Sample_Task_Order_TOX_Assessment_for_RFQ_CPSC-Q-16-0038.docx

SAMPLE TASK ORDER TOXICOLOGY ASSESSMENT FOR RFQ# CPSC-Q-16-0038

SAMPLE TASK ORDER TOXICOLOGY ASSESSMENT FOR RFQ# CPSC-Q-16-0038

STATEMENT OF WORK

Toxicity Review of Tris(2-chloroethyl) phosphate Background Flame retardants (FRs) are chemicals that are added to natural and synthetic materials to improve their resistance to ignition or reduce flame spread after ignition occurs (WHO, 1998). FRs are used in a variety of consumer products including upholstered furniture, mattresses, appliances, electronics, and apparel. The U.S. Consumer product Safety Commission (CPSC) has been studying the toxicity of FR chemicals since the 1970’s. CPSC has investigated the use of FRs in children’s sleepwear (CPSC, 1977; Ulsamer et al., 1980), upholstered furniture cover fabrics (Babich and Thomas, 2001; NRC, 2000), upholstered furniture foam (Babich, 2006), and mattresses (Thomas and Brundage, 2006). Currently, the CPSC staff is interested in the use of FR chemicals in children’s products, specifically the use of Tris(2-chloroethyl) phosphate (TCEP). Chemical Abstracts Service (CAS) numbers associated with TCEP include 115-96-8 and 29716-44-7. CPSC has found 183 TOXLINE citations relating to TCEP, and it has been reviewed in a number of documents (Babich, 2005; Babich, 2006; Bittner et al., 2001; EPA, 2005; Ferrante, 1999).

Objective The objective of this task is to summarize the available hazard data for TCEP.

Description of Task The Contractor shall provide an estimate for the outlined work for TCEP. The CPSC Contracting Officer Representative (COR) will provide a preliminary literature search by CAS number of TOXLINE citations and electronic copies of references already in their possession.

The Contractor shall:

Meet with the COR by telephone prior to beginning the task.

Meet with the COR by telephone following the completion of each of the subtasks listed below to discuss progress on the task.

Select and obtain references for TCEP that include data relating to 1) relevant physico- chemical properties and 2) the potential for human and toxicity and exposure.

· The Contractor shall supplement the preliminary literature search using any additional databases available and considering synonyms and chemical names in addition to the CAS number.

The Contractor may rely on authoritative reviews for general toxicity and physic-chemical information but should review key references on health effects. Key references include those that identify no adverse effect levels, lowest adverse effect levels, or dose response information for carcinogenicity, reproductive/developmental effects, or chronic organ toxicity.

In reviewing the toxicity data, a higher priority will be given to studies relating to human toxicity. This will include data in humans, animal studies, and in vitro studies.

Information on environmental effects (e.g., ecotoxicity, bioaccumulation, and biopersistence) is of secondary interest, unless other data do not exist and it can be related to human or mammalian toxicity.

After consultation with the CPSC COR, summarize the relevant references into a report.

The report will be broken down into discussion points using the following format, where possible. This format is not all inclusive and can be added to or subtracted from when information does or does not exist.

1. Introduction

2. Physico-chemical Characteristics

· To include basic physico-chemical data, CAS numbers, chemical names, trade names, and synonyms as identified in ChemIDplus (http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp)

3. Manufacture, Supply, and Use

4. Toxicokinetics

· Absorption

· Distribution

· Metabolism

· Excretion

5. Hazard Information

· Acute Single Dose Toxicity

· Acute, Subchronic, and Chronic Single- and Repeat-Dose Toxicities

· Lowest Hazard Endpoints (i.e., NOAEL, LOAEL) by organ system and exposure duration

· Overall Uncertainty

6. Human Exposure, with emphasis on residential or consumer exposures

· Exposure studies will be listed and briefly summarized as to results and type of study

7. Discussion—including significant data gaps

8. References

Sections under “Hazard Information” should also discuss dosing duration (i.e. Acute, Subchronic, and Chronic) when the information exists.

Copies of references cited and the report will be made available to the CPSC COR in electronic form where possible or paper form where electronic form is not available.

The report is subject to CPSC acceptance. The Contractor shall work with the CPSC COR to address comments from CPSC reviewers.

Period of Performance The period of performance shall be 120 calendar days from the task order award date.

Deliverables or Performance The Contractor shall provide the requested information in the form of a written report to the CPSC COR within ninety (90) calendar days after the initial meeting. The report shall be in the format of a scientific report with full citations, tables, and figures as discussed above. The reviewer will e-mail the report to the CPSC COR in a Microsoft Word (preferred) or WordPerfect file.

Delivery Schedule

Place of Delivery U.S. Consumer Product Safety Commission 5 Research Pl Rockville, MD 20850

Inspection and Acceptance The Draft Toxicity Review report submitted to CPSC will be reviewed within 15 calendar days of receipt for questions and/or comments. If returned to the Contractor as a result of the review, the Contractor shall address and/or revise their report accordingly and return the draft final version to the COR within 30 calendar days of receipt. The CPSC COR will then have 15 calendar days to review the Final Toxicity Review report. If necessary, any additional questions and/or comments from the CPSC COR will be addressed by the Contractor within 7 calendar days of receipt. The CPSC COR will then have 7 calendar days for final acceptance.

Requirement for CPSC Clearance The final report is the property of the CPSC. The Contractor shall not publish the final report, present the information at scientific meetings, or in any other way make the findings public in any form without the written permission of the COR. Any publication must be cleared following CPSC procedures, as outlined in the Consumer Product Safety Act.

References Babich, M.A. 2005. Nomination of FR Chemicals for NTP Testing. Letter from Michael A. Babich, CPSC to Scott Masten, National Toxicology Program. U.S. Consumer Product Safety Commission. August 1, editor.

Babich, M.A. 2006. CPSC Staff Preliminary Risk Assessment of Flame Retardant (FR) Chemicals in Upholstered Furniture Foam. D.f.H.S. U.S. Consumer Product Safety Commission, Bethesda, MD 20814. December 21, 2006, editor.

Babich, M.A., and T.A. Thomas. 2001. CPSC staff exposure and risk assessment of flame retardant chemicals in residential upholstered furniture. B. U.S. Consumer Product Safety Commission, MD 20814. April 2001, editor.

Bittner, P.M., J. Ferrante, K.M. Hatlelid, L.E. Saltzman, and M.A. Babich. 2001. An evaluation of the toxicity data for selected flame retardant chemicals. The Toxicologist. 60:2014A.

CPSC. 1977. Children's wearing apparel containing TRIS; interpretation as a banned hazardous substance. Federal Register. 42:18850-18854. [Later withdrawn following judicial proceedings.].

EPA. 2005. Furniture flame retardancy partnership: Environmental profiles of chemical flame-retardant alternatives for low-density polyurethane foam. Design for the Environment Program, u.S. Environmental Protectin Agency, Washington, DC. September 2005.

Ferrante, J. 1999. Toxicity review of aromatic phosphate plasticizers. U.S. Consumer product Safety Commission, Bethesda, MD 20814.

NRC. 2000. Toxicological Risks of Selected Flame Retardant Chemicals. National Research Council, National Academy Press, Washington, DC.

Thomas, T.A., and P. Brundage. 2006. Quantitative assessment of potential health effects from the use of flame retardant (FR) chemicals in mattresses. B. U.S. Consumer Product Safety Commission, MD 20814. January 2006, editor.

Ulsamer, A.G., R.E. Osterberg, and J.J. McLaughlin. 1980. Flame retardant chemicals in textiles. Clin Toxicol. 17:101-132.

WHO. 1998. Environmental Health Criteria, 209. Flame retardants: Tris(Chloropropyl) phosphate and Tris(2-Chloreothyl) phosphate. In WHO. ENVIRONMENTAL HEALTH CRITERIA, 209; FLAME RETARDANTS: TRIS (CHLOROPROPYL) PHOSPHATE AND TRIS(2-CHLOREOTHYL) PHOSPHATE. XIX+106P. WHO: GENEVA, SWITZERLAND. ISBN 92-4-157209-4; 209 (0). 1998. i-xix; 1-106.