The term “nano” is a metric prefix meaning “one billionth.” Nanotechnology involves the manipulation of matter at some of the smallest possible scales; i.e., having at least one dimension that is 1 to 100 nanometers in size. The manipulation of matter at the nanoscale may produce novel property changes in surface area, magnetisim, reactivity, electrical conductivity, thermal properties, and super elasticity. Nanoscale materials and products using them have grown into huge business — predicted to be as large as $75 billion world-wide by 2025.
Protorae Law’s nanotechnology practice assists clients at all stages in their products’ lifecycle — planning, financing, research and development, commercialization, and manufacturing. We have deep experience in meeting the unique intellectual property, regulatory, and business needs of small, mid-size, and large companies developing nanoscale materials and products that use them. Our attorney’s experience includes helping to:
- Negotiate complex Toxic Substances Control Act (“TSCA”) consent orders with EPA, including workplace protection, worker exposure monitoring, toxicity testing, process and use restrictions, release to water restrictions, and disposal restrictions. Obtain internal expert input and comment from stakeholders. Use existing EPA relationships to successfully conduct negotiations.
- Identify new chemical substances for possible premanufacture notice (“PMN”) submission in connection with chemists and external experts.
- Prepare and file PMNs on behalf of commercial chemical clients. Comply with TSCA confidential business information substantiation requirements.
- Conduct pre-submission in-person meetings and telephone conferences with EPA to facilitate PMN submittal and consent order negotiations. We have excellent contacts within EPA’s Office of Pollution Prevention and Toxics, NIOSH, and other federal agencies and institutes, and additional close contacts with state and local regulators in certain regions.
- Provide client reports regarding EPA stages of review of PMN submissions, monitor progress, and prompt EPA as needed to help speed completion.
- Assist clients with retention of laboratories and scientists to meet toxicity testing requirements of consent orders, including aquatic and rat inhalation toxicity testing. Coordinate TSCA activities with toxicologists and other scientists.
- Conduct extensive negotiations with EPA to obtain classification of client’s product as a “naturally occurring substance” under TSCA, avoiding PMN requirements.
- Provide advice regarding applicability of TSCA “polymer exemption” and implement reporting and document retention policies. Provide advice regarding TSCA “research and development” and “solely export” exemptions, including documentation and labeling requirements.
- Provide advice regarding TSCA definitions of “mixture,” “article,” “processing,” “manufacture,” and other terms of art. Utilize same in PMN analysis and submission activities.
- Provide advice regarding TSCA definition of “significant new use” for regulatory purposes. Negotiate language of significant new use rules with EPA and procure publication of proposed SNURs in federal register despite regulatory opposition.
- Draft and submit application to EPA for “low volume” exemption for new chemical under TSCA.
- Provide advice regarding potential applicability of TSCA test data rule and potential need for generation of testing data to accompany PMN submission.
- Successfully protect and advise clients during TSCA enforcement inspection of facilities and EPA audit of activities with little advanced notice.
- Provide advice regarding TSCA Section 8 reporting and record keeping requirements, including chemicals covered, persons covered, information to be reported and retained, and reporting deadlines.
- Provide advice regarding TSCA Section 12 export notification requirements and implement same. Incorporate notice requirements into client sales documents and supply agreements.
- Provide advice regarding applicability of FIFRA to core-products utilizing nanoscale materials.
- Assist 22,000 employee 501(c)(3) charitable trust in identifying and managing potential environmental, health, and safety exposure arising from research, development, and commercialization of cutting-edge chemical application. Implement global environmental, health, and safety program for application. Counsel global in-house counsel regarding potential liability issues.
- Assist European subsidiary of U.S.-based commercial aircraft brake system manufacturer with complex REACH due diligence and planning related to products incorporating nanoscale chemical materials.
- Draft safety data sheets and hazard communications and provide advice regarding distribution methods.
- Draft and submit formal comments regarding various proposed environmental, health, and safety regulations on local, state, and federal levels.