implications (in particular, obsolete stocks
of pesticides and clean-up of contaminated sites):
    a. Technical feasibility.
    b. Cost.
    v. Access to information and public education.
    vi. Status of control and monitoring capacity.
    vii. Any national or regional control actions taken, including
information on alternatives, and other relevant risk management
information.
    viii. Other relevant information for the risk management
evaluation.

III. History of Proposed Chemicals to Date

A. First Five Chemicals Proposed

    The first meeting of POPRC (POPRC 1) took place November 7-11,
2005, in Geneva, Switzerland. Information about the Convention, POPRC
meetings, and the meeting reports are available on the Convention
website. Five chemical proposals were submitted for consideration for
addition to Annexes A, B, and/or C of the Convention. Three of the five
proposals were for industrial chemicals:
     Pentabromodiphenyl ether (PeBDE).

     Hexabromobiphenyl (HBB).
     Perfluorooctane sulfonate (PFOS).
    Two of the five proposals were for pesticides:
     Lindane.
     Chlordecone.
    With regard to all five chemicals, POPRC decided that it was
satisfied that the screening criteria had been fulfilled and that
further work should therefore be undertaken to develop risk profiles
for the five chemicals. Therefore, POPRC, through the Secretariat,
requested that Parties and observers provide information, per Annex E,
relevant to POPRC's development of risk profiles for the five chemicals
listed in this unit. See the Federal Register notice of January 30,
2006 (71 FR 4913) (FRL-7758-9) for additional information.
    The second meeting of POPRC (POPRC 2) took place on November 6-10,
2006, in Geneva, Switzerland. See the Federal Register notice of
October 6, 2006 (71 FR 59108) (FRL-8099-2) for additional information.
Information about POPRC 2 is also available on the Convention website.
At that meeting, risk profiles were considered for the five previously
proposed chemicals and POPRC decided that these chemicals were likely,
as a result of their long-range environmental transport, to lead to
significant adverse human health and environmental effects such that
global action is warranted. Consequently, the five chemicals were moved
forward to the next step in the listing process. In the Federal
Register notice of December 20, 2006 (71 FR 76325) (FRL-8109-1), EPA
invited commenters to provide information, per Annex F, to support the
development of risk management evaluations. That information collection
step was followed by the development of risk management evaluations.
These risk management evaluations were then considered by POPRC 3 in
November 2007. At POPRC 3, for commercial PeBDE, chlordecone, HBB,
lindane, and PFOS, POPRC completed its review of the available
documents, considered the possible control measures, the available
social and economic information, and comments and information submitted
by Parties and observers relating to the considerations specified in
Annex F. POPRC decided to recommend to COP, in accordance with
paragraph 9 of Article 8 of the Convention, that COP consider listing
the chemicals in Unit III.A., with some modifications, in the
Convention. Parties were invited to notify the Secretariat of any
relevant issues they wish to raise to COP. Additional information on
production, use, and alternatives for PFOS was also requested.

B. Second Five Chemicals Proposed

    Also at POPRC 2, five new chemicals were submitted for
consideration for addition to the Convention.
    1. Two of the five proposals were for industrial chemicals:
    i. Commercial octabromodiphenyl ether (c-octaBDE).
    ii. Short-chained chlorinated paraffins (SCCPs).
    2. One of the five proposals was for a chemical with both
industrial and pesticidal uses: Pentachlorobenzene (PeCB).
    3. Two of the five proposals were for pesticides:
    i. Alpha-hexachlorocyclohexane (alpha-HCH).
    ii. Beta-hexachlorocyclohexane (beta-HCH).
    EPA provided notice of POPRC 2 and POPRC's intention to consider
proposals for the five chemicals listed in this unit in the October 6,
2006 Federal Register notice. Additional information about the POPRC 2
meeting is available on the Convention website. POPRC 2 decided that
the Annex D screening criteria had been fulfilled and requested that
Parties and observers provide information, per Annex E, relevant to
development of risk profiles for the five chemicals listed in this
unit. POPRC 2 also requested additional information on the
environmental fate of SCCPs or information relating to their properties
which would enable a more comprehensive evaluation of their
environmental fate. In the December 20, 2006 Federal Register notice,
EPA invited commenters to provide information, per Annex E, for the
development of risk profiles. Risk profiles were developed and
presented in November 2007 for the consideration by POPRC 3.
    In accordance with the procedure in Article 8 of the Convention,
POPRC 3 examined the risk profiles for the chemicals in this unit and
decided that the chemicals, except for SCCPs, are likely, as a result
of their long-range environmental transport, to lead to significant
adverse human health and/or environmental effects such that global
action is warranted. POPRC 3 directed the collection of information,
per Annex F, to be used in the development of the risk management
evaluations and also requested additional information related to
commercial octaBDE and its congeners, and PeCB. Initial draft risk
management evaluations were developed during the spring of 2008 for
consideration at POPRC 4 in October 2008. At POPRC 4, the risk
management evaluations for c-octaBDE, PeCB, alpha-HCH, and beta-HCH
were approved. POPRC decided to recommend, for c-octaBDE, that COP
consider listing in Annex A hexa- and heptaBDEs present in c-octaBDE,
using BDE-153, BDE-154, BDE-175, and BDE-183 as markers for enforcement
purposes. For PeCB, it was decided to recommend to COP that the
substance be listed in Annexes A and C. POPRC also decided to recommend
to COP that it consider listing alpha- and beta-HCH in Annex A, giving
due consideration to the by-production of these substances from the
production of lindane. Those recommendations are expected to be
presented to COP 4 in May 2009.
    The draft risk profile for SCCPs was also examined at POPRC 3, but
POPRC considered the information available to be insufficient to
support the Convention Annex E-related decision that the chemical is
likely as a result of its long-range environmental transport to lead to
significant adverse human health and/or environmental effects such that
global action is warranted and therefore did not agree upon a risk
profile for the chemical. POPRC agreed to the further development of
the risk profile, asked Parties and observers for additional
information for the SCCP risk profile, and delayed the Convention Annex
E- related decision on SCCPs to POPRC 4. A revised risk profile was
prepared for consideration at POPRC 4. POPRC 4 agreed to consider the
risk profile, as revised, at POPRC 5.

C. Newest Chemicals Proposed

    In the period between POPRC 3 and POPRC 4, two additional chemicals
were proposed for consideration to be listed in Annex A, B, and/or
Annex C to the Convention. Proposals were submitted for endosulfan, a
pesticide, and for hexabromocyclododecane (HBCDD), an industrial
chemical. The Secretariat reviewed the proposals and verified that they
contain the information specified in Annex D. Those evaluations are
posted on the Convention website. At POPRC 4, it was decided to not
take action on the HBCDD proposal since the relevant documentation was
not submitted sufficiently in advance of the meeting. POPRC 5 will
consider the HBCDD proposal. Regarding the endosulfan proposal, POPRC 4
decided that alpha endosulfan, beta endosulfan, and technical
endosulfan, fulfill the screening criteria, established a working group
to prepare a draft risk profile in accordance with Annex E of the
Convention, and invited Parties and observers to submit the information
specified in Annex E to the Secretariat.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.

    Dated: December 1, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-28982 Filed 12-5-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 244 (Thursday, December 21, 2017)]
[Notices]
[Pages 60596-60597]
[FR Doc No: 2017-27492]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-614-001.
    Applicants: Kincaid Generation, L.L.C.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/15/17.
    Accession Number: 20171215-5000.
    Comments Due: 5 p.m. ET 1/5/18.

    Docket Numbers: ER15-1641-002.
    Applicants: Dynegy Fayette II, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5154.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER15-1642-002.
    Applicants: Dynegy Hanging Rock II, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5156.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER15-1648-002.
    Applicants: Dynegy Washington II, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5160.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1658-001.
    Applicants: Calumet Energy Team, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5152.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1659-001.
    Applicants: Northeastern Power Company.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5162.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1660-001.
    Applicants: Pleasants Energy, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5163.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1718-003.
    Applicants: Dynegy Dicks Creek, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5153.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1719-003.
    Applicants: Dynegy Killen, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5157.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1720-003.
    Applicants: Dynegy Miami Fort, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5158.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1721-004.
    Applicants: Dynegy Stuart, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5159.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER17-1722-003.
    Applicants: Dynegy Zimmer, LLC.
    Description: Compliance filing: Informational Filing Regarding
Upstream Change in Control to be effective N/A.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5161.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER18-365-001.
    Applicants: Access Energy Solutions, LLC.
    Description: Tariff Amendment: MBR Tariff to be effective 1/29/
2018.
    Filed Date: 12/14/17.
    Accession Number: 20171214-5103.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER18-454-000.
    Applicants: The United Illuminating Company.
    Description: Sec.  205(d) Rate Filing: Third Supplement to Lease
Agreement with CDOT to be effective 12/15/2017.

    Filed Date: 12/14/17.
    Accession Number: 20171214-5155.
    Comments Due: 5 p.m. ET 1/4/18.

    Docket Numbers: ER18-455-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO-NE and NEPOOL Filing Re:
CSO Transfer Improvements to be effective 3/1/2018.
    Filed Date: 12/15/17.
    Accession Number: 20171215-5054.
    Comments Due: 5 p.m. ET 1/5/18.

    Docket Numbers: ER18-456-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of 1st
Rev. Service Agreement No. 2195, Queue No. X1-074 to be effective 1/13/
2018.
    Filed Date: 12/15/17.
    Accession Number: 20171215-5061.
    Comments Due: 5 p.m. ET 1/5/18.

    Docket Numbers: ER18-457-000.
    Applicants: Gainesville Renewable Energy Center, LLC.
    Description: Tariff Cancellation: Cancellation of MBR Tariff to be
effective 12/18/2017.
    Filed Date: 12/15/17.
    Accession Number: 20171215-5069.
    Comments Due: 5 p.m. ET 1/5/18.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 15, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-27492 Filed 12-20-17; 8:45 am]
 BILLING CODE 6717-01-P