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

• Premanufacture Notifications (PMNs): 800+

• EPA has 90-days to make risk determination

• Low Volume Exemptions (LVEs): 500+

• EPA has 30-days to make risk determination

• Most PMN submissions have no property, fate, or toxicity 

data...10-15% of submissions have health and/or eco data

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

distribution in commerce, use, or disposal may present an unreasonable risk

• 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.

• Making chemical substances is a scientific endeavor

• By definition, this means understanding the substance

• 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

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• Basic Data Needed:

• Physicochemical Properties

• Environmental Release/Distribution

• Environmental Fate

• Environmental Toxicity

• Why?:

• Basic understanding

• Predictive modeling where data are absent

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• Development of Good Laboratory Practices

• Malpractice, misuse and fraud in developing data for pharmaceutical, 

pesticide, and industrial chemical companies

• 1979: GLPs Developed by the USFDA and USEPA

• Other countries followed; key developments:

• Organization for Economic Cooperation and Development (OECD) 

adoption of GLPs 

• 1981: Beginning of the OECD Test Guideline Program

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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

• Following robust procedural requirements does not 

guarantee study results are valid or acceptable; 

sometimes chemistry and biology don’t cooperate! 

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• OECD Test Guidelines – 34 countries

• Mutual Acceptance of Data (MAD)

• http://www.oecd.org/env/ehs/testing/mutualacceptanceofdatamad.htm

• OECD Test Guidelines

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

htm#Test_Guidelines

• EPA Test Guidelines

• http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm

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

guidelines and following GLP.

• 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.

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