Mona R. Zarifa, Ph.D.

Publications

Conributed to the development of the following guidance/background documents, manuals and federal register notices at FDA and EPA.

1. CHEMUSE Users Manual, Version 3.0, Contract No. 68-DO-0020, Prepared for EPA/Office of Toxic Substances, by Dynamac Corporation, October 1991.
2. Data Quality Objectives for Analysis of Polychlorinated Dibenzodioxins and Dibenzofurans in Herbicide Waste Samples (SW-846 Method 8280). This is one of over 25 reports for the assessment of SW-846 methods I wrote while employed at SAIC (1992-1993).
3. Docket Report on Health-Based Levels and Solubilities Used in the Evaluation of Delisting Petitions, Submitted under 40 CFR 260.20.22, Prepared for EPA/Office of Solid Waste, Contract No. 68-W9-0091, by SAIC, July 1992.
4. Extraction Procedure for Oily Wastes (SW-846 Method 1330). This is one of over 15 methods developed and published by Dynamac for EPA/Office of Solid Waste that I contributed to during my employment (1987-1992) .
5. Guidance for Industry: Botanical Drug Products, Draft Guidance, FDA/CDER, released for comments in September 1997 and finalized in August 2000.
6. Land Disposal Restrictions for Newly Listed Wastes and Contaminated Debris; Proposed Rule, 57 FR 6, January 9, 1992.
7. New Chemical Review Process Manual, EPA/Office of Toxic Substances, EPA 560-3-86-002, March 1986.
8. SW-846 Methods, Chapter One: Quality Control, December 1987, prepared by Dynamac Corporation for EPA/Office of Solid Waste.
9. SW-Method 1311 Toxicity Characteristics Leaching Procedure (TCLP), 55 FR 61, March 29, 1990.
10. Toxic Chemical Release Inventory Reporting Form R and Instructions, Revised 1990 Version, Section 313 of the Emergency Planning and Community Right-to-Know Act (Title III of the Superfund Amendments and Reauthorization Act of 1986), EPA/Office of Toxic Substances, EP 560/4-91-007, January 1991.
11. TSCA CBI Computer Security Analysis: Options for Protecting and Disseminating TSCA Confidential Business Information in Automated Information Systems, Contract NO. 68-02-4283, Prepared for EPA/Office of Toxic Substances, by Dynamac Corporation, October 1988.