oEPA United States Environmental Protection Agency Prevention, Pesticides And Toxic Substances (TS-794) EPA 743-B-92-001 September 1992 EPA Biotechnology Directory • 1 4 7 * 2 5 8 0 3 6 9 # Printed on Recycled Paper ------- ALPHABETICAL LISTING AND OFFICE OF ENFORCEMENT (OE) OFFICE OF GENERAL COUNSEL (OGC) OFFICE OF PESTICIDES PROGRAM (OPP) OFFICE OF POLICY, PLANNING AND EVALUATION (OPPE) OFFICE OF POLLUTION PREVENTION AND TOXIC (OPPT) OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES (OPPTS) OFFICE OF RESEARCH AND DEVELOPMENT REGIONS ------- BIOTECHNOLOGY DIRECTORY ALPHABETICAL NAME: Robert J. Allen TITLE: Acting TRI Program Manager ORGANIZATION: EPA Region 5, Environmental Sciences Division, Pesticide and Toxics Substances Branch MAIL CODE: SP-14J PHONE NUMBER: 312-353-5871 PAX NUMBER: 312-353-4342 BRIEF DESCRIPTION: Group handles TSCA Sections 4, 5,8,12, and 13 including PMNs. Background in environmental engineering with a Ph.D. in Bioengineering. Ten years in academic and public health. NAME: Robert Andrei TITLE: Economist ORGANIZATION: OPPT/ETD/RIB MAIL CODE: TS-779 PHONE NUMBER: 202-260-7693 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Preparation of the Regulatory Impact Analysis for the proposed TSCA rule and preparation of economic assessments in connection with standard reviews of biotechnology PMNs. ------- NAME: Mary Jane Angelo, J.D. TITLE: Attorney ORGANIZATION: OGC/PTSD MAIL CODE: LE-132P, Rm. W1031 PHONE NUMBER: 202-260-7524 FAX NUMBER: 202-260-2432 BRIEF DESCRIPTION: Advises on FIFRA biotechnology matters and related issues. NAME: Karl H. Arne TITLE: Pesticide Specialist ORGANIZATION: EPA Region 10 MAIL CODE: AT-083 PHONE NUMBER: 206-553-8577 FAX NUMBER: 206-553-0110 BRIEF DESCRIPTION: Region 10 pesticide section biotechnology contact, Chemist. NAME: H. Kay Austin, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/EED MAIL CODE: TS-798 PHONE NUMBER: 202-260-3927 FAX NUMBER: 202-260-0018 BRIEF DESCRIPTION: Assess Environmental Fate and Non- occupational exposure of genetically modified micro- organisms released to the environment; gene stability and gene transfer; protocol review; field test data review. ------- NAME: Pat Bagley TITLE: Plant Pathologist/Entomologist ORGANIZATION: OPP/RD/IRB MAIL CODE: H7505C PHONE NUMBER: 703-305-5412 FAX NUMBER: 703-305-6920 BRIEF DESCRIPTION: Works mostly with pheromones and fungal entomopathogens. NAME: Donald Baumgartner TITLE: Life Scientist ORGANIZATION: ESD/PTSB, EPA Region 5, Pesticides Section MAIL CODE: SP-14J PHONE NUMBER: 312-886-7835 FAX NUMBER: 312-353-4342 BRIEF DESCRIPTION: As a general biologist, with a specialty in medical entomology, provides reviews of biotechnology products used as pesticides under FIFRA. Technical assistance relating to biotechnology is also provided to Region 5. NAME: David Bays, Ph.D TITLE: Microbiologist ORGANIZATION: OPP/EFED/EEB MAIL CODE: H7507C PHONE NUMBER: 703-305-6449 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Biological pesticides/biotechnology/ transgenic plant pesticides/ecological effects risk assessment. ------- MAKE: Clay Beegle, Ph.D. TITLE: Entomologist ORGANIZATION: OPP/EFGWB MAIL CODE: H7507C PHONE NUMBER: 703-305-5893 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Reviewer/insect pathologist/member OPP biotechnology workgroup. NAME: Bob Benson TITLE: Senior Policy Analyst ORGANIZATION: OPPE/TSPB MAIL CODE: PM-220 PHONE NUMBER: 202-260-8668 FAX NUMBER: 202-260-0174 BRIEF DESCRIPTION: OPPE analyst for OPPT biotechnology activities (including TSCA Rule). NAME: Frederick S. Betz TITLE: Acting Chief, Science Analysis and Coordination Staff ORGANIZATION: OPP/SACS/EFED MAIL CODE: H7507C PHONE NUMBER: 703-305-6307 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Coordinates development and imple- mementation of OPP's Regulatory Program for Biological Pesticides. ------- Name: Joan Blake TITLE: Biologist ORGANIZATION: OPPT/CMD/CRB MAIL CODE: TS-798 PHONE NUMBER: 202-260-6236 PAX NUMBER: 202-260-1724 BRIEF DESCRIPTION: Responsible for writing Headquarters permits for disposal of PCBs with Bioremediation processes. NAME: Michael W. Broder, Ph.D. TITLE: Microbiologist; Technical Integrator ORGANIZATION: OPPT/HERD/CREB MAIL CODE: TS-796 PHONE NUMBER: 202-260-3498 FAX NUMBER: 202-260-1283 BRIEF DESCRIPTION: Microbiologist - Technical Integrator for TSCA biotechnology PMNs. Assembles the individual ecological, human health, exposure, and chemistry reports into the final integrated risk assessments for standard reviews of biotechnology PMNs. ------- Name: Diane D. Buxbaum TITLE: Environmental Protection Specialist ORGANIZATION: EPA Region 2, Pesticides and Toxics Substances Branch MAIL CODE: MS-105 PHONE NUMBER: 908-906-6893 FAX NUMBER: 908-906-6788 BRIEF DESCRIPTION Epidemiologist/Biologist. Liaison person for biotechnology issues and responsible for technical assistance for the Pesticides and Toxic Substances Branch. NAME: Alan H. Carpien, J.D. TITLE: Attorney ORGANIZATION: OGC/PTSD MAIL CODE: LE-132P, Km. W1045 PHONE NUMBER: 202-260-7217 FAX NUMBER: 202-260-2432 BRIEF DESCRIPTION: Advises on TSCA biotechnology matters and related issues. NAME: Ellie Clark TITLE: Rule Editor ORGANIZATION: OPPT/CCD/PDB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3402 FAX NUMBER: 202-260-0118 or 202-260-1216 BRIEF DESCRIPTION: Responsible for the development of the biotechnology rule for TSCA and interpretation of the 1986 Policy Statement. This includes addressing policy issues that arise and may affect the biotechnology regulations. OPPT representative on the workgroups for the FIFRA biotechnology rule and transgenic plants policy. ------- NAME: Edward H. Cohen TITLE: Environmental Scientist ORGANIZATION: EPA Region 3, TSCA Enforcement Section MAIL CODE: 3AT31 PHONE NUMBER: 215-597-7668 PAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: TSCA Biotechnology Coordinator; Sections 5,8,12,13, GLP and 6 (disposal methods for PCBs). Chemist with strong biochemical, GLP, Biology and previous biotechnology experience (Pre-1970). NAME: David F. Cole • TITLE: Environmental Protection Specialist ORGANIZATION: EPA Region 6, Pesticides Section, Pesticides and Toxics Branch, Air, Pesticides and Toxics Division MAIL CODE: 6T-PT PHONE NUMBER: 214-655-7239 FAX NUMBER: 214-655-2164 BRIEF DESCRIPTION: Biotechnology Test Compilation, Arkansas Special Initiatives. Background: 24 years in research and development in chemical processing of semiconductor devices at Texas Instruments. Bachelor of Science in Chemistry, Ph.D. in Physical Chemistry, M.B.A. NAME: Leonard Cole TITLE: ORGANIZATION: OPP MAIL CODE: H7505C PHONE NUMBER: 703-305-7801 FAX NUMBER: BRIEF DESCRIPTION: ------- NAME: Christina Colt, TITLE: Environmental Engineer ORGANIZATION: EPA Region 10, Toxic Substances Section MAIL CODE: AT-083 PHONE NUMBER: 206-553-8577 FAX NUMBER: 206-553-0110 BRIEF DESCRIPTION: Core TSCA Coordinator (includes tech- nical assistance, review of HQ documents, and enforce- ment of biotechnology rules). Background: Mechanical Engineering degree from U.C. Davis with emphasis on bio- engineering for Aquaculture and Aquatic medicine. NAME: Larry Culleen TITLE: Chief, New Chemicals Branch ORGANIZATION: OPPT/CCD/NCB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3725 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Coordinates policy and. procedural issues arising in the TSCA biotechnology program. NAME: Glenda Dugan TITLE: Life Scientist ORGANIZATION: Region 9, Pesticides and Toxics Branch MAIL CODE: A-4-5 PHONE NUMBER: 415-774-1066 FAX NUMBER: 415-774-1073 BRIEF DESCRIPTION: Sub-Lead Regional Coordinator for biotechnology, responsible for regional review, technical assistance for TSCA and FIFRA biotechnology issues. Background: Biologist with USDA-ARS in food safety research. ------- NAMEi Laura Dye TITLE: Biologist ORGANIZATION: OPP/IRB/RO MAIL CODE: H7505C PHONE NUMBER: 703-305-6891 PAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Works mostly with pheromones, microbial and transgenic plants. NAME: Tracy Fitzgerald TITLE: Regional Liaison ORGANIZATION: OPP/FOD/ROB/RSS MAIL CODE: H7506C PHONE NUMBER: 703-305-6140 FAX NUMBER: 703-308-3259 BRIEF DESCRIPTION: Responds to regional concerns, problems, and informational needs. Principal OPP liaison for Regional Biotechnology Teleconference calls. NAME: Robert J. Frederick, Ph.D. TITLE: ORD Biotechnology Research Coordinator ORGANIZATION: ORD/OEPER/R&D MAIL CODE: RD-682 PHONE NUMBER: 202-260-5971 FAX NUMBER: 202-260-6370 BRIEF DESCRIPTION: Liaison for Biotechnology Research with Regulatory Program Offices, Federal Agencies, Academia, and International Programs. Advanced degree in Microbiology and Molecular Biology; Research Scientist (8 years), Regulatory Program (OTS, 4 years). ------- NAME: Damon P. Frizzell • TITLE: Environmental Scientist ORGANIZATION: EPA Region 7 MAIL CODE: ARTX/TOPE/PPDS PHONE NUMBER: 913-551-7560 PAX NUMBER: 913-551-7065 BRIEF DESCRIPTION: Masters Degree in Weed Science, from Oklahoma State University. Five years experience in crop research and field development. Two years experience in regional pesticides program. NAME: Scott Garrison TITLE: Attorney ORGANIZATION: OE/TLD MAIL CODE: LE-134P PHONE NUMBER: 202-260-3073 FAX NUMBER: 202-260-1347 BRIEF DESCRIPTION: OE representative on TSCA and FIFRA biotechnology rules. NAME: David Giamporcaro TITLE: Section Chief, Biotechnology Program ORGANIZATION: OPPT/CCD/PDB MAIL CODE: TS-794 PHONE NUMBER: 202-260-6362 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Responsible for managing the TSCA biotechnology program, including review of biotechnology PMNs, interpretation of the 1986 Policy Statement, and development of the proposed TSCA biotechnology regulations. ------- NAME: Susanne Giannini TITLE: Senior Policy Analyst ORGANIZATION: OPPE/PPB MAIL CODE: PM-220 PHONE NUMBER: 202-260-7570 PAX NUMBER: 202-260-0174 BRIEF DESCRIPTION: OPPE Analyst for OPP biotechnology activities (including FIFRA Rule and Transgenic Plant Policy). NAME: Jerry Gidner TITLE: Attorney ORGANIZATION: OE/TLD MAIL CODE: LE-134P PHONE NUMBER: 202-260-8694 PAX NUMBER: 202-260-1347 BRIEP DESCRIPTION: Headquarters Attorney newly assigned to OPP Transgenic Plants workgroup. Background in Bio- logy and Zoology. NAME: Carl Grable, Ph.D. TITLE: Plant Pathologist ORGANIZATION: OPP/RD/FHB MAIL CODE: H7505C PHONE NUMBER: 703-305-7392 PAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Registration specialist for biotechnology products which are fungicides, herbicides, nematocides or plant regulators. ------- NAME: R. Paul Grimm TITLE: Compliance Inspector, Chemical Engineer ORGANIZATION: EPA Region 8, Air, Radiation and Toxics Division, Toxic Substances Branch MAIL CODE: SART-TS PHONE NUMBER: 303-293-0981 FAX NUMBER: 303-294-7559 BRIEF DESCRIPTION: Compliance Inspector under TSCA Sections 5 and 8 and EPCRA - Title III Section 313. More than 30 years of experience in the Chemical and Chemical Related Industries, including plant operations and plant design. NAME: Steven M. Hassur, Ph.D. TITLE: Senior Chemist ORGANIZATION: OPPT/ETD/ICB MAIL CODE: TS-779 PHONE NUMBER: 202-260-1735 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Directs the biotechnology chemical review activities of the Industrial Chemistry Branch (ICB) in ETD. An organic chemist, with research experience in analytical biochemistry, DNA/RNA synthesis, enzymology, and immunology. NAME: Linda A. Hollis TITLE: Microbiologist ORGANIZATION: OPP/IRB/RD MAIL CODE: H7505C PHONE NUMBER: 703-305-6397 FAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Responsible for the scientific review of data and labels for the registration of biologicals/ genetically engineered microbial pesticides. ------- NAME: Shirley D. Howard TITLE: Environmental Protection Specialist ORGANIZATION: OPPT/CCD/PDB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3780 PAX NUMBER: 202-260-0118 or 202 260-1216 BRIEF DESCRIPTION: Responsible for initiating the HQ/Regional Teleconference calls and developing the Biotechnology directory. Serves as liaison between the TSCA biotechnology program, and OPP, other HQ offices, and the Regions. Also assists the senior Program Managers during standard reviews of Biotechnology PMNs. NAME: Phil Hutton TITLE: Supervisory Biologist - Product Manager (18) ORGANIZATION: Insecticide/Rodenticide Branch MAIL CODE: H7505C PHONE NUMBER: 703-305-7690 FAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Heads Product Management Team 18, responsible for registration of Microbial, Botanical, Biochemical and Transgenic Insecticides. ------- NAME: Y'Vonne Jones-Brown, Ph.D. TITLE: Senior Microbiologist ORGANIZATION: OPPT/IMD/CIS/CDB MAIL CODE: TS-793 PHONE NUMBER: 202-260-1549 FAX NUMBER: 202-260-1657 BRIEF DESCRIPTION: Expertise: Microbiologist with know- ledge/experience purifying and characterizing active bio- logical substances. Duties: Inventory - develop policies/interpretative guidance and procedures for describing microorganisms on the Inventory; make Inventory status determinations; participate in development of TSCA Biotechnology rule; participate in review of Biotechnology submissions. NAME: Robert W. Koethe TITLE: Pesticides Expert ORGANIZATION: EPA Region 1, Pesticides Section MAIL CODE: APP PHONE NUMBER: 617-565-3702 FAX NUMBER: 617-565-4939 BRIEF DESCRIPTION: NAME: John L. Kough TITLE: Biologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-308-2833 FAX NUMBER: 703-305-5147 BRIEF DESCRIPTION: Reviews toxicity, taxonomy and DNA construct data to support biological pesticides regis- trations. Expert in plant pathology, microbial taxonomy, and molecular biology. ------- NAME: Leo LaSota, Ph.D. TITLE: Biologist ORGANIZATION: OPP/EFED/EFGWB MAIL CODE: H7507C PHONE NUMBER: 703-305-5774 PAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Works with transgenic plant pesticides, gene flow and environmental fate. NAME: Cynthia A. Lewis TITLE: Attorney ORGANIZATION: OPPT/IMD/PALS/CDB MAIL CODE: TS-793 PHONE NUMBER: 202-260-4399 FAX NUMBER: 202-260-1675 BRIEF DESCRIPTION: Attorney dealing with Confidential Business Information (CBI) issues and related matters. NAME: Susan Lewis TITLE: Product Manager ORGANIZATION: OPP/RD/FHB/Team 21 MAIL CODE: H7505C PHONE NUMBER: 703-305-6900 FAX NUMBER: 703-305-1825 BRIEF DESCRIPTION: Works with registration of fungicides and herbicides. ------- NAME: Don Lott (FIFRA) TITLE: Section Chief, Pesticides Management Section ORGANIZATION EPA Region 3 MAIL CODE: 3AT32 PHONE NUMBER: 215-597-9870 PAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: Entomologist/Environmental Scientist; 20 years professional experience in pesticides field; 5 years with EPA. NAME: Greg Macek TITLE: Chemical Engineer ORGANIZATION: OPPT/ETD MAIL CODE: TS-779 PHONE NUMBER: 202-260-9597 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Develops occupational exposure and environmental release assessments for biotechnology PMNs. Also provides technical support to 5(h)(4) exemption assessment process. ------- NAME: Sharlene Matten, Ph.D. TITLE: Biologist ORGANIZATION: OPPTS, Science and Policy Staff MAIL CODE: TS-788 PHONE NUMBER: 202-260-6900 FAX NUMBER: 202-260-1847 BRIEF DESCRIPTION: Ph.D. in biochemistry (plant-pathogen interaction) in 1989 from Oklahoma State University. Post-doctoral work in prokaryotic molecular biology at the University of Maryland. Joined EPA in June 1991 as part of the OPPTS Assistant Administrator's Science and Policy staff. Duties are to help coordinate and develop biotechnology policy under FIFRA, TSCA, and FFDCA. Serves as a liaison between OPPTS and OPP. Name: Susan Mayer. TITLE: Life Scientist ORGANIZATION: EPA Region 4, Pesticides Section MAIL CODE: 4 APT PHONE NUMBER: 404-347-3222 FAX NUMBER: 404-347-1681 BRIEF DESCRIPTION: Regional contact person for Biotech- nology in Region 4, Pesticides Section. Background in Biology and Microbiology. ------- NAME: J. Thomas McClintock, Ph.D. TITLE: Microbiologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-305-7973 PAX NUMBER: 703-305-5174 BRIEF DESCRIPTION: Involved in the toxicological evalua- tion of data pertaining to microbial and biochemical pest control agents, and in the evaluation of the molecular construction of genetically engineered microbial and transgenic plant pesticides for regulatory compliance. Participates in the development of policy and in the establishment of guidelines for transgenic pesticidal plants. HED Product Manager for biochemical pesticide products. NAME: .Gwendolyn McClung, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/HERD/EEB MAIL CODE: TS-796 PHONE NUMBER: 202-260-1272 FAX NUMBER: 202-260-7883 BRIEF DESCRIPTION: Soil Microbiologist responsible for ecological hazard assessments for deliberately modified microorganisms and for development of an ecological tier- testing scheme for such microorganisms. ------- NAME: Michael L. Mendelsohn TITLE: Microbiologist ORGANIZATION: OPP/RD/Product Management Team 18 MAIL CODE: H7505C PHONE NUMBER: 703-305-5409 PAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Member of OPP Biotechnology Work- group. Product reviewer in Registration Division. Insecticide/pesticides reviewer. Product Management Team 18 contact for Bacillus thurinqiensis. NAME: Elizabeth Milewski, Ph.D. TITLE: Special Assistant for Biotechnology ORGANIZATION: OPPTS MAIL CODE: TS-788 PHONE NUMBER: 202-260-6900 FAX NUMBER: 202-260-1847 BRIEF DESCRIPTION: Ph.D. - Molecular Biology, Institute Pasteur, Paris, France. NAME: Gordon E. Moore TITLE: Environmental Scientist/Regional Pesticide Expert ORGANIZATION EPA Region 3, Pesticides Management Section MAIL CODE: 3AT32 PHONE NUMBER: 215-597-9869 FAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: Regional contact for FIFRA-related biotechnology matters. Past experience - 28 years as environmental scientist, entomologist, and insect pathologist. ------- Name: Ken Moss TITLE: Program Manager ORGANIZATION: OPPT/CCD/NCB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3395 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Manages the 90-day review of TSCA Premanufacture Notices submitted for biotechnology products, and handles written and telephone inquiries about the biotechnology PMN program. NAME: Willie H. Nelson TITLE: Senior Biologist ORGANIZATION: OPP/RO MAIL CODE: H7505C PHONE NUMBER: 703-305-6601 FAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Reviews administrative and scientific data in support of microbial pesticide registration actions under FIFRA. NAME: Suzanne M. Parent TITLE: Core TSCA Coordinator ORGANIZATION: EPA Region 1 MAIL CODE: ATC-111 PHONE NUMBER: 617-565-3704 FAX NUMBER: 617-565-4939 BRIEF DESCRIPTION: Responsible for regional review, comment, and interaction on TSCA biotechnology rules, policies, planning, outreach, and initiatives. Back- ground: Biologist. ------- SAME: David Phillippi TITLE: Biologist DRGANIZATION: EPA Region 7 HAIL CODE: ARTX/TOPE/TSCA PHONE NUMBER: 913-551-7020 PAX NUMBER: 913-551-7065 BRIEF DESCRIPTION: TSCA Grants, Case Review and Biotech- nology. NAME: Bob Pilsucki TITLE: Microbiologist DRGANIZATION: OPP/EFED/EFGWB MAIL CODE: H7507C PHONE NUMBER: 703-305-7442 PAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Oversees review of environmental fate concerns for biological pesticides. ------- Name: DeLois Mitchell Powell, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/CDB/IMD/CIS MAIL CODE: TS-793 PHONE NUMBER: 202-260-1547 FAX NUMBER: 202-260-1657 BRIEF DESCRIPTION: Areas of interest: ecology, immuno- logy, and taxonomy. Experience: practical and clinical laboratory work; teaching; research; oral and written communication; associated training in regulation develop- ment and wordprocessing skills. Involved in biotechnology rule writing, specifically addressing issues related to the Inventory and pre- paration of Inventory descriptions for microorganisms; supports review, identification, and status determination of biotechnology submissions and the operation of the Inventory; chairs and participates in workgroups related to development and promotion of overall OPPT goals in biotechnology. NAME: Ernest A. Regna TITLE: Chief, Pesticides and Toxic Substances Branch ORGANIZATION: EPA Region 2 MAIL CODE: MS 105, Bldg. 10 PHONE NUMBER: 908-906-6765 FAX NUMBER: 908-906-6788 BRIEF DESCRIPTION: ------- NAME: Patricia A. Roberts, J.O. TITLE: Assistant General Counsel ORGANIZATION: OGC/PTSD MAIL CODE: LE-132P, Rm. W1045 PHONE NUMBER: 202-260-7205 FAX NUMBER: 202-260-2432 BRIEF DESCRIPTION: Coordinates OGC involvement on FIFRA and TSCA biotechnology matters and related issues. NAME: Robert I. Rose, Ph.D. TITLE: Biologist ORGANIZATION: OPP/RD/FHB/PMT-21 MAIL CODE: H7505C PHONE NUMBER: 703 305-6700 FAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: M.Sc. and Ph.D. in applied insect pathology. As a registrant, registered 20 B.t. vars. Kurstaki and israelensis products. 20 + years public and private experience with biocontrol and Integrated Pest Management. 30 publications + 10 years overseas experience. NAME: Sally A. Sasnett TITLE: Environmental Protection Specialist ORGANIZATION: OCM/TEPB MAIL CODE: EN-342 PHONE NUMBER: 202-260-7832 FAX NUMBER: 202-260-0641 BRIEF DESCRIPTION: TSCA Biotechnology enforcement analyst for Office of Compliance Monitoring/TEPB. Provides workgroup input and regulatory review related to enforceability issues. Also provides enforcement policy oversight for several other areas of TSCA. ------- NAME: Philip G. Sayre, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/HERD/EEB MAIL CODE: TS-796 PHONE NUMBER: 202-260-9570 FAX NUMBER: 202-260-7003 BRIEF DESCRIPTION: Review microbial products subject to TSCA by examining (1) the genetic construct and (2) eco- logical hazards posed by the microorganisms. Also has OPPT lead for identifying biotechnology risk assessment research needs. Specifically, is knowledgeable in areas of (1) prokaryotic gene transfer (2) bioremediation and oil pollution, (3) aquatic microbial ecology, (4) mole- cular biology and (5) risks related to deliberately modified nitrogen fixing bacteria. NAME: Cindy Schaffer TITLE: Microbiologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-308-2850 FAX NUMBER: 703-305-5147 BRIEF DESCRIPTION: Scientific reviewer for biotechnology products. ------- NAME: William R. Schneider, Ph.D. TITLE: Microbiologist/Biotechnology Coordinator ORGANIZATION: OPP/EFED MAIL CODE: H7507C PHONE NUMBER: 703-305-7682 PAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Coordinator for review of biological products, OPP biotechnology research, and data require- ments for microbial pesticides and plants. NAME: Mark Segal, Ph.D. TITLE: Senior Microbiologist ORGANIZATION: OPPT/HERD/CREB MAIL CODE: TS-796 PHONE NUMBER: 202-260-3389 FAX NUMBER: 202-260-1283 BRIEF DESCRIPTION: Risk assessment overview, development of information tools for Biotechnology, budget develop- ment, confirmation of organism identity for risk assess- ment, Project Officer on risk information management cooperative agreement with National Institutes of Health on developing international biotechnology data networks and related projects. NAME: Heidi Siegelbaum TITLE: Attorney ORGANIZATION: OPPT/CCD/NCB MAIL CODE: TS-794 PHONE NUMBER: 202-260-8262 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Provides program attorney guidance on any issues which are raised in conjunction with the TSCA biotechnology program's work. ------- NAME: Deborah Sisco TITLE: Section Head ORGANIZATION: OPP/PSPS MAIL CODE: H7501C PHONE NUMBER: 703-305-7102 FAX NUMBER: 703-305-6244 BRIEF DESCRIPTION: Responds to inquiries from Congress and other outside groups. Reviews rules and policy documents produced in OPP pertaining to biotechnology. NAME: Roy Sjoblad, Ph.D. TITLE: Microbiologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-305-7973 FAX NUMBER: 703-305-5147 BRIEF DESCRIPTION: Participates in policy development for biological pesticides, and reviews molecular genetic construction, taxonomy, and mammalian toxicity data/ information for microbial and transgenic plant pesticides. NAME: Bernice Slutsky, Ph.D. TITLE: Biologist ORGANIZATION: OPP/EFED/SACS MAIL CODE: H7507C PHONE NUMBER: 703-305-7974 FAX NUMBER: 703-305-6709 BRIEF DESCRIPTION: Coordinator for development of OPP policy for transgenic plants. ------- NAME: Edward L. Stearns TITLE: Pesticide Specialist ORGANIZATION: EPA Region 8, Toxic Substances Branch, Pesticide Section MAIL CODE: 8 ART-TS PHONE NUMBER: 303-293-1745 FAX NUMBER: 303-293-1229 RIEF DESCRIPTION: Refer use permits to enforcement. Serve as a focal point for collecting information. NAME: Arthur M. Stern, Ph.D. TITLE: Senior Environmental Science Advisor ORGANIZATION: HERD/OPPT MAIL CODE: TS-796 PHONE NUMBER: 202-260-5281 FAX NUMBER: 202-260-1283 BRIEF DESCRIPTION: Serves as a reviewer of biotechnology- related documents on an "as needed basis". These include pre-PMN submissions, PMN submissions, certain aspects of the Biotechnology rule, etc. Also serves as a member of the Biotechnology Workgroup. NAME: Kathy Taylor TITLE: Regional Operational Branch Chief ORGANIZATION: OPP/FOD/ROB/RSS MAIL CODE: H7506C PHONE NUMBER: 703-305-7891 FAX NUMBER: 703-305-3259 BRIEF DESCRIPTION: Responsible for coordination between Headquarters (HQ) and EPA's Regional offices. This branch coordinates Regional conference calls, mailings and provides a forum for Regional participation in HQ's activities. ------- NAME: Gail Tomimatsu, Ph.D. TITLE: Plant Pathologist ORGANIZATION: OPP/BAB/BEAD MAIL CODE: H7503W PHONE NUMBER: 703-308-8133 PAX NUMBER: 703-308-8090 BRIEF DESCRIPTION: Regulatory Plant Pathologist with Office of Pesticide Programs; division lead with OPP Biotechnology Workgroup. Academic Background: M.S. Aquatic Microbiology, Ph.D. Ecology of Soil Micro- organisms - Plant Pathology. NAME: Jenny Tou, Ph.D. TITLE: Chemist ORGANIZATION: OPPT/ETD/ICB MAIL CODE: TS-779 PHONE NUMBER: 202-260-5534 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Member of the biotechnology PMN review team. Provides specific chemical information about the PMN microorganism and/or its products, including a detailed construct analysis. Organic chemist with experience in recombinant DNA, organic synthesis, protein and DNA/RNA purification; formerly a patent examiner for patents utilizing nucleic acids. ------- NAME: Bruce Wilkinson TITLE: Life Scientist ORGANIZATION: EPA Region 5, Pesticides Section MAIL CODE: SP-14J PHONE NUMBER: 312-886-6002 PAX NUMBER: 312-353-4342 BRIEF DESCRIPTION: Former Research Technician with USDA- ARS in sugarbeet research, former farmer. Responsibili- ties include FIFRA Biotechnology. NAME: K. K. Wu TITLE: TSCA Section 5 and 8 Coordinator ORGANIZATION: Region 3, TSCA/TRI Enforcement Section MAIL CODE: 3AT31 PHONE NUMBER: 215-597-7683 FAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: Responsible for the development and implementation of Regional TSCA Sections 5/8 compliance monitoring program including the TSCA biotechnology rule. Technical Background: chemical engineering and chemical manufacturing process. NAME: Jim Yang TITLE: Environmental Scientist ORGANIZATION: EPA Region 6 MAIL CODE: 6T-PT PHONE NUMBER: 214-655-7578 NUMBER: 214-655-2164 BRIEF DESCRIPTION: TSCA Section 5 and 8 Enforcement and Technical expertise includes chemistry and toxicology. ------- NAME: Larry Zeph, Ph.D. TITLE: Biologist ORGANIZATION: OPPTS, Science and Policy Staff MAIL CODE: TS-788 PHONE NUMBER: 202-260-6900 FAX NUMBER: 202-260-1847 BRIEF DESCRIPTION: Ph.D. - Microbiology, Penn State University; Member of the Assistant Administrator's Science and Policy staff. Primary role is to work with program offices in the development of Biotechnology Policy for OPPTS. ------- OE NAME: Scott Garrison TITLE: Attorney ORGANIZATION: OE/TLD MAIL CODE: LE-134P PHONE NUMBER: 202-260-3073 PAX NUMBER: 202-260-1347 BRIEF DESCRIPTION: OE representative on TSCA and FIFRA biotechnology rules. NAME: Jerry Gidner TITLE: Attorney ORGANIZATION: OE/TLD MAIL CODE: LE-134P PHONE NUMBER: 202-260-8694 PAX NUMBER: 202-260-1347 BRIEP DESCRIPTION: Headquarters Attorney newly assigned to OPP Transgenic Plants workgroup. Background in Biology and Zoology. ------- OGC NAME: Mary Jane Angelo, J.D. TITLE: Attorney ORGANIZATION: OGC/PTSD MAIL CODE: LE-132P, Rm. W1031 PHONE NUMBER: 202-260-7524 FAZ NUMBER: 202-260-2432 BRIEF DESCRIPTION: Advises on FIFRA biotechnology matters and related issues. NAME: Alan H. Carpien, J.D. TITLE: Attorney ORGANIZATION: OGC/PTSD MAIL CODE: LE-132P, Rm. W1045 PHONE NUMBER: 202-260-7217 FAZ NUMBER: 202-260-2432 BRIEF DESCRIPTION: Advises on TSCA biotechnology matters and related issues. NAME: Patricia A. Roberts, J.D. TITLE: Assistant General Counsel ORGANIZATION: OGC/PTSD MAIL CODE: LE-132P, Rm. W1045 PHONE NUMBER: 202-260-7205 FAZ NUMBER: 202-260-2432 BRIEF DESCRIPTION: Coordinates OGC involvement on FIFRA and TSCA biotechnology matters and related issues. ------- OPP NAME: Pat Bagley TITLE: Plant Pathologist/Entomologist ORGANIZATION: OPP/RD/IRB MAIL CODE: H7505C PHONE NUMBER: 703-305-5412 FAX NUMBER: 703-305-6920 BRIEF DESCRIPTION: Works mostly with pheromones and fungal entomopathogens. NAME: David Bays, Ph.D. TITLE: Microbiologist ORGANIZATION: OPP/EFED/EEB MAIL CODE: H7507C PHONE NUMBER: 703-305-6449 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Biological pesticides/biotechnology/ transgenic plant pesticides/ecological effects risk assessment. NAME: Clay Beegle, Ph.D. TITLE: Entomologist ORGANIZATION: OPP/EFGWB MAIL CODE: H7507C PHONE NUMBER: 703-305-5893 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Reviewer/insect pathologist/member OPP biotechnology workgroup. ------- NAME: Frederick S. Betz TITLE: Acting Chief, Science Analysis and Coordination Staff ORGANIZATION: OPP/SACS/EFED MAIL CODE: H7507C PHONE NUMBER: 703-305-6307 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Coordinates development and imple- mentation of OPP's Regulatory Program for Biological Pesticides. NAME: Leonard Cole TITLE: ORGANIZATION: OPP MAIL CODE: H7505C PHONE NUMBER: 703-305-7801 FAX NUMBER: BRIEF DESCRIPTION: NAME: Laura Dye TITLE: Biologist ORGANIZATION: OPP/IRB/RD MAIL CODE: H7505C PHONE NUMBER: 703-305-6891 FAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Works mostly with pheromones, microbial and transgenic plants. ------- NAME: Tracy Fitzgerald TITLE: Regional Liaison ORGANIZATION: OPP/FOD/ROB/RSS MAIL CODE: H7506C PHONE NUMBER: 703-305-6140 PAX NUMBER: 703-308-3259 BRIEF DESCRIPTION: Responds to regional concerns, problems, and informational needs. Principal OPP liaison for Regional Biotechnology Teleconference calls. NAME: Carl Grable, Ph.D. TITLE: Plant Pathologist ORGANIZATION: OPP/RD/FHB MAIL CODE: H7505C PHONE NUMBER: 703-305-7392 PAX NUMBER: 703-305-6596 BRIEP DESCRIPTION: Registration specialist for biotechnology products which are fungicides, herbicides, nematocides or plant regulators. NAME: Linda A. Hoi1is TITLE: Microbiologist ORGANIZATION: OPP/IRB/RD MAIL CODE: H7505C PHONE NUMBER: 703-305-6397 PAX NUMBER: 703-305-6596 BRIEP DESCRIPTION: Responsible for the scientific review of data and labels for the registration of biologicals/ genetically engineered microbial pesticides. ------- NAME: Phil Button TITLE: Supervisory Biologist - Product Manager (18) ORGANIZATION: Insecticide/Rodenticide Branch MAIL CODE: H7505C PHONE NUMBER: 703-305-7690 PAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: Heads Product Management Team 18, responsible for registration of Microbial, Botanical, Biochemical and Transgenic Insecticides. NAME: John L. Kough TITLE: Biologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-308-2833 PAX NUMBER: 703-305-5147 BRIEF DESCRIPTION: Reviews toxicity, taxonomy and DNA construct data to support biological pesticides regis- trations. Expert in plant pathology, microbial taxonomy, and molecular biology. NAME: Leo LaSota, Ph.D. TITLE: Biologist ORGANIZATION: OPP/EFED/EFGWB MAIL CODE: H7507C PHONE NUMBER: 703-305-5774 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Works with transgenic plant pesticides, gene flow and environmental fate. ------- NAME: Susan Lewis TITLE: Product Manager ORGANIZATION: OPP/RD/FHB/Team 21 MAIL CODE: H7505C PHONE NUMBER: 703-305-6900 FAX NUMBER: 703-305-1825 BRIEF DESCRIPTION: Works with registration of fungicides and herbicides. NAME: J. Thomas McClintock, Ph.D. TITLE: Microbiologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-305-7973 FAX NUMBER: 703-305-5174 BRIEF DESCRIPTION: Involved in the toxicological evaluation of data pertaining to microbial and biochemical pest control agents, and in the evaluation of the molecular construction of genetically engineered microbial and transgenic plant pesticides for regulatory compliance. Participates in the development of policy and in the establishment of guidelines for transgenic pesticidal plants. HED Product Manager for biochemical pesticide products. ------- NAME: Michael L. Mendelsohn TITLE: Microbiologist ORGANIZATION: OPP/RD/Product Management Team 18 MAIL CODE: H7505C PHONE NUMBER: 703-305-5409 PAX NUMBER: 703-305-6596 BRIEP DESCRIPTION: Member of OPP Biotechnology Work- group. Product reviewer in Registration Division. Insecticide/pesticides reviewer. Product Management Team 18 contact for Bacillus thuringiensis. NAME: Willie H. Nelson TITLE: Senior Biologist ORGANIZATION: OPP/RD MAIL CODE: H7505C PHONE NUMBER: 703-305-6601 PAX NUMBER: 703-305-6596 BRIEP DESCRIPTION: Reviews administrative and scientific data in support of microbial pesticide registration actions under FIFRA. NAME: Bob Pilsucki, Ph.D. TITLE: Microbiologist ORGANIZATION: OPP/EFED/EFGWB MAIL CODE: H7507C PHONE NUMBER: 703-305-7442 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Oversees review of environmental fate concerns for biological pesticides. ------- NAME: Robert I. Rose, Ph.D. TITLE: Biologist ORGANIZATION: OPP/RD/FHB, PMT-21 MAIL CODE: H7505C PHONE NUMBER: 703 305-6700 PAX NUMBER: 703-305-6596 BRIEF DESCRIPTION: M.Sc. and Ph.D. in applied insect pathology. As a registrant, registered 20 B.t. vars. Kurstaki and israelensis products. 20 + years public and private experience with biocontrol and Integrated Pest Management. 30 publications + 10 years overseas experience. NAME: Cindy Schaffer TITLE: Microbiologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-308-2850 FAX NUMBER: 703-305-5147 BRIEF DESCRIPTION: Scientific reviewer for biotechnology products. NAME: William R. Schneider, Ph.D. TITLE: Microbiologist/Biotechnology Coordinator ORGANIZATION: OPP/EFED MAIL CODE: H7507C PHONE NUMBER: 703-305-7682 FAX NUMBER: 703-305-6309 BRIEF DESCRIPTION: Coordinator for review of biological products, OPP biotechnology research, and data require- ments for microbial pesticides and plants. ------- NAME: Deborah Sisco TITLE: Section Head ORGANIZATION: OPP/PSPS MAIL CODE: H7501C PHONE NUMBER: 703-305-7102 FAX NUMBER: 703-305-6244 BRIEF DESCRIPTION: Responds to inquiries from Congress and other outside groups. Reviews rules and policy documents produced in OPP pertaining to biotechnology. NAME: Roy Sjoblad, Ph.D. TITLE: Microbiologist ORGANIZATION: OPP/HED/SACB MAIL CODE: H7509C PHONE NUMBER: 703-305-7973 FAX NUMBER: 703-305-5147 BRIEF DESCRIPTION: Participates in policy development for biological pesticides, and reviews molecular genetic construction, taxonomy, and mammalian toxicity data/ information for microbial and transgenic plant pesticides. NAME: Bernice Slutsky, Ph.D. TITLE: Biologist ORGANIZATION: OPP/EFED/SACS MAIL CODE: H7507C PHONE NUMBER: 703-305-7974 FAX NUMBER: 703-305-6709 BRIEF DESCRIPTION: Coordinator for development of OPP policy for transgenic plants. ------- NAME: Kathy Taylor TITLE: Regional Operational Branch Chief ORGANIZATION: OPP/FOD/ROB/RSS MAIL CODE: H7506C PHONE NUMBER: 703-305-7891 PAX NUMBER: 703-305-3259 BRIEF DESCRIPTION: Responsible for coordination between Headquarters (HQ) and EPA's Regional offices. This branch coordinates Regional conference calls, mailings and provides a forum for Regional participation in HQ's activities. NAME: Gail Tomimatsu, Ph.D. TITLE: Plant Pathologist ORGANIZATION: OPP/BAB/BEAD MAIL CODE: H7503W PHONE NUMBER: 703-308-8133 PAX NUMBER: 703-308-8090 BRIEP DESCRIPTION: Regulatory Plant Pathologist with Office of Pesticide Programs; division lead with OPP Biotechnology Workgroup. Academic Background: M.S. Aquatic Microbiology, Ph.D. Ecology of Soil Micro- organisms - Plant Pathology. ------- OPPE NAME: Bob Benson TITLE: Senior Policy Analyst ORGANIZATION: OPPE/TSPB MAIL CODE: PM-220 PHONE NUMBER: 202-260-8668 FAX NUMBER: 202-260-0174 BRIEF DESCRIPTION: OPPE analyst for OPPT biotechnology activities (including TSCA Rule). NAME: Susanne Giannini TITLE: Senior Policy Analyst ORGANIZATION: OPPE/PPB MAIL CODE: PM-220 PHONE NUMBER: 202-260-7570 FAX NUMBER: 202-260-0174 BRIEF DESCRIPTION: OPPE Analyst for OPP biotechnology activities (including FIFRA Rule and Transgenic Plant Policy). ------- BIOTECHNOLOGY DIRECTORY OPPT NAME: Robert Andrei TITLE: Economist ORGANIZATION: OPPT/ETD/RIB MAIL CODE: TS-779 PHONE NUMBER: 202-260-7693 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Preparation of the Regulatory Impact Analysis for the proposed TSCA rule and preparation of economic assessments in connection with standard reviews of biotechnology PMNs. NAME: H. Kay Austin, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/EED MAIL CODE: TS-798 PHONE NUMBER: 202-260-3927 FAX NUMBER: 202-260-0018 BRIEF DESCRIPTION: Assess Environmental Fate and Non- occupational exposure of genetically modified micro- organisms released to the environment; gene stability and gene transfer; protocol review; field test data review. ------- NAME: Joan Blake TITLE: Biologist ORGANIZATION: OPPT/CMD/CRB MAIL CODE: TS-798 PHONE NUMBER: 202-260-6236 PAX NUMBER: 202-260-1724 BRIEF DESCRIPTION: Responsible for writing Headquarters permits for disposal of PCBs with Bioremediation processes. NAME: Michael W. Broder, Ph.D. TITLE: Microbiologist; Technical Integrator ORGANIZATION: OPPT/HERD/CREB MAIL CODE: TS-796 PHONE NUMBER: 202-260-3498 FAX NUMBER: 202-260-1283 BRIEF DESCRIPTION: Microbiologist - Technical Integrator for TSCA biotechnology PMNs. Assembles the individual ecological, human health, exposure, and chemistry reports into the final integrated risk assessments for standard reviews of biotechnology PMNs. ------- NAME: Ellie Clark TITLE: Rule Editor ORGANIZATION: OPPT/CCD/PDB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3402 PAX NUMBER: 202-260-0118 or 202-260-1216 BRIEF DESCRIPTION: Responsible for the development of the biotechnology rule for TSCA and interpretation of the 1986 Policy Statement. This includes addressing policy issues that arise and may affect the biotechnology regulations. OPPT representative on the workgroups for the FIFRA biotechnology rule and transgenic plants policy. NAME: Larry Culleen TITLE: Chief, New Chemicals Branch ORGANIZATION: OPPT/CCD/NCB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3725 PAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Coordinates policy and procedural issues arising in the TSCA biotechnology program. NAME: David Giamporcaro TITLE: Section Chief, Biotechnology Program ORGANIZATION: OPPT/CCD/PDB MAIL CODE: TS-794 PHONE NUMBER: 202-260-6362 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Responsible for managing the TSCA biotechnology program, including review of biotechnology PMNs, interpretation of the 1986 Policy Statement, and development of the proposed TSCA biotechnology regulations. ------- NAME: Steven M. Hassur, Ph.D. TITLE: Senior Chemist ORGANIZATION: OPPT/ETD/ICB MAIL CODE: TS-779 PHONE NUMBER: 202-260-1735 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Directs the biotechnology chemical review activities of the Industrial Chemistry Branch (ICB) in ETD. An organic chemist, with research experience in analytical biochemistry, DNA/RNA synthesis, enzymology, and immunology. NAME: Shirley D. Howard TITLE: Environmental Protection Specialist ORGANIZATION: OPPT/CCD/PDB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3780 FAX NUMBER: 202-260-0118 or 202-260-1216 BRIEF DESCRIPTION: Responsible for initiating the HQ/Regional Teleconference calls and developing the Biotechnology directory. Serves as liaison between the TSCA biotechnology program, and OPP, other HQ offices, and the Regions. Also assists the senior Program Managers during standard reviews of biotechnology PMNs. ------- NAME: Y'Vonne Jones-Brown, Ph.D. TITLE: Senior Microbiologist ORGANIZATION: OPPT/IMD/CIS/CDB MAIL CODE: TS-793 PHONE NUMBER: 202-260-1549 FAX NUMBER: 202-260-1657 BRIEF DESCRIPTION: Expertise: Microbiologist with knowledge/experience purifying and characterizing active biological substances. Duties: Inventory - develop policies/interpretative guidance and procedures for describing microorganisms on the Inventory; make Inventory status determinations; participate in development of TSCA biotechnology rule; participate in review of biotechnology submissions. NAME: Cynthia A. Lewis TITLE: Attorney ORGANIZATION: OPPT/IMD/PALS/CDB MAIL CODE: TS-793 PHONE NUMBER: 202-260-4399 FAX NUMBER: 202-260-1675 BRIEF DESCRIPTION: Attorney dealing with Confidential Business Information (CBI) issues and related matters. NAME: Greg Macek TITLE: Chemical Engineer ORGANIZATION: OPPT/ETD MAIL CODE: TS-779 PHONE NUMBER: 202-260-9597 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Develops occupational exposure and environmental release assessments for biotechnology PMNs. Also provides technical support to 5(h)(4) exemption assessment process. ------- NAME: Gwendolyn McClung, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/HERD/EEB MAIL CODE: TS-796 PHONE NUMBER: 202-260-1272 FAX NUMBER: 202-260-7883 BRIEF DESCRIPTION: Soil Microbiologist responsible for ecological hazard assessments for deliberately modified microorganisms and for development of an ecological tier- testing scheme for such microorganisms. NAME: Ken Moss TITLE: Program Manager ORGANIZATION: OPPT/CCD/NCB MAIL CODE: TS-794 PHONE NUMBER: 202-260-3395 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Manages the 90-day review of TSCA Premanufacture Notices submitted for biotechnology products, and handles written and telephone inquiries about the biotechnology PMN program. ------- NAME: DeLois Mitchell Powell, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/IMD/CDB/CIS MAIL CODE: TS-793 PHONE NUMBER: 202-260-1547 FAX NUMBER: 202-260-1657 BRIEF DESCRIPTION: Areas of interest: ecology, immuno- logy, and taxonomy. Experience: practical and clinical laboratory work; teaching; research; oral and written communication; associated training in regulation development and wordprocessing skills. Involved in biotechnology rule writing, specifically addressing issues related to the Inventory and pre- paration of Inventory descriptions for microorganisms; supports review, identification, and status determination of biotechnology submissions and the operation of the Inventory; chairs and participates in workgroups related to development and promotion of overall OPPT goals in biotechnology. NAME: Sally A. Sasnett TITLE: Environmental Protection Specialist ORGANIZATION: OCM/TEPB MAIL CODE: EN-342 PHONE NUMBER: 202-260-7832 FAX NUMBER: 202-260-0641 BRIEF DESCRIPTION: TSCA Biotechnology enforcement analyst for Office of Compliance Monitoring/TEPB. Provides workgroup input and regulatory review related to enforceability issues. Also provides enforcement policy oversight for several other areas of TSCA. ------- NAME: Philip G. Sayre, Ph.D. TITLE: Microbiologist ORGANIZATION: OPPT/HERD/EEB MAIL CODE: TS-796 PHONE NUMBER: 202-260-9570 FAX NUMBER: 202-260-7003 BRIEF DESCRIPTION: Reviews microbial products subject to TSCA by examining (1) the genetic construct and (2) eco- logical hazards posed by the microorganisms. Also has OPPT lead for identifying biotechnology risk assessment research needs. Specifically, is knowledgeable in areas of (1) prokaryotic gene transfer (2) bioremediation and oil pollution, (3) aquatic microbial ecology, (4) mole- cular biology and (5) risks related to deliberately modified nitrogen fixing bacteria. NAME: Mark Segal, Ph.D. TITLE: Senior Microbiologist ORGANIZATION: OPPT/HERD/CREB MAIL CODE: TS-796 PHONE NUMBER: 202-260-3389 FAX NUMBER: 202-260-1283 BRIEF DESCRIPTION: Risk assessment overview, development of information tools for biotechnology, budget develop- ment, confirmation of organism identity for risk assess- ment, Project Officer on risk information management cooperative agreement with National Institutes of Health on developing international biotechnology data networks and related projects. ------- NAME: Heidi Siegelbaum TITLE: Attorney ORGANIZATION: OPPT/CCD/NCB MAIL CODE: TS-794 PHONE NUMBER: 202-260-8262 FAX NUMBER: 202-260-0118 BRIEF DESCRIPTION: Provides program attorney guidance on any issues which are raised in conjunction with the TSCA biotechnology program's work. NAME: Arthur M. Stern, Ph.D. TITLE: Senior Environmental Science Advisor ORGANIZATION: HERD/OPPT MAIL CODE: TS-796 PHONE NUMBER: 202-260-5281 FAX NUMBER: 202-260-1283 BRIEF DESCRIPTION: Serves as a reviewer of biotechnol- ogy-related documents on an "as needed basis". These include pre-PMN submissions, PMN submissions, certain aspects of the biotechnology rule, etc. Also serves as a member of the biotechnology workgroup. NAME: Jenny Tou, Ph.D. TITLE: Chemist ORGANIZATION: OPPT/ETD/ICB MAIL CODE: TS-779 PHONE NUMBER: 202-260-5534 FAX NUMBER: 202-260-0981 BRIEF DESCRIPTION: Member of the biotechnology PMN review team. Provides specific chemical information about the PMN microorganism and/or its products, including a detailed construct analysis. Organic chemist with experience in recombinant DNA, organic synthesis, protein and DNA/RNA purification; formally a patent examiner for patents utilizing nucleic acids. ------- OPPTS NAME: Sharlene Matten, Ph.D. TITLE: Biologist ORGANIZATION: OPPTS, Science and Policy Staff MAIL CODE: TS-788 PHONE NUMBER: 202-260-6900 FAX NUMBER: 202-260-1847 BRIEF DESCRIPTION: Ph.D. in biochemistry (plant-pathogen interaction) in 1989 from Oklahoma State University. Post-doctoral work in prokaryotic molecular biology at the University of Maryland. Joined EPA in June 1991 as part of the OPPTS Assistant Administrator's Science and Policy staff. Duties are to help coordinate and develop biotechnology policy under FIFRA, TSCA, and FFDCA. Serves as a liaison between OPPTS and OPP. NAME: Elizabeth Milewski, Ph.D. TITLE: Special Assistant for Biotechnology ORGANIZATION: OPPTS MAIL CODE: TS-788 PHONE NUMBER: 202-260-6900 FAX NUMBER: 202-260-1847 BRIEF DESCRIPTION: Ph.D. - Molecular Biology, Institute Pasteur, Paris, France. ------- NAME: Larry Zeph, Ph.D. TITLE: Biologist ORGANIZATION: OPPTS, Science and Policy Staff MAIL CODE: TS-788 PHONE NUMBER: 202-260-6900 FAX NUMBER: 202-260-1847 BRIEF DESCRIPTION: Ph.D. - Microbiology, Penn State University; Member of the Assistant Administrator's Science and Policy staff. Primary role is to work with program offices in the development of Biotechnology Policy for OPPTS. ------- ORD [AME: Robert J. Frederick, Ph.D. TTLE: ORD Biotechnology Research Coordinator ORGANIZATION: ORD/OEPER/R&D [AIL CODE: RD-682 •HONE NUMBER: 202-260-5971 •AX NUMBER: 202-260-6370 IRIEF DESCRIPTION: Liaison for Biotechnology Research rith Regulatory Program Offices, Federal Agencies, Lcademia, and International Programs. Advanced degree in [icrobiology and Molecular Biology; Research Scientist 8 years), Regulatory Program (OTS, 4 years). ------- REGIONS REGION 1 NAME: Robert W. Koethe (FIFRA) TITLE: Pesticides Expert ORGANIZATION: EPA Region 1, Pesticides Section MAIL CODE: APP PHONE NUMBER: 617-565-3702 FAX NUMBER: 617-565-4939 BRIEF DESCRIPTION: NAME: Suzanne M. Parent (TSCA) TITLE: Core TSCA Coordinator ORGANIZATION: EPA Region 1 MAIL CODE: ATC-111 PHONE NUMBER: 617-565-3704 FAX NUMBER: 617-565-4939 BRIEF DESCRIPTION: Responsible for regional review, comment, and interaction on TSCA biotechnology rules, policies, planning, outreach, and initiatives. Background: Biologist. ------- REGION 2 NAME: Diane D. Buxbaum (TSCA) TITLE: Environmental Protection Specialist ORGANIZATION: EPA Region 2, Pesticides and Toxic Substances Branch MAIL CODE: MS-105 PHONE NUMBER: 908-906-6893 PAX NUMBER: 908-906-6788 BRIEF DESCRIPTION: Epidemiologist/Biologist. Liaison person for biotechnology issues and responsible for technical assistance for the Pesticides and Toxic Substances Branch. NAME: Ernest A. Regna (TSCA/FIFRA) TITLE: Chief, Pesticides and Toxic Substances Branch ORGANIZATION: EPA Region 2 MAIL CODE: MS 105, Bldg. 10 PHONE NUMBER: 908-906-6765 FAX NUMBER: 908-906-6788 BRIEF DESCRIPTION: ------- REGION 3 NAME: Edward H. Cohen (TSCA) TITLE: Environmental Scientist ORGANIZATION: EPA Region 3, TSCA Enforcement Section MAIL CODE: 3AT31 PHONE NUMBER: 215-597-7668 PAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: TSCA Biotechnology Coordinator; Sections 5,8,12,13, GLP and 6 (disposal methods for PCBs). Chemist with strong biochemical, GLP, Biology and previous biotechnology experience (Pre-1970). NAME: Don Lott (FIFRA) TITLE: Section Chief, Pesticides Management Section ORGANIZATION EPA Region 3 MAIL CODE: 3AT32 PHONE NUMBER: 215-597-9870 PAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: Entomologist/Environmental Scientist; 20 years professional experience in pesticides field; 5 years with EPA. ------- NAME: Gordon E. Moore (FIFRA) TITLE: Environmental Scientist/Regional Pesticide Expert ORGANIZATION EPA Region 3, Pesticides Management Section MAIL CODE: 3AT32 PHONE NUMBER: 215-597-9869 PAX NUMBER: 215-597-3156 BRIEF DESCRIPTION: Regional contact for FIFRA-related biotechnology matters. Past experience - 28 years as environmental scientist, entomologist, and insect pathologist. NAME: K. K. Wu (TSCA) TITLE: TSCA Section 5 and 8 Coordinator ORGANIZATION: EPA Region 3, TSCA/TRI Enforcement Section MAIL CODE: 3AT31 PHONE NUMBER: 215-597-7683 PAX NUMBER: 215-597-3156 BRIEP DESCRIPTION: Responsible for the development and implementation of Regional TSCA Sections 5/8 compliance monitoring program including the TSCA biotechnology rule. Technical Background: chemical engineering and chemical manufacturing process. ------- REGION 4 NAME: Susan Mayer (TSCA/FIFRA) TITLE: Life Scientist ORGANIZATION: EPA Region 4, Pesticides Section MAIL CODE: 4 APT PHONE NUMBER: 404-347-3222 FAX NUMBER: 404-347-1681 BRIEF DESCRIPTION: Regional contact person for biotech- nology in Region 4, Pesticides Section. Background in Biology and Microbiology. ------- :GION s NAME: Robert J. Allen (TSCA) TITLE: Acting TRI Program Manager ORGANIZATION: EPA Region 5, Environmental Sciences Division, Pesticide and Toxics Substances Branch MAIL CODE: SP-14J PHONE NUMBER: 312-353-5871 PAX NUMBER: 312-353-4342 BRIEF DESCRIPTION: Group handles TSCA Sections 4,5,8,12, and 13 including PMNs. Background in environmental engineering with a Ph.D. in Bioengineering. Ten years in academic and public health. NAME: Donald Baumgartner (FIPRA) TITLE: Life Scientist ORGANIZATION: ESD/PTSB, EPA Region 5, Pesticides Section MAIL CODE: SP^14J PHONE NUMBER: 312-886-7835 FAX NUMBER: 312-353-4342 BRIEF DESCRIPTION: As a general biologist, with a specialty in medical entomology, provides reviews of biotechnology products used as pesticides under FIFRA. Technical assistance relating to biotechnology is also provided to Region 5. ------- NAME: Bruce Wilkinson (FIFRA) TITLE: Life Scientist ORGANIZATION: EPA Region 5, Pesticides Section MAIL CODE: SP-14J PHONE NUMBER: 312-886-6002 PAX NUMBER: 312-353-4342 BRIEF DESCRIPTION: Former Research Technician with USDA- ARS in sugarbeet research, former farmer. Responsibili- ties include FIFRA Biotechnology. ------- REGION 6 NAME: David F. Cole (FIFRA) TITLE: Environmental Protection Specialist ORGANIZATION: EPA Region 6, Pesticides Section, Pesticides and Toxics Branch, Air, Pesticides and Toxics Division MAIL CODE: 6T-PT PHONE NUMBER: 214-655-7239 PAX NUMBER: 214-655-2164 BRIEF DESCRIPTION: Biotechnology Test Compilation, Arkansas Special Initiatives. Background: 24 years in research and development in chemical processing of semiconductor devices at Texas Instruments. Bachelor of Science in Chemistry, Ph.D. in Physical Chemistry, M.B.A. NAME: Jim Yang (TSCA) TITLE: Environmental Scientist ORGANIZATION: EPA Region 6 MAIL CODE: 6T-PT PHONE NUMBER: 214-655-7578 FAX NUMBER: 214-655-2164 - BRIEP DESCRIPTION: TSCA Sections 5 and 8 Enforcement and Technical expertise includes chemistry and toxicology. ------- REGION 7 NAME: David Phillippi (TSCA) TITLE: Biologist ORGANIZATION: EPA Region 7 MAIL CODE: ARTX/TOPE/TSCA PHONE NUMBER: 913-551-7020 PAX NUMBER: 913-551-7065 BRIEF DESCRIPTION: TSCA Grants, Case Review and Biotechnology. NAME: Damon P. Frizzell (FIFRA) TITLE: Environmental Scientist ORGANIZATION: EPA Region 7 MAIL CODE: ARTX/TOPE/PPDS PHONE NUMBER: 913-551-7560 PAX NUMBER: 913-551-7065 BRIEF DESCRIPTION: Masters Degree in Weed Science, from Oklahoma State University. Five years experience in crop research and field development. Two years experience in regional pesticides program. ------- REGION 8 NAME: R. Paul Grimm (TSCA) TITLE: Compliance Inspector, Chemical Engineer ORGANIZATION: EPA Region 8, Air, Radiation and Toxics Division, Toxic Substances Branch MAIL CODE: 8ART-TS PHONE NUMBER: 303-293-0981 PAX NUMBER: 303-294-7559 BRIEF DESCRIPTION: Compliance Inspector under TSCA Sections 5 and 8 and EPCRA - Title III Section 313. More than 30 years of experience in the Chemical and Chemical Related Industries, including plant operations and plant design. NAME: Edward L. Stearns (FIFRA) TITLE: Pesticide Specialist ORGANIZATION: EPA Region 8, Toxic Substances Branch, Pesticide Section MAIL CODE: 8 ART-TS PHONE NUMBER: 303-293-1745 FAX NUMBER: 303-293-1229 BRIEF DESCRIPTION: Refer use permits to enforcement. Serve as a focal point for collecting information. ------- REGION 9 NAME: Glenda Dugan (TSCA & FIFRA) TITLE: Life Scientist ORGANIZATION: Region 9, Pesticides and Toxics Branch MAIL CODE: A-4-5 PHONE NUMBER: 415-774-1066 FAX NUMBER: 415-774-1073 BRIEF DESCRIPTION: Sub-Lead Regional Coordinator for biotechnology, responsible for regional review, technical assistance for TSCA and FIFRA biotechnology issues. Background: Biologist with USDA-ARS in food safety research. ------- REGION 10 NAME: Karl H. Arne (FIFRA) TITLE: Pesticide Specialist ORGANIZATION: EPA Region 10 MAIL CODE: AT-083 PHONE NUMBER: 206-553-8577 FAX NUMBER: 206-553-0110 BRIEF DESCRIPTION: Region 10 pesticide section biotechnology contact, Chemist. NAME: Christina Colt (TSCA) TITLE: Environmental Engineer ORGANIZATION: EPA Region 10, Toxic Substances Section MAIL CODE: AT-083 PHONE NUMBER: 206-553-8577 FAX NUMBER: 206-553-0110 BRIEF DESCRIPTION: Core TSCA Coordinator (includes tech- nical assistance, review of HQ documents, and enforce- ment of biotechnology rules). Background: Mechanical Engineering degree from U.C. Davis with emphasis on bio- engineering for Aquaculture and Aquatic medicine. ------- |