Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's Regulatory Definition of Pests To Include Prion EPA-HQ-OPP-2010-0427

EPA-HQ-OPP-2010-0427

[Federal Register: January 26, 2011 (Volume 76, Number 17)] [Proposed Rules] [Page 4602-4608] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26ja11-30]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2010-0427; FRL-8850-4] RIN 2070-AJ26

Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's Regulatory Definition of Pests To Include Prion

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to declare a prion (i.e., proteinaceous infectious particle) a ``pest'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to expressly include prion within the regulatory definition of pest. EPA currently considers a prion to be a pest under FIFRA, so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a ``prion-related product'') is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain a section 3 registration, section 24(c) registration, or a section 18 emergency exemption before it can be distributed or sold in the United States. This proposed rule would codify the Agency's current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in the regulatory definition of pest. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion-related products under FIFRA. Codifying the Agency's current interpretation of FIFRA will not change the manner in which EPA currently regulates prion-related products under FIFRA sections 3, 24(c) and 18. Regulating prion-related products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective.

DATES: Comments must be received on or before March 28, 2011.

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0427, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805. Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2010-0427. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e- mail. The regulations.gov website is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e- mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends

[[Page 4603]]

that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5448; fax number: (703) 308-6467; e-mail address: kempter.carlton@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you apply for or own pesticide registrations. Potentially affected entities may include, but are not limited to: Producers of pesticide products (NAICS code 32532). Producers of antimicrobial pesticides (NAICS code 32561). Veterinary testing laboratories (NAICS code 541940). Medical pathology laboratories (NAICS code 621511). Taxidermists, independent (NAICS code 711510). Surgeons (NAICS code 621111). Dental surgeons (NAICS code 621210). Mortician services (NAICS code 812210). Manufacturers of medical tissue devices of human and animal origin (NAICS code undetermined). Manufacturers of other human cellular and tissue products (NAICS code undetermined). Organ banks, body (NAICS code 621991). Plasma, blood, merchant wholesalers (NAICS code 424210). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

A. What action is the Agency taking?

EPA has decided that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) a prion is considered to be a pest, and proposes to declare a prion to be a pest and to explicitly include it in the lists of pests in 40 CFR 152.5. These actions would affirm the Agency's authority to regulate products distributed or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., prion-related products). Prion-related products are currently regulated under FIFRA and subject to all requirements and provisions of the Act based on EPA's September 10, 2003 decision that prions share enough characteristics of an ``other micro-organism'' or ``form of life'' (as those terms are used in FIFRA) to fall within the scope of FIFRA section 2(t) and 40 CFR 152.5(d). This proposal ensures that the regulatory definition reflects the Agency's authority to regulate products distributed or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., prion-related products). The primary impact of declaring that a prion is a pest and including ``prion'' in the regulatory definition of ``pest'' is to provide regulatory clarity that prion-related products must be registered or exempted under FIFRA sections 3, 24(c), or 18 before such products may be distributed or sold in the United States. Note that not all prions and prion-related products are affected by the proposed rule. Firstly, EPA's regulations at 40 CFR 152.5(d) exclude pests ``* * * in or on living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs * * * and cosmetics.'' Therefore, the proposed rule would not apply to those uses of prion-related products. Secondly, the definition of ``pesticide'' in FIFRA section 2(u) excludes new animal drugs and liquid chemical sterilants intended for use on a critical or semi- critical device. Accordingly, products which fall into those categories would not be covered by the proposed rule.

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B. What is the Agency's authority for taking this action?

This action is issued under the authority of sections 2 through 34 of FIFRA (7 U.S.C. 136-136y).

III. Prion as a Pest Under FIFRA

A. What is a prion?

snip...see full text ;

http://edocket.access.gpo.gov/2011/2011-1636.htm


Friday, August 29, 2008

CREEKSTONE VS USDA COURT OF APPEALS, BUSH SAYS, NO WAY, NO HOW

http://madcowtesting.blogspot.com/2008/08/creekstone-vs-usda-court-of-appeals.html



Creekstone Farms Premium Beef v. USDA Civ. Action No. 06-544 (JR) Plaintiff’s Summary Judgment Reply and Opposition

http://www.cwd.cc/061103_CFPB_Exh_8_Brown_declaration.pdf


Tuesday, November 02, 2010

BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992

http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html


Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act

Posted Apr 09 2009 7:13pm March 31 - April 1, 2009

Panel Member List FIFRA Scientific Advisory Panel Open Meeting, March 31 - April 1, 2009

Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods

Environmental Protection Agency Conference Center Lobby Level, One Potomac Yard (South Bldg.), 2777 Crystal Dr., Arlington, VA 22202

FIFRA SAP Website: http://www.epa.gov/scipoly/sap/ Docket Number EPA-HQ-OPP-2008-0859 OPP Docket Telephone: 703-305-5805

FIFRA SAP Session Chair

Steven G. Heeringa, Ph.D. Research Scientist & Director for Statistical Design University of Michigan Institute for Social Research Ann Arbor, MI

Designated Federal Official

Myrta R. Christian, M.S. US Environmental Protection Agency Office of Science Coordination & Policy FIFRA Scientific Advisory Panel EPA East Building, MC 7201M 1200 Pennsylvania Avenue, NW Washington, DC 20460 Tel: 202-564-8450, Fax: 202-564-8382, mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:Chr

FIFRA Scientific Advisory Panel Members

John R. Bucher, Ph.D., DABT Associate Director Environmental Toxicology Program National Institute of Environmental Health Sciences Research Triangle Park, NC

Janice E. Chambers, Ph.D., DABT, ATS William L. Giles Distinguished Professor Director, Center for Environmental Health Sciences College of Veterinary Medicine Mississippi State University Mississippi State, MS

Kirby C. Donnelly, Ph.D. Professor and Head Department of Environmental and Occupational Health School of Rural Public Health Texas A&M University System Health Science Center College Station, TX

Carey N. Pope, Ph.D. Professor, Head & Sitlington Chair of Toxicology Department of Physiological Sciences Oklahoma State University College of Veterinary Medicine Stillwater, OK

Kenneth M. Portier, Ph.D. Program Director, Statistics American Cancer Society National Home Office Atlanta, GA

Daniel Schlenk, Ph.D. Professor of Aquatic Ecotoxicology & Environmental Toxicology Department of Environmental Sciences University of California, Riverside Riverside, CA

FQPA Science Review Board Members

Jason C. Bartz, Ph.D. Assistant Professor Department of Medical Microbiology & Immunology Creighton University School of Medicine Omaha, Nebraska

Dr. Jason C. Bartz is an Assistant Professor in the Department of Medical Microbiology and Immunology in the School of Medicine at Creighton University where he conducts research on prion diseases. Dr. Bartz received a Ph.D. in veterinary science from the University of Wisconsin where he focused on interspecies transmission and adaptation of prions to new host species. Dr. Bartz has over 15 years of experience in prion disease research and is currently investigating the biology of prion strains. Specifically, Dr. Bartz is interested in the mechanisms of strain-specific routes of neuroinvasion, prion strain targeting in the central nervous system and prion strain interference. Dr. Bartz has been an advisor to panels of the National Institutes of Health and the Department of Defense.

Byron Caughey, Ph.D. Senior Investigator & Chief - TSE/Prion Biochemistry Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana

Dr. Byron Caughey is a Senior Investigator and Chief of the TSE/prion Biochemistry Section of the Laboratory of Persistent Viral Diseases, Rocky Mountain Laboratories, National Institute for Allergy and Infectious Diseases, National Institutes of Health in Hamilton, Montana. Dr. Caughey got his Ph.D. in Biochemistry from the University of Wisconsin-Madison in 1985. In 1986, after post-doctoral studies in neurochemistry at Duke University, he began TSE/prion research at Rocky Mountain Laboratories. Dr. Caughey has published extensively in the TSE/prion field on biochemical, biophysical, cell biological, diagnostic and therapeutic aspects of TSE/prion diseases. He has served on journal editorial boards and is currently a senior editor for the Journal of Virology. He has been a member of institutional scientific review committees for the Institute for Animal Health (UK) and the NIDDK (NIH), and chaired the TSEs Review Panel for the 2006 USDA Scientific Quality Review. He has been an ad hoc reviewer for numerous granting agencies and is currently a member of the scientific advisory boards of the funding agencies PrioNet Canada and Alberta Prion Research Institute.

Kenneth D. Clinkenbeard, D.V.M., Ph.D. Professor & Coordinator, Veterinary Biomedical Sciences Graduate Program Department of Veterinary Pathobiology College of Veterinary Medicine Oklahoma State University Stillwater, Oklahoma

Dr. Kenneth D. Clinkenbeard is Professor of Veterinary Pathobiology and coordinator of the Veterinary Biomedical Sciences Graduate Program at the College of Veterinary Medicine, Oklahoma State University where he teaches graduate and veterinary students and conducts research in the areas of infectious disease pathogenesis and ecology. Ken earned his PhD degree at The Johns Hopkins University School of Medicine in physiological chemistry in Albert Lehninger’s department studying enzymology and was a NIH postdoctoral fellow under Nobel prize winner Dr. Edwin G. Krebs at the University of California at Davis, where he also earned his DVM degree. Dr. Clinkenbeard has over thirty-five years experience working with infectious diseases including disseminate histoplasmosis in dogs and cats; shipping fever, pinkeye, and E coli O157:H7 in cattle; tularemia and plague in wildlife; and chronic wasting disease in cervids. Recently, he has along with his collaborators from DNA Solutions, Inc. developed an in vitro model for detection and study of chronic wasting disease using an immortalized whitetail deer cell line developed in his laboratory under Phase II Small Business Innovative Research funding from the DoD.

Christina Egan, Ph.D. Director, Biodefense Laboratory Wadsworth Center New York State Department of Health Albany, New York

Dr. Christina Egan is the Director of the Biodefense Laboratory at the Wadsworth Center, New York State Department of Health (NYSDOH). Dr. Egan has been with the NYSDOH since 1999 joining the Wadsworth Center as a New York State Emerging Infectious Disease fellow and then as a research scientist and member of the Bioterrorism Response Team which was responsible for the analysis of environmental and clinical specimens for anthrax in 2001. Dr. Egan has 10 years experience working with biological pathogens and high containment laboratories and has obtained specialized certification as a C.B.S.P (Certified Biosafety Professional) through the National Registry of Microbiologists. She has been involved in the development of new diagnostic assays designed to test clinical specimens and environmental samples for bacterial, toxins, and viral agents and oversees the validation process of these molecular assays. Additionally, she has been involved with the development and presentation of many training courses for laboratorians, first responders, Civil Support Teams, and members of the law enforcement community in New York State. She has participated on a number of different federal, state, and scientific panels and committees such as Association of Analytical Communities Biothreat Methods Committee to create standards for biothreat detection method and the EPA Science Advisory Board. She has numerous publications and book chapters related to the development of diagnostic assays for biothreat assays and other issues related to public health preparedness and is an Assistant Professor in the SUNY School of Public Health, Departments of Biomedical Sciences and Environmental Health Sciences.

Kurt Giles, D. Phil. Assistant Adjunct Professor Department of Neurology Institute for Neurodegenerative Diseases University of California at San Francisco San Francisco, California

Dr. Kurt Giles is an Assistant Adjunct Professor at the University of California San Francisco (UCSF). He is director of the transgenics core and a senior scientist at the Institute for Neurodegenerative Diseases (directed by Nobel laureate Dr Stanley B. Prusiner). Kurt received his Ph.D. in pharmacology from Oxford University, United Kingdom, where he used biochemical tools to determine abnormally functioning proteins in Alzheimer’s disease. This was followed by post-doctoral research at the Weizmann Institute of Science, Israel, where he expanded on these studies focusing on protein structure analysis. Kurt has held faculty positions at the Weizmann Institute and at Oxford University prior to moving to UCSF. He has taught undergraduate and graduate courses, and given workshops in many countries, and serves on the editorial board of the journal Biochemistry and Molecular Biology Education. He is also involved in education outreach with High Schools. Kurt has over 15 years experience in neurodegenerative disease research, and he uses transgenic mouse models to understand the molecular basis of various neurodegenerative diseases. He is an expert in prion diseases, where his research encompasses determining the molecular basis for transmission of prion strains between species, understanding the endogenous function of the prion protein, and devising methods to inactivate prions. He has also pioneered the use of survival analysis techniques to more rigorously quantify prion inactivation. Kurt has published widely on the use of transgenic mouse models to measure prion infectivity, and on the inactivation of prions.

Nancy J. Hanson, Ph.D. Associate Professor Department of Medical Microbiology Director of Molecular Biology Center for Research in Anti-Infectives and Biotechnology Creighton University School of Medicine Omaha, Nebraska

Dr. Nancy D. Hanson is an Associate Professor and Director of Molecular Biology for the Center for Research in Anti-Infectives and Biotechnology in the Department of Medical Microbiology and Immunology at Creighton University. Dr. Hanson received her PhD in Medical Microbiology from the University of Nebraska Medical Center. She joined the faculty of Creighton University in 1995. Dr. Hanson has an active research laboratory and has trained several Master and PhD level students. Her area of expertise involves the study of molecular mechanisms of antibiotic resistance in Gram-negative organisms such as E. coli, K. pneumoniae, Salmonella spp. and Pseudomonas aeruginosa. Her research explores two aspects of antibiotic resistance mechanisms: 1) the regulation of the genes involved in resistance and 2) the development of PCR-based diagnostic tests that can be used by clinical laboratories to detect resistance genes in clinical isolates. Dr. Hanson has served as an ad-hoc grant reviewer for National Institutes of Health study sections, the Wellcome Trust, and the British Society for Antimicrobial Chemotherapy. Dr. Hanson has been the invited speaker for the Australian Society of Microbiology, General Society for Microbiology held in Edinburgh Scotland, the American Society of Microbiology and the Interscience Conference on Antimicrobial Agents and Chemotherapy. She serves as an ad-hoc reviewer for 12 scientific journals. Dr. Hanson has also been involved in the Fulbright mentoring program training recipients of the fellowship from countries such as Nigeria and Egypt. In 2007, Dr. Hanson was awarded researcher of the year by the Nebraska Chapter of the Cystic Fibrosis Foundation for her work on P. aeruginosa infecting patients with cystic fibrosis.

Corinne I. Lasmezas, D.V.M., Ph.D. Professor, Department of Infectology The Scripps Research Institute, Scripps Florida Jupiter, Florida

Dr. Corinne I. Lasmézas is Professor at the Department of Infectology of The Scripps Research Institute, Scripps Florida where she directs a research laboratory focusing on the study of prion diseases. Corinne Lasmézas has a Doctorate of Veterinary Medicine from the University of Toulouse, France, and a Ph.D. in Neurosciences from the University Pierre&Marie Curie in Paris, France. She has over fifteen years of experience in the study of prion diseases. Her research in France has contributed to demonstrate the transmissibility to humans of bovine spongiform encephalopathy by showing the similarity of this prion strain with that of the human variant Creutzfeldt-Jakob Disease. She has established a non-human primate model for the study of the pathogenesis and iatrogenic risk from the bovine prion. She has studied prion pathogenesis in rodent models, including the involvement of the lymphoreticular system, the relationship between infectivity and the misfolded prion protein, prion therapy and the interaction of the prion protein with cell surface proteins. Since 2005 Corinne Lasmézas continues her research in the USA at the newly created Department of Infectology of the Scripps Research Institute located in Jupiter, Florida, where her group focuses on the mechanisms of neurodegeneration in prion diseases, the search for a therapy, and a better understanding of the molecular mechanisms underlying prion replication and the strain phenomenon. She serves as a scientific reviewer for research programs and journals, and is a member of several advisory panels in Europe for issues related to ruminant and human prion diseases including the iatrogenic risk linked to human derived medicinal products.

Laura Manuelidis, M.D. Professor & Head of Neuropathology Department of Surgery Yale University School of Medicine New Haven, Connecticut

Dr. Laura Manuelidis is a Professor and Head of the Section of Neuropathology in the Department of Surgery at Yale, as well as on the interdepartmental faculty of Virology and Neuroscience. She received her MD at Yale and trained in both pathology and neuropathology. Major research contributions have been the discovery and sequencing of alpha satellite DNA and retroviral LINES in the 1970s, with the development of non-isotopic in-situ methods for defining chromosome and nuclear structure at high resolution. She also has done broad diagnostic work as Chief of the Neuropathology service for many years, and has been deeply involved in Creutzfeldt-Jakob disease (CJD) research. The first small animal models of CJD were developed at Yale in the 1970s and these have been fundamental for pathogenesis and infectivity studies. Recent tissue culture models of various CJD and a variety of distinct scrapie agent strains have simplified the study of these agents, including variant CJD (vCJD). The vCJD human isolate is derived from the "mad cow disease" agent (UK BSE). Dr. Manuelidis has been a consultant for the NIH, FDA, NATO, the Wellcome Trust, SEAC and the USDA and continues to participate in editorial boards and activities.

Suzette A. Priola, Ph.D. Senior Investigator & Chief - TSE/Prion Molecular Biology Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana

Dr. Suzette A. Priola is a Senior Investigator and Chief of the TSE/Prion Molecular Biology Section in the Laboratory of Persistent Viral Diseases at the National Institutes of Health’s Rocky Mountain Laboratories. She obtained her PhD in Microbiology and Immunology from the University of California, Los Angeles and specializes in infectious diseases of the central nervous system. She has over 18 years of research experience in the field of prion diseases during which time her laboratory has identified novel prion disease inhibitors and studied multiple different aspects of prion pathogenesis including how prions infect cells and the molecular basis of prion species barriers and strains. She was a member of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathy (TSE) Advisory Committee for five years and Chair for almost three years. She has served as a consultant to both the FDA’s Center for Biologics Evaluation and Research and the World Health Organization (WHO) and was a member of the National Prion Research Program administered by the Department of Defense’s Congressionally Directed Medical Research Programs. She has been an editorial board member at the Journal of Biological Chemistry and is currently on the editorial board of the journal Virology.

Juergen A. Richt, DVM, Ph.D. Regents Distinguished Professor Kansas State University College of Veterinary Medicine Diagnostic Medicine/Pathobiology Manhattan, Kansas

Dr. Jürgen A. Richt, DVM, PhD, is the Regents Distinguished Professor at the College of Veterinary Medicine at Kansas State University in Manhattan, KS. He received his DVM from the University of München, Germany, and his PhD in Virology from the University of Giessen, Germany. Dr. Richt has been working in the area of emerging zoonotic diseases for more than 20 years. In his early research years, Dr. Richt focused on the immunopathogenesis and molecular biology of Borna Disease Virus (BDV). After his move to the United States, Dr. Richt’s work focused on influenza virus infections in animals, especially swine, and on animal transmissible spongiform encephalopathies (TSEs) or prion diseases. Dr. Richt has published more than 90 peer-reviewed manuscripts in his area of expertise. He is one of the Editors for the journal Virus Genes and on the Editorial Board of numerous other journals. His research program is funded by the NIH and the CDC. He was recently appointed to the Scientific Advisory Board of OIE, Paris, France.

Lynne Sehulster, Ph.D. Health Scientist Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia

Dr. Lynne Sehulster is a Health Scientist in the Division of Healthcare Quality Promotion (DHQP) within the National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) at the Centers for Disease Control and Prevention (CDC). She has been at CDC for 12 years. She received her MS and PhD in Microbiology from Rutgers, the State University of New Jersey, and has her certificate as a Microbiologist with the American Society of Clinical Pathologists (M[ASCP]). Prior to coming to CDC, she completed a postdoctoral assignment in the Department of Virology and Epidemiology at Baylor College of Medicine in Houston doing laboratory research in hepatitis B virus inactivation. She subsequently served as an infectious disease epidemiologist for 15 years at the Texas Department of Health (currently known as the Texas Department of State Health Services). While in Texas she was the state health department’s point of contact for viral hepatitis and influenza epidemiology and surveillance activities. Her current areas of expertise at CDC focus on environmental infection control, transmission of infectious diseases, and microbial inactivation. She advises the agency, health care professionals, and the public on issues concerning indoor environmental cleaning, sterilization and disinfection, prion inactivation and risk assessment, and environmental management of emerging diseases. She also provides perspective to CDC on regulated medical waste and other healthcare facility issues such as laundry and environmental services. She is the coordinator of and contributor to the CDC/HICPAC “Guidelines for Environmental Infection Control in Health-Care Facilities” that was released in 2003.

Claudio Soto, Ph.D. Professor, Department of Neurology University of Texas Medical School at Houston Houston, Texas

Dr. Claudio Soto is the Director of the George and Cynthia Mitchell Center for Neurodegenerative Diseases and Professor on the Departments of Neurology, Neuroscience & Cell Biology and Biochemistry & Molecular Biology at the University of Texas Medical Branch in Galveston. Dr. Soto holds the Green Distinguished University Chair in Neuroscience, the largest endowed professorship in the University of Texas. Currently he is also the Founder, Vice-President and Chief Scientific Officer of AMPRION Inc. He received his PhD in biochemistry and molecular biology from the University of Chile in 1993 and was a postdoctoral fellow at the Catholic University of Chile and at the New York University School of Medicine, where he became an assistant professor of research in 1995. Between 1999-2003, Dr Soto was Senior Scientist, Chairman of the Department of Molecular Neuropathology and Senior Executive Scientific Advisor for Neurobiology at Serono International in Switzerland. For the past 13 years, he and his colleagues have engaged in research into the molecular basis of neurodegenerative diseases associated to the misfolding and brain accumulation of proteins, particularly focusing in Alzheimer’s and prion-related disorders. His work has led to the development of novel strategies for treatment and diagnosis of these diseases. He has published more than 90 peer review scientific publications and contributed to more than 15 books, including one written entirely by Dr. Soto. Many of his studies have been published in the most prestigious scientific journals (including Cell, Nature, Science, Nature medicine, EMBO Journal, etc) and several of them have produced a large impact in the scientific community.

http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html


AGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)OPEN MEETINGMarch 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/ OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.)2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsPlease note that all times are approximate(See note at the end of the Agenda)Tuesday, March 31, 20098:30 A.M. Opening of Meeting and Administrative Procedures by Designated Federal Official – Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members - Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Welcome and Opening Remarks – Steven Bradbury, Ph.D., Deputy Director, Office of Pesticide Programs, EPA9:00 A.M Background and Overview - Jeff Kempter, Senior Advisor, Antimicrobials Division, Office of Pesticide Programs, EPA9:20 A.M. A Regulatory Approach to C&D for CWD and EPA’s Role in the Process – Dean Goeldner, D.V.M., Chronic Wasting Disease Program Manager, USDA-APHIS-VS-NCAHP-RHP, Riverdale, MD9:40 A.M. FDA Approach to Claims for Reducing TSE Infectivity on Medical Devices - Sheila Murphey, M.D., Chief, Infection Control Devices Branch; Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation; Center for Devices and Radiologic Health; FDA, Rockville, MD10:15 A.M. Break10:30 A.M. EPA’s “White Paper” – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC10:50 A.M. EPA’s Guidance for Efficacy Test Methods for Products Bearing11:15 A.M. Prion Infectivity Assays – Christopher J. Silva, Research Chemist, Foodborne contaminants Research Unit, Western Regional Research Center, Albany, CA11:40 A.M. Transmissible Spongiform Encephalopathies (TSEs/Prion Diseases): Target Criteria for Assessing Agent Clearance – David M. Asher, MD, Chief, Laboratory of Bacterial, Parasitic and Unconventional Agents; Division of Emerging and Transfusion-Transmitted Diseases; Office of Blood Research and Review; Center for Biologics Evaluation and Research; FDA, Rockville, Maryland3:45 P.M. Charge to Panel – Question 11. White Paper Issue: Whether EPA’s draft review paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),” adequately identifies and summarizes available, relevant scientific studies.Prion-Related Claims – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC12:00 P.M. Lunch1:00 P.M. Public Comment3:30 P.M. BreakIn 2005, EPA established a Work Group to develop a Notice of Proposed Rulemaking (NPRM) that defines a prion as a “pest” under FIFRA. To assure that it considers key available scientific studies that are relevant to the issue of whether a prion is a “pest” under FIFRA, the Work Group drafted a review paper. While the paper received intra-Agency review, it was not subjected to peer review outside of EPA. Accordingly, EPA seeks the SAP’s peer review of the attached, draft review paper (USEPA 2008). Some of the key references cited in the review paper have been provided to the SAP.EPA wishes to point out that the NPRM will also focus on legal and policy matters that are not addressed in depth in the “white paper.” EPA is presenting this paper to the SAP solely for review as to its characterization of the scientific issues, and is not asking the SAP to interpret legal/policy issues such as Congress’ intent in drafting FIFRA.•Please comment on the accuracy of the characterization of the nature of prions, and the adequacy of the review of the relevant scie ific information to support that characterization, as presented in EPA’s draft paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).”5:00 P.M. AdjournmentOPEN MEETINGAGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)March 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/ OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.) 2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsWednesday, April 1, 20098:30 A.M. Opening of Meeting - Administrative Procedures by Designated Federal Official - Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members -Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Follow-up from Previous Day’s Discussion – Jeff Kempter, Senior Advisor, Antimicrobial Division, Office of Pesticide Programs, EPA9:15 A.M. Charge to Panel – Question 22. Efficacy Guidance Test Method Issue: Whether the specific test systems recommended in the draft guidance document are scientifically appropriate to support the registration of pesticide products with prion-related claims.The draft efficacy guidance document (USEPA 2009) recommends a carrier-based, animal infectivity test method, if the intended use of a product is for treating environmental surfaces, and a suspension-based, animal infectivity test method if the intended use of a product is for treating liquids. The draft efficacy guidance document also states that the test methods may either be end-point titration or incubation time interval assays. EPA is interested in knowing the SAP’s opinion on whether these recommended test systems are scientifically sound and appropriate approaches to evaluating the efficacy of pesticide products with prion-related claims. EPA would also like to know whether the SAP recommends that other test methods be considered to evaluate the efficacy of pesticide products used either on•b.3. Efficacy Guidance Performance Criterion Issue: Whether the product performance criterion specified in the draft guidance document to support the registration of pesticide products with prion-related claims is scientifically sound.environmental surfaces or in liquid media.Please comment on the scientific appropriateness of:a.Carrier-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used on environmental surfaces (e.g., hard, nonporous surfaces).Suspension-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used in liquid media (e.g., wastewater).Any other known test methods for evaluating the efficacy of pesticide products used on either environmental surfaces or in liquid media.10:30 A.M. Break10:45 A.M. Charge to Panel - Question 3The draft efficacy guidance document recommends a target efficacy criterion of six (6) logs of reduction of infectivity in the treated versus untreated (control) groups. This criterion is widely used in the current scientific literature. EPA would like the SAP’s comment on this proposed product performance criterion.•Please comment on the scientific soundness of the product performance criterion recommended in the draft guidance document to support the registration of pesticide products with a prion claim.12:00 P.M. Lunch1:00 P.M. Charge to Panel – Question 44. Efficacy Guidance Labeling Claim Issue: Whether the labeling claim described in the draft guidance document is scientifically appropriate based on the recommended test systems and product performance standard.The draft efficacy guidance document recommends a carefully worded labeling claim statement: “Has been demonstrated to reduce infeci ity of prions (TSE agents) based on testing using (insert type of organism in which the prions were raised) (insert prion type).” EPA believes that claims that may normally be applied to microorganisms (e.g., “destroy,” “mitigate,” “eliminate,” “control”) may be misleading when applied to prions. Because currently available test methods can only measure a reduction in infectivity, and the total elimination or destruction of prions cannot be•5. Efficacy Guidance Hierarchy Issue: Whether different prion types exhibit variation in the degree of resistance to inactivation by pesticide chemicals and whether a hierarchy of resistance by prion type can be reliably determined at this time.Comparisons of different types of prions in a common animal infectivity assay indicate there may be significant differences with regard to their ability to resist inactivation by pesticide chemicals. For example, Peretz et al. (2006) compared the resistance of hamster scrapie and human CJD prions in transgenic mice expressing either hamster PrP or a chimeric mouse-human PrP transgene and found that human sCJD prion tested was 100,000 fold more difficult to inactivate than hamster Sc237 prion. Preliminary additional studies indicate that the cow BSE prion may be even more resistant to inactivation than the human CJD prion (Giles et al. 2006; 2008 in press).measured, EPA believes that “reduce infectivity” is the only appropriate claim.Please comment on the scientific appropriateness of the term “reduce infectivity” in a label claim to reflect the action of a pesticide on prions.3:00 P.M. Break3:15 P.M. Charge to Panel – Question 5•Please comment on whether a hierarchy of resistance among prion types can be reliably demonstrated for different pesticide chemicals based on the available data.5:00 P.M. AdjournmentPlease be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the

http://www.epa.gov/scipoly/sap/meetings/2009/march/033109agenda.pdf


FIFRA Scientific Advisory Panel; Notice of Public Meeting PDF Version (3 pp, 80K, About PDF)

[Federal Register: December 17, 2008 (Volume 73, Number 243)] [Notices] [Page 76639-76641] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17de08-76]

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ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0859; FRL-8392-9]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA). ACTION: Notice.

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SUMMARY: There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Scientific Issues Associated with Designating a Prion as a ``Pest'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods.

http://www.epa.gov/EPA-MEETINGS/2008/December/Day-17/m29977.htm


Associated with Designating a Prion as a "Pest" under the Federal insecticide,. Fungicide, and Rodenticide Act (FlFRA), and Related Efficacy Test Methods. These ... whether Prions Are a Pest' under the Federal insecticide, Fungicide, and Rodenticide Act (fifra)." 2. Efficacy Guidance Test Method issue: Whether the ...

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064808df7ef&di


http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&di


----- Original Message -----

From: "Terry S. Singeltary Sr." flounder9@verizon.net

To: "Bovine Spongiform Encephalopathy" BSE-L@aegee.org

Cc: heggem.daniel@epa.gov; sibert.christopher@epa.gov; denne.jane@epa.gov; hazen.susan@epa.gov; mcrosby@ucsusa.org; erobinson@ucsusa.org; enegin@ucsusa.org; cjdvoice@yahoogroups.com; madcow@lists.iatp.org Sent: Monday, April 28, 2008 9:48 PM

Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency

Reports and Research

Interference at the EPA

Science and Politics at the U.S. Environmental Protection Agency

The U.S. Environmental Protection Agency (EPA) has the simple yet profound charge "to protect human health and the environment." EPA scientists apply their expertise to protect the public from air and water pollution, clean up hazardous waste, and study emerging threats such as global warming. Because each year brings new and potentially toxic chemicals into our homes and workplaces, because air pollution still threatens our public health, and because environmental challenges are becoming more complex and global, a strong and capable EPA is more important than ever.

Yet challenges from industry lobbyists and some political leaders to the agency's decisions have too often led to the suppression and distortion of the scientific findings underlying those decisions—to the detriment of both science and the health of our nation. While every regulatory agency must balance scientific findings with other considerations, policy makers need access to the highest-quality scientific information to make fully informed decisions.

Concern over this problem led the Union of Concerned Scientists (UCS) to investigate political interference in science at the EPA. The investigation combines dozens of interviews with current and former EPA staff, analysis of government documents, more than 1,600 responses to a survey sent to current EPA scientists, and written comments from EPA scientists.

The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations.

These findings highlight the need for strong reforms to protect EPA scientists, make agency decision making more transparent, and reduce politicization of the regulatory process. Congress, the next president, and the next EPA Administrator must restore independence and scientific integrity to the EPA by:

Protecting EPA Scientists: Scientists should be free to report the distortion, manipulation, and suppression of their work without fear of retribution. Congress should pass a whistleblower law that includes protection for scientists. The EPA should adopt a communications policy that lets scientists speak freely to the press about their findings. Making the EPA More Transparent: Too many decisions are made behind closed doors with little accountability. The EPA’s scientific findings should be freely available to the public. The EPA should open up its decision-making process to congressional and public scrutiny to help reveal misuses of science Reforming the Regulatory Process: The White House should not change scientific findings in order to weaken, delay, or prevent new public protections. Ensuring Robust Scientific Input to EPA's Decision Making: The EPA should review and strengthen how it uses the scientific expertise of its staff and external advisory committees to create policies—especially when scientific input is critical or required by law. Depoliticizing Funding, Monitoring, and Enforcement: Problems with funding, monitoring and enforcement also need to be addressed by Congress and the next President to ensure that the EPA is the robust environmental agency that our country needs. Political interference is not unique to the EPA. Use the links on this page to explore surveys of scientists at other federal agencies and scores of examples of the abuse of science on issues ranging from prescription drugs to endangered species.

Program Overview Political Interference in Science Restoring Scientific Integrity Stay Informed

Sign up for our online action networks or electronic newsletters. Enter your email address for a list of options.

Contents Scientist Statement on Scientific Integrity 2008 Statement: Scientific Freedom and the Public Good Evidence of Political Interference Report: Interference at the EPA Report: Federal Science and the Public Good Examples of Political Interference in Science Surveys of Scientists at Federal Agencies Focus on Climate Science Focus on Endangered Species Science more... News & Views Scientific Integrity Update--01/2008 Scientific Integrity in the News Editorials on the Misuse of Science Poll: The Public's Belief in Independent Science Science, Evolution, and Intelligent Design Resources & Information Info for the Media Info For Congressional Staff Scientific Integrity Curriculum Guide Other Groups Addressing Scientific Integrity Science Idol: The Scientific Integrity Editorial Cartoon Contest

The Report Press Release Executive Summary (PDF) Interference at the EPA: Full Report (PDF) FAQ's about the Report (PDF) Essay Responses From Scientists Select Quotes (PDF) All Essays (PDF) Survey of EPA Scientists Survey Summary and Supporting Documents Congress Reacts Letter to EPA from Rep. Waxman (CA) Statement by Senator Whitehouse (RI) Statement by Rep. Holt (NJ) Other Resources EPA and the White House (PDF) Air Pollution and the EPA (PDF) Climate Change and the EPA (PDF) Toxics and the EPA (PDF) Focus on Region 4 (PDF) Focus on Region 9 (PDF) Related Information Take Action A-to-Z Guide to Political Interference

http://www.ucsusa.org/scientific_integrity/interference/a-to-z-alphabetical.html


Executive Summary

snip...

The Bush administration’s direct abuse of science—combined with systemic changes to the regulatory system that threaten the in- tegrity of EPA science—highlight the need for strong action by the next president and Con- gress to restore scientific integrity to the agen- cy’s decision making. Only then can the EPA fully mobilize to serve the public good and ensure the nation’s health.

Report: Federal Science and the Public Good

http://www.ucsusa.org/scientific_integrity/interference/interference-at-the-epa.html


*************************************************************


April 29, 2004 (Supercedes March 2, 2004 memorandum) Consideration of Prions as a Pest under FIFRA

http://www.epa.gov/oppad001/records_of_decision_on_prions.pdf


CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA WILLIAM L. KOVACS 1615 H S TREET , N.W. VICE PRESIDENT WASHINGTON , D.C. 20062 ENVIRONMENT , TECHNOLOGY & (202) 463 5457 REGULATORY AFFAIRS December 22, 2005

Likewise, some agency records of decision, as well as internal memoranda, establish precedent for regulatory policy making that at times extend the regulatory reach of federal agencies far beyond the statutorily mandated powers given by Congress. A recent example of a record of decision with regulatory impact would be the EPA’s decision to regulate prions.4 Prions are protein structures which, when infectious, are suspected of causing transmissible spongiform encephalopathy diseases, such as mad cow disease in cattle.5 EPA’s decision to classify prions as “pests” under FIFRA stems from an internal agency memorandum asserting jurisdiction over prions,6 even though prions are not living things (a prerequisite for EPA jurisdiction under FIFRA).7 Moreover, acting under the authority granted to itself in this memorandum, EPA issued emergency exemptions to several states to authorize the use of pesticides not registered under FIFRA to treat prioninfected surfaces. Therefore, EPA is treating this memorandum as though it is the issuance of a rule, without providing notice to the public or the opportunity to comment on the agency’s interpretation of its authoritative scope.8 The U.S. Chamber specifically requested EPA publish its prior discussion in the Federal Register for notice and comment, but EPA did not respond to that request. 3 Letter from Robert P. Murphy, General Counsel, General Accounting Office, to The Honorable David M. McIntosh, U.S. House of Representatives, January 20, 1999. 4 S.B. Hazen, Memorandum “Consideration of Prions as a Pest under FIFRA” to the Record, April 29, 2004; accessed at:

http://www.epa.gov/oppad001/records_of_decision_on_prions.pdf.

5 See definition of prion at http://en.wikipedia.org/wiki/Prion. 6 Memorandum from Susan B. Hazen, Principle Deputy Assistant Administrator, to the record, dated April 29, 2004. The memorandum is available on EPA’s Web site at:

http://www.epa.gov/oppad001/records_of_decision_on_prions.pdf.

7 7 U.S.C. 136(t). 8 The Administrative Procedure Act defines a “rule” as … an agency statement of general or particular applicability and future effect designed to implement, interpret, or proscribe law or policy…5 U.S.C. 551(4).

snip...full text ;

http://www.whitehouse.gov/omb/inforeg/good_guid/c-commerce.pdf


Rulemaking to Establish Criteria for the Importation of Designated Ruminants and Ruminant Products From Canada into the United States Final Environmental Assessment, December 2004

While FSIS recommends the use of disinfectants, EPA regulates disinfectants under FIFRA. Prior to 2003, prions were not considered pests, and therefore their treatment with disinfectants was not regulated. In September of 2003, EPA classified prions as a pest (Hazen, 2004) and, therefore, the agency was required to regulate the “microorganisms” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

http://www.aphis.usda.gov/newsroom/hot_issues/bse/background/documents/03-080-3%20environmental%20assessment.pdf


From: flounder9@verizon.net

Date: 2008-06-21 11:28:34

Subject: Re: [CJDVoice] Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency

White House invokes executive privilege in EPA inquiry

The Bush administration refuses to turn over subpoenaed documents related to the agency's decision to prevent California from enacting stricter emissions standards than the federal government.

By Richard Simon, Los Angeles Times Staff Writer

June 21, 2008

WASHINGTON -- Escalating a fight with Democrats on Capitol Hill, the White House on Friday invoked executive privilege in refusing to turn over documents to a congressional committee investigating the Environmental Protection Agency's decision to deny California permission to implement its own vehicle emission standards.

The Bush administration asserted executive privilege hours before the House Oversight and Government Reform Committee was to vote on whether to bring contempt-of-Congress proceedings against EPA Administrator Stephen L. Johnson and Susan Dudley, administrator of regulatory affairs in the White House Office of Management and Budget, for refusing to turn over subpoenaed documents.

Committee Chairman Henry A. Waxman (D-Beverly Hills) put off a vote on the contempt resolutions while he considers his options.

"I don't think we've had a situation like this since Richard Nixon was president," he said, appearing determined to press ahead, even if it leads to a court fight. "We don't know whether this privilege that's being asserted is valid or not."

Presidents since George Washington have claimed rights to executive branch confidentiality, according to the nonpartisan Congressional Research Service. The Bush White House invoked executive privilege to prevent officials from testifying about the dismissal of nine U.S. attorneys in 2006. President Clinton cited presidential privilege during investigations into the Monica Lewinsky scandal and on other issues.

House and Senate committees have been investigating what role the White House played in EPA decisions preventing California and other states from enacting tougher emissions rules than the federal government and in the EPA's approval of new ozone pollution standards.

The administration's claim of executive privilege is the latest twist in the escalating legal and political battle over California's efforts to implement its own law combating global warming. Critics of the EPA decision contend that it was based on politics, not science or the law.

As Waxman considered his next move in his fight with the White House, another House committee in the room next door grilled former Bush Press Secretary Scott McClellan, who wrote a revealing book about his days in the White House. The hearings were a sign of determination by Democrats not to ease up on their oversight activities, even in the final months of the Bush administration.

In asserting executive privilege in the EPA inquiry, the administration made public a copy of a letter sent to the president by Atty. Gen. Michael B. Mukasey saying that releasing internal documents "could inhibit the candor of future deliberations among the president's staff."

EPA spokesman Tim Lyons said the agency had provided the committee with more than 7,000 documents and devoted 2,200 hours of staff time to responding to requests for information, and he called it "disappointing" that the committee had decided to "politicize environmental regulations."

Jim Nussle, director of the Office of Management and Budget, took issue with Waxman's "sudden and unwarranted" move to consider contempt proceedings, noting that Dudley had appeared before Waxman's committee last month and was asked "only four questions" -- and only one by the panel chairman.

"There is no valid reason for moving from mutual cooperation to unilateral confrontation," Nussle wrote Waxman.

Waxman said: "I am very disappointed and disturbed that the administration is keeping this information from us, and I think we have a right to it."

richard.simon@latimes.com

http://www.latimes.com/news/nationworld/nation/la-na-epa21-2008jun21,0,1939720.story


snip...please see full text ;


http://sciencebushwhacked.blogspot.com/2008/06/white-house-invokes-executive-privilege.html


http://sciencebushwhacked.blogspot.com/


Wednesday, January 19, 2011

EFSA BIOHAZ Scientific Opinion on the revision of the quantitative risk assessment (QRA) of the BSE risk posed by processed animal proteins (PAPs)

EFSA Journal 2011;9(1):1947

http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-biohaz-scientific-opinion-on.html


Monday, January 17, 2011

MAD COW Update on Feed Enforcement Activities to Limit the Spread of BSE January 13, 2011

January 2011


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/mad-cow-update-on-feed-enforcement.html


Friday, January 7, 2011

MEAT AND BONE MEAL AND MINERAL FEED ADDITIVES MAY INCREASE THE RISK OF ORAL PRION DISEASE TRANSMISSION

Journal of Toxicology and Environmental Health, Part A, 74:161-166, 2011 Copyright © Taylor & Francis Group, LLC ISSN: 1528-7394 print / 1087-2620 online DOI: 10.1080/15287394.2011.529066


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/meat-and-bone-meal-and-mineral-feed.html


Wednesday, January 19, 2011

EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011

http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html


UPDATED DATA ON 2ND CWD STRAIN

Wednesday, September 08, 2010

CWD PRION CONGRESS SEPTEMBER 8-11 2010

http://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html


Tuesday, January 25, 2011

Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions

http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html


Tuesday, January 18, 2011

Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease

http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html


2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006

http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html


Tuesday, December 14, 2010

Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings part 4, Annex A1, Annex J, UPDATE DECEMBER 2010

http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html


Friday, November 30, 2007

CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION

http://cjdquestionnaire.blogspot.com/


CAN someone please tell me why hunters can have their deer and elk tested for CWD i.e. prion disease, but consumers cannot have their beef tested for the BSE PrPSc TSE i.e. prion disease ???


what's the difference $$$


Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518


Don't look, don't find, and damn sure don't let anybody else look, i.e. USA SSS BSE policy of shoot, shovel, and shut the hell up $$$