Tuesday, April 29, 2008

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

----- 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

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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


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01

[Federal Register: January 9, 2007 (Volume 72, Number 5)] [Proposed Rules] [Page 1101-1129] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ja07-21]

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8152


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 Date: January 9, 2007 at 9:08 am PST

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f3412


PLEASE NOTE, THESE EPA DOCKET URLS ON MY SUBMISSION TO Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 ARE NO LONGER GOOD ???

Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION

http://docket.epa.gov/edkfed/do/EDKStaffItemDetailView?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007d48096b40d


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA

https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Sent: Monday, July 24, 2006 1:09 PM

To: FSIS RegulationsComments

Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


IN A NUT SHELL ;

(Adopted by the International Committee of the OIE on 23 May 2006)

11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries. The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to the Central Bureau,

http://www.oie.int/eng/Session2007/RF2006.pdf


$$$ Science abused at the EPA $$$

Greetings,

I will be taking part in this action. Please be on the lookout for my letter to an EPA scientist. I would further like to add to the ;

A-to-Z Guide to Political Interference

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


BOVINE SPONGIFORM ENCEPHALOPATHY TYPICAL AND ATYPICAL BOTH OF WHICH HAVE BEEN FOUND IN NORTH AMERICA.

The FDA/USDA et al have failed the public terribly in surveillance, testing, and mad cow feed ban. all of which were/are fraught with errors, time and time again, to a point of great suspicion $

and to add insult to injury, they have blatantly lied and covered up mad cow disease and other TSEs, to a point of finally after 5 years of request after request, they have officially denied my F.O.I.A. request for the final time. They tell me if i want that info on those mad sheep of mad river valley in Vermont, they tell me ;

"As FOIA requires an agency only to produce responsive non-exempt records to a requester, OIG is not obligated to answer questions regarding the TSE occurrence as you requested. Therefore, I am denying your appeal with respect to your questions."

Mr. Terry S. Singeltary, Sr. Page 3

"For these reasons, I am denying your FOIA appeal. This is the final agency decision. You may seek judicial review of this decision in the United States district court for the judicial district in which you reside or have your principal place of business or in the District of Columbia, pursuant to 5 U.S.C. & 552(a)(4)(B)."

please see full text ;

Thursday, April 24, 2008

RE-FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. OF FOREIGN ORIGIN IN THE UNITED STATES [Docket No. 00-072-1]

http://foiamadsheepmadrivervalley.blogspot.com/2008/04/re-foia-of-declaration-of-extraordinary.html


NOR-98 ATYPICAL SCRAPIE 5 cases documented in USA in 5 different states USA 2007

http://nor-98.blogspot.com/


Friday, April 25, 2008

Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46

http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html


Wednesday, April 16, 2008

REPORT ON THE INVESTIGATION OF THE ELEVENTH CASE OF BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN CANADA

http://madcowtesting.blogspot.com/2008/04/report-on-investigation-of-eleventh.html


BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA

http://madcowtesting.blogspot.com/


Sunday, March 16, 2008

MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE (please note the last two mad cows documented in the USA, in Texas and Alabama were both atypical BSE. please note, atypical BSE is more virlent than typical BSE.

http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html


PLEASE SEE THE LARGEST EVER LONG TERM LIVE CASE STUDY WITH OUR CHILDREN BEING EXPOSED TO MAD COW DISEASE IN THE NATIONS SCHOOL LUNCH PROGRAM, but does anyone in the USDA/FDA et al even care to follow them $$$

DOWNER COW SCHOOL LUNCH PROGRAM

http://downercattle.blogspot.com/


http://downercattle.blogspot.com/2008/02/transcript-technical-briefing.html


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


Creutzfeldt-Jakob Disease (Variant) and Bovine Spongiform Encephalopathy (Prion Diseases) Description Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks, primarily in Europe, of a disease in cattle called bovine spongiform encephalopathy (BSE, or “mad cow disease”) and a disease in humans called variant Creutzfeldt-Jakob disease (vCJD). Both disorders, which are caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years (1). Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; the specific foods associated with this transmission are unknown. However, a recently published case-control study involving 132 vCJD cases in the United Kingdom (UK) showed evidence of an increased risk for vCJD associated with the frequency of consuming beef products likely to contain mechanically recovered meat and head meat (such as burgers, meat pies, and sausages) (2). Bioassays and molecular tests have enabled identification of what World Health Organization consultants have classified as “high-infectivity” and “lower infectivity” tissues of cattle with BSE (3). The high-infectivity tissues include the brain, spinal cord, retina, optic nerve, and dorsal root and trigeminal ganglia, suggesting that these tissues can pose a relatively high risk of transmission. The lower infectivity tissues include peripheral nerves (e.g., sciatic and facial nerves), tonsils, nictitating membrane (third eye lid), distal ileum, bone marrow, and possibly thigh muscle. The latter tissue from one cow with BSE transmitted disease to highly BSE-sensitive transgenic mice at a rate indicative of trace levels of infectivity.

http://wwwn.cdc.gov/travel/yellowBookCh4-VariantPrions.aspx


Progress Report from the National Prion Disease Pathology Surveillance Center April 3, 2008

Progress Report from the National Prion Disease Pathology Surveillance Center

An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD

April 3, 2008

Dear Member:

Once again we are writing to thank you for your continued support in enhancing surveillance of prion diseases in the United States and to bring you up to date on the National Prion Disease Pathology Surveillance Center (NPDPSC).

In large part because of your support, the number of cases examined by biopsy, autopsy and 14-3-3 protein determination has increased significantly over the years (see Tables 1 and 2). We are now able to establish a definitive diagnosis of prion disease in an estimated 60-70% of the cases in the United States, a percentage which exceeds that in even some major surveillance centers. In addition, we receive from you cerebrospinal fluid (CSF) for 14-3-3 determination, a surrogate protein which is helpful in the diagnosis of prion disease, probably in most if not all cases of suspected Creutzfeldt-Jakob disease (CJD). We are making constant efforts to reach our goal of at least 80% definitively diagnosed cases.

The major obstacle to our further increasing the autopsy rate remains the inadequate reporting of suspected cases of CJD to the NPDPSC or to the State Health Department, which in turn would notify us. Since you are the one likely to request the 14-3-3 test on these cases, please include in your request the information needed to contact you, which we will do if the test proves positive. If your institution uses a referral laboratory to send us the CSF, please provide your name, phone, and fax numbers to the lab, which will in turn submit it to us along with the sample. If this information is missing in the request accompanying the CSF sample (as it happens in about 30% of the cases), we will be unable to contact the caregiving physician. Having your contact information would also allow us to send results directly to you, thus reducing turnaround times. ...

snip...

Prion surveillance in cattle has been reduced by 90% (from about 470,000 to 40,000 in the U.S. in 2007 out of about 35 million cattle slaughtered). Termination of human prion surveillance would therefore remove the second line of surveillance, thereby eliminating prion surveillance in the U.S. entirely. This development would be extremely worrisome in view of recent reports that precautions to limit the spread of the prion infectious agent may not have been followed in some slaughter houses in the U.S. Cattle affected with bovine spongiform encephalopathy (BSE) continue to be discovered in Canada, which has more rigorous BSE surveillance than the U.S. At the same time, Canada imposes few limitations in the trade of potentially prion-infectious cattle with the U.S.

snip...

Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.

please see full text with additional comments and links @ ;

http://prionunitusaupdate2008.blogspot.com/


CJD USA

*Acquired in UK ** Acquired in Saudi Arabia *** Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007. **** Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1 from 2001, 1 from 2003, 4 from 2004, 3 from 2005, 4 from 2006) and 36 type pending (2 from 2005, 8 from 2006, 26 from 2007).

Notes:

-- Cases are listed based on the year of death when available. If the year of death is not available, the year of sample receipt is used.

-- Referrals: Cases with possible or probable prion disease from which brain tissue or blood in the case of familial disease were submitted.

-- Inconclusive: Cases in which the samples were not sufficient to make a diagnosis.

-- Non-vCJD type unknown are cases in which the tissue submitted was adequate to establish the presence but not the type; in all cases, vCJD could be excluded.

-- Communicated by: Terry S. Singeltary Sr.

[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]

http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963


There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.

He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535


THE PATHOLOGICAL PROTEIN Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9

June 2003

BY Philip Yam

CHAPTER 14 LAYING ODDS

Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.

http://www.thepathologicalprotein.com/


SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html


SPECIFIED RISK MATERIALS

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html


10 Million Baby Boomers to have Alzheimer's in the coming decades 2008 Alzheimer’s disease facts and figures

http://betaamyloidcjd.blogspot.com/2008/03/association-between-deposition-of-beta.html


re-Association between Deposition of Beta-Amyloid and Pathological Prion Protein in Sporadic Creutzfeldt-Jakob Disease

http://betaamyloidcjd.blogspot.com/2008/04/re-association-between-deposition-of.html


Alzheimer's and CJD

http://betaamyloidcjd.blogspot.com/


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