1. EPA's Call for Use Information for the First 10 Chemicals to Undergo Risk Evaluation
March 8, 2017

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3. Herbert Estreicher, J.D., Ph.D.
Herbert Estreicher, J.D., Ph.D. has a broad practice in international environmental regulatory law. He has an interdisciplinary approach combining law and science. He represents leading manufacturers of chemicals, pesticides, insect repellents, food additives, and consumer products before Federal and State regulatory agencies. He helps clients secure and maintain chemical approvals and pesticide registrations in the U.S., Canada, Europe, and Korea, advises clients on TSCA Reform, the CEPA challenge program, Korea REACH, and provides advice on European chemical directives and initiatives, such as the EU Biocidal Products Regulation, and the EU REACH regulation. •
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4. Marisa Kreider , PhD DABT
Dr. Kreider is a Senior Managing Health Scientist and board-certified toxicologist at Cardno ChemRisk. She serves as the firm’s Practice Area Lead for Toxicology, and has experience in designing and managing toxicity testing, conducting exposure and risk assessments, and supporting clients in regulatory compliance and product stewardship/sustainability efforts. She has over 10 years of experience as a consultant in the areas of human health risk assessment. •

5. Today’s Agenda What Information is EPA requesting?
How to Respond to EPA’s information request.
How EPA considers uses and specific
conditions of use in a risk evaluation?
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6. First Ten Chemicals Slated for Risk Evaluation
1,4-Dioxane; 1-Bromopropane; Asbestos; Carbon Tetrachloride; Cyclic Aliphatic Bromide Cluster; Methylene Chloride; N-methylpyrrolidone; Pigment Violet 29; Tetrachloroethylene; and, Trichloroethylene.
These 10 chemicals were drawn from EPA’s 2014 TSCA Work Plan.
EPA must release a scoping document by June 19, 2017 for each chemical. This will include the hazard(s), exposure(s), conditions of use, and the potentially exposed or susceptible subpopulation(s) EPA plans to consider in the evaluation, which must be completed by December 19, 2019 but can be extended by 6 months.
EPA’s position is that they must evaluate at least to some degree all conditions of use of the chemical.
Conditions of use = All known, intended, and reasonably foreseen activities associated with the subject chemical.
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7. EPA Call For Information
EPA has asked for the public to provide conditions of use information to assist the Agency in identifying potential exposure scenarios.
EPA has established separate dockets for each of the 10 chemicals.
Information is Requested by March 15th
Because of the tight deadlines the scoping documents will not be open to public comment.
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8. What Use Information Would Be Useful
Start with the Proposition That Actual Conditions of Use Information is Better than Modeled Information. Provide as much detailed information as you can on:
Physical form of product and product specifications
Operational conditions and risk management measures related to workers: Duration and frequency of exposure; applied amount of chemical; process temperature; process containment; for indoor use the room volume (and ventilation); Risk management measures used to protect workers.
Operational conditions and risk management measures related to consumers in case of consumer use: Applied amount of chemical; duration and frequency of exposure; measures integrated to the design of the product to reduce consumer exposure, i.e., concentration of a substance in the product, whether supplied in form of granules or tabs to reduce exposure to dust, in fixed dose or ready-for-use package size. Detailed examples of consumer labeling.
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9. What Use Information Would Be Useful?
Operational conditions and risk management measures related to the environment: process containment; differentiate between continuous, frequent and intermittent release; capacity factor or the dilution factor of the surface water system and also the sewage system; information on recycling of solvents, re-use of process water in vent gas scrubbers, closing the process water circulation, different waste water and waste gas treatment methods, restriction in spreading of sludges.
Operational conditions and risk management measures related to substances in articles.
Operational conditions and risk management measures related to the waste life stage.
Federal, State and Local Regulations that Reduce Exposure
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10. How Will EPA Incorporate Use Information into Risk Evaluation?
Characterization
Hazard
Identification
Dose
Response
Exposure
Assessment
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11. Use Identification
EPA identified uses for 10 chemicals to undergo the first round of risk evaluation
Source of information used:
Agency data (TRI, PMNs, CDR)
Subscription search resources (CAS-STN)
Publically available information
Open literature and web searches
Stakeholder meetings

12. The Conceptual Exposure Model
Solvent Degreaser
Air
Workers and Bystanders in Small Commercial Settings
Consumer Users and Bystanders
Sources
Exposure Pathway
Receptors
Spotting Agent
Air
Workers and Bystanders in Dry Cleaning Facilities
Plastic Clear Protective Coating Spray
Air
Conceptual Exposure Model for TCE

13. Exposure Modeling: 101
EPA often relies on models for predicting exposure
Inherently conservative
Example with TCE work plan assessment
Exposure Type
Screening Models
Occupational Exposure
ChemSTEER
Consumer Exposure
E-FAST/CEM
Environmental Exposure
ChemSTEER; E-FAST; AERMOD; REACH-SCAN; VVWM

14. Examples of Use Conditions Key to Exposure Predictions
Form of chemical
Frequency of activities
Volume/amount of use
Engineering controls
Personal protective equipment usage
Etc.

15. SUMMARY Take a Hard Look at Your Operations Talk to Customers
Work with Sector-Specific Trade Associations Particularly Downstream User Groups
Think About the Default Assumptions EPA Uses in Their Standard Assessment Models and Try to Introduce Greater Realism with Hard Data.
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16. The Next TSCA 30/30: Wednesday, April 12th
For more information on past and future TSCA 30/30 programs, please visit and for the most up-to-date TSCA news
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17. TSCA, Food-Contact Substances and Other FDA-Regulated Products Seminar
Chicago, IL
May 9-11, 2017
For those of you interested in Workplace Safety and Health matters, check out our OSHA 30/30 program. The next OSHA 30/30 is scheduled for Wednesday, March 22nd.
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18. Estreicher@khlaw.com Marisa.Kreider@cardno.com 202.434.4334
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