September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 1 

# Tala Henry, Ph.D. Director Risk Assessment Division 

# Office of Pollution Prevention and Toxics

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# FY 2014 Snapshot (Oct 1, 2013 to present):

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# Premanufacture Notifications (PMNs): 800+ • 

# EPA has 90 - days to make risk determination
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# Low Volume Exemptions (LVEs): 500+ • 

# EPA has 30 - days to make risk determination
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# Most PMN submissions have no property, fate, or toxicity data...10 - 15% of submissions have health and/or eco data September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 2• 

## TSCA finds: some chemical substances and mixtures manufacture, processing,

distribution in commerce, use, or disposal may present an unreasonable risk
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## TSCA Policy: adequate data should be develop with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures.
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## Making chemical substances is a scientific endeavor • 

### By definition, this means understanding the substance
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## Understanding the substance requires studying all aspects of it • 

### Synthesis: including composition, impurities, byproducts, wastes, etc. • 

### Formulation: application of substance in product[s] for eventual use • 

### Use: how it behaves during and after it is used September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 3

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# Basic Data Needed:

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# Physicochemical Properties • 

# Environmental Release/Distribution • 

# Environmental Fate • 

# Environmental Toxicity • 

# Why?: • 

# Basic understanding • 

# Predictive modeling where data are absent September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 4

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# Development of Good Laboratory Practices

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## Malpractice, misuse and fraud in developing data for pharmaceutical, pesticide, and industrial chemical companies
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# 1979: GLPs Developed by the USFDA and USEPA

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# Other countries followed; key developments: • 

## Organization for Economic Cooperation and Development (OECD) 

## adoption of GLPs • 

## 1981: Beginning of the OECD Test Guideline Program September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 5

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# Identification of resources • 

# Characterization of test items and test systems • 

# Rules (protocols) • 

# Results (raw data, final report and archives) • 

# Quality assurance

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# Following robust procedural requirements does not guarantee study results are valid or acceptable; sometimes chemistry and biology don’t cooperate! September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 6

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# OECD Test Guidelines – 34 countries

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# Mutual Acceptance of Data (MAD) • http ://www.oecd.org/env/ehs/testing/mutualacceptanceofdatamad.htm 

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# OECD Test Guidelines • 

### http ://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals. 

### htm#Test_Guidelines 

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# EPA Test Guidelines • 

### http ://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm September 10 - 11, 2014 Difficult -To -Test Workshop - Arlington, VA 7• 

## Ideally, tests will be been conducted under optimal conditions using established

guidelines and following GLP.

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## However, EPA will consider: • Studies conducted for other purposes or by other entitites such as industry or government reports, journal publications, etc., etc. • To be ‘considered’ the information must provide sufficient details and documentation to evaluate the robustness and limitation of the study, such as (all the things Guidelines intend for us not to forget/forego): chemical identification (e.g., composition, purity, impurities), test methods (species, equipment, water chemistry, etc.), analytical methods (e.g., instrumentation, standards, etc.), results (e.g., controls, raw or uncollated data, etc.), QA/QC procedures, etc. • Studies designed and conducted specifically or specially to assess a particular PMN substance • EPA strongly encourages submitters to discuss such an approach with EPA ahead of time and generally will ask to review protocols – before conducting the testing! • Key to success is Communication – Before, During and After the testing. September 10 - 11, 2014 Difficult -To - Test Workshop - Arlington, VA 8