Chemical Constituents of Cigarette Butts

Part 1 - Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

This solicitation is being issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-88-1.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541690. Its associated Small Business size standard is $15M. This solicitation is for full and open competition.

Part 2 - Supplies or Services and Prices/Costs

Purchase Order Type: Firm-Fixed Price
Base Year
Task Description Price
1 Cigarette Butt Collection, Identification of Test Methods, and Analysis Plan Development
2 Preparation of Leachate
3 Analysis of Leachate
4 Draft Final Report
5 Final Report
6 Final Briefing
Total

Part 3 - Description/Specifications

3.1 Background
A major existing environmental consequence of cigarette use is the waste disposal of discarded cigarette filters, as an estimated 4.5 trillion cigarette butts are thrown away every year worldwide and 1.69 billion
pounds of cigarette butts are disposed of as toxic trash each year. , In addition, research has shown cigarette butt leachate to be toxic to fish.

The National Environmental Policy Act requires an impact analysis on the environment, as well as scenarios that could lead to human health impact, for federal actions, such as tobacco product marketing authorizations. Information about the identities and amounts of constituents that leach from cigarette butts is limited and is necessary to characterize the hazard and model the fate and transport of the constituents in the environment. A preliminary study to identify leachable constituents, including Harmful/Potentially Harmful Constituents (HPHCs), from cigarette butts will provide information to design focused, high value, cost effective fate and effects studies when needed in the future.

3.2 Statement of Work

The objectives of this study are to:
• conduct laboratory analysis of three replicates from a single cigarette butt leachate; and
• characterize and quantify the different chemical constituents and HPHCs from the lab analysis for the leachate

Under the contract, the FDA is interested in conducting a study to support characterization and quantification of specific chemical constituents and HPHCs in leachate from cigarette butts.

Tasks/Requirements
The Contractor shall:
• determine appropriate "off the shelf" analytical methodologies (e.g. - EPA Methods 8270 and 8310 for organics and EPA Method 200 series for metals) for the constituents of concern identified in Task 2;
• collect cigarette butts for analysis;
• prepare cigarette butt leachate;
• measure the amounts of each chemical constituent and HPHCs in the leachate;
• identify unknown constituents that have a mass greater than 10% of the total injected mass;
• monitor, manage, and maintain data collected during the contract period; and
• submit a final report that includes the following sections: executive summary, methods, results, discussion, and conclusions.

The Contractor shall follow all federal, state, and local environmental, health, sanitation and emissions regulations. In addition, the Contractor shall follow all applicable Environmental Protection Agency (EPA) and Occupational Safety & Health Administration (OSHA) regulations. Disposal of cigarette butts, leachates and laboratory waste must follow the above environmental, health and safety regulations.

Task 1: Cigarette Butt Collection, Identification of Test Methods, and Analysis Plan Development

The Contractor shall identify the project timeline, develop and implement a cigarette butt collection plan, and develop an analytical methods plan for conducting the leachate tests. Additionally, the Contractor shall conceptualize how the analysis shall be performed based on the list of chemical constituents in Task 3. The Contractor must verify that the selected test methods have been validated to achieve the study's objectives. The methods must be determined to be fit for purpose, which includes consideration of, but not limited to, the following method characteristics: accuracy, precision, robustness, limit of detection, limit of quantification, range, and specificity. The Contractor, with concurrence from the COR, may perform multiple tasks at one time for efficiency. The Contractor shall submit a cigarette butt collection plan, test methods for conducting leachate tests, and an analysis plan to the COR for concurrence and feedback.

The Contractor shall collect cigarette butts to use for preparing the leachate. This study is not a human subject study. This study is not a research activity involving human subjects for study recruitment. It does not involve obtaining information about living individuals. There will be no interaction or intervention with individuals. No individuals will be interviewed nor their individually identifiable information obtained. The study does not involve videotaping, recording, or surveying individuals. The Contractor shall collect only cigarette butts and will not interact with humans from whom cigarette butts are obtained.

Task 2: Preparation of Leachate

The Contractor shall prepare a leachate by placing cigarette butts in distilled or deionized water for 24 hours, making note of cigarette butt weights, number of butts used and water volume. The Contractor shall determine the appropriate volume of water and number of butts to use in order to minimize the need for, or number of, extraction and concentration steps.

Task 3: Analysis of Leachate

Using the validated analytical methods proposed in Task 4, the Contractor shall analyze three replicates of the leachate to quantify levels of each chemical constituent and HPHC. The Contractor shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. The Contractor shall quantify the chemical constituents and HPHCs listed below:

1,3-Butadiene Acrolein Crotonaldehyde PAHs (total) Chromium (Cr)
1-Aminonaphthalene Acrylonitrile Formaldehyde Phenol and catechol Lead (Pb)
2-Aminonaphthalene Aldehydes (total) Isoprene m-, p-, and o-cresol Mercury (Hg)
4-Aminobiphenyl Benzene Nicotine (total and free) Arsenic (As) pH
Acetaldehyde Benzo[a]pyrene NNK and NNN Cadmium (Cd) Glycerol, propylene glycol ethylene glycol, and diethylene glycol

In addition to the above list, the Contractor shall identify any constituents not on the list (i.e. - unknown) that have a mass greater than 10% of the injected mass. Analytical results will be reported in mg/L, mg/cigarette butt and mg/kg of cigarette butts.

Task 4: Draft Final Report

The Contractor shall submit a draft of the final report within 3 months of contract award. The Contractor shall prepare a detailed final report including: 1) an executive summary; 2) identification of the laboratory used and methods describing how the data was collected and analyzed; 3) results of the analysis; 4) discussion, including problems encountered during the study and their solutions; and 5) conclusions; and 6) related appendices. As a part of the final report, the Contractor shall submit analytical procedures (including details regarding extraction procedures and/or any other procedures used during sample preparation), validation reports, system suitability, and any other pertinent information for measuring the analytes indicated in Task 3.

Task 5: Final Report

The Contractor shall submit a Final Report within 4 months that presents the objectives, methods, results of the analyses, and summarizes the findings and conclusions of the project. The Final Report shall include the required elements outlined for the draft report (Task 4) and shall incorporate any revisions based on comments received from the FDA.

The Contractor shall provide the Final Report to the COR in the following manner:
1. An electronic version of the final report.
2. The final report delivered on a CD Rom.

Task 6: Final Briefing

Within 4 months of the award, the Contractor shall conduct a final briefing to FDA personnel via web conference. This briefing shall consist of a 30- to 40-minute presentation of the project and shall include a background on the problem, descriptions of methods used, the results of the tasks, and a brief discussion of the results and problems encountered during the study. The Contractor shall be prepared with appropriate briefing materials and shall send their presentation materials to the COR for review within two days prior to the presentation date.

Key Personnel

The Contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel

• Principal Investigator/Project Manager
• Lead Scientist
• Technician

Part 4 Performance and Deliverables

4.1 Place of Performance

The work for this project will take place at the Contractor's laboratory facility and contractor site. All deliverables shall be sent to the COR electronically at the following address:

COR / Point of Contact:
Food and Drug Administration
Center for Tobacco Products
Division of Regulatory Project Management, Branch I
10903 New Hampshire Avenue
White Oak Campus, Bldg. 32, Rm 4144
Silver Spring, MD 20993

ATTN: TBD

4.2 Deliverables

Task Description Estimated Completion Date
1 Kickoff Meeting/ Initial Briefing Within 2 weeks after award
1 Develop a cigarette butt collection plan, test methods, and an analysis plan Within 2 weeks after award
1 Collect cigarette butts to use for preparing the leachate Within 1 month after award
2 Prepare leachate Within 1 ½ months after award
3 Analyze replicates of the leachate Within 2 months after award
4 Summarize findings in draft report Within 3 months after award
5 Summarize findings for Final Report Within 4 months after award
6 Prepare briefing materials 2 days prior to final briefing
6 Conduct Final Briefing Within 4 months after award

4.3 Reporting

The COR may request conference calls to discuss status of deliverables and any other issues which may arise with the contract. The COR will coordinate a schedule with the Contractor to determine when the conference calls will occur on an as needed basis.

Monthly Progress Reports

The Contractor shall furnish one electronic copy to the FDA COR by the 1st of each month. At a minimum, the progress report shall include a narrative description of the following items:
1. Accomplishments made during the reporting period.
2. Plans for accomplishments in the next reporting period.
3. Interim results, conclusions, trends or other items of information that the Contractor believes are of interest to the FDA.
4. Problems or delays that the Contactor has experienced in the performance of his/her services, as well as any quality assurance and control measures taken during the reporting period
5. Specific action(s) that the Contactor would like the FDA to undertake to alleviate a problem.
6. Due dates for upcoming deliverables.

4.4 Period of Performance

The period of performance is four (4) months or October 1, 2016 to February 3, 2017.

Part 5 - Inspection and Acceptance

The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COR - to be determined upon contract award) is the authorized representative of the Contracting Officer.

The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided.

For the purpose of this PART, (COR) is the authorized representative of the Contracting Officer.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Sean Wybenga
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Sean.Wybenga@fda.hhs.gov;
(240) 402-7629

The contact information for the Contract Specialist is the following:

Lisa Yaw
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Lisa.Yaw@fda.hhs.gov;
(240) 402-4018