Submission by the United States of America by svh21117

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									                                                                 Submitted by the United States of America


                SUBMISSION BY THE UNITED STATES OF AMERICA
       COMPILATION OF RESOURCES, ACTIVITIES, TOOLS AND INFORMATION
   CONTRIBUTING TO AND IN SUPPORT OF PARTICIPANTS’ IMPLEMENTATION OF THE
   STRATEGIC APPROACH TO INTERNATIONAL CHEMICALS MANAGEMENT (SAICM)

The United States is providing this select compilation of resources, activities, tools and
information related to implementation of the Strategic Approach to International
Chemicals Management (SAICM). Other SAICM participants are invited to use the
resources and information contained in this document to support their own
implementation of SAICM. The document is organized according to the five categories
of objectives of the SAICM Overarching Policy Strategy (OPS): risk reduction,
knowledge and information, governance, capacity-building and technical cooperation,
and illegal international traffic.

                                           TABLE OF CONTENTS

RISK REDUCTION ......................................................................................................... 6

   Reviewing New Industrial Chemicals ......................................................................... 6
     New Chemicals Program .......................................................................................... 6
     Toxic Substances Control Act (TSCA) Biotechnology Program .......................... 7

   Reviewing New Pesticides............................................................................................. 7
     Pesticides Registration Program ............................................................................. 7
     Antimicrobial Pesticides and Biopesticides ............................................................ 8

   Reassessment and Risk Management of Currently Registered Pesticides .............. 8
     Reregistration Program............................................................................................ 8
     Registration Review .................................................................................................. 8
     Reassessing Existing Tolerances .............................................................................. 8
     Pesticide Product Labels .......................................................................................... 9
     Emphasis on Children .............................................................................................. 9
     Storage and Disposal of Pesticides .......................................................................... 9

   Pesticide Field Programs .............................................................................................. 9
     Pesticide Environmental Stewardship Program .................................................... 9
     School Integrated Pest Management Programs ..................................................... 9
     Worker Protection Standards ................................................................................ 10
     Certification and Training of Pesticide Applicators ............................................ 10
     National Strategies for Health Care Providers Pesticide Initiative.................... 10
     Pesticide Poisoning Handbook ............................................................................... 10

   Managing Existing Industrial Chemicals ................................................................. 10
    Chemical Assessment and Management Program (ChAMP) ............................. 10
    PFOA Stewardship Program ................................................................................. 11
    PFAS-Related Significant New Use Rule (SNUR) ............................................... 11



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     EPA Mercury Roadmap ......................................................................................... 11
     Mercury-Related Significant New Use Rule (SNUR) .......................................... 12
     Mercury-Containing Products and Alternatives Database................................. 12
     Reducing Children’s Lead Exposure .................................................................... 12
     Reducing Exposure to Asbestos ............................................................................. 13
     Great Lakes Binational Toxics Strategy ............................................................... 14

  Working to Prevent Pollution .................................................................................... 14
   Environmentally Preferable Purchasing (EPP) ................................................... 14
   Green Suppliers Network ....................................................................................... 15
   Waste Minimization Program ............................................................................... 15
   Performance Track ................................................................................................. 16

  Chemical Risk Reduction Through Pollution Prevention ....................................... 16
    Design for the Environment (DfE) Program ........................................................ 16
    Green Chemistry Program..................................................................................... 16
    Green Engineering Program .................................................................................. 17
    National Partnership for Environmental Priorities (NPEP) .............................. 17
    Chemical Management Services (CMS) ............................................................... 18
    Global Partnerships to Reduce Health Risks from Key Pollutants ................... 18

  Sector-Focused Pollution Prevention Programs ...................................................... 18
    Sector Strategies Program ..................................................................................... 18
    Green Building ........................................................................................................ 19
    Environmentally Sound Electronics Design and Lifecycle Management .......... 19
      Electronic Product Environmental Assessment Tool (EPEAT) ........................... 19
      Federal Electronics Challenge (FEC) ................................................................... 20
      Cathode Ray Tube (CRT) Rule............................................................................. 20
    Coal Combustion Products Partnership (C2P2) .................................................. 20

  Pollution Prevention Technical Assistance Programs ............................................. 20
    Pollution Prevention Resource Exchange (P2Rx) ................................................ 20
    Compliance Assistance Centers ............................................................................. 21

  Community-Focused Programs ................................................................................. 21
    Community Action for a Renewed Environment (CARE) ................................. 21
    EPA Office of Pollution Prevention and Toxics Tribal Program ....................... 21
    Indigenous Peoples Community Action Initiative ............................................... 22

KNOWLEDGE AND INFORMATION ....................................................................... 23

  Information Collection and Access............................................................................ 23
    High Production Volume (HPV) Challenge Program ......................................... 23
    High Production Volume Information System (HPVIS) ..................................... 23
    Chemical Substance Inventory Update Reporting .............................................. 23
    Voluntary Children’s Chemical Evaluation Program (VCCEP) ....................... 24



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   Nanoscale Materials Stewardship Program (NMSP) .......................................... 25
   Toxics Release Inventory (TRI) ............................................................................. 25
     Access to TRI Data and Information .................................................................... 25
     TRI Data Quality................................................................................................... 27
     Facilitation of Reporting of TRI Data and Information to EPA’s TRI Program .. 27
   ACToR (Aggregated Computational Toxicology Resource)............................... 28
   EPA Air Toxics Web Site ....................................................................................... 28
   Clearinghouse for Inventory and Emissions Factors .......................................... 29
   Plug-In To eCycling: Guidelines for Materials Management............................. 29
   Materials and Waste Exchanges ............................................................................ 29

Facilitating the Interpretation of Chemical and Other Information ..................... 30
  Sustainable Futures ................................................................................................ 30
  Analog Identification Methodology (AIM) ........................................................... 30
  Chemical Structure Based Toxicity Prediction .................................................... 31
  Risk-Screening Environmental Indicators (RSEI) .............................................. 31
  Fate, Exposure, and Risk Analysis ........................................................................ 31
  Support Center for Regulatory Atmospheric Modeling ..................................... 31
  Economic Analysis .................................................................................................. 31

Pesticides Knowledge & Information........................................................................ 32
  Online Registration Kit .......................................................................................... 32
  Pesticide Product Label System............................................................................. 32
  Pesticide Web Resources ........................................................................................ 32
  National Pesticide Information Center ................................................................. 33
  Restricted Use Products Report ............................................................................ 33

Tools and Methods for Analyzing Chemical Properties ......................................... 33
  Predicting Hazard, Characterizing Toxicity Pathways, and Prioritizing the
  Toxicity Testing of Environmental Chemicals ..................................................... 33
  Structure Activity Relationships, or SAR............................................................. 34
    The EPI (Estimation Program Interface) SuiteTM ................................................. 34
    ECOSAR (Ecological Structure Activity Relationships) ..................................... 34

Risk Assessment Tools ................................................................................................ 35
  Risk Assessments and Integrated Risk Information System .............................. 35
  Screening Level Risk Assessment Tools ................................................................ 35
    Chemical Screening Tool for Exposures and Environmental Releases
    (ChemSTEER) ...................................................................................................... 36
    Exposure, Fate Assessment Screening Tool (E-FAST) ........................................ 36
    Pesticide Inert Risk Assessment Tool (PIRAT).................................................... 37
  High Tiered Risk Assessment Tools ...................................................................... 37
    Multi-Chamber Concentration and Exposure Model, (MCCEM) ........................ 38
    Wall Paint Exposure Assessment Model (WPEM) .............................................. 38
    Swimmer Exposure Assessment Model (SWIMODEL) ...................................... 39
  Exposure Databases and Models ........................................................................... 39



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          Residential Exposure Standard Operating Procedures ......................................... 39

   Screening, Testing, and Prioritization Programs and Tools ................................... 40
     Pesticide-Related Harmonized Test Guidelines ................................................... 40
     SOPs for Antimicrobial Testing Methods............................................................. 40
     Endocrine Disruptor Screening Program ............................................................. 40
     Priority-Setting Scoring Tools ............................................................................... 40
       PBT Profiler .......................................................................................................... 41
       Use Clusters Scoring System (UCSS) .................................................................. 41

   International Knowledge and Information Programs............................................. 42
     OECD High Production Volume (HPV) Chemicals Program ............................ 42
     OECD eChemPortal ............................................................................................... 42
     OECD New Chemicals Clearing House ................................................................ 42
     OECD Test Guidelines Program ........................................................................... 43
     OECD Working Party on Manufactured Nanomaterials (WPMN) .................. 43
     Chemical Information Exchange Network (CIEN) ............................................. 43

GOVERNANCE.............................................................................................................. 45

   Selection of Relevant United States Laws ................................................................. 45
     Toxic Substances Control Act (TSCA) ................................................................. 45
     Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)........................... 45
     Federal Food, Drug, and Cosmetic Act (FFDCA) ............................................... 45
     Food Quality Protection Act of 1996 (FQPA) ...................................................... 46
     Resource Conservation and Recovery Act ........................................................... 46
     Comprehensive Environmental Response, Compensation, and Liability Act .. 46
     Emergency Planning & Community Right-to-Know Act ................................... 46
     Pollution Prevention Act (PPA) ............................................................................. 46
     National Environmental Policy Act ....................................................................... 46

   Improving Environmental Governance Through Training and Capacity Building
   ....................................................................................................................................... 47

   Pollutant Release and Transfer Registries ............................................................... 47
     OECD and PRTRs .................................................................................................. 48
     North American Commission for Environmental Cooperation (CEC) and
     PRTRs ...................................................................................................................... 48
     United Nations Environment Program (UNEP) and PRTRs ............................. 49
     UNITAR and PRTRs ............................................................................................. 49

CAPACITY-BUILDING AND TECHNICAL COOPERATION .............................. 50

   Western Hemisphere Capacity-Building and Technical Cooperation ................... 50
    Commitments to Ensure Safe Manufacture and Use of Industrial Chemicals . 50
    Regional Implementation of SAICM in North America ..................................... 50



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     Central America and Dominican Republic Free Trade Agreement .................. 51

  Mercury-Related Capacity-Building and Technical Assistance ............................. 51

  Other Capacity-Building and Technical Cooperation Efforts ............................... 52
    Arctic Contaminants Action Program .................................................................. 52
    Arctic Military Environmental Cooperation (AMEC) Program ....................... 52
    Partnership with the U.S. National Library of Medicine .................................... 53
    Promoting Shared Scientific and Technical Expertise on Pesticides ................. 53

ILLEGAL INTERNATIONAL TRAFFIC .................................................................. 54

     UNEP’s Green Customs Initiative ......................................................................... 54
     Survey Training Course for Customs Officers and Inspectors .......................... 54
     Importing and Exporting Industrial Chemicals .................................................. 54
     Importing and Exporting Pesticide Products ....................................................... 55
     Importing and Exporting Foods Containing Pesticide Residues ........................ 55




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A. RISK REDUCTION

                               OVERARCHING POLICY STRATEGY
RISK REDUCTION (including preventing, reducing, remediating, minimizing and eliminating
risks) is a key need in pursuing the sound management of chemicals throughout their entire life
cycle including, where appropriate, products and articles containing chemicals. It is recognized
that: a.) Risk assessment and management strategies, supported by improved scientific
understanding of the role and behaviour of substances, addressing product life-cycles, are central
to achieving risk reduction; b.) Risk reduction measures, appropriately informed by scientific
methods and consideration of social and economic factors, are needed to reduce or eliminate the
harmful effects of chemicals and their inappropriate uses; c.) Risk reduction measures need to be
improved to prevent the adverse effects of chemicals on the health of children, pregnant women,
fertile populations, the elderly, the poor, workers and other vulnerable groups and susceptible
environments; d.) The development of safer alternatives, including alternatives to chemicals of
concern, and affordable sustainable technologies should be accelerated; e.) Developing countries
and countries with economies in transition need better access to affordable, safer technologies and
alternatives, which will also assist in reducing illegal traffic in hazardous chemicals.


Reviewing New Industrial Chemicals

New Chemicals Program
The U.S. Environmental Protection Agency's (EPA's) New Chemicals Program was
established to help manage the potential risk from chemicals new to the marketplace. It is
mandated by Section 5 of the Toxic Substances Control Act (TSCA). TSCA, enacted by
Congress in 1976, gives EPA broad authority to identify and control substances that may
pose a threat to human health or the environment.

The New Chemicals Program functions as a "gatekeeper" which can identify conditions,
up to and including a ban on production, to be placed on the use of a new chemical before
it is entered into commerce. Anyone who plans to manufacture or import a new chemical
substance for a non exempt commercial purpose is required by Section 5 of TSCA to
provide EPA with notice before initiating the activity. This pre-manufacture notice, or
PMN, must be submitted at least 90 days prior to the manufacture or import of the
chemical. (See http://www.epa.gov/opptintr/newchems/)

In 1987, after several years of experience in reviewing new chemical submissions, EPA
had enough accumulated experience to group new chemicals with shared chemical and
toxicological properties into categories, enabling both new chemical submitters and EPA
reviewers to benefit from the accumulated data and past decisional precedents allowing
reviews to be facilitated. The first category was "acrylates and methacrylates." Currently,
there are a total of 45 categories. As expected, establishing these categories has
streamlined the process for Agency review of new chemical substances. EPA groups
chemicals with shared chemical and toxicological properties into categories so that new
chemical reviews are facilitated.
(See http://www.epa.gov/opptintr/newchems/pubs/chemcat.htm)



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Toxic Substances Control Act (TSCA) Biotechnology Program
The New Chemicals Program is also home to the TSCA Biotechnology Program. This
program is responsible for the safe commercial introduction of new or intergeneric
microorganisms with industrial applications, such as bioremediation, or the production of
specialty enzymes.

EPA published final rules on Microbial Products of Biotechnology in 1997 that fully
implemented its screening program for new microorganisms under Section 5 of TSCA.
These regulations create a reporting vehicle specifically designed for intergeneric
microorganisms, the Microbial Commercial Activity Notice (MCAN). The rules also
address microorganisms used in research and development for commercial purposes and
create a vehicle for reporting on the testing of new microorganisms in the environment, a
TSCA Experimental Release Application (TERA). In recognition of the needs of
researchers, TERA is designed to provide a high measure of flexibility and a shorter
review period.

EPA reviews MCAN and TERA submissions, working closely at times with the
submitters, to ensure the microorganisms do not present an unreasonable risk to human
health or the environment. Since 1997, EPA has received and reviewed 20 MCANs.
Based on review of information provided in the MCANs, EPA determined that these
submissions did not warrant regulation because they were not expected to pose an
unreasonable risk or have substantial or significant exposure. Since 1997, EPA has also
received and approved 20 TERAs. (See http://www.epa.gov/biotech_rule/)


Reviewing New Pesticides
United States federal law requires that before selling or distributing a pesticide in the
United States, a person or company must obtain registration, or license, from EPA.
Before registering a new pesticide or new use for a registered pesticide, EPA must first
ensure that the pesticide, when used according to label directions, can be used with a
reasonable certainty of no harm to human health and without posing unreasonable risks to
the environment. To make such determinations, EPA requires more than 100 different
scientific studies and tests from applicants. Where pesticides may be used on food or feed
crops, EPA also sets tolerances (maximum pesticide residue levels) for the amount of the
pesticide that can legally remain in or on foods.
(See http://www.epa.gov/pesticides/regulating/registering/index.htm)

Pesticides Registration Program
EPA gives priority in its registration program for conventional chemical pesticides to
pesticides that meet reduced risk criteria: low-impact on human health, low toxicity to
non-target organisms (birds, fish, and plants), low potential for groundwater
contamination, lower use rates, low pest resistance potential, and compatibility with
Integrated Pest Management.
(See http://www.epa.gov/opprd001/workplan/completionsportrait.pdf)




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Antimicrobial Pesticides and Biopesticides
The registration requirements for antimicrobial pesticides and biopesticides differ from
those of other conventional pesticides. For antimicrobial pesticides and all other
pesticides intended to control public health pests, EPA requires special tests to ensure
efficacy of public health pesticides when the pests are disease-causing microbes.
Biopesticides include naturally occurring substances that control pests (biochemical
pesticides), microorganisms that control pests (microbial pesticides), and pesticidal
substances produced by plants containing added genetic material (plant-incorporated
protectants).
(See http://www.epa.gov/oppad001/ and http://www.epa.gov/pesticides/biopesticides/)


Reassessment and Risk Management of Currently Registered Pesticides
EPA ensures that each registered pesticide continues to meet the highest standards of
safety to protect human health and the environment. EPA has embarked on several
programs to reevaluate pesticides as the standards evolve. The EPA Web pages describe
EPA’s activities for registration review, reregistration and tolerance reassessment
described below.
(See http://www.epa.gov/oppsrrd1/reevaluation/ for a general overview.)

Reregistration Program
In 1988, EPA initiated a program called Reregistration to reassess older pesticides. EPA
is completing this one-time program to review older pesticides (those initially registered
before November 1984) under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) to ensure that they meet current scientific and regulatory standards. This process
considers the human health and environmental effects of pesticides and results in actions
to reduce risks that are of concern. EPA will be completing all remaining reregistration
eligibility decisions by 2008, although implementation of the decisions will continue
beyond 2008. (See http://www.epa.gov/oppsrrd1/reevaluation/)

The status of each pesticide in the Reregistration program is available on EPA’s Web
page. Links to decision documents, fact sheets and related documents are also included.
(See http://www.epa.gov/pesticides/reregistration/status.htm)

Registration Review
In 2006, EPA initiated a new program called Registration Review to reevaluate all
pesticides on a regular cycle. The program’s goal is to review each pesticide active
ingredient every 15 years to make sure that as the ability to assess risks to human health
and the environment evolves and as policies and practices change, all pesticide products
in the marketplace can still be used safely.
(See http://www.epa.gov/oppsrrd1/registration_review/)

Reassessing Existing Tolerances
Two United States federal laws called for reassessing existing tolerances (maximum
limits for pesticide residues in food) and tolerance exemptions to ensure that they meet
the safety standard of the law. EPA integrated reregistration and tolerance reassessment



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to accomplish the goals of both programs most effectively. One law required EPA to give
priority to the review of those pesticides that appear to pose the greatest risk to public
health, and to reassess nearly 10,000 tolerances. The Agency had completed more than
99% of tolerance reassessments by the end of 2006.
(See http://www.epa.gov/pesticides/regulating/tolerances.htm)

Pesticide Product Labels
EPA reviews the label of each pesticide product through its Registration, Reregistration,
and Registration Review programs to ensure the label includes appropriate information
about the proper handling and use of the product for risk management. EPA also ensures
the directions for use and the use restrictions on the label reflect EPA’s conclusions of the
supporting science and risk assessments for the pesticide.

Pesticide product labels provide critical information about how to safely handle and use
pesticide products. EPA has several projects underway to improve pesticide labels as well
as to streamline the development and distribution of labels.
(See http://www.epa.gov/pesticides/regulating/labels/product-labels.htm)

Emphasis on Children
EPA places particular emphasis on children in making regulatory decisions about
pesticides. Risk assessments include evaluations for children in various age groups, since
children's eating and activity patterns change as they grow up.
(See http://www.epa.gov/pesticides/health/children.htm)

Storage and Disposal of Pesticides
EPA also regulates the storage and disposal of pesticides and their containers. EPA also
provides guidance to household consumers, farmers, registrants, retailers, commercial
applicators and others. (See http://www.epa.gov/pesticides/regulating/storage.htm)


Pesticide Field Programs
EPA has a number of programs that are implemented in communities and the field where
pesticides are used. The focus of these programs is to provide advice and training and
information to pesticide users and workers as well as the public on pesticide risk
reduction.

Pesticide Environmental Stewardship Program
One of these field programs is the Pesticide Environmental Stewardship Program. It is a
voluntary program that forms partnerships with pesticide users to reduce the potential
health and environmental risks associated with pesticide use and implement pollution
prevention strategies. (See http://www.epa.gov/pesp/)

School Integrated Pest Management Programs
The EPA recommends that schools use integrated pest management (IPM) to reduce
pesticide risk and exposure to children. A school IPM program uses common sense




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strategies to reduce sources of food, water and shelter for pests in your school buildings
and grounds. (See http://www.epa.gov/pesticides/ipm/index.htm)

Worker Protection Standards
EPA revised Worker Protection Standards (WPS) for agricultural pesticides. The WPS is
a federal regulation designed to protect employees on farms, forests, nurseries, and
greenhouses from occupational exposures to agricultural pesticides. Implementing the
WPS is a key part of EPA’s strategy for reducing occupational exposures to agricultural
pesticides. (See http://www.epa.gov/pesticides/health/worker.htm)

Certification and Training of Pesticide Applicators
EPA has a program on the certification and training of pesticide applicators. Employers
are responsible for training workers and handlers in the safe use of pesticides. Employers
must ensure that their employees understand the basic concepts of pesticide safety.
(See http://www.epa.gov/oppfead1/safety/applicators/applicators.htm)

National Strategies for Health Care Providers Pesticide Initiative
The National Strategies for Health Care Providers Pesticide Initiative is aimed at
improving the training of health care providers in the recognition, diagnosis, treatment,
and prevention of pesticide poisonings among those who work with pesticides.
(See http://www.epa.gov/oppfead1/safety/healthcare/healthcare.htm)

Pesticide Poisoning Handbook
The latest edition of EPA's pesticide poisoning handbook Recognition and Management
of Pesticide Poisonings is available in English and Spanish.
(See http://www.epa.gov/oppfead1/safety/healthcare/handbook/handbook.htm)


Managing Existing Industrial Chemicals

Chemical Assessment and Management Program (ChAMP)
The Chemical Assessment and Management Program (ChAMP) is conducting screening-
level risk characterizations and taking action, as appropriate, on more than 6,750
chemicals produced above approximately 10 tones per year. This U.S. commitment to
complete assessments and take action on these chemicals will apply the results of EPA’s
work on High Production Volume (HPV) chemicals - those chemicals produced or
imported in the United States in quantities of approximately 500 metric tones or more per
year - and extend its efforts to moderate production volume chemicals - those produced
or imported in quantities above 10 tones and less than 500 tones per year. As part of the
efforts under ChAMP, EPA is developing screening-level documents that summarize
basic hazard and exposure information on HPV chemicals, identify potential risks, note
scientific issues and uncertainties, and indicate the initial priority being assigned by the
Agency for potential future appropriate action.

In 2007, EPA began creating screening-level exposure characterizations and risk
characterizations to assemble data needed to produce initial risk-based prioritizations on
HPV chemicals. As of November 2008, EPA has posted initial risk-based prioritizations


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for 151 HPV chemicals and hazard-based prioritizations for 38 MPV chemicals to its
Web site, and will continue to develop and post prioritizations for additional chemicals.
Also, on November 6, 2008, EPA posted a Risk Based Prioritization document for
elemental mercury in certain products and substitutes and determined that mercury in
these products poses a ―high priority, special concern.‖ (See
http://www.epa.gov/hpvis/rbp/Mercury_RBP_10.31.08_FINAL.pdf).

The plan is for the ChAMP program to encompass initial prioritizations for potential
actions, as needed, for both HPV and MPV chemicals. ChAMP also represents U.S.
implementation of broader North American commitments under the August 2007
Montebello statement which called for cooperation on chemicals and outlined
commitments on behalf of the United States, Canada, and Mexico to work together to
ensure the safe manufacture and use of industrial chemicals. Each country is sharing
scientific information and approaches to chemical testing and risk management.
(See http://www.epa.gov/champ/)

PFOA Stewardship Program
In January 2006, EPA Administrator Johnson initiated the PFOA Stewardship Program,
in which the eight major companies in the industry committed voluntarily to reduce
facility emissions and product content of perfluorooctanoic acid (PFOA) and related
chemicals on a global basis by 95 percent no later than 2010, and to work toward
eliminating emissions and product content of these chemicals by 2015. By March 1,
2006, EPA received company response letters from all eight invited companies.
Companies submitted their baseline-year emissions and product content data in October
2006, and that baseline data is available in summary form. The companies submitted
their first annual progress reports in October 2007, and that information is also available
in summary form. (See http://www.epa.gov/oppt/pfoa/pubs/pfoastewardship.htm)

PFAS-Related Significant New Use Rule (SNUR)
Related regulatory activities include a final Significant New Use Rule (SNUR), issued
October 9, 2007, for 183 perfluoroalkyl sulfonate (PFAS) chemicals that were not
included in prior perfluorooctyl sulfonate (PFOS)-related SNURs. Public comments on
the 2006 proposed SNUR resulted in information about ongoing uses of some PFAS
chemicals in the surface-finishing industry; therefore, the final SNUR contains exclusions
for those uses.
(See http://www.epa.gov/fedrgstr/EPA-TOX/2007/October/Day-09/t19828.htm)

EPA Mercury Roadmap
On July 5, 2006, U.S. EPA issued its report titled EPA's Roadmap for Mercury
("Roadmap"). This document describes the Agency's progress to date in addressing
mercury issues domestically and internationally, and outlines EPA's major ongoing and
planned actions to address risks associated with mercury. The Roadmap focuses on six
key areas:

1.   addressing mercury releases to the environment;
2.   addressing mercury uses in products and industrial processes;



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3.   managing commodity-grade mercury supplies;
4.   communicating risks to the public;
5.   addressing international mercury sources; and
6.   conducting mercury research and monitoring.

The report highlights mercury sources, describes progress to date in addressing mercury
sources, and outlines priority activities for addressing remaining mercury risks.
(See http://www.epa.gov/mercury/roadmap.htm)

Mercury-Related Significant New Use Rule (SNUR)
A mercury-related regulatory activity included the issuance on October 5, 2007 of a final
Significant New Use Rule (SNUR), for elementary mercury used in convenience light
switches, anti-lock braking system (ABS) switches, and active-ride-control-system
switches in certain motor vehicles.
(See http://www.epa.gov/fedrgstr/EPA-TOX/2007/October/Day-05/t19705.htm)

Mercury-Containing Products and Alternatives Database
EPA has developed the Mercury-Containing Products and Alternatives Database. The
Database compiles information on the manufacturers, sectors of use, product descriptions
and quantity of mercury-containing products nationwide using secondary sources.
Alternatives to the mercury-containing products are also included. This database will be
made publicly available when complete.

Additional mercury-related activities are described under in the Capacity Building and
Technical Cooperation section.

Reducing Children’s Lead Exposure
Lead is a highly toxic metal that was used for many years in products found in and
around our homes. Lead may cause a range of health effects, from behavioral problems
and learning disabilities to seizures and death. Children under six years of age are most at
risk. Research suggests that the primary sources of lead exposure for most children are
deteriorating lead-based paint, lead-contaminated dust, and lead-contaminated residential
soil.

EPA has played a major role in addressing these residential lead hazards. EPA has largely
completed the regulatory framework assigned to it by Congress in Title X of the
Residential Lead-Based Paint Hazard Reduction Act of 1992 by:

    Issuing rules creating a training and certification program for individuals and firms
     engaged in lead-based paint activities;
    Establishing hazard standards for lead in paint, dust, and soil; and
    Requiring pre-renovation education and lead hazard disclosure in target housing.

In order to meet the 2010 federal government goal of eliminating childhood lead
poisoning as a major public health concern, EPA is focusing funding resources on the
most vulnerable populations in state, localities and tribal areas -- those that have rates of


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lead poisoning above the national average and those in areas where sufficient screening
has not yet occurred to determine rates of lead poisoning. EPA has addressed populations
still at risk for elevated blood-lead levels through three competitive grant programs. The
grants are available to a wide range of applicants, including state and local governments,
federally-recognized Indian tribes and tribal consortia, territories, institutions of higher
learning, and nonprofit organizations.

In another step to achieve the 2010 goal, in March 2008 EPA finalized its Lead
Renovation, Repair, and Painting rule requiring persons engaged in renovation, repair,
and painting activities in pre-1978 housing and child-occupied facilities to be trained and
certified and to use lead-safe work practices for activities that disturb lead-based paint.
The purpose of the rule is to reduce potential exposure to dangerous levels of lead
resulting from lead-based paint in older housing.
(See http://www.epa.gov/fedrgstr/EPA-TOX/2008/April/Day-22/t8141.pdf)

Reducing Exposure to Asbestos
Asbestos is the common name for a group of naturally occurring mineral fibers with high
tensile strength, the ability to be woven, and resistance to heat and most chemicals.
Because of these properties, asbestos fibers have been used in a wide range of
manufactured goods, including construction materials and friction products such as
automobile clutches and brakes.

Exposure to asbestos can be harmful to human health if fibers are released into the air
when asbestos is disturbed or in poor condition. These fibers can cause serious health
problems when inhaled into the lungs. Asbestos exposure has been associated with a
number of serious health problems and diseases, including asbestosis, lung cancer, and
mesothelioma. EPA is committed to providing the public with accurate and timely public
health information and is continuing to address concerns about asbestos.
(See http://www.epa.gov/asbestos/)

The Asbestos Model Accreditation Plan (MAP) provides training requirements training
requirements for states to follow when developing their own state programs for training
asbestos professionals. The asbestos MAP requires initial training (which includes
hands-on training) and annual refresher training for the various course disciplines.
(See http://www.epa.gov/asbestos/pubs/training.html)

On April 2, 2007, EPA released a new brochure that provides health and safety
information for professional and do-it-yourself mechanics who may work with asbestos-
containing automotive components. Current Best Practices for Preventing Asbestos
Exposure Among Brake and Clutch Repair Workers emphasizes the need to prevent
asbestos fibers from escaping into the air during repair work. While it is impossible to tell
if clutch and brake components contain asbestos, the brochure advises that mechanics
should automatically assume the possible presence of asbestos.
(See http://www.epa.gov/asbestos/pubs/brakesbrochure.html)




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Great Lakes Binational Toxics Strategy
Signed in 1997 by Environment Canada (EC) and the United States Environmental
Protection Agency (US EPA), the Great Lakes Binational Toxics Strategy (GLBTS, or
Strategy) established challenge goals for Canada and the U.S. for 12 Level 1 persistent
toxic substances and targeted a list of Level 2 substances for pollution prevention
measures. Over the past ten years, the governments of Canada and the U.S., along with
stakeholders from industry, academia, state/provincial and local governments, Tribes,
First Nations, and environmental and community groups have worked together toward
the achievement of the Strategy’s challenge goals. Of the Strategy’s 17 challenge goals
that were established in 1997, 13 have been achieved and significant progress has been
made toward the remaining four challenge goals. Under the Strategy, EC and US EPA
also agreed to consider additional substances that may present threats to the Great Lakes
ecosystem.

Given the variety of emerging substances that have been detected and reported in the
Great Lakes, the U.S and Canada decided in September 2007 to explore a new path
forward under the GLBTS, in addition to continuing Strategy work toward the reduction
of legacy contaminants, where appropriate. Specifically, EC and the US EPA proposed
the creation of a Substance Group and a Sector Group under the Strategy. The Substance
Group will gather information to identify persistent toxic substances that may pose a
threat to the Great Lakes Basin and will explore potential management strategies. The
GLBTS Sector Group will review information on industrial sectors within the basin and
explore potential opportunities for the GLBTS process to enhance environmental
management activities of industry sectors, as appropriate. (See www.binational.net)


Working to Prevent Pollution

Pollution prevention (P2) is the act of reducing or eliminating waste at the source by
modifying production processes, promoting the use of non-toxic or less-toxic substances,
implementing conservation techniques, and re-using materials rather than putting them
into the waste stream. Since Pollution Prevention is a key policy in national
environmental protection activities, a number of partnership programs (See
http://www.epa.gov/partners/ ) and other EPA initiatives that utilize this approach.

As a first step in preventing pollution through source reduction, the Environmental
Protection Agency has established a source reduction program which collects and
disseminates information, provides financial assistance to States, and implements the
other activities provided for in the Pollution Prevention Act of 1990.
(See http://www.epa.gov/p2/pubs/p2policy/act1990.htm)

Environmentally Preferable Purchasing (EPP)
Environmentally Preferable Purchasing (EPP) is a program that encourages and assists
federal agencies in buying or leasing environmentally preferable products and services.
Environmentally preferable products are those products or services that have a lesser or
reduced effect on human health and the environment when compared with competing
products or services that serve the same purpose. EPA recognizes the influence the


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United States, and in particular, the U.S. government has on what products and services
are produced due to our tremendous purchasing power, and works to leverage that
influence to minimize environmental burdens.

Implementing EPP has numerous benefits, including:

    Improved ability to meet existing environmental goals
    Improved worker safety and health
    Reduced liabilities
    Reduced health and disposal costs

EPA’s EPP web site (See http://www.epa.gov/epp/) provides guidance for federal
purchasers, information on federal programs related to EPP, tools for finding and
evaluating environmentally preferable products and services, and information for
vendors.

Green Suppliers Network
The Green Suppliers Network is a collaborative venture among industry, EPA, and the
U.S. Department of Commerce's Manufacturing Extension Partnership (MEP). The
Green Suppliers Network works with all levels of the manufacturing supply chain to
improve processes and minimize waste generation. Through onsite technical reviews,
suppliers continuously learn ways to increase energy efficiency, identify cost-saving
opportunities, and optimize resources and technologies to eliminate waste. The result has
been more effective processes and products with higher profits and fewer environmental
impacts.

In recent months, this effort has expanded to Mexico and Canada, with the North
American Commission for Environmental Cooperation (CEC) launching a new
partnership to ―green the supply chain‖ in the North American automotive industry.
(See http://www.epa.gov/greensuppliers/index.htm)

Waste Minimization Program
EPA's Waste Minimization Program seeks to reduce or eliminate waste in manufacturing
in the United States. To do this, EPA promotes the concept of sustainability while
encouraging and recognizing industries that are already moving toward sustainable
production and seeking an opportunity to introduce it to other industries who have not yet
embraced this concept. A successful manufacturing future must be dedicated to the
sustainable use of resources. The Waste Minimization Program is working on and
promoting the use of advanced production and management tools including lean
manufacturing, chemical management services, greening the supply chain, and waste-to-
energy technologies.

Overall goals of the Waste Minimization Program include the following:

1.   Complete elimination of, or substitution for, priority chemicals, wherever possible;




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2.   Minimizing the amount of priority chemicals used whenever elimination or
     substitution is not possible;
3. Maximizing recycling whenever elimination, substitution, or minimization is not
     possible, creating closed loop materials management systems that eliminate or
     constrict release pathways;
4. Promoting cradle-to-cradle waste management instead of cradle-to-grave waste
     management;
5. Increase cooperative efforts between EPA, States, and the regulated community
     through partnership programs.
(See http://epa.gov/epawaste/hazard/wastemin/index.htm )

Performance Track
EPA’s Performance Track works to enhance the environmental performance of chemical
manufacturers. In 2004, the American Chemistry Council (ACC) established a
partnership with EPA's Performance Track program, the agency's leading voluntary
program for recognizing and driving environmental excellence by encouraging facilities
with strong environmental records to go above and beyond their legal requirements. The
partnership focuses on using ACC's Responsible Care initiative as a vehicle for
continuous environmental improvement. Responsible Care is an initiative that addresses
the environmental, health, safety, and security performance of member companies
through implementation of a management system, measuring, and public reporting on
environmental, health, and safety performance, and obtaining independent certification
that a management system is in place and functions according to professional standards.
(See http://www.epa.gov/performancetrack/)


Chemical Risk Reduction Through Pollution Prevention

Design for the Environment (DfE) Program
EPA’s Design for the Environment (DfE) Program works in partnership with a broad
range of stakeholders to reduce risk to people and the environment by preventing
pollution. DfE focuses on industries that combine the potential for chemical risk
reduction and improvements in energy efficiency with a strong motivation to make
lasting, positive changes. Examples of the partnerships include the Lead-Free Solder
Partnership, the Wire & Cable Partnership, the Printed Circuit Board Flame Retardancy
Partnership, the Formulator Partnerships, and the Automotive Refinishing Partnership.
Of note is the work under the Furniture Flame Retardancy Partnership to foster informed
substitution by providing objective information about hazard considerations associated
with flame retardant chemicals, allowing furniture manufacturers to select safer
substitutes when selecting flame retardants for foam applications.
(See http://www.epa.gov/oppt/dfe/)

Green Chemistry Program
EPA’s Green Chemistry Program works with the chemical community to promote the
environmentally conscious design of chemical products and processes that are safer to
human health and the environment. The Program's flagship activity, the annual



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Presidential Green Chemistry Challenge Awards, encourages and recognizes the
significant scientific, economic, human health, and environmental benefits that green
chemistry technologies offer.

The Presidential Green Chemistry Challenge Awards Program celebrated its 13th year at
the June 2008 awards ceremony. To date the Program has given out 67 awards – 14
awards to academic researchers, 13 awards to small businesses, and 40 awards to larger
businesses and organizations. (See http://www.epa.gov/greenchemistry/)

Green Engineering Program
Green engineering is defined as the design, commercialization and use of processes &
products that are feasible & economical while minimizing: generation of pollution at the
source and risk to human health & the environment. The goal of EPA’s Green
Engineering Program is to incorporate risk related concepts into chemical processes and
products designed by academia and industry. This program targets four major sectors:

    Educators: A Green Engineering textbook, Green Engineering: Environmentally
     Conscious Design of Chemical Processes has been developed which can be used by
     educators for instructing "green" thinking in engineering processes and
     applications. Also, academic workshops have been held for professors and students
     to disseminate green engineering materials and software.
     (See http://www.epa.gov/opptintr/greenengineering/pubs/textbook.html)

    Software: Provides chemical engineers with an integrated risk based suite of tools
     for assessing chemical hazards in process design.
     (See http://www.epa.gov/opptintr/greenengineering/pubs/software.html)

    Industry: Continuing education courses from the conversion of academic materials,
     methodologies, and case studies utilized to illustrate green engineering alternatives
     in chemical process design for new and practicing engineers.
     (See http://www.epa.gov/opptintr/greenengineering/pubs/industry.html)

    Outreach: Sources, which promote and disseminate green engineering approaches
     to academia and industry facilitating a continuous flow of information and ideas for
     new and existing courses, case studies, and process design methodologies, are
     presented.
     (See http://www.epa.gov/opptintr/greenengineering/pubs/outreach.html)

For more information on Green Engineering, please see:
http://www.epa.gov/opptintr/greenengineering/index.html

National Partnership for Environmental Priorities (NPEP)
EPA has established a National Waste Minimization Goal to act as a measurement of
program success. The goal is to encourage industry and the public to reduce the use or
release of 4 million pounds of priority chemicals by 2011. The National Partnership for
Environmental Priorities Program (NPEP), a voluntary program, is EPA’s primary


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vehicle for waste minimization. NPEP encourages public and private organizations to
form voluntary partnerships with EPA that reduce the use or release of any of 31 Priority
Chemicals. Data and examples of the success of this program can be found at
http://www.epa.gov/epaoswer/hazwaste/minimize/success.htm.)

Chemical Management Services (CMS)
CMS is a business model in which a customer purchases chemical services rather than
just chemicals. These services can encompass all aspects of the chemical management
lifecycle including: procurement, delivery/distribution, inventory, use (including
chemical substitute research), collection, monitoring/reporting, training, treatment,
disposal, information technology, and even process efficiency improvements; each of
which poses its own costs and risks.

Under CMS, the service provider is compensated based on the quality and quantity of
services provided that reduce chemical lifecycle costs, risks, and environmental impacts,
not on the volume of chemical sold. Therefore the service provider has the same
objective as their customer: to reduce chemical use and cost. Both participants achieve
bottom line benefits through reduced chemical use, cost, and waste. This model is now
widely used in the automotive, aerospace, and microelectronics sectors where
environmental benefits observed include reduced chemical use, reduced emissions, and
reduced waste generation, as well as substantial cost savings.
(See http://www.epa.gov/epawaste/hazard/wastemin/minimize/cms.htm)

Global Partnerships to Reduce Health Risks from Key Pollutants
EPA participates in three global Partnerships which reduce health risks from key
pollutants.       These are the UNEP Global Mercury Partnership (see
http://www.chem.unep.ch/MERCURY/partnerships/new_partnership.htm),                 which
addresses mercury use and releases in a range of sectors, the Partnership for Clean
Fuels and Vehicles (see http://www.unep.org/pcfv/), which has successfully eliminated
lead from gasoline in most countries and is working to reduce sulfer and other emissions,
and the Partnership for Clean Indoor Air (see http://www.pciaonline.org/) which
reduces health risks from indoor burning of coal and other fuels which emit air toxics as
well as criteria pollutants.


Sector-Focused Pollution Prevention Programs

Sector Strategies Program
EPA's Sector Strategies Program develops comprehensive action strategies that enable
major U.S. manufacturing and business sectors to significantly improve their
environmental performance and resource efficiency. The chemical manufacturing
industry is a participating sector in this program. Sector-specific strategies include
actions by both government and business, such as targeted regulatory changes to reduce
barriers to enhanced performance, or industry-wide stewardship initiatives to achieve
better environmental results on a broad scale. The program tracks the performance trends
of each participating sector and addresses priority issues in all environmental media. To



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date, the program's work with the chemical industry has focused on environmental and
energy issues from chemical plant operations, not chemical product design. The 2008
Sector Performance Report presents current data on the chemical manufacturing industry
and is available online at www.epa.gov/sectors.

Green Building
Green or sustainable building is the practice of creating healthier and more resource
efficient models of construction, renovation, operation, maintenance, and demolition.
The buildings in which we live, work, and play protect us from Nature's extremes: cold,
heat, wind, rain, and snow. But these structures affect and shape our environment too.
Constructing and operating buildings requires enormous amounts of energy, water, and
materials and creates large amounts of waste. Where and how they are built affects the
ecosystems around us in countless ways. And the buildings themselves create new indoor
environments that present new environmental problems and challenges.

As the environmental impact of buildings becomes more apparent, a new field called
green building is arising to reduce that impact at the source. Green or sustainable building
is the practice of creating healthier and more resource efficient models of construction,
renovation, operation, maintenance, and demolition. The many elements of green
building include:

    Energy: Designing and operating buildings to use energy efficiently and to use
     renewable sources of energy, including solar, wind, and biomass.
    Water: Designing and operating buildings to use water efficiently.
    Materials: Using building materials that, in comparison to competing brands, have a
     reduced effect on the environment throughout their life cycle (e.g. recycled content,
     low toxicity, energy efficiency, biodegradability, and/or durability).
    Waste: Reducing the waste from construction, remodeling, and demolition.
    Indoor Environment: Designing and operating buildings that are healthy for their
     occupants.
(See http://www.epa.gov/opptintr/greenbuilding/)

To find out what EPA is doing to make its own buildings greener, please see the EPA's
Green Buildings page at http://www.epa.gov/greeningepa/projects/index.htm.

Environmentally Sound Electronics Design and Lifecycle Management

Electronic Product Environmental Assessment Tool (EPEAT)
EPEAT is a tool that helps purchasers buy environmentally preferable electronics. A list
of EPEAT registered products and participating manufacturers and guidance for
purchasers on how to buy EPEAT registered products is located on EPEAT’s web site
(see http://www.epeat.net/). EPEAT-registered computer desktops, laptops, and monitors
must meet an environmental performance standard for electronic products – IEEE 1680-
2006. IEEE 1680-2006 is a voluntary consensus standard which was developed by the
IEEE through an open, consensus based process. EPEAT products contain less toxic and




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hazardous substances, are easier to recycle, and are more energy efficient than
conventional products serving the same purpose.
(See http://www.epa.gov/epp/pubs/products/epeat.htm)

Federal Electronics Challenge (FEC)
The FEC is a partnership program that empowers federal agencies to manage their
electronics in an environmentally sound manner during all three life-cycle phases -
acquisition and procurement, operation and maintenance, and end-of-life management.
The FEC supports efforts to continuously improve environmental stewardship of
electronic assets government-wide in order to better assist federal agencies and facilities
in     meeting     the     requirements    of    Executive       Order     13423      (see
http://www.ofee.gov/eo/EO_13423.pdf ). The FEC also provides resources and technical
assistance to help federal agencies and facilities improve electronics management
throughout the lifecycle. (See www.federalelectronicschallenge.net)

Cathode Ray Tube (CRT) Rule
In July 2006, the U.S. streamlined the federal hazardous waste management requirements
for cathode ray tubes (CRTs) and CRT glass destined for recycling. These standards aim
to increase the collection and recycling of CRTs, which in turn will save energy, conserve
resources, and allow for the recovery and reuse of lead and glass. Under the previous
regulations, businesses and other organizations responsible for the recycling or disposal
of CRTs were sometimes uncertain about the proper way to recycle or dispose of this
material. Such uncertainty sometimes prevented CRTs from being recycled and reused.
The US has changed CRT waste management requirements to eliminate this confusion in
order to encourage increased reuse and recycling of CRTs.
(See http://www.epa.gov/osw/hazard/recycling/electron/)

Coal Combustion Products Partnership (C2P2)
The Coal Combustion Products Partnership (C2P2) is a joint government and industry
program to increase the beneficial use of coal combustion products which leads to
reduced energy consumption, greenhouse gas emissions and increased industrial
recycling. The goals of the C2P2 program are to increase the use of coal ash as a
replacement for Portland cement in concrete from 12.6 million tons in 2002 to 20 million
tons in 2010, which will reduce future greenhouse gas generation by over 6.5 million tons
annually, and increase the overall use of CCPs from 35%, 2002, to 45 by 2008.
(See http://www.epa.gov/osw/partnerships/c2p2/index.htm)


Pollution Prevention Technical Assistance Programs

Pollution Prevention Resource Exchange (P2Rx)
The Pollution Prevention Resource Exchange (P2Rx) is a consortium of eight regional
pollution prevention information centers, funded in part through grants from EPA. These
centers all provide pollution prevention information, networking opportunities and other
services to States, local governments and technical assistance providers in their region.
The centers represent a broad constituency, including state and local pollution prevention



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programs, manufacturing extension partnerships, cooperative extension and nonprofit
organizations. The diversity of audience contributes to an overall breadth of P2
information and opportunities. (See http://www.p2rx.org/)

Compliance Assistance Centers
Compliance Assistance Centers help businesses, local governments, and federal facilities
understand and comply with federal environmental requirements and save money through
pollution prevention techniques. The Centers offer easy access to plain-language
materials and other resources on environmental compliance through:

    web sites targeted to industry sectors,
    virtual plant tours,
    telephone assistance,
    "ask the expert,"
    email discussion groups,
    State Resource Locators that offer a wide range of topics on environmental
     compliance information for your state.

Compliance Assistance Centers are sponsored by EPA in partnership with industry,
academic institutions, environmental groups, and other agencies. (See
http://www.assistancecenters.net/)


Community-Focused Programs

Community Action for a Renewed Environment (CARE)
Community Action for a Renewed Environment (CARE) is a competitive grant program
that offers an innovative way for a community to organize and take action to reduce toxic
pollution in its local environment. Through CARE, a community creates a partnership
that implements solutions to reduce releases of toxic pollutants and minimize people's
exposure to them. By providing financial and technical assistance, EPA helps CARE
communities get on the path to a renewed environment.
(See http://www.epa.gov/air/care/index.htm)

EPA Office of Pollution Prevention and Toxics Tribal Program
EPA’s Office of Pollution Prevention and Toxics is committed to working in partnership
with tribal governments to safeguard and protect the environment from toxic hazards and
to promote pollution prevention in Indian country. The first priority of the OPPT Tribal
Program is continuing to improve communication to better exchange information
regarding environmental concerns and issues facing Indian country today.

OPPT publishes the OPPTS Tribal newsletter, which features a wide variety of
environmental information, perspectives, and issues that affect American Indian Tribes.
This newsletter is sent out to all federally-recognized tribes, Tribal environmental groups,
Tribal colleges, Tribal news media and EPA Tribal advisory groups and other interested
parties. (See http://www.epa.gov/oppt/tribal/pubs/index.html)


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Indigenous Peoples Community Action Initiative
Indigenous Peoples Community Action Initiative is a program implemented by EPA and
the Russian Association of Indigenous Peoples of the North (RAIPON) under the Arctic
Contaminants Action Program (ACAP). The initiative addresses management of local
sources of contamination in the indigenous communities of the Russian Arctic.




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B. KNOWLEDGE AND INFORMATION


                               OVERARCHING POLICY STRATEGY
KNOWLEDGE, INFORMATION AND PUBLIC AWARENESS are basic needs for decision-making for
the sound management of chemicals, including products and articles containing chemicals. It is
recognized that: a.) Technological information, the results of hazard and risk assessments, socio-
economic methodologies and the tools to develop and apply science-based standards, harmonized
risk assessment and management principles are not available to all actors, and the pace of
scientific research in these areas needs to be accelerated; b.) There is a lack of clear, accessible,
timely and appropriate information on chemicals for ready use by local populations.


Information Collection and Access

High Production Volume (HPV) Challenge Program
Under the High Production Volume (HPV) Challenge Program, companies are
"challenged" to make health and environmental effects data publicly available on
chemicals produced or imported in the United States in the greatest quantities. HPV
chemicals are classified as those chemicals produced or imported in the United States in
quantities of 500 tones or more per year. Since the Program’s inception, companies have
sponsored more than 2,250 HPV chemicals, with approximately 1,400 chemicals
sponsored directly through the HPV Challenge Program and roughly 860 chemicals
sponsored indirectly through international efforts. This represents 93% of the total
volume of chemicals in commerce in the U.S.

Access to HPV chemical information enables the public to participate in environmental
decision-making at all levels – federal, state, and local. With voluntary data collection
nearing its conclusion, the focus of the HPV Challenge Program has shifted to data use,
both by the public and by EPA in its mission to protect human health and the
environment. (See http://www.epa.gov/chemrtk/)

High Production Volume Information System (HPVIS)
The U.S. created the High Production Volume Information System (HPVIS), which is a
database that provides access to health and environmental effects information of
chemicals produced or imported into the U.S. in quantities of about 1 million pounds or
more per year. HPVIS enables users to search for summary information, test plans, and
new data on HPV chemicals as they are received by the Agency. Currently, the HPVIS
database contains over 346 submissions, representing 1,102 chemical substances, either
as a single chemical submission or as a member of a chemical category.
(See http://www.epa.gov/chemrtk/hpvis/index.html)

Chemical Substance Inventory Update Reporting
Information on chemicals manufactured (including imported) in the United States and
listed on the TSCA Chemical Substance Inventory is collected periodically by the EPA.


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This collection began following the promulgation of the Inventory Update Reporting
(IUR) regulation in 1986. In 2003, EPA amended the IUR requirements to match the data
collected more closely with EPA's information needs.

During 2007, EPA completed the first Inventory Update Reporting (IUR) collection since
major amendments from 2003. EPA received updated information for approximately
7,500 organic and inorganic chemicals. For the first time, this information included:

    Manufacturing information for inorganic chemicals,
    Enhanced manufacturing information for organic chemicals (e.g., the physical form
     of the chemical and the number of potentially exposed workers), and
    Additional screening-level exposure-related processing and use information for
     organic chemicals produced at 300,000 pounds or greater at a single site.

Under the Toxic Substances Control Act (TSCA), companies that manufacture or import
chemicals may be required to report information about these chemicals - the identity of
the chemicals, the amounts manufactured or processed, certain details about their
manufacture, and other data. This information is stored in EPA's TSCA Chemical
Substance Inventory, and is used by EPA and other government agencies to identify
potential use and exposure scenarios so that they may protect human health and the
environment. (See http://www.epa.gov/oppt/iur/)

EPA launched a new IUR information management system in 2006, consolidating
information submitted to EPA online using EPA’s Central Data Exchange (CDX)
(see http://www.epa.gov/cdx) on CDs and in hard copy. The new information system
provides improved access to IUR information for Agency data users to make regulatory
and risk management decisions. It provides improved searchability, supports a graphical
user interface (GUI), and potentially provides direct electronic downloads of IUR data to
existing chemical tools and models. Currently, the system is only accessible to Agency
users because it contains Confidential Business Information (CBI). A subset of the non-
CBI data (e.g., production volume information is reported in ranges) will be made
available to the public in the future. It will allow users to search the EPA IUR website
for specific IUR information on the chemical.

Voluntary Children’s Chemical Evaluation Program (VCCEP)
Developed through a public stakeholder process, the Voluntary Children’s Chemical
Evaluation Program (VCCEP) is helping the public better understand the potential health
risks to children associated with certain chemical exposures. VCCEP is a three-tiered
assessment program designed to fully evaluate hazards, exposures and risks of chemicals
to children and to develop information needed to adequately assess the risks to children.
Under VCCEP, EPA collects three tiers of increasingly detailed information on a
chemical's toxicity and exposure and resulting potential risk to children.

So far EPA has asked companies to volunteer to sponsor their chemical(s) for Tier 1.
After completing the evaluation of some Tier 1 chemical assessments, EPA asked
companies to volunteer to sponsor higher tier testing for several chemicals. VCCEP is


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more an information collection program than a testing program. Rigorous chemical
selection criteria were used to identify 23 chemicals for the pilot program. Companies
have agreed to sponsor 20 of the 23 chemicals in the pilot.

Similar to the HPV Challenge Program, the goal of VCCEP is to make data publicly
available. The implementation process builds on and models the HPV Challenge Program
whenever possible. (See http://www.epa.gov/oppt/vccep/)

Nanoscale Materials Stewardship Program (NMSP)
In January 2008, EPA launched the Nanoscale Materials Stewardship Program (NMSP)
to help provide a firmer scientific foundation for regulatory decisions by encouraging
submission and development of information, including risk management practices, for
nanoscale materials. Nanoscale materials that are either new or existing chemical
substances (as determined by the status of the substance on the U.S. Toxic Substances
Control Act (TSCA) Chemical Substances Inventory) can be included in the program.
(See http://www.epa.gov/oppt/nano/stewardship.htm)

Toxics Release Inventory (TRI)
EPA’s Toxics Release Inventory (TRI) database is publicly available and contains
information on toxic chemical releases and other waste management activities reported
annually by certain covered industry groups as well as federal facilities. This inventory
was established under the Emergency Planning and Community Right-to-Know Act of
1986 (EPCRA) and expanded by the Pollution Prevention Act of 1990. The EPA TRI
Program is working to improve the efficiency and effectiveness of data collection,
processing, and dissemination using advanced information system technologies. The
Program is also working to ensure that the TRI data and information are useful and
meaningful to the public and a variety of stakeholders both inside and outside the
Agency.

Access to TRI Data and Information
EPA’s TRI Program provides the public and others several ways to access TRI data and
information. Additional details are provided below, and can also be accessed from the
Internet at http://www.epa.gov/tri/tridata.

Early (electronic)-Facility TRI Data Release (e-FDR)
The e-FDR is a facility-level, form-by-form release of TRI data as reported by July 1st of
each calendar year, for the preceding calendar year. The e-FDR does not include analyses
of the TRI data, such as national trend analysis. EPA created the e-FDR to get the data
out to communities sooner. Some data quality checks are completed for the forms
released under the e-FDR, however facilities are still reviewing the forms to verify
submissions and may revise their data prior to the final release of the TRI data in the
spring Public Data Release report. When the annual TRI Public Data Release (PDR)
report (see http://www.epa.gov/tri/tridata/#pdr#pdr) is published and released to the
public, the e-FDR query tool will not be available until the following year.
(See www.epa.gov/tri-efdr/ )




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Annual TRI Public Data Release (PDR)
The annual TRI Public Data Release (PDR) includes an overview of the most recently
reported TRI data, information on trends, and downloadable data files of all TRI reports
submitted for the reporting year. On February 21, 2008, the 2006 TRI data were released
marking the earliest release of the TRI data since the program's inception. The 2006 PDR
includes key findings, and links to the data via the TRI Explorer data access tool.
(See www.epa.gov/tri/tridata/tri06/index.htm )

TRI Explorer
The TRI Explorer is an online data access tool that enables users to search the TRI
database by chemical, facility-type, zip code, county, and state, as well as at the national
level, to obtain TRI data and information. Combined with hazard and exposure
information, it is a valuable tool for identifying potential chemical hazards in
communities. (See www.epa.gov/triexplorer/ )

Envirofacts
Envirofacts is another online tool that provides access to the TRI database, as well as
other EPA databases. EPA created the Envirofacts Warehouse to provide the public with
direct access to the wealth of information contained in the Agency's various databases
(including TRI). Envirofacts enables users to query and view all fields for each TRI
reporting form submitted by a facility. (See www.epa.gov/enviro/ )

TRI.NET
EPA is near completion in developing its TRI.NET tool, an advanced tool for accessing
and analyzing TRI data. This tool was developed in-house and is currently undergoing
beta-testing. The tool is focused on capabilities a Power User needs to analyze TRI data
effectively, such as a robust ad hoc query capability and the ability to integrate with web
2.0 mapping technologies. In addition, the very fast response is more effective for
analysts who need a highly-interactive environment in order to refine their queries and
analyses in an efficient and productive way. Routine, simple access needs can be met by
other available tools, although the TRI .NET tool certainly is another means for
supporting such needs.

The TRI.NET uses the latest mapping technologies of Virtual Earth, Google Earth, and
Google Maps for Mashups. It is consistent with EPA’s current interest in "Web 2.0"
approaches as it leverages current technologies to create a more agile environment that
takes advantage of the capabilities of modern PCs on the user side and Internet
capabilities to serve up data and provide geospatial services.

TRI.NET will also allow the user to get a micro picture of TRI releases by showing TRI
releases in small communities and mapping those TRI facilities releasing chemicals in
their neighborhood. The software has the ability to geocode addresses so that the user can
base queries on the ad hoc neighborhood.




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TRI Data Quality
The quality of TRI data and related information that is submitted to EPA is solely the
responsibility of the facilities that are required to submit such data and information.
Nonetheless, given the widespread use and importance of the TRI database as an
information source and decision making tool, EPA’s TRI Program has for many years
been voluntarily proactive in identifying and implementing activities aimed at optimizing
the quality of TRI data. These activities include: development of industry-specific and
chemical-specific technical guidance documents; detailed reporting forms and
instructions, sponsoring training workshops; establishment of the TRI Information
Center; development of the TRI-ME software product; in-house data quality analyses, to
name a few. As a result of the Internet, advances in electronic information technology,
and computational power, EPA is planning to implement some new approaches designed
to improve TRI data quality, and explore some additional approaches that may offer
significant advances in improving the quality of TRI data. These include: development
and incorporation of: web-based TRI ME; statistical-based identification of potential
reporting inaccuracies; and industry sector analyses, to name a few.

Facilitation of Reporting of TRI Data and Information to EPA’s TRI Program
TRI reports (facility TRI submissions) must be submitted annually to EPA’s TRI
Program. Reports by July 1 of each year and cover activities at the facility during the
previous calendar year (i.e., the reporting year follows the calendar year). The TRI
Program strongly encourages facilities to submit electronic reports to the Agency. Of the
23,000 facilities required to report in reporting year 2005, approximately 66 percent
submitted electronic reports via EPA's Central Data Exchange (CDX), 30 percent
submitted electronic reports using diskettes, and 4 percent submitted reports using paper
forms. Electronic submission enables the TRI Program to process, analyze, and
disseminate the data to the public more quickly.

TRI-Made Easy (TRI-ME) and TRI-MEweb
The TRI Program has developed an interactive software program known as TRI Made
Easy or TRI-ME which assists facilities in completing and submitting TRI reporting
forms. Recently, the TRI Program completed a Web-based version, TRI-MEweb, which
was successfully piloted during the submission of 2005 reporting year data. This
interactive web-based software tool is designed to identify potential data errors, and has
other data quality checks. The tool reduces the regulatory burden of TRI reporting for
facilities, helps to improve the quality of TRI data, and enables EPA to release TRI data
sooner. (See www.epa.gov/tri/report/software/index.htm )

TRI State Data Exchange
EPA’s TRI Program is working with U.S. state partners to implement the TRI State Data
Exchange. As of May 2007, 14 states were participating in the TRI State Data Exchange.
First implemented for the 2004 reporting year, the TRI State Data Exchange enables
facilities in participating states to simultaneously submit data to both EPA and their state.
In addition, states participating in this program are able to receive TRI data via the
Exchange Network (thus enabling states to discontinue individual state data collection
systems). The TRI Program has expanded the data available through the TRI State Data



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Exchange to include not only reports submitted to EPA electronically via CDX but also
to include those submitted via diskette and paper. Due to this recent enhancement,
participating states are reporting greater efficiencies and significant savings in their data
collection efforts. (See www.epa.gov/tri/stateexchange/)

ACToR (Aggregated Computational Toxicology Resource)
ACToR is a collection of databases collated or developed by the US EPA National Center
for Computational Toxicology (NCCT). More than 200 sources of publicly available
data on environmental chemicals have been brought together and made searchable by
chemical name and other identifiers, and by chemical structure. Data includes chemical
structure, physico-chemical values, in vitro assay data and in vivo toxicology data.
Chemicals include, but are not limited to, high and medium production volume industrial
chemicals, pesticides (active and inert ingredients), and potential ground and drinking
water contaminants.

At present, data on environmental chemicals resides in a variety of specialized databases,
in many different and incompatible formats and in many different locations. Up to now,
in order to compile all information on a given chemical, one needed to search multiple
databases and then manually compile the resulting data. While this is possible to do for
specific chemicals, it is very difficult to compile comprehensive data sets on chemically-
similar sets of compounds using structure searching tools. By bringing together data from
a large number of sources and making the data structure-searchable, ACToR will
facilitate searches that transcend available data and chemical number. As such, it will be
an important tool for the advancement of computational toxicology, which requires
evaluation of information across broad scales of chemical class, use, structure and
biological activity.

The ACToR project is compiling data (both quantitative and qualitative) from a large
number of sources (called data collections), including EPA databases, PubChem, other
NIH and FDA databases, state and other national sources, and from academic groups.
One novel data collection is ToxRefDB, which includes detailed information on in vivo
guideline study results for pesticides and other potentially toxic chemicals that has been
assembled by the National Center of Computational Toxicology. ACToR is also the
primary repository of data being produced by the EPA ToxCast (see
http://www.epa.gov/ncct/toxcast/) chemical screening prioritization program. The
majority of chemicals in ACToR have chemical structures, which will facilitate studies of
structure-function relationships in sets of environmental chemicals. The DSSTox
Program (see http://www.epa.gov/ncct/dsstox/index.html) in the NCCT is responsible for
structure annotation in ACToR. (See http://www.epa.gov/NCCT/databases.html)

EPA Air Toxics Web Site
This website addresses many aspects of an air toxic management program, including
rules and implementation, air toxics assessment, urban and regional programs, education
and outreach, and the National Air Toxics Assessment (NATA) program. NATA is a
state-of-the-art screening tool used to assess the risk of cancer and other serious adverse
health effects due to inhaling toxic contaminants in the ambient air. Assessments



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performed under NATA can include both cancer and non-cancer effects resulting from
outdoor air pollution. (See www.epa.gov/ttn/atw/index.html)

Clearinghouse for Inventory and Emissions Factors
Information on both emission inventories and emission factors, including EPA's National
Emission Inventory, are provided at this webpage. Emission inventories are the basis for
numerous efforts involving trends analysis, regional and local scale air quality modeling,
regulatory impact assessments, and human exposure modeling. Emission factors are used
to estimate emissions from industrial and mobile sources based on some source
characteristic such as hours of operation, quantity of product produced, or vehicle miles
traveled. Emission inventories and factors can be useful for estimating sources of toxic
air contaminants and emission rates into the atmosphere. This website also provides
guidance on the determining the quality of emission inventories and factors and on
developing new inventories and factors. (See www.epa.gov/ttn/chief/)

Plug-In To eCycling: Guidelines for Materials Management
EPA has developed Guidelines for Materials Management, a voluntary guidance tailor-
made for participants in EPA's Plug-In To eCycling program, a partnership between EPA
and consumer electronics manufacturers, retailers, and service providers that offers
opportunities to donate or recycle used electronics. The Guidelines encourage anyone
who handles used electronic equipment to:

    Maximize reuse, refurbishment, and recycling over disposal and incineration.
    Ensure that exported electronic products are being sent for legitimate reuse,
     recycling, or refurbishment, and provide for special handling of components which
     may contain substances of concern.
    Make sure that collection, recycling, refurbishing, and disposal facilities follow
     management practices that are consistent with the Guidelines.

In addition to ensuring environmentally safe recycling of old electronics, these
Guidelines aim to promote and maintain adequate markets for the reuse and recycling of
electronic equipment by providing safe, reusable equipment or industrial feedstock
materials to legitimate markets, wherever they exist.

EPA issued the Guidelines in 2004. Over the past few years, EPA has been facilitating a
multi-stakeholder initiative for the development of ―responsible recycling‖ practices that
likely will be incorporated into a certification program for e-waste recyclers.
(See http://epa.gov/osw/partnerships/plugin/guide.htm)

Materials and Waste Exchanges
U.S. EPA and US states have encouraged and supported materials and waste exchanges,
which are markets for buying and selling reusable and recyclable commodities and are
important vehicles for diverting materials out of landfills. These exchanges may be
physical warehouses that advertise available commodities through printed catalogs, while
others are simply Web sites that connect buyers and sellers. Some are coordinated by
state and local governments. Others are wholly private, for-profit businesses. The


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exchanges also vary in terms of area of service and the types of commodities exchanged.
In general, waste exchanges tend to handle hazardous materials and industrial process
waste while materials exchanges handle non-hazardous items. Typically, the exchanges
allow subscribers to post materials available or wanted on a Web page listing.
Organizations interested in trading posted commodities then contact each other directly.
As more and more individuals recognize the power of this unique tool, the number of
Internet-accessible materials exchanges continues to grow, particularly in the area of
national commodity-specific exchanges.
(See http://www.epa.gov/epaoswer/non-hw/recycle/jtr/comm/exchange.htm)


Facilitating the Interpretation of Chemical and Other Information

Sustainable Futures
Sustainable Futures, a partnership among EPA, the chemical industry, and other
stakeholders, offers computerized chemical screening models that enable those
developing chemicals to quickly and cost effectively screen them for hazards and/or risks
early in the development process.

Because Sustainable Futures also enables comparing and contrasting hazard and risk
profiles of chemicals and processes, participation in the program can allow companies to
more quickly commercialize environmentally preferable new chemical products and
identify safer alternatives for existing chemical products. Training and follow-up
assistance in the proper use of these screening models is offered now on a fee-for-service
basis by Agency grantees that have worked closely with EPA on the Sustainable Futures
Initiative.

Interest continues in Sustainable Futures with more than 80 people, including
representatives of 30 chemical companies, taking training during 2007 in the use,
interpretation and applicability of Sustainable Futures chemical screening models.
Participants in the training sessions (see http://www.epa.gov/oppt/sf/meetings/train.htm)
also included government scientists from Australia, Europe (Poland, Germany, Slovakia,
and the Netherlands) and Japan, and scientists from several consulting firms.
(See http://www.epa.gov/oppt/sf/index.htm)

Analog Identification Methodology (AIM)
EPA is currently developing the Analog Identification Methodology (AIM) to address
needs identified by participants in the Sustainable Futures Initiative. AIM is expected to
be released to the public in 2008. For chemicals lacking data, identifying a close analog
with measured data is the most challenging step in using screening models and
quantitative structure activity relationship (QSAR) methods that predict the toxicity of
chemicals based on their structural similarity to chemicals for which toxicity data are
available. AIM is being developed to identify close analogs that have measured data and
it points to sources where those data can be found. Like the PBT Profiler, AIM will be
available for use on-line and at no cost.
(See http://www.epa.gov/oppt/sf/presentations/sf/sf-aim1a.pdf)



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Chemical Structure Based Toxicity Prediction
Distributed Structure-Searchable Toxicity (DSSTox) Database Network is a project of
EPA's National Center for Computational Toxicology (see http://www.epa.gov/ncct/),
helping to build a public data foundation for improved structure-activity and predictive
toxicology capabilities. The DSSTox website provides a public site for searching
standardized chemical structure files associated with toxicity data. The structure browser
developed from available structure-viewing freeware and open-source programming
tools, delivers a simple, easy-to-use structure-searching capability through the chemical
inventory of published DSSTox Data Files. The DSSTox Structure-Browser application
can be accessed directly from this website.

Risk-Screening Environmental Indicators (RSEI)
Risk-Screening Environmental Indicators (RSEI) is a computer-based screening tool
developed by EPA that analyzes risk factors to put Toxics Release Inventory (TRI) (see
http://www.epa.gov/tri/) release data into a chronic health context. RSEI is often used by
government regulators, communities, journalists, industry and others to examine trends,
identify important emissions situations for follow-up, support community-based projects
and initially screen potential impacts of emissions. (See http://www.epa.gov/oppt/rsei/)

Fate, Exposure, and Risk Analysis
The tools found on EPA’s Fate, Exposure, and Risk Analysis website (see
www.epa.gov/ttn/fera/) are useful for evaluating the health risks and environmental
effects of air pollution. Information is provided on EPA's Total Risk Integrated
Methodology model, multimedia fate and transport modeling, human exposure modeling,
and risk assessment methodologies. Links are provided to EPA risk assessment policy
and guidelines; to other human exposure, multimedia fate, and transport models; and to
databases needed to support exposure modeling.

Support Center for Regulatory Atmospheric Modeling
The Support Center for Regulatory Atmospheric Modeling, maintained by EPA's Air
Quality Modeling Group, contains a wealth of information on models and other
mathematical simulation techniques used to assess air quality and emission control
strategies and to support regulatory decisions. Documentation and guidance for these air
quality models is provided, including downloadable computer code, input data, and
model processors. The website is divided into separate sections addressing air quality
models (including documentation, source code, and user guides), modeling applications
and tools (including assessment of control strategies and source culpability), modeling
guidance and support (including the Modeling Clearinghouse for guidance on specific
applications), and meteorological data and processors (including data derived from both
ambient measurements and meteorological models). (See www.epa.gov/ttn/scram/)

Economic Analysis
EPA conducts economic analyses as part of its decision making process, for example,
during strategic planning or priority setting, development of voluntary actions and
regulations, and the measurement of results. Economic analyses include market studies,



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financial feasibility studies, and industry sector studies. More detailed economic
analyses, commonly referred to as regulatory impact analyses (RIAs), incorporate risk
findings with valuation to assess benefits of actions being considered and compare these
benefits to estimated costs. Economic analyses provide Agency decision makers with
information about potential economic impacts of actions developed to protect human
health and the environment. For more details on these analyses, please see
http://www.epa.gov/opptintr/economics/.


Pesticides Knowledge & Information

Through its website, EPA provides numerous sources of information about its pesticide
regulatory programs, pesticide regulatory decisions of specific pesticides and general
information about the proper use of pesticides. Sources for key subjects are included
below.

Online Registration Kit
EPA has assembled an online registration kit which contains pertinent forms and
information needed to register a pesticide product with EPA.
(See http://www.epa.gov/pesticides/registrationkit/)

Pesticide Product Label System
For pesticide labels which have been approved by EPA, the Pesticide Product Label
System is a collection of images, in multi-page TIFF format.
(See http://www.epa.gov/pesticides/pestlabels/)

Pesticide Web Resources
    EPA posts an alphabetical listing of the status of each pesticide in the re-registration
     and registration review processes, and provides links to a chemical's Web page and
     any decision documents or fact sheets that are available.
     (See http://www.epa.gov/pesticides/reregistration/status.htm)

    EPA posts an alphabetical listing of the pesticides that have begun the registration
     review process.
     (See http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm)

    EPA posts a collection of health and safety fact sheets, regulatory action fact sheets,
     and specific chemical fact sheets.
     (See http://www.epa.gov/pesticides/factsheets/index.htm)

    In addition to the information on EPA’s website, EPA provides printed information
     on a variety of pesticide issue and topics to the public. These printed documents
     and other information are available through the National Service Center for
     Environmental Publications.
     (See http://www.epa.gov/oppfead1/Publications/catalog/subpage3.htm)



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     Also, the National Agriculture Compliance Assistance Center provides information
      on how to comply with U.S. pesticides laws. (See http://www.epa.gov/agriculture/)

National Pesticide Information Center
The National Pesticide Information Center provides objective, science-based information
about pesticides and pesticide-related topics to enable people to make informed decisions
about pesticides and their use. (See http://npic.orst.edu/)

Federal law requires pesticide product registrants to submit adverse effects information
about their products to the EPA. A description of this requirement is at
http://www.epa.gov/pesticides/fifra6a2/.

Restricted Use Products Report
EPA issues the Restricted Use Products Report, a compilation of both active and
cancelled pesticide products classified as "Restricted Use". The "Restricted Use"
classification restricts a product, or its uses, to use by a certificated pesticide applicator or
under the direct supervision of a certified applicator because EPA has determined the
pesticide product may pose high risks to users and/or the environment unless special
restrictions are followed during handling and use.
(See http://www.epa.gov/opprd001/rup/)


Tools and Methods for Analyzing Chemical Properties

Predicting Hazard, Characterizing Toxicity Pathways, and Prioritizing the Toxicity
Testing of Environmental Chemicals
In 2007, EPA launched ToxCast™ in order to develop a cost-effective approach for
prioritizing the toxicity testing of large numbers of chemicals in a short period of time.
Using data from state-of-the-art high throughput screening (HTS) bioassays developed in
the pharmaceutical industry, ToxCast™ is building computational models to forecast the
potential human toxicity of chemicals. These hazard predictions will provide EPA
regulatory programs with science-based information helpful in prioritizing chemicals for
more detailed toxicological evaluations, and lead to more efficient use of animal testing.

In its first phase, ToxCast™ is profiling over 300 well-characterized chemicals (primarily
pesticides) in over 400 HTS endpoints. These endpoints include biochemical assays of
protein function, cell-based transcriptional reporter assays, multi-cell interaction assays,
transcriptomics on primary cell cultures, and developmental assays in zebrafish embryos.
Almost all of the compounds being examined in Phase 1 of ToxCast™ have been tested
in traditional toxicology tests, including developmental toxicity, multi-generation studies,
and sub-chronic and chronic rodent bioassays. ToxRefDB, a relational database being
created to house this information, will contain nearly $1B worth of toxicity studies in
animals when completed. ToxRefDB is integrated into a more comprehensive data
management system developed by NCCT called ACToR (Aggregated Computational
Toxicology Resource), that manages the large-scale datasets of ToxCast™. ACToR is
comprised of several independent data repositories linked to a common database of



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chemical structures and properties, and to tools for development of predictive HTS and
genomic bioactivity signatures that strongly correlate with specific toxicity endpoints
from ToxRefDB. These ToxCast™ signatures will be defined and evaluated by their
ability to predict outcomes from existing mammalian toxicity testing, and identify
toxicity pathways that are relevant to human health effects.

The second phase of ToxCast™ will screen additional compounds representing broader
chemical structure and use classes, in order to evaluate the predictive bioactivity
signatures developed in Phase I. Following successful conclusion of Phases I and II,
ToxCast™ will provide EPA regulatory programs an efficient tool for rapidly and
efficiently screening compounds and prioritizing further toxicity testing.
See (http://www.epa.gov/NCCT/toxcast/chemicals.html)

Structure Activity Relationships, or SAR, is a technique routinely used by EPA to
estimate physical, chemical and toxilogical properties of chemicals being reviewed by the
EPA in response to Pre-Manufacture Notices mandated by Section 5 of the Toxic
Substances Control Act (TSCA) SAR analysis defines the relationship between the
structure of a molecule and its ability to affect a biological system.

The EPI (Estimation Program Interface) SuiteTM is a Windows® based suite of
physical/chemical property and environmental fate estimation models developed by the
EPA and Syracuse Research Corporation (SRC).
(See http://www.epa.gov/oppt/exposure/pubs/episuite.htm)

ECOSAR (Ecological Structure Activity Relationships) is a personal computer software
program that is used to estimate the toxicity of chemicals used in industry and discharged
into water. The program predicts the toxicity of industrial chemicals to aquatic organisms
such as fish, invertebrates, and algae by using Structure Activity Relationships (SARs).
The program estimates a chemical's acute (short-term) toxicity and, when available,
chronic (long-term or delayed) toxicity.
(See http://www.epa.gov/oppt/newchems/tools/21ecosar.htm)

EPA continually strives to provide the American public with improved analytical tools
and access to environmental information, so that the public is empowered to make better
decisions about protecting human health and the environment. To this end, and to
improve the usefulness of TRI data and information, the TRI Program is currently
exploring the usefulness of EPA-developed tools that can estimate human exposure to
industrial emissions of toxic chemicals, and the corresponding risks to human health.
While EPA tools, such as TRI Explorer, Envirofacts, and soon to be available TRI.NET
can be used to obtain TRI data and information, the TRI Program would like to direct
TRI users to tools that will assist them in exploring the human health risk associated with
TRI emissions.

At least eleven EPA models are currently available to the public that have the capability
to use emission data (e.g., TRI release data), either directly or indirectly, to estimate
human exposure and/or risk to toxic chemicals. These models are: AERMOD; ASPEN;



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Model-3/CMAQ; E-FAST V2.0; APEX; HAPEM6; SHEDS-AT; BMDS; TRIM.Risk;
HEM-3; and the TRIM.Fate model. These models vary greatly in their levels of
complexity; their ability to factor: environmental fate and transport of a toxic chemical
following its release; who may come in contact with the toxic chemical, and at what
concentration, and for how long (exposure); and the likelihood that such exposure will
case an adverse effect in exposed individuals (risk). The TRI Program is currently
evaluating the utility of these models to use TRI data to estimate human risks from
emissions of TRI chemicals. The TRI Program plans to make its findings available to the
public once this undertaking is completed.


Risk Assessment Tools

Risk Assessments and Integrated Risk Information System
Through the performance of risk assessments, researchers seek to understand the
fundamental processes that underlie human health problems that are caused by pollutants
in the environment. Risk assessments address questions of exposure and the adverse
outcomes associated with exposure. IRIS (Integrated Risk Information System) is a
resource that can assist with human health risk assessments. IRIS is a compilation of
electronic reports on specific substances found in the environment and their potential to
cause human health effects. IRIS was initially developed for EPA staff in response to a
growing demand for consistent information on substances for use in risk assessments,
decision-making and regulatory activities. The information in IRIS is intended for those
without extensive training in toxicology, but with some knowledge of health sciences.
(See http://cfpub.epa.gov/ncea/iris/index.cfm)

Please see the EPA Risk Assessment Portal at http://www.epa.gov/risk/ for additional
information on risk, risk assessment, and risk assessment tools.

Screening Level Risk Assessment Tools
Screening Level Tools are developed to be easy to use, fast and conservative. These tools
are often used in the absence of appropriate monitoring data or to compliment exposure
related data. They are designed to quickly "bin" chemicals by priority for future work and
are commonly used in screening level risk assessments. Screening Level Tools include
Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER),
Exposure, and Fate Assessment Screening Tool (E-FAST). These tools have the
following characteristics:

Require Minimal Data Entry: A challenging aspect of exposure assessment is finding
exposure factor values that are truly representative of the exposure a user is evaluating.
Using readily available data and standard (i.e., default) exposure factors can be a helpful
time saver and enable consistent comparisons of exposures. All of the Screening Level
Tools include default values which can be changed by the user. The standard default
values were carefully selected, often from Agency guidance documents, and their impact
on the results has been characterized and described in the model or accompanying
documentation. If the default values are used, the descriptive language should be included



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in the results. If other values are used, they should be carefully selected, and their impact
evaluated and described in the results.

Quickly Screen Exposure Concerns: Because these models have minimal data entry and
are pre-loaded with many default values, these tools can be quickly applied to exposure
assessment scenarios.

Create Conservative Estimates of Exposure: These tools were designed for exposure
screening activities and therefore err on the side of safety (i.e., they estimate high or
perhaps higher than actual values of exposure). These artificially high estimates mean
that some substances will have exposure concerns where there actually are none;
however, this bias provides a level of confidence that substances with exposure estimates
indicating no concern are in fact not a concern.

Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER)

What Does ChemSTEER Do?
    Estimates occupational inhalation and dermal exposure to a chemical during
     industrial and commercial manufacturing, processing, and use operations involving
     the chemical.
    Estimates releases of a chemical to air, water, and land that are associated with
     industrial and commercial manufacturing, processing, and use of the chemical.

How Does ChemSTEER Work?
ChemSTEER allows users to select predefined industry-specific or chemical functional
use-specific profiles or user-defined manufacturing, processing and use operations. Using
these operations and several chemical-specific and case-specific parameters and general
models, the ChemSTEER computer program estimates releases and occupational
exposures. (See http://www.epa.gov/opptintr/exposure/pubs/chemsteer.htm)

Exposure, Fate Assessment Screening Tool (E-FAST)

What Does E-FAST Do?
E-FAST provides screening level estimates of the concentrations of chemicals released to
air, surface water, landfills, and from consumer products.

How Can E-FAST Be Used?
When new chemicals are developed, or new uses are found for existing chemicals,
companies in the U.S. are required to gain approval from the U.S. EPA. E FAST Version
2 is being designed to help EPA reviewers assess the safety of chemicals by providing
estimates of exposure through inhalation, dermal contact and ingestion. Modeled
estimates of concentrations and doses are designed to reasonably overestimate exposures,
for use in screening level assessments.




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How Does E-FAST Work?
E FAST calculates appropriate human potential dose rates for a wide variety of chemical
exposure routes and estimates the number of days per year that an aquatic
ecotoxicological concern concentration will be exceeded for organisms in the water
column. (See http://www.epa.gov/oppt/exposure/pubs/efast.htm)

Pesticide Inert Risk Assessment Tool (PIRAT)

What Does PIRAT Do?
Provides screening level estimates of exposure and risk to pesticide inert ingredients that
are used in a residential setting. This includes assessing both indoor and outdoor
residential uses of pesticide products. PIRAT will assess acute and chronic risks and will
be able to assess adults and children separately.
How Does PIRAT Work?
PIRAT calculates human dose rate and Margin of Exposure (MOE) for a wide variety of
chemical exposure routes. The model is organized by the type of pesticide product, for
example liquid ready-to-use or granular products, as well as by application technique,
such as spray can or drop-type spreader.

How Are PIRAT Data Used?
The PIRAT output is a summary table which highlights the dose and MOE for residential
exposures estimated for each model run. Risk assessors can then use the MOEs estimated
by PIRAT in evaluating any possible health concerns for the inert ingredient in question.
(See http://www.epa.gov/oppt/exposure/pubs/pirat.htm)

High Tiered Risk Assessment Tools
Higher Tier Tools are designed to be tailored to (e.g., simulate) the specific exposures
and the specific environment in which exposures occur. These tools are commonly used
in detailed risk assessments. When used appropriately, these models can provide
comprehensive exposure estimates with a greater level of accuracy. Higher tier tools have
the following characteristics:

Provide Detailed Exposure Assessment: These tools are designed for tailored exposure
assessment estimations. These tools are complex and are designed for use by individuals
with a science, chemistry, engineering or related background.

Require Detailed Data Sources: These models require detailed data to be entered into the
programs. This often allows for more realistic exposure scenario development, however
this also requires more user effort and data collection. In many cases, data sources
accompany the tools for ease of use.

Be Used by Knowledgeable Scientists: These tools are designed for individuals with
solid technical knowledge and an understanding of exposure assessment concepts. The
advantage of these products is that experienced exposure assessors can use them to
develop the detailed and specific exposure assessment estimates.




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Multi-Chamber Concentration and Exposure Model, (MCCEM) version 1.2

What Does MCCEM Do?
    Estimates average and peak indoor air concentrations of chemicals released from
     products or materials in houses, apartments, townhouses, or other residences. The
     data libraries contained in MCCEM are limited to residential settings. However, the
     model can be used to assess other indoor environments (e.g. schools, offices) if the
     user can supply the necessary inputs.
    Estimates inhalation exposures to these chemicals, calculated as single day doses,
     chronic average daily doses, or lifetime average daily doses. (All dose estimates are
     potential doses; they do not account for actual absorption into the body.)

How Does MCCEM Work?
    MCCEM is a user-friendly software product that estimates indoor air concentrations
     using a mass balance approach.
    Maintains a library of residences, containing data on zone or area volumes,
     interzonal air flows, and whole-house exchange rates.
    Allows you to tailor your analysis to a particular location, and to model air
     concentrations in as many as four zones for a given residence.
    Estimates exposure for periods ranging from 1 hour to 1 year. Develops seasonal or
     annual exposure profiles using a long-term model.
    Offers several different options for dealing with 'sinks'. A sink is a material (e.g.,
     carpeting, wallboard) that can absorb chemicals from the air; the absorption can be
     either reversible or irreversible.
(See http://epa.gov/opptintr/exposure/pubs/mccem.htm)

Wall Paint Exposure Assessment Model (WPEM)

What Does WPEM do?
    The Wall Paints Exposure Assessment Model (WPEM) estimates the potential
     exposure of consumers and workers to the chemicals emitted from wall paint which
     is applied using a roller or a brush.

How Does WPEM Work?
    WPEM is a user-friendly, flexible software product that uses mathematical models
     developed from small chamber data to estimate the emissions of chemicals from
     oil-based (alkyd) and latex wall paint. This is then combined with detailed use,
     workload and occupancy data (e.g., amount of time spent in the painted room, etc,)
     to estimate exposure.
    The output of WPEM was evaluated in a home used by EPA for testing purposes
     and, in general, the results were within a factor of 2. The WPEM provides exposure
     estimates such as Lifetime and Average Daily Doses, Lifetime and Average Daily
     Concentrations, and peak concentrations.
(See http://www.epa.gov/opptintr/exposure/pubs/wpem.htm)



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Swimmer Exposure Assessment Model (SWIMODEL)
A Swimmer Exposure Assessment Model (SWIMODEL) has been developed for
estimating the human exposure doses to the pesticides and toxic pollutants in swimming
pools. This model is a modification of a study used by J. A. Beech (1980) for estimating
exposure to Trihalomethanes (THM) in swimming pools. Based on the exposure routes
and age-specific contact factors, exposure duration and frequency, chemical/physical
properties of the pollutant, and pollutant concentration, total exposure doses can be
approximated by the model. Using exposure scenarios for competitive and
noncompetitive (recreational-type) swimmers and toxicity data for the pollutant of
interest, the risks of exposure can also be demonstrated for these two populations.
(See http://www.epa.gov/oppad001/swimodel.htm)

Exposure Databases and Models
Exposure databases define the intensity, frequency, and duration of a chemical's exposure
to a biological system within a given context, defined by the use or release of the
chemical and the activity patterns of those (human or ecological systems) exposed. For
human screening level risk assessments, exposure databases may relate to particular
contexts, such as occupational exposure to industrial chemicals and industrial and
institutional products, and general public exposure to consumer products. Exposure
databases provide data regarding chemical use, physiological or ecological data and
descriptors typically required in exposure modeling (Pittinger 2003).

Residential Exposure Standard Operating Procedures
The Residential Exposure Standard Operating Procedures (SOPs) are designed for those
who assess exposures to pesticides in a residential setting. The objective of these SOPs is
to provide standard default methods for developing residential exposure assessments for
both handler and post application exposures when chemical - and/or site-specific field
data are limited. (See http://www.epa.gov/oppfead1/trac/science/)

EPA is strongly committed to transparency in making its pesticide regulatory decisions.
One way the Agency is ensuring transparency is making its science policies and
procedures available to the public, including more than 25 aquatic, terrestrial,
atmospheric and health effects models. Databases are also available on environmental
effects, environmental fate, water, health effects, and regulatory information.
(See http://www.epa.gov/pesticides/science/models_db.htm)

In evaluating a pesticide registration application, EPA assesses a wide variety of potential
human health and environmental effects associated with use of the product. Potential
registrants must generate scientific data necessary to address characteristics pertaining to
the identity, composition, potential adverse effects, and environmental fate of each
pesticide.




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Screening, Testing, and Prioritization Programs and Tools

Pesticide-Related Harmonized Test Guidelines
EPA recommends the pesticide registrant provide data from tests conducted according to
EPA’s Harmonized Test Guidelines. The purpose for harmonizing these guidelines into a
single set of guidelines is to minimize variations among the testing procedures that must
be performed to meet the data requirements under U.S. Federal laws. Information about
the specific scientific studies required for pesticide registration may be found on EPA’s
website. (See http://www.epa.gov/pesticides/science/guidelines.htm)

EPA publishes many pesticide analytical methods and procedures, including residue
analytical methods for food, feed, and animal commodities.
(See http://www.epa.gov/oppbead1/methods/ramindex.htm)

SOPs for Antimicrobial Testing Methods
EPA publishes Standard Operating Procedures for antimicrobial testing methods describe
the methods to determine the efficacy of hard surface disinfectants against
Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella choleraesuis, and
Mycobacterium bovis BCG. http://www.epa.gov/oppbead1/methods/atmpa2z.htm
EPA also publishes environmental chemistry methods for soil and water are used to
determine the fate of pesticides in the environment.
(See http://www.epa.gov/oppbead1/methods/ecmindex.htm)

Endocrine Disruptor Screening Program
EPA is developing requirements for the screening and testing of pesticides, commercial
chemicals, and environmental contaminants for their potential to disrupt the endocrine
system. Although EPA has some data on endocrine-disrupting pesticides, insufficient
scientific data are available for most of the chemicals produced today to allow for an
evaluation of endocrine associated risks. The science related to measuring and
demonstrating endocrine disruption is relatively new and validated testing methods are
still being developed. International coordination for endocrine disruptor screening is also
already being coordinated with the OECD.

EPA is following the interagency validation framework in the development and
refinement of assays to reduce animal use, refine procedures involving animals to make
them less stressful, and replace animals where scientifically appropriate. When complete,
EPA will use these validated methods or assays to identify and characterize the endocrine
activity of pesticides, commercial chemicals, and environmental contaminants,
specifically in relation to estrogen, androgen, and thyroid hormones. In addition, EPA is
working with the Organization for Economic Cooperation and Development's Endocrine
Testing and Assessment Task Force to validate and harmonize endocrine screening tests
of international interest.
(See http://www.epa.gov/endo/pubs/edspoverview/background.htm)

Priority-Setting Scoring Tools




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These tools are designed to quickly prioritize concerns and are especially useful when
trying to evaluate large numbers of chemicals or chemical products. However, the level
of detail and accuracy of exposure/relative risk estimations must be considered when
using tools developed for priority setting purposes. The PBT Profiler and the Use Cluster
Scoring System are examples of a Priority Setting Scoring Tools. These tools have the
following characteristics:

Broadly Rank/Score Concerns: Priority Setting Scoring Tools are effective in comparing
multiple chemicals on the basis of standardized criteria. These chemicals can be
evaluated in a variety of different ways for different concerns.

Evaluate Large Numbers of Chemicals: Priority Setting Scoring Tools enable one to rank
and compare a large number of chemicals or products. For example, the PBT Profiler is
linked to a database containing the CAS RNs and the associated chemical structures for
over 100,000 discrete chemical substances.

PBT Profiler
The PBT Profiler is an online risk-screening tool that predicts a chemical's potential to
persist in the environment, bio-concentrate in animals, and be toxic, properties which
cause concern for human health and the environment. PBT stands for Persistence,
Bioaccumulation and Toxicity. Basing its assessment on a chemical's structure, the PBT
Profiler determines if a chemical is expected to exceed the PBT criteria under EPA's New
Chemicals Program and/or Toxic Release Inventory. The PBT Profiler can also tell the
user if the chemical belongs to a category that is known to present human health concerns
as described in EPA's Chemicals Category Report, found at
http://www.epa.gov/oppt/newchems/pubs/chemcat.htm.

The PBT Profiler was developed by EPA through a collaborative effort with the chemical
industry and Environmental Defense. It was developed to be a voluntary screening tool to
identify pollution prevention opportunities for chemicals without experimental data.
(See http://www.epa.gov/oppt/sf/tools/pbtprofiler.htm)

Use Clusters Scoring System (UCSS)

What Does UCSS Do?
    Identifies and screens clusters of chemicals ("use clusters") that are used to perform
     a particular task. A use cluster is a set of chemicals that may be substituted for one
     another in performing a given task.
    Identifies clusters of potential concern and provides an initial ranking of chemicals
     using human and environmental hazard and exposure data from a number of
     sources.

How does UCSS work?
   For each chemical in a cluster, allows user to enter data indicating the potential for
    human and ecological exposure and hazard, and the level of U.S. Environmental
    Protection Agency (EPA) interest.


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    Calculates health and ecological risk or toxicity rating scores for each chemical
     within a cluster using the information entered and preprogrammed scoring
     algorithms.
    Uses individual chemical scores to calculate an overall cluster score, which is an
     indicator of potential risk for the use cluster.
    Contains data on nearly 400 use clusters and 4,700 chemicals.
(See http://www.epa.gov/opptintr/exposure/pubs/ucss.htm)


International Knowledge and Information Programs

OECD High Production Volume (HPV) Chemicals Program
The Organization for Economic Cooperation and Development (OECD) High Production
Volume (HPV) Chemicals Program is an international voluntary program in which EPA
is an active participant. Within the program, each participating country’s government
works with industry to obtain screening-level toxicity data and other basic information on
HPV chemicals. Each country prepares assessments of these data for presentation at
biannual meetings. In addition to presenting chemical assessments, each meeting
provides a forum for technical discussions.

Under the OECD HPV Chemicals Program, EPA is sponsoring a growing number of
HPV chemicals. While the United States has committed to be responsible for 25 percent
of the chemicals in this program, in practice it has currently handled 45 percent and has
committed to review approximately 500 chemicals between 2005 and 2010. (See
http://www.oecd.org/document/21/0,2340,en_2649_34379_1939669_1_1_1_1,00.html)

OECD eChemPortal
In addition, the U.S. helped support the development and launch of the first phase of the
OECD eChemPortal and continues to participate in the development of the second phase
of the Portal. The eChemPortal provides public access to information on properties and
effects of chemicals prepared by international, national and regional chemical review
programs. The eChemPortal currently provides searching by chemical substances and, in
phase two, will provide searching by chemical properties. It allows the public to
simultaneously search participating databases, obtain direct links to relevant datasets and
assessment reports, and read descriptions of scientific reviews the data have undergone.
The eChemPortal provides access to databases such as the US HPV Info. System
(HPVIS), European Chemical Substances Info. System (ESIS which also includes
EINECS, ELINCS, IUCLID, etc. REACH-IT will subsequently be added into the Portal),
Japan’s Chemical Risk Info. Platform (ChRIP), INCHEM, and databases from Finland,
Australia and New Zealand. (See www.oecd.org/ehs/echemportal/)

OECD New Chemicals Clearing House
EPA continues to participate in the work of the OECD New Chemicals Clearing House.
This work includes further development of a database to generate a consolidated new
chemicals notification form that integrates the reporting elements from all OECD
countries. It also includes further work to develop a ―parallel‖ review process with other


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OECD countries, development of OECD new chemicals working definitions, exemptions
and reduced notification approaches.
(See http://www.oecd.org/department/0,3355,en_2649_34799_1_1_1_1_1,00.html)

OECD Test Guidelines Program
EPA scientists participate in the OECD Test Guidelines Program to develop protocols for
studies to assess physicochemical properties, environmental fate, ecotoxicity, and health
effects endpoints. The OECD is an international organization consisting of 30
industrialized countries in Europe, North America, Asia, and the Pacific. A foundation of
the OECD chemicals program is the Mutual Acceptance of Data (MAD) agreement
among OECD countries to accept for review studies generated in accordance with OECD
Test Guidelines and Principles of Good Laboratory Practice regardless of where the study
is performed in or among OECD countries.
(See http://www.oecd.org/department/0,3355,en_2649_34377_1_1_1_1_1,00.html)

OECD Working Party on Manufactured Nanomaterials (WPMN)
EPA also actively participates in the Working Party on Manufactured Nanomaterials
(WPMN), established by OECD, that is engaged in a variety of projects to further our
understanding of the properties and potential risks of nanomaterials:

    Development of a Database on Environmental Health and Safety (EHS) Research
    EHS Research Strategies on Manufactured Nanomaterials
    Safety Testing of a Representative Set of Manufactured Nanomaterials
    Manufactured Nanomaterials and Test Guidelines
    Cooperation on Voluntary Schemes and Regulatory Programs
    Cooperation on Risk Assessments
    The Role of Alternative Methods in Nano Toxicology
    Exposure Measurement and Exposure Mitigation

Of particular relevance to the in-depth portion of the Agency's Nanoscale Materials
Stewardship Program (NMSP) is the project on Safety Testing of a Representative Set of
Manufactured Nanomaterials. The WPMN has identified a representative list of
manufactured nanoscale materials for environmental health and safety testing, and has
also published a list of testing endpoints.

In addition, the WPMN has launched a Sponsorship Program for Testing Manufactured
Nanomaterials. The OECD Secretariat has asked delegations about their willingness to
sponsor, or co-sponsor, one or more nanomaterials and endpoints. The OECD will act as
a clearinghouse for the sponsorship program and will prepare a guidance manual for
sponsors. EPA is sponsoring environmental effects and fate testing of fullerenes, single
walled carbon nanotubes, multiwalled carbon nanotubes, and cerium oxide.
(See http://www.oecd.org/department/0,2688,en_2649_37015404_1_1_1_1_1,00.html)

Chemical Information Exchange Network (CIEN)
EPA worked with UNEP to develop the Chemical Information Exchange Network
(CIEN) program, which improves access to chemicals management information by


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developing an in-country network of government officials and stakeholders, providing
Internet connectivity where needed, and providing training on accessing chemicals
management information and developing country-specific web resources. (Note: EPA
supported past CIEN efforts and continues to support the concept with activities,
exchanges and broader chemicals management initiatives though it does not provide
funding at present.) (See http://jp1.estis.net/communities/cien/)

EPA has worked with a number of non-governmental and international organizations to
develop public information tools on specific topics. Examples include web pages for the
World Bank’s Communities and Small Scale Mining site which provide guidance on
reducing mercury risks from artisanal gold mining (see www.artisanalmining.org) and
support for development of a television program run on Chinese tv on mercury.

EPA’s own website provides a wealth of information on chemicals management. For
example, the mercury portal includes information for reducing exposure and risks for a
wide range of mercury uses and releases and for a wide range of population groups.
www.epa.gov/mercury.




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C. GOVERNANCE



                                OVERARCHING POLICY STRATEGY
GOVERNANCE is an important issue that needs to be addressed through a multi-sector and multi
stakeholder approach in pursuing the sound management of chemicals. There is therefore a need
to recognize: a.) That in many countries some stakeholders, particularly women and indigenous
communities, still do not participate in all aspects of decision-making related to the sound
management of chemicals, a situation which needs to be addressed; b.) That implementation of
the present international regime for the sound management of chemicals, including binding
instruments and other relevant initiatives, is uneven, a situation which needs to be addressed.
There are gaps, overlaps and duplication in chemicals management activities and there is a need
in many countries for enhanced coherence, consistency and cooperation to ensure efficient and
effective use of available resources at the national, regional, and international levels. Many
countries have not ratified or implemented regional and global legally binding instruments and
other relevant initiatives, addressed gaps in national chemicals regimes or developed national
mechanisms for coordinating chemicals activities; c.) That the mechanisms used to address the
social and economic impacts of chemicals on human health, society and the environment,
including liability, compensation and redress, need to be improved in some countries; d.) That
chemicals issues are only sometimes featured in relevant national policy documents, including
development assistance plans or strategies, sustainable development strategies and, as
appropriate, poverty reduction strategies; e.) That there is a need to promote the role of all sectors
of civil society and the private sector in the implementation of the Strategic Approach.


Selection of Relevant United States Laws

Toxic Substances Control Act (TSCA)
The goal of the Toxic Substances Control Act is to ensure that chemicals sold and used in
the United States do not pose an unreasonable risk to human health and the
environment. The law covers production and distribution of commercial and industrial
chemicals. Under TSCA, EPA has established reporting, record-keeping, testing, and
control-related requirements for new and existing chemicals.
(See http://www.epa.gov/oppt/pubs/laws.htm)

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
The Federal Insecticide, Fungicide, and Rodenticide Act provides the basis for regulation,
sale, distribution and use of pesticides in the U.S. FIFRA authorizes EPA to review and
register pesticides for specified uses. EPA also has the authority to suspend or cancel the
registration of a pesticide if subsequent information shows that continued use would pose
unreasonable risks. (See http://www.epa.gov/pesticides/regulating/laws.htm)

Federal Food, Drug, and Cosmetic Act (FFDCA)
The Federal Food, Drug, and Cosmetic Act authorizes EPA to set maximum residue
levels, or tolerances, for pesticides used in or on foods or animal feed.
(See http://www.epa.gov/pesticides/regulating/laws.htm)


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Food Quality Protection Act of 1996 (FQPA)
The Food Quality Protection Act of 1996 amended FIFRA and FFDCA setting tougher
safety standards for new and old pesticides and to make uniform requirements regarding
processed and unprocessed foods.
(See http://www.epa.gov/pesticides/regulating/laws.htm)

Resource Conservation and Recovery Act
The Resource Conservation and Recovery Act (RCRA) gives EPA the authority to
control hazardous waste from the "cradle-to-grave." This includes the generation,
transportation, treatment, storage, and disposal of hazardous waste. RCRA also set forth a
framework for the management of non-hazardous solid wastes. The 1986 amendments to
RCRA enabled EPA to address environmental problems that could result from
underground tanks storing petroleum and other hazardous substances.

Comprehensive Environmental Response, Compensation, and Liability Act
The Comprehensive Environmental Response, Compensation, and Liability Act --
otherwise known as CERCLA or Superfund -- provides a Federal "Superfund" to clean
up uncontrolled or abandoned hazardous-waste sites as well as accidents, spills, and other
emergency releases of pollutants and contaminants into the environment. Through
CERCLA, EPA was given power to seek out those parties responsible for any release and
assure their cooperation in the cleanup.

Emergency Planning & Community Right-to-Know Act
Also known as Title III of the Superfund Amendments and Reauthorization Act (SARA),
the Emergency Planning & Community Right-to-Know Act -- otherwise known as
EPCRA -- was enacted by Congress as the national legislation on community safety. This
law is designed to help local communities protect public health, safety, and the
environment from chemical hazards.

Pollution Prevention Act (PPA)
With enactment in 1990 of the Pollution Prevention Act, the office's responsibilities
expanded. This law established pollution prevention as the national policy for controlling
industrial pollution at its source -- in other words, to keep pollutants from getting to the
environment. EPA works to reduce pollution before it occurs by supporting innovative
changes in the production and use of raw materials.
(See http://www.epa.gov/oppt/pubs/laws.htm)

National Environmental Policy Act
The National Environmental Policy Act -- otherwise known as NEPA -- was one of the
first laws ever written that establishes the broad national framework for protecting our
environment. NEPA's basic policy is to assure that all branches of government give
proper consideration to the environment prior to undertaking any major federal action
that significantly affects the environment.




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Improving Environmental Governance Through Training and Capacity Building

EPA works with a number of countries to improve environmental governance through
training and capacity building. In the context of bilateral programs, EPA conducts
training on enforcement and compliance, development of environmental laws,
environmental inspections, and environmental impact assessment. In addition, EPA has
provided tailored expertise to various countries on structuring environmental agencies
and strengthening public participation in environmental decision-making. In addition,
EPA is active in INECE, the International Network for Environmental Compliance and
Enforcement.

EPA works bilaterally and regionally to improve countries’ abilities to control toxic
releases through both voluntary and regulatory programs. For example, EPA has MOUs
with both China and India which include toxics annexes that describe the bilateral efforts.
In addition, under the Arctic Council Action Program (ACAP), EPA/OIA works with the
Russian Federation to develop the first Integrated Hazardous Waste Management
Strategy to address safe management of toxic and hazardous wastes containing POPs and
heavy metals. (Seehttp://acap.arctic-council.org/)

EPA also works with bilateral trading partners to promote implementation of
environment chapters of Free Trade Agreements as well as framework consultative
mechanisms for environmental cooperation and capacity building. Complementary
Environmental Cooperation Agreements are negotiated for all bilateral and regional trade
agreements. Work under these agreements has included work on PRTRs and other
chemicals issues. For example, the U.S. – Chile Environmental Cooperation Agreement
has done work to improve environmental management of mining operations there. See
also CAFTA-DR, below.

The Middle East Partnership Initiative, since 2004, has provided regional and country-
specific workshops on various aspects of governance as well as on industrial sector
environmental improvement. For example, hazardous and solid waste capacity building
in Morocco has resulted in new regulations for waste management, while enforcement
and compliance training in Jordan has resulted in a skilled compliance corps called the
Environmental Rangers. As part of such capacity building, a focus on specific toxics
could be incorporated.

Pollutant Release and Transfer Registries
EPA’s pollutant release and transfer registry, or PRTR (i.e. TRI) is the oldest and most
comprehensive PRTR system in the world. Environmental authorities in other countries
throughout the world are gradually but increasingly implementing their own PRTR
programs, using the EPA’s PRTR as the benchmark prototype model upon which their
respective PRTRs are based. As of 2008, there are over twenty PRTRs in the world, and
at least five additional PRTRs are currently being planned. In the coming years many
more PRTRs will undoubtedly be implemented.




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EPA’s TRI Program works closely with international organizations and participates in
international activities to assist in the development of PRTR programs in other countries.
These international organizations and activities are listed below.

OECD and PRTRs
The OECD began work to encourage development of PRTRs in 1993, as a follow-up to a
United Nations Conference on Environment and Development. OECD works with
governments, industry, and non-governmental organizations to develop practical tools
that facilitate efforts by member countries, provide outreach to non-member countries,
and coordinate international activities.

To help member countries implement efficient and effective PRTR systems, OECD
produces documents describing the experiences of countries that have developed PRTRs;
current and emerging uses of PRTR data; how PRTRs differ; and the identification,
selection, and adaptation of release estimation techniques that industry can use to
calculate pollutant releases and transfers.

The OECD coordinates PRTR activities between the industrialized nations of Europe,
North America and Asia-Pacific through its PRTR Task Force. The goal of the Task
Force is to enable the OECD member countries to provide and improve information
about implementation of PRTRs.

    As of 2008, nearly 20 OECD countries have an operational PRTR.
    In the next few years, almost 50 countries will have implemented PRTRs.

For more details on OECD PRTR efforts, please see the following internet sites:
http://www.oecd.org/env/prtr
http://www.prtr.net/prtr/index_e.cfm
http://www.prtr.net

North American Commission for Environmental Cooperation (CEC) and PRTRs
The North American Commission for Environmental Cooperation (CEC) was established
under the North American Agreement on Environmental Cooperation (NAAEC), to
address regional environmental concerns, help prevent potential trade and environmental
conflicts, and to promote the effective enforcement of environmental law. The
Agreement compliments the environmental provisions of the North American Free Trade
Agreement (NAFTA).

Three countries and their respective PRTRs are affiliated with the CEC. These countries
are: the United States, Canada, and Mexico. Canada’s PRTR program is the National
Pollutant Release Inventory (NPRI) and is maintained by Environment Canada. Mexico’s
PRTR program is the Registro de Emisiones y Transferencia de Contaminantes (RETC)
and is maintained by Mexico’s Ministry of Environment and Natural Resources (La
Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT)).

The CEC annually publishes its Taking Stock: North American Pollutant Releases and


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Transfers report, which is a consolidation of certain PRTR data from the Canadian
National Pollutant Release Inventory, the U.S. Toxics Release Inventory, and Mexico’s
Registro de Emisiones y Transferencia de Contaminantes. Only those data common to all
three PRTR systems are used. (There are only about nine industrial sectors and 60
chemicals that are commonly reported to each of these PRTRs.)

For more details on CEC PRTR efforts, please see the following internet sites:
http://www.cec.org/naatlas/prtr/
http://cec.org/programs_projects/pollutants_health/prtr

United Nations Environment Program (UNEP) and PRTRs
UNEP’s International Register of Potentially Toxic Chemicals (IRPTC) is the
international clearinghouse for PRTRs and leads the effort to exchange PRTR-related
information through its internet site. IRPTC is also helping to develop guidance for
emissions estimation and to foster compatibility of PRTR information systems.

For more details on UNEP and its PRTR efforts, please see the following internet sites:
http://www.unep.org
http://www.chem.unep.ch/prtr/

UNITAR and PRTRs
Under a cooperative agreement established under the Dominican Republic - Central
American – United States Free Trade Agreement (CAFTA-DR), development of PRTRs
in Central America and the Dominican Republic were identified as primary goals.
UNITAR, through funding from EPA and in coordination with the Comision
Centroamericana de Ambiente y Desarrollo (CCAD), is working to facilitate
development of PRTRs in two countries in Central America. EPA’s TRI Program is
providing technical guidance to this undertaking.

Another PRTR effort of UNITAR was to assist in the development of a PRTR in Chile.
This work was done under a cooperative project established by the United States-Chile
Free Trade Agreement. The U.S. EPA and Canada’s Environment Canada provided
UNITAR with financial support as well as technical guidance for this project.

For more details on UNITAR and its PRTR efforts, please see the following internet
sites:
http://www.unitar.org
http://www.unitar.org/cwm/prtr/




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D. CAPACITY-BUILDING AND TECHNICAL COOPERATION


                              OVERARCHING POLICY STRATEGY
CAPACITY-BUILDING AND TECHNICAL ASSISTANCE in relation to all aspects of the sound
management of chemicals are among the essential elements for the successful implementation of
the Strategic Approach: a.) The widening gap in capacity between developed countries on the one
hand and developing countries and countries with economies in transition on the other should be
bridged in order to make progress towards the goal articulated in paragraph 23 of the
Johannesburg Plan of Implementation. Some developed countries, however, also face capacity
issues in striving to meet this goal; b.) There is a need for enhanced cooperation aimed at
strengthening the capacities of developing countries and countries with economies in transition
for the sound management of chemicals and hazardous wastes and promoting adequate transfer of
cleaner and safer technology to those countries.



Western Hemisphere Capacity-Building and Technical Cooperation

Commitments to Ensure Safe Manufacture and Use of Industrial Chemicals
The Security and Prosperity Partnership of North America Leaders’ Summit, held in
Montebello, Canada, in August 2007, called for cooperation on chemicals and outlined
commitments on behalf of the United States, Canada, and Mexico to work together to
ensure the safe manufacture and use of industrial chemicals. Each country is sharing
scientific information and approaches to chemical testing and risk management.
To fulfill its part of the SPP commitment, the United States will, by 2012, complete
screening-level hazard and risk characterizations and initiate action, as appropriate, on
more than 6,750 chemicals produced above 25,000 pounds per year. The U.S.
commitment to complete assessments and initiate needed action on these chemicals will
apply the results of EPA’s work on high production volume (HPV) chemicals - those
chemicals produced or imported in the United States in quantities of 1 million pounds or
more per year - and extend its efforts to moderate production volume (MPV) chemicals -
those produced or imported in quantities above 25,000 and less than 1 million pounds per
year.

Regional Implementation of SAICM in North America
At the regional level, the U.S. developed a strategy with Canada and Mexico for regional
implementation of SAICM in North America. The Council of Ministers of the North
American Commission for Environmental Cooperation in June 2008 approved a renewed
North American agenda for chemicals management, involving the following:

1.   Establish a foundation for chemicals management in North America; to increase
     comparability of chemical management approaches across North America, with
     special emphasis on assisting Mexico to build capacity in the sound management of
     chemicals at the national level. An early initiative in this area is to involve
     supporting Mexico’s efforts to develop an inventory of industrial chemicals.



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                                              Submitted by the United States of America


2.   Develop and implement a sustainable regional approach for environmental and
     human biomonitoring and assessment to enhance North American monitoring
     capacity, with an early emphasis on supporting Mexico in the initial stages of
     implementation of its Environmental Monitoring and Assessment Program
     (Programa de Monitoreo y Evaluación Ambiental—PRONAME).
3.   Reduce or eliminate the risk from chemicals of mutual concern in North America,
     as identified by the Sound Management of Chemicals Working Group. This
     includes continuation of efforts to reduce the risk from mercury; dioxins and furans,
     and hexachlorobenzene; and lindane and other isomers of hexachlorocyclohexane.
4.   Improve environmental performance of sectors to reduce the risks from toxic
     chemicals in North America by working strategically with key industrial sectors.
(See
http://www.cec.org/programs_projects/pollutants_health/project/index.cfm?projectID=25
&varlan=english)

Central America and Dominican Republic Free Trade Agreement
The U.S. is also working with its counterparts under the Central America and Dominican
Republic Free Trade Agreement (CAFTA-DR) on SAICM implementation.
This project includes a number of elements designed to promote overall chemicals
management and responds to the SAICM Overarching Policy Strategy of integrating
SAICM objectives in relevant programs, plans or strategies at the national level; and of
integration of the SAICM objectives into multilateral and bilateral development
assistance cooperation.

For mercury, the 2010 goal for the project is for the CAFTA-DR countries to be able to
complete at least two concrete partnership/demonstration projects to be supported for two
years. It is expected that 2 or more partnership projects for sound chemicals
management, involving government, business and industry, and public interest and labor
organizations are implemented as a result of this initiative.


Mercury-Related Capacity-Building and Technical Assistance

EPA has made substantial progress in developing formal partnerships with other
countries to reduce mercury in products under the UNEP Global Mercury Partnership.
This partnership seeks to transfer best practices related to reducing releases from the
manufacture, use, and disposal of mercury-containing products by identifying effective
substitutes.

The partnerships have increased in number to include:
    A CEC, USEPA, and Mexican Ministry of the Environment Partnership which is
     developing a mercury market report and mercury products and alternatives database
     for Mexico
    Partnerships with China, Costa Rica, and Argentina, which are reducing mercury in
     hospitals.




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                                              Submitted by the United States of America


    Partnerships with Burkina Faso, South Africa, Chile, Ecuador, and Panama, which
     are conducting mercury product inventories, market studies and mercury risk
     management projects.

EPA also co-hosted "Mercury In Our World: Conference on Mercury and Other
Hazardous Chemicals in Southeast Asia Schools," in Bangkok, Thailand, April 22-24,
2008. Other conference sponsors were Thailand's Pollution Control Department, UNEP,
and Merck Thailand. The conference was designed to be a train-the-trainer session for
university and high school students, teachers, and school administrators, enabling them to
return to their countries and schools and share what they had learned about safe
management and disposal of mercury and other hazardous chemicals. Instruction manuals
aimed at teachers/administrators and students were developed and shared at the
conference, emphasizing the importance of:

    Mercury and chemical management,
    Identification of hazardous chemicals and equipment in schools, and
    Policies and actions for school administrators and teachers.

The student manuals also contained information for student projects and activities
designed to solidify their understanding of international chemical symbols, where
hazardous chemicals are typically found in schools, identifying specific hazards, scenario
role playing, and student projects using various media to present the message.
(See http://epa.gov/mercury/pdfs/mercury_conf_report_web.pdf)


Other Capacity-Building and Technical Cooperation Efforts

Arctic Contaminants Action Program
EPA is active under the Arctic Contaminants Action Program (ACAP) to implement
projects addressing management of POPs and heavy metals in the Arctic Rim countries
including the Russian Federation. (See http://acap.arctic-council.org/)

Projects are as follows:
    Environmentally-safe management of obsolete and prohibited pesticides in the
     Russian Federation,
    Reduction of dioxins/furans emissions in the Arctic Regions of Russia
    Reduction of mercury releases from the Arctic States.
    Work under the UNEP Global Mercury Partnership with chlor-alkali facilities in
     Russia to reduce mercury use and emissions.

Arctic Military Environmental Cooperation (AMEC) Program
EPA works with the Russian Military under the Arctic Military Environmental
Cooperation (AMEC) Program to address wastes containing POPs and heavy metals at
the Russian military bases. Projects include:
    Cleaning, compaction and recycling of drums containing toxic and hazardous
     wastes (AMEC Project 1.11 2a)


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                                              Submitted by the United States of America


    Collection, storage and recycling of mercury-containing lamps at the military bases
     in the Arctic. (AMEC Project 1.11 2b)

Partnership with the U.S. National Library of Medicine
For many years the National Library of Medicine's (NLM) Specialized Information
Services (SIS) Division has made EPA's Toxics Release Inventory (TRI) data available
through the NLM's ToxNet and ToxMap online tools. The TRI Program has had a
longstanding relationship with the NLM's SIS in the dissemination of TRI data to the
public through the NLM's ToxNet and ToxMap tools and services. In addition to TRI
data, these online sources serve as a gateway to other NLM databases that provide other
information, such as toxicity information on TRI chemicals and other chemicals.
(See http://toxnet.nlm.nih.gov ; http://toxmap.nlm.nih.gov/toxmap/main/index.jsp)

Promoting Shared Scientific and Technical Expertise on Pesticides
EPA works with other countries and international organizations to promote shared
scientific and technical expertise on pesticides, lessen the resource burden on
governments and the regulatory community, and maintain high standards for the
protection of human health and the environment. The worksharing, harmonization and
technical assistance programs listed below are described in more detail at
http://www.epa.gov/oppfead1/international/worksharing/index.html#topic8.

    China collaboration
    Worker Safety and Training in Mexico and Central America
    International Food Safety Standards (CODEX)
    FAO/WHO Joint Meeting on Pesticide Residues
    Globally Harmonized System (GHS) for Classification and Labeling of Chemicals
    North American Free Trade Agreement Technical Working Group on Pesticides
    National Profile on Chemical Management
    OECD Working Group on Pesticides
    International Program on Chemical Safety
    International Visitors Program




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                                               Submitted by the United States of America



E. ILLEGAL INTERNATIONAL TRAFFIC


                                OVERARCHING POLICY STRATEGY
ILLEGAL INTERNATIONAL TRAFFIC in hazardous substances and dangerous products is a
pressing problem for many countries, especially for developing countries and countries with
economies in transition.


UNEP’s Green Customs Initiative
EPA and Department of State provide resources to UNEP’s Green Customs Initiative,
building the capacity of customs officials to combat illegal trade in ozone-depleting
substances and other hazardous chemicals. (See http://www.greencustoms.org/)

Survey Training Course for Customs Officers and Inspectors
EPA developed, adapted and has delivered a survey training course to build capacity in
Central American national governments, in close cooperation with the MEA Secretariats
(mostly within the U.N. Environment Program), the International Network for
Environmental Compliance and Enforcement (INECE), the Central America Commission
for Environment and Sustainable Development, and the Customs agencies of each of the
countries. The training materials focus primarily on trade in hazardous wastes (Basel
Convention), ozone-depleting substances (ODS; Montreal Protocol), severely restricted
and banned chemicals covered by the Rotterdam and Stockholm Conventions, and
endangered species (CITES), for which controls are already established although not
always well implemented.         The Survey Course reference above was designed for
Customs officers and inspectors and environmental officers and inspectors of national
governments who are middle managers and can influence or establish the necessary
policy, legal, enforcement, and managerial authorities and working relationships needed
to enable front-line officers and inspectors to interdict non-compliant shipments.
Material for the course is available in English and Spanish.

Importing and Exporting Industrial Chemicals
EPA’s Core Toxic Substances Control Act (TSCA) program is an exclusively federal
program that provides for review of the toxicity of chemicals prior to their manufacture
or importation to prevent unreasonable risk to human health and the environment. TSCA
Section 12(b) requires a person who exports or intends to export a chemical substance or
mixture that is regulated by TSCA Sections 4, 5 or 6 to notify EPA of the export. TSCA
Section 13 requires the Secretary of the Treasury to refuse entry into the US for a
shipment of any chemical substance or mixture that fails to comply with the Import
Certification requirements. For most enforcement cases under TSCA, the Agency
pursues an administrative civil penalty action in order to expeditiously receive a
monetary penalty and remedy the violation. (See http://www.epa.gov/oppt/import-
export/)




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                                            Submitted by the United States of America


Importing and Exporting Pesticide Products
EPA is committed to assisting, growers, importers, and exporters to comply with
pesticide regulatory trade requirements to minimize trade barriers and facilitate fair
competition while maintaining strict safety standards.
(See http://www.epa.gov/oppfead1/international/trade/index.html)

Importing and Exporting Foods Containing Pesticide Residues
EPA sets limits on how much of a pesticide residue can remain on food and feed
products, or commodities. These pesticide residue limits are known as tolerances. Food
imported into the U.S. is subject to a variety of Federal laws.
(See http://www.epa.gov/oppfead1/international/trade/index.html)




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