U.S. High Production Volume (HPV) Challenge Program Diane Sheridan U.S. Environmental Protection...

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

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

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


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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)


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HPV Challenge ProgramGoals and Approach

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)


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HPV Challenge ProgramDesign Features

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

– Voluntary and Regulatory


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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


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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


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Sponsorship

2,252 sponsored– 1,398 directly in the program– 854 indirectly through the International Council of

Chemical Associations (ICCA)


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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


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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


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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


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Guidance Documents

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


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Existing Data

6,801

4,800Published Studies(4,800) (41%)

Unpublished Studies(6,801) (59%)


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HPV Challenge Program Timeline

1998 1999 2000 2001 2002 2003 2004 2005

December 31, 2004All test plans for sponsored

chemicals should be submitted.

December 31, 2005All data for sponsored

chemicals shouldbe submitted.

April 2000The first test plans and data

summaries are posted on EPA’sHPV Challenge Program Website.

2001 - 2003The majority of materials are submitted

to the Agency, covering 1,031chemicals that were sponsored

directly in the HPV Challenge Program.

October 1998The HPV Challenge Program is officially

launched. EPA sends a letter tomanufacturers, soliciting companies

to sponsor chemicals in the Program.


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“Orphan” Chemicals

289 unsponsored (aka “orphan”) chemicals


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Orphans

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


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HPVIS

HPV Information System (HPVIS) Sophisticated data-searchable web

application Release scheduled by end of 2005


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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


19

National HPV Data Users Conference

Late Fall 2006 3 Days Audience

– EPA Regions– EPA HQ– State technical health and environmental personnel– Academia– NPPTAC members– Consumers– NGOs– Industry


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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


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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


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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


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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


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HPV Challenge Program

Homepage: http://www.epa.gov/chemrtk/volchall.htmDiane Sheridan

[email protected] (202)-564-8176

U.S. High Production Volume (HPV) Challenge Program Diane Sheridan U.S. Environmental Protection...

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