U.S. High Production Volume (HPV) Challenge Program

Diane Sheridan U.S. Environmental Protection Agency October 25, 2005 Region 2 Emerging Chemicals Workshop

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HPV Challenge Program Topics

 History  How the Program Works  Data Submissions  HPV Information System  Outreach October 25, 2005 Region 2 Emerging Chemicals Workshop

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History

 Earth Day 1998: then-VP Gore announces collaborative effort – Industry, environmental groups, and government  3 studies show lack of HPV data: – – –

Toxic Ignorance,

1997 (Environmental Defense, or ED)

Data Availability Study,

1998 (American Chemistry Council, or ACC)

Chemical Hazard Data Availability Study,

1998 (EPA) Region 2 Emerging Chemicals Workshop October 25, 2005

HPV Challenge Program Goals and Approach

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HPV Challenge goal is public availability of a baseline set of health and environmental effects data on approximately 2800 HPV chemicals; goal is not testing chemicals Defined list of chemicals and battery of tests – Screening Information Data Set (SIDS) Submit detailed summary information in robust summary format . December 26, 2000 (65 FR 81686)

October 25, 2005 Region 2 Emerging Chemicals Workshop

HPV Challenge Program Design Features

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Voluntary program for companies to make basic hazard data on their HPV chemicals publicly available by 2005 Strongly encourage greater international testing efforts under OECD HPV/SIDS, ICCA Public involvement at every step Incorporate animal welfare considerations and encourage use of SAR/category approach 2 Components

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Voluntary and Regulatory

October 25, 2005 Region 2 Emerging Chemicals Workshop

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Data Types

 SIDS Data Set – (1) acute toxicity – – (2) repeat dose toxicity (3) developmental & reproductive toxicity – (4) mutagenicity – (5) ecotoxicity – (6) environmental fate Region 2 Emerging Chemicals Workshop October 25, 2005

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Screening Information Data Set (SIDS) Elements

Physicochemical properties:

melting & boiling pts., vapor pressure, water solubility, partition coeff.

Environmental fate:

photodegradation, stability in water, biodegradation, transport (model)

Environmental effects:

acute toxicity in fish, aquatic invertebrates and aquatic plants

Health effects:

acute and subchronic toxicity, genetic toxicity, reproductive and developmental toxicity Region 2 Emerging Chemicals Workshop October 25, 2005

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Sponsorship

 2,252 sponsored – 1,398 directly in the program – 854 indirectly through the International Council of Chemical Associations (ICCA) October 25, 2005 Region 2 Emerging Chemicals Workshop

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Data Submissions

 376 test plans with robust summaries  Cover 1,313 of the 1,398 (94%) chemicals  Robust Summaries and Test Plans webpage: http://www.epa.gov/chemrtk/viewsrch.htm

October 25, 2005 Region 2 Emerging Chemicals Workshop

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Public Comments

   Test Plan posted, then 120-day comment period Industry, environmental protection groups, animal welfare groups, universities, private citizens, etc. - may comment Provided Comments – – – – Environmental Defense: 89% PETA and PCRM: 62% Other: 3% EPA: must comment on 100% of materials Region 2 Emerging Chemicals Workshop October 25, 2005

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Chemical Categories

   Category = “group of substances similar in chemical structure that show a regular pattern of properties and effects; where not every endpoint needs to be tested” Benefits: – – – reduced animal testing $$ saved time saved 81% of chemicals in a category Region 2 Emerging Chemicals Workshop October 25, 2005

Guidance Documents

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 EPA provides clear guidance to assist stakeholders in participating in the Program  Guidance provided for subjects such as: – – category formation developing robust data summaries – assessing adequacy of existing data http://www.epa.gov/chemrtk/guidocs.htm

October 25, 2005 Region 2 Emerging Chemicals Workshop

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Existing Data

6,801 4,800 Published Studies (4,800) (41%) Unpublished Studies (6,801) (59%)

October 25, 2005 Region 2 Emerging Chemicals Workshop

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HPV Challenge Program Timeline

October 1998 The HPV Challenge Program is officially launched. EPA sends a letter to manufacturers, soliciting companies to sponsor chemicals in the Program.

2001 - 2003 The majority of materials are submitted to the Agency, covering 1,031 chemicals that were sponsored directly in the HPV Challenge Program.

December 31, 2005 All data for sponsored chemicals should be submitted.

1998 1999 2000 April 2000 The first test plans and data summaries are posted on EPA’s HPV Challenge Program Website.

2001 2002 2003 2004 2005 December 31, 2004 All test plans for sponsored chemicals should be submitted.

October 25, 2005 Region 2 Emerging Chemicals Workshop

“Orphan” Chemicals

 289 unsponsored (aka “orphan”) chemicals

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October 25, 2005 Region 2 Emerging Chemicals Workshop

Orphans

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   Accepting new commitments to chemicals until approximately next month’s: – TSCA Section 8(a) Preliminary Assessment and Information Reporting (PAIR) rule, and – TSCA Section 8(d) Health and Safety Data Reporting (HaSDR) rule New commitments after those rules’ effective date will require submission of health and safety studies.

TSCA Section 4 Test Rules = regulatory mechanisms to secure data October 25, 2005 Region 2 Emerging Chemicals Workshop

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HPVIS

 HPV Information System (HPVIS)  Sophisticated data-searchable web application  Release scheduled by end of 2005 October 25, 2005 Region 2 Emerging Chemicals Workshop

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HPVIS

 Search for specific endpoint data or other data related to a specific chemical – E.g., ecotoxicity of nitroglycerine to flathead minnow in range of mg/L  Audience: generally technical October 25, 2005 Region 2 Emerging Chemicals Workshop

National HPV Data Users Conference

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   Late Fall 2006 3 Days Audience – EPA Regions – – – – – – – EPA HQ State technical health and environmental personnel Academia NPPTAC members Consumers NGOs Industry October 25, 2005 Region 2 Emerging Chemicals Workshop

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Data Users Conference

 Purpose – – – – – Familiarize participants with the HPV Challenge Program Communicate capabilities of the HPVIS and how the database is used Encourage HPVIS use by states and others Show what information can and can not be gleaned from HPV data Useful links to other databases; i.e., TRI, that might contain additional information on some HPV chemicals Region 2 Emerging Chemicals Workshop October 25, 2005

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NPPTAC

 National Pollution Prevention and Toxics Advisory Committee (NPPTAC) and NPPTAC’s HPV Work Group  Working together to develop a screening approach for identifying and prioritizing chemicals for further work Region 2 Emerging Chemicals Workshop October 25, 2005

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Emerging HPVs

 ACC/SOCMA/SDA created the Emerging HPV (EHPV) Program of 573 chemicals that are HPV in 2002 IUR  EPA input, but run by private industry October 25, 2005 Region 2 Emerging Chemicals Workshop

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Future of EPA HPV Programs?

 Will EPA have its own program for recently emerging HPV chemicals?

 EPA Regions can be involved – Communicate with chemical manufacturers in your region October 25, 2005 Region 2 Emerging Chemicals Workshop

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HPV Challenge Program

 Homepage: http://www.epa.gov/chemrtk/volchall.htm

Diane Sheridan  [email protected]

 (202)-564-8176 October 25, 2005 Region 2 Emerging Chemicals Workshop