Chemical Assessment andManagement Program
Tala Henry, Ph.D.
ChAMP Coordinator
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
Workshop at Ministry of Environment
Tokyo, JapanFebruary 20091

Background

Security & ProsperityPartnership2

North American Cooperation on
Chemical Management• At the Security and Prosperity Partnership(SPP) Summit in August 2007, the U.S.
President, Canadian Prime Minister andMexican President committed to specificgoals to enhance regulatory cooperation
among Canada, Mexico, U.S.
– Accelerate and improve effectiveness of actions tosafeguard health and environment– Provide cost-effectiveness for business andgovernment– Retain national regulatory authority
3

SPP Commitments• Regional Commitments– Canada & U.S. work will with Mexico to establish
a Mexican chemical inventory and a strengthened
North American chemical regime– Research and development on new approaches
to testing and assessment.
• US and Canada have begun collaborating– Create mechanisms to share domestic scientificinformation and best practices for chemicalassessment and management.
– Enhance Mexico’s capacity for chemicalassessment and management– Reaffirmed: WSSD 2020 goal; Regional SAICM
implementation4

SPP Commitments• National Commitments– U.S.: Assess and initiate needed action onover 6,000 chemicals– Canada: Realize its Chemical ManagementPlan– Mexico: Establish a chemical inventory

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ChAMP

Scope & Chemical Universe6Chemicals Assessment andManagement Program (ChAMP)• ChAMP encompasses U.S. SPP
commitments and enhancements to U.S.
EPA’s existing chemical program which
include:– Resetting the TSCA Inventory– HPV Challenge type program for highproduction volume “inorganic” chemicals
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U.S. Commitments Under SPP• Assess and initiate needed action on the over 6,000*
existing chemicals produced above 25,000 lbs/yr theU.S.

• Includes High Production Volume (HPV) andModerate Production Volume (MPV) chemicals• Builds off of prior efforts:• HPV Challenge• IUR Reporting• Canadian categorization, etc.

• Make and publicly release screening level decisions
and initiate needed action*Based on preliminary statistics from 2006 IUR Data8

SPP Commitments Under ChAMP
1979

62,000
Original TSCA
Inventory

1979 - Present
21,000New Chemicals

83,000Current Inventory= SPP Commitment~ 7,500 1
IUR Chemicals≥ 25,000 lbs.

~ 6,750 1Organics≥ 25,000 lbs.
2,750 1
Organic HPVs
≥ 1 million lbs.

~ 4,000 1
Organic MPVs
≥ 25,000 lbs. &< 1 million lbs.

HPVs

~ 75,500
Non-IUR Chemicals,(Polymers, < 25,000 lbs.)~ 750 1Inorganics≥ 25,000 lbs.

TSCA = Toxic Substances Control Act
IUR = Inventory Update Rule
HPV = High Production Volume
MPV = Moderate Production Volume

MPVs
1Statistics are based upon preliminary 2006 IUR data; the actual numbers may change slightly when official
statistics are available.
Note: The 2006 IUR introduces new reporting thresholds.

9ChAMPRisk-Based Prioritization10

Risk-Based Prioritization Process
HPV Chemicals• Assess and prioritize HPV chemicals
based on hazard/ exposure information– HPV Challenge hazard data
– IUR exposure/use data

• Develop Risk-Based Prioritization (RBP)• Identify and initiate needed action, e.g.
– Gather/generate needed information– Take control measures– Identify as current low priority and set aside• Document and post assessments on the web11

HPV Risk-Based Screening
Decision Process – Components• Hazard Characterization (HC)– U.S. HPV Challenge (test data developed andimplemented in 1998-2005)– OECD HPV Programme• Exposure Characterization (EC)
– 2006 Inventory Update Reporting (IUR)• Risk Characterization (RC)– Combines the Hazard and IUR Exposure/Use data
– Informs the Risk-Based Prioritization Decision
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Risk-Based Prioritization –Components
HPV
Challengeor OECD
HPV Data

IUR Use &Exposure
Data

Screening-Level
Hazard & Fate
Characterizations(HC)

Integrated
Screening-Level Risk
Characterizations & RiskBased Prioritizations(RBP)

Screening-Level
Exposure
Characterizations(EC)

Ongoing
Implementation
2008 – 2012+Low Concern

Voluntary
Actions bySponsor

Non-Regulatory
Actions by EPARegulatory
Actionsby EPA

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HPV Challenge Program• A voluntary initiative launched in 1998 aimed at developing
and making publicly available screening-level health andenvironmental effects information on HPV chemicals.
• A complete data submission contains data or information on
18 internationally agreed to “SIDS” (Screening Information
Data Set) endpoints:– 5 Human Health Screening Endpoints: Acute, Repeated-Dose,
Reproductive, Developmental and Genetic Toxicity– 3 Ecological Screening Endpoints: Acute Aquatic Toxicity (Fish,Invertebrates, Plants); Chronic Aquatic Toxicity (case-by-case)– 10 P-Chem Properties & Environmental Fate Parameters• As of 2007, companies have sponsored more than 2,200
HPVs14

Screening-LevelHazard Characterization (HC)• Based on summary of data submitted under
HPV Challenge Program, TSCA 8(e) health &safety data and literature search of selectedsources conducted by EPA• Hazards characterized for human health andecological hazards as high, medium, or low
based on Hazard Characterization Guidance,
which includes toxicity criteria derived and/or
used previously:– OECD Globally Harmonized System (GHS) for theClassification and Labeling of Chemicals
15– TSCA 8(e) Program – Notices of Substantial Risk

Screening-Level
Exposure Characterization (EC)
• Uses information from IUR and a selected number ofpublic sources:– IUR – production volume, use, occupational setting
concentrations– Hazardous Substances Data Bank– HPV Challenge submission– OECD HPV SIDS Dossier– TSCA Test Rules– Toxics Release Inventory• Addresses several exposure scenarios:– Occupational– Non-occupational exposures, including:• Environment (aquatic organisms)• General population• Consumers• Children16

Screening-Level
Risk Characterization (RC)• Results from the HC and the EC are integrated
to provide the RC.
• The RC provides a qualitative(High/Medium/Low) risk concern level for eachof the five exposure groups assessed.

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Risk-Based Prioritization (RBP)• Low Priority – no follow-up action suggested at thistime• Medium Priority – possible concern – follow-up asneeded• High Priority – promptly begin efforts to better
understand and/or address concern

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Risk-Based Prioritization (RBP)• RBPs and supporting HCs, ECs andRCs are posted on the web:
http://www.epa.gov/chemrtk/hpvis/aboutrbd.htm• A document explaining the procedure and criteria
used in preparing RBPs will be posted to the ChAMP
website soon: Methodology for Risk-BasedPrioritization Under ChAMP19

Screening Prioritization Process
MPV Chemicals• Produced or imported at quantities ≥ 25,000 lbs/yrand <1 million lbs/yr.
• Apply available data and EPA Structure Activity
Relationships (SAR) analysis to assess hazard andfate.
• Basic exposure/use data are available only forMPVs produced at > 300,000 lbs at a site
• Use Hazard Characterizations (HCs) to identify
MPVs that require follow-up, initiate actions– Gather additional data (exposure, testing, etc.)– Risk management• Document and post prioritizations on the web.

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Chemical Clustering• Identify analogs using a chemical fragment-based
approach with 645 individual molecular fragments• Database of chemicals with publicly available toxicity
data– 31,031 potential analogs with publicly available toxicity data
– On-Line Databases: TSCATS, HSDB, IRIS

– U.S. Government Documents
NTP, ATSDR, HPV Challenge Program– Other Sources: RTECS, IUCLID, AEGLS

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Data Gathering & Modeling•Endpoints Included – Similar, but more than HPV:– Pchem/Fate– Ecotoxicity• Fish/Invert/Plant – Acute & Chronic– Health• Quantitative (LC50, NOAEL/LOAEL): Acute, Repeated-Dose, Reproductive,
Developmental• Qualitative (+/-): Genetox, Cancer, Neurotox, Immunotox, Irritation,Sensitization•Data Sources – Similar to HPV:– OECD & US HPV Dossiers, Section 4, Section 8(e)– IRIS, NTP, ATSDR, ECOTOX, HSDB, PhysProp, EFDB
– Canadian DSL•

Models Employed – much more than HPV:

22– EPISuite, SPARC (pKA), ECOSAR, OncoLogic, OECD QSAR Toolbox

Approach for MPV Hazard Characterization
1986–2006
IUR

New
Chemicals

Identify
StructuralClusters

Cluster 1 …

Physical-Chemical Properties – HPV, PhysProp, EPISuite, SPARC
Environmental Fate – HPV, PhysProp, EPISuite
Ecotox break pt 1

Ecotoxicity

Ecotoxicity – HPV, ECOTOX, ECOSAR

HH break pt 1

Human HealthEndpt 1

HH break pt 2

Human HealthEndpt 2

Human HealthEndpt 3

OncoLogic®
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Hazard-Based Prioritization (HBP)• A document explaining the procedure andcriteria used in preparing HBPs is posted on
the ChAMP website:
http://www.epa.gov/champ/pubs/abouthbp.htm• HBPs and supporting HCs are posted on theweb:
http://www.epa.gov/champ/pubs/hbpdocs.htm
24Tools to Address Concerns• When additional information or action is needed toaddress concerns, the options include:– Contact producers with request for information, informal action– Collect and review data from other EPA offices, Agencies,States, Canada, EU, and OECD
– Issue TSCA 㼲8(a) reporting rules (e.g., exposure, release data)– Issue TSCA 㼲5(a)(2) Significant New Use Rules (SNURs)– Engage with stakeholders (e.g. Design for the Environment, orDfE, voluntary action, etc.)– Issue TSCA 㼲4 test rules– Develop/implement Challenge programs, other risk reduction
actions– Consider other TSCA actions (e.g., 㼲5(b)(4) list, 㼲6)25

Meeting the SPP Goals• 2007– Developed process for screening-level Hazard Characterizations(HCs) and Risk Characterizations (RCs), and Risk-BasedPrioritizations (RBPs) on HPV chemicals– Posted over 150 HCs (precursor to RBP)

• 2008– Posted RBPs for 151 chemicals– Developed process for screening-level Hazard-BasedPrioritization (HBP)– Posted initial MPV HBPs for 55 chemicals• 2009– Continue posting RBPs and HBPs

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ChAMP Enhancements
TSCA Inventory Reset
Inorganic HPV (IHPV) Challenge

27TSCA Inventory ResetChAMP Enhancements• Following an extensive stakeholder engagement
effort during the Spring of 08, EPA announced inSeptember 2008 the decision on two ChAMP
Program enhancements. EPA intends to:– Update the current Toxic Substances Control Act (TSCA)
Inventory of industrial chemicals by "resetting“ it to betterreflect the chemicals actually in commerce in the U.S.
– Develop a phased approach to challenge the U.S. chemicalindustry to develop health and safety data on inorganic HPVchemicals.

• EPA outlined and solicited stakeholder input on bothof these efforts at a one-day public meeting held on
December 8, 2008.
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TSCA Inventory Reset• Current TSCA Inventory nearly 84,000 chemicals– U.S. EPA believes that many chemicals are no longer
manufactured/imported; or– Are produced only in low or episodic volumes• TSCA 㼲8(b) requires EPA to “compile, keep current,and publish” TSCA Inventory.
• Resetting the Inventory would give EPA and others abetter understanding of which chemicals are actuallyin commerce.
• A more accurate Inventory would allow EPA to better
plan and execute its mission of protecting humanhealth and the environment.
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TSCA Inventory Reset• EPA will further engage stakeholders but is considering
a “clean reset” which would remove chemicals no longer
being manufactured or imported.
• A new chemical notice would only be needed if acompany decided, at a later date, to produce a chemicalno longer on the reset inventory.
• EPA would also anticipate periodic resets in the future tocontinue to keep the Inventory current.

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EPA Proposed “Clean Reset”
Approach• The public version of the Inventory would be
posted online, with chemical identities (genericname if claimed CBI) and associated CAS or
Accession numbers• Companies would certify that they have
manufactured a chemical listed on theInventory within a specified timeframe– Companies would certify their chemicals online via asecure website, e.g., by flagging.
– EPA is considering a three year time period for theInventory reset process.
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Coordination with IUR· EPA proposed to make the “Reset Inventory” available
in time for the next TSCA Inventory Update Reporting(IUR) period (to occur June 1 through September 30,
2011, for chemicals manufactured during 2010 calendar
year).
· This would help ensure that the IUR reporting iscoordinated with an accurate accounting of the chemical
substances currently manufactured for commercial
purposes at any production volume.
· Subsequent periodic Inventory reset efforts could betimed to occur in conjunction with IUR reporting.
33Inorganic HPV Challenge

Inorganic Chemicals• Inorganics first included on IUR in 2006,
allowing identification of Inorganic HPVs
– Production volume only
– No exposure data reporting until 2011

• Examples: metals & salts, ammonia & cmpds,
minerals & fibers (bentonite, zeolite, asbestos,etc.), inorganic acids (HCl, HNO3, H2SO4),etc.
• Of 750 Inorganics reported on 2006 IUR,
approximately 400 - 500 are HPV35

IHPV Challenge• U.S. EPA proposed an approach for an IHPVChallenge Program• Approach proposes to:– Look to OECD guidance and experience on inorganics– Apply approaches and procedures similar to those used in HPVChallenge Program (especially categories)– Apply established EPA Guidance on inorganics assessment– Assess, prioritize, and initiate needed action on IHPV
chemicals

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IHPV Challenge Approach• Outlined in the document entitled “Proposed Approachfor the Inorganic High Production Volume (IHPV)Challenge Program”• Available in the following docket atwww.regulations.gov: EPA-HQ-OPPT-2008-0807• Also in this docket are the Federal Register Noticeannouncing the public meeting on IHPV Challenge andthe slides presented at that meeting.

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IHPV Challenge Program –Proposed Approach• Phase 1: “Challenge” - Develop, Launch & Sign-Up– Now Through December 2009

• Phase 2: Implement the Challenge Receive/Review Data
– approximately 2010 – 2013
– Vigorous use of TSCA 㼲4 test rule authority to deal with“orphans”• Phase 3: Assess and Initiate Actions – Consider IHPV
Data and IUR Exposure/Use Information for QualitativeRisk Based Prioritization– approximately 2013 – 2015
– MPV inorganics would subsequently be assessed and prioritized38Chemical Assessment andManagement Program
Resettingthe Inventory

Non-IUR
Chemicals

CurrentTSCA
Inventory

IUR
Chemicals= SPP CommitmentOrganics
SPP

Inorganics HPVChallenge

Assess &Initiate FollowUp Action

Assess &Initiate FollowUp Action

20122012 – 2014?

= Possible
Enhancements

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ChAMP Next Steps• Continue developing Risk-BasedPrioritizations for HPV & “Data Available”
chemicals.
• Continue developing Hazard-BasedPrioritizations for MPVs & “Data Poor”
chemicals.

• Finalize approach for IHPV Program andlaunch the “Challenge”.
• Determine approach for TSCA Reset; propose
rule and implement shortly thereafter.
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For More Information
ChAMP -http://www.epa.gov/ChAMP/

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