EPA published its long awaited draft Concept Paper for Nanoscale Materials Stewardship Program Under TSCA yesterday.  The paper contains a draft framework for EPA’s voluntary reporting program.  Public comment is invited and a public meeting will be held on August 2 here in Washington, D.C.  EPA’s framework is designed to collect data from manufacturers of nanoscale materials regarding the materials they make, encourage risk management practices, develop foundational scientific data for later EHS work, and promote a balance between nanotechnology’s positive contributions and minimized possible EHS effects.

EPA suggests four primary categories of companies should participate in the program: manufacturers or importers of engineered nanoscale materials; companies that modify engineered nanoscale materials for subsequent use; companies that modify bulk materials producing engineered nanoscale materials; and companies that use engineered nanoscale materials in the manufacture of their products.

Participants will be asked to implement a nano-risk management program considering relevant input from EPA and to report back regarding its efficacy.  EPA intends to base its nano-risk management program on the results of its October 2006 scientific consultation on nano-risk management practices, and also is encouraging additional public submissions on this specific issue.

Participants will also be asked to provide information regarding their current use of engineered nanoscale materials under two plan levels.

The first "basic" level seeks information EPA believes is already in most companies’ possession or should be easy for them to ascertain: materials characterization, hazard, use, potential exposure, and risk management practices.  These broad topics, of course, have numerous subtopics.  To give readers some idea of the extent of the information EPA is seeking, the draft questionnaire for this "basic" level is 25 pages long.

The second, "in depth" level asks select participants to essentially partner with EPA to collect additional data on a specific limited number of nanomaterials of greatest potential concern (tbd).  Participants will jointly review existing data, conduct preliminary assessments, identify any additional data needs, and then work on a joint action plan.  Joint research topics include: "characterizing the physical/chemical properties of the material; testing for health and environmental hazards; monitoring or estimating exposures and releases; determining fate and transport characteristics; evaluating the effectiveness of protective equipment or engineering controls; developing a model worker education program; and other evaluations agreed to under the plan of action."  EPA envisions some companies taking a direct/active role in this research, while others may chose to work in loosely formed coalitions.  After completing the research, there will be a final joint risk assessment for each material studied, and any additional actions/steps will be considered on a case-by-case basis.

EPA advises all of the information collected under both levels of the plan will be treated as being formally submitted under TSCA.  Companies will have the opportunity to designate certain information as "confidential business information" which will be subject to all existing TSCA protections.  EPA plans to use the collected information to determine "how and whether certain nanoscale materials or categories may present risks to human health and the environment," to identify any existing data gaps, prioritize nanomaterials for further research, and develop risk mitigation techniques (assuming the information warrants such measures).

EPA believes all nano-manufacturers and importers should participate in the program in order to encourage "responsible development of nanoscale materials" and to avail themselves of enhanced informed decision making, benefiting "all stakeholders."  EPA also believes the program will foster the openness and transparency many in the public and certain NGO’s believe is crucial to the success of any regulatory program. 

Actual participation in the voluntary program, however, remains a concern.  EPA is asking the public for new ideas on providing incentives to companies to participate in the program.  At the same time EPA states that participation will not "relieve or replace" existing TSCA requirements that are otherwise applicable to each specific manufacturer and nanomaterial.

The paper also has several informative attachments.  Of particular interest are "Annex A" which contains a glossary of nanotechnology terms and notes substantial nomenclature gaps, and "Annex D" which identifies "issues and challenges" confronting the program.