EPA PMN, SNUN, Bona-Fide and NOC Services

On behalf of Reddwall Solutions, I’m pleased to offer information and pricing on the provision of Consultation Services for USEPA PMN–SNUN Registration involving Carbon Nanotube Materials and Products. Per our discussions, this proposal presents a narrow Scope of Work (SOW) and is limited to consultation and support services related to obtaining EPA-TSCA approval for the import and manufacturing Carbon Nanotube Materials and Products. 

As a part of this work, Reddwall Solutions, LLC (“RWS”) will collate existing EPA-TSCA and client documentation, communicate with EPA as needed to support requirements, advise client as to findings and iteratively process the documentation necessary to facilitate TSCA Registration of client materials. More specifically, as outlined by the anticipated schedule of activities, RWS will serve as expert intermediary between client and EPA to facilitate filings, respond to EPA requests for additional information and generate data where needed to complete Registration of client products. Upon completion and achievement of the goals set forth herein, client will gain the ability to process and import those products and materials needed to commercially produce and distribute Carbon Nanotube Materials and Products within the United States of America.

The services described herein provide universal support activities including communications with EPA, filing of required Registration paperwork and iterative exchanges, both verbally and in writing with EPA to update filing information and to facilitate completion of the Registration process.

PMN-SNUN Consulting Services

EPA-TSCA REGISTRATION SERVICES

The purpose of this proposal is to support the manufacturing efforts of the Favored Client named above (now referred to as “Sponsor”) by providing guidance, consultation and navigation within the United State Environmental Protection Agency’s Premanufacture Notice (PMN) and Significant New Use Notice (SNUN) regulatory framework. The scope of activity involves the introduction of Carbon Nanotube importing and manufacturing to Sponsor operations within the United States and relates specifically to those chemical substances specified by Sponsor.

The purpose of this proposal is to support the manufacturing efforts of the Favored Client named above (now referred to as “Sponsor”) by providing guidance, consultation and navigation within the United State Environmental Protection Agency’s Premanufacture Notice (PMN) and Significant New Use Notice (SNUN) regulatory framework. The scope of activity involves the introduction of Carbon Nanotube importing and manufacturing to Sponsor operations within the United States and relates specifically to those chemical substances specified by Sponsor.
Carbon Nanotubes

Our technical approach to meeting the Statement of Work requirements outlined above is as follows:

  1. Advise Sponsor as to significant details required as part of filing the PMN-SNUN application to USEPA. Overarching content includes:
    • Information on the entity submitting the notice plus key technical personnel
    • General information on the composition, characterization, amount, and production processes associated with the chemical(s) of interest
    • Physicochemical properties of the material(s)
    • Toxicological data for the specific chemical(s) of interest
    • Information related to potential human exposure and environmental release
    • Pollution prevention plans
  2. Provide Sponsor with Registration process support including:
    • Contact and establish working relationship with a PMN-SNUN representative within EPA on Sponsor’s behalf (Prenotice Communication – PC).
    • Acquire detailed information from Sponsor and complete all USEPA documents required for submission.
    • Electronically submit completed forms to USEPA, respond to questions and provide revision statements.
    • Provide Sponsor with bi-weekly status updates and path forward assessments until Registration is complete or services terminate.

This proposal does not include any testing services that USEPA may require. A subsequent quote will be provided for these activities once requirements have been ascertained. Testing may include (but is not limited to):

1.    Material characterization of raw ingredients, intermediates, and As-Presented material(s)

2.    Aerosolization capabilities of the As-Presented material(s) for toxicology purposes

3.    Toxicological assessment & hazard identification (e.g., inhalation)

4.    Workplace industrial hygiene and waste remediation assessments

5.    End-of-life considerations including potential exposure to humans and/or the environment

The period of performance to complete the Scope of Work as laid out is 2-4 months from start unless additional testing is required. The estimated number of hours required to perform the SOW ranges from 65–130 hours depending upon the availability of technical data and extent of EPA inquiry. We understand that Sponsor would like to proceed with USEPA PMN–SNUN Registration in the shortest possible period and in this regard, we will use all reasonable endeavors to perform the work promptly.

The period of performance to complete the Scope of Work as laid out is 2-4 months from start unless additional testing is required. The estimated number of hours required to perform the SOW ranges from 65–130 hours depending upon the availability of technical data and extent of EPA inquiry. We understand that Sponsor would like to proceed with USEPA PMN–SNUN Registration in the shortest possible period and in this regard, we will use all reasonable endeavors to perform the work promptly
CNT – Molecular Structure

All services will be provided incrementally so client has direction over this work. We propose the following decision points whereupon we will:

  1. update client as to services provided and concurrent billing amounts
    • submit updated progress billing for activities performed since prior billing cycle,
  2. identify documents and actions to be prepared and conducted during next steps of work,
  3. clarify ongoing activities and receive approval for next course of work from Sponsor,
  4. provide updated estimate of time and costs for near future and long-term work activities.

Sponsor shall decide whether to further proceed with services in accordance with the decision points stipulated below. We will not proceed with subsequent work steps until Sponsor provides written approval to proceed.

Decision Point 1 – Service Hours to complete and report on PC (5-10 Hours)

Decision Point 2 – Preparation & filing of PMN-SNUN (25-50 Hours)

Decision Point 3 – Review and summarize EPA response to initial filing (5-10 Hours)

Decision Point 4 – Preparation and resubmission of 2nd PMN-SNUN filing (20-40 Hours)

Decision Point 5 – Review and summarize EPA response to 2nd filing (5-10 Hours)

Decision Point 6 – Toxicological Testing Design and Implementation (Quote – If Required)

Decision Point 7 – Preparation and resubmission of 3rd PMN-SNUN filing (Quote – If Required)

Sponsor will be provided with service logs detailing the hours worked and activities performed by each member of the Registration Consulting Team identified below. These logs will be utilized in the preparation of service billings and submitted to Sponsor upon completion of each Decision Point activity. Personnel assigned to the SOW are outlined in the fee structure shown below and individual CVs are attached for review.

PMN-SNUN Consulting Services

TERMS OF SERVICE

In connection with the provision of consultation and support services defined herein, RWS and client agree to the following general terms and conditions:

RWS will:

  1. Provide client with availability and scheduling of services in accordance with the SOW;
  2. Provide qualified professional(s) to perform all activities including consultation, document preparation, EPA communications and analytical services;
  3. Provide client with complete reporting, copies of EPA communications and tabulation of billable activities;
  4. Provide all laboratory equipment and services necessary to conduct the work as described;
  5. Offer similarly priced ongoing services for a period of 180 days from the date of this proposal;
  6. Promptly refund any undisputed client monies retained by RWS, upon either completion of work or termination of this agreement.

Client will:

  1. Provide staffing and support as needed to participate in the work described herein;
  2. Provide documentation as requested, on an expedited basis, to support the work being undertaken;
  3. Determine acceptance of this agreement and issue email acknowledgement of this acceptance;
  4. Provide Reddwall Solutions, LLC with the approval form needed to facilitate client’s contractual arrangements;
  5. Forward a $5000 service retainer to RWS prior to start of work, specific to the performance of work (retained amount shall be held until completion of work or termination of this agreement and applied to any unpaid billings).

The services, as described herein, are offered as a best estimate of the consultation hours needed for completion of each activity and include all normal office services and supply expenses. While RWS expects to achieve Registration within the period prescribed, actual times may be reduced or increased by EPA actions and client submission/approval processing. All services will be provided in accordance with the consultation fee structure outlined herein.

TSCA PMN-SNUN Consulting Services Fee Schedule
TSCA PMN-SNUN Consulting Services Fee Schedule

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Prices supplied are for Consultation Services related to USEPA PMN–SNUN Registration as specified herein and with activity limitations as described. Those tasks and hours identified represent our best estimate, based on the level of information currently available. Client will be advised of any complications or changes in scope which may increase costs, delay completion, or impact our ability to provide services as described. All service billings terms are “due upon receipt.”

This price estimate is subject to Reddwall Solutions’ Terms and Conditions