Wednesday, July 9, 2008

[Docket No. FDA-2008-N-0369] Ruminant Feed Ban Support Project; ``Response to RFA-FDA-08-008''

[Federal Register: July 9, 2008 (Volume 73, Number 132)] [Notices] [Page 39316-39318] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09jy08-69]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0369]

Ruminant Feed Ban Support Project; Availability of Cooperative Agreements Under a Limited Competition; Request for Applications: RFA- FD-08-008; Catalog of Federal Domestic Assistance Number: 93.449

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) in coordination with the Center for Veterinary Medicine (CVM), is announcing the availability of cooperative agreements funding to further enhance the infrastructure of State, territorial, and tribal animal feed safety and bovine spongiform encephalopathy (BSE) prevention programs. These cooperative agreements are intended to fund additional personnel, equipment, supplies, and training support activities related to the FDA ruminant feed ban (referred to as the BSE/ruminant feed ban), in State, territory, and tribal governments. FDA anticipates providing approximately $1 million in direct plus indirect costs in support of this program in fiscal year (FY) 2008. It is anticipated that four awards will be made for up to $250,000 per award per year for up to 2 years.

DATES: The application receipt date is August 8, 2008.

ADDRESSES: Applications may be submitted on or after the opening date and must be successfully received by http://www.grants.gov\1\ no later than 5 p.m. local time (of the applicant institution/organization) on the application submission/receipt date. If an application is not submitted by the receipt date and time, the application may be delayed in the review process or not reviewed. ---------------------------------------------------------------------------

\1\ FDA has verified the non-FDA Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register. ---------------------------------------------------------------------------

The required application, SF-424, can be completed and submitted online. The package should be labeled ``Response to RFA-FDA-08-008''. If you experience technical difficulties with your online submission you should contact Marc Pitts by telephone at 301-827-7162 or by e-mail at mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000133/!x-usc:mailto:marc.pitts@fda.hhs.gov. Paper applications will not be accepted.

FOR FURTHER INFORMATION CONTACT: Regarding the administrative and financial management aspects of this notice: Marc Pitts, Office of Acquisitions and Grants Management, Food and Drug Administration (HFA-500), 5630 Fishers Lane, suite 2104, Rockville MD 20857 (see also ADDRESSES). Regarding the programmatic aspects of this notice:Jennifer Gabb, Division of Federal-State Relations (DFSR), Office of Regulatory Affairs, Food and Drug Administration (HFC- 150), 5600 Fishers Lane, Rm. 12- 07, Rockville, MD 20857, 301- 827- 2899, e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000133/!x-usc:mailto:jennifer.gabb@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

Under these cooperative agreements, the State, territory, and tribal governments would enhance their feed/BSE safety programs to increase the ability to locate and visit firms involved in the manufacture, distribution, and transportation of animal feed and operations feeding ruminant animals in their jurisdiction, to verify compliance with the ruminant feed ban. Funds could be used to increase State, territory, and tribal personnel dedicated to conducting these inspections. Funds could be used for supplies, training, and laboratory equipment for feed sample testing using FDA validation methods. Funds could also be used to conduct outreach educational activities and materials as needed to further and enhance the industries knowledge and compliance with ruminant feed ban. The goal of enhancing their feed/BSE safety programs is to increase State, territory, and tribal inspections under section 702 of the Federal Food, Drug, and Cosmetic Act (act) (21 U.S.C. 372) of renderers, protein blenders, and feed mills that manufacture animal feeds and feed ingredients, and inspections of salvagers of food and feed, and transporters of animal feed and feed ingredients utilizing materials prohibited under the ruminant feed ban. Finally, the Feed Ban Support Project funds are intended to supplement, not replace, State funding for program improvement. The following are seven key project areas identified for this effort: (1) Hire and/or train State/territory/tribal personnel to conduct ruminant feed ban inspections. Training of State/territory/ tribal personnel may be accomplished through the ORA University, or the Association of American Feed Control Officials Annual Feed Seminar, or other training that meets State/territory/tribal and FDA requirements. New hires for this program must meet the State/territory/tribal agency's qualifications for feed inspections and sampling techniques; (2) hire and/or train laboratory personnel to verify that feed samples are free of materials prohibited under the ruminant feed ban. Laboratory analyses must utilize FDA accepted methodologies for detection of prohibited materials; (3) identify and inspect renderers, protein blenders, commercial animal feed manufacturers, feed salvagers, distributors (including retailers), transporters of animal feed and feed ingredients, on-farm animal feed mixers, and ruminant feeders within the State/territory/tribal jurisdiction that have not already been identified and/or inspected for compliance with the ruminant feed ban. These inspections would be conducted under section 702 of the act using and completing the FDA Ruminant Feed Ban Inspection Checklist and Ruminant Feed Ban Compliance Program to verify compliance with the BSE/ ruminant feed ban. These inspections would be conducted by officers and employees duly commissioned by FDA in accordance with section 702 of the act; (4 ) conduct surveillance sampling of renderers, protein blenders, and feed mills that manufacture with materials prohibited under the BSE/ruminant feed ban. Sample feeds formulated without prohibited material. A minimum of one sample from each facility would be obtained during the inspection and would be analyzed by the State/ territorial/tribal government for prohibited materials. This surveillance sampling would be conducted under section 702 of the act using and completing the FDA Ruminant Feed Ban Inspection Checklist and Ruminant Feed Ban Compliance Program to verify compliance with the BSE/ ruminant feed ban. This surveillance sampling would be conducted by officers and employees duly commissioned by FDA in accordance with section 702 of the act; (5) provide copies of all completed BSE/ Ruminant Feed Ban checklists and sample results as a part of the mid- year program progress report to the FDA Project officer or designated office, as well as provide completed checklists and sample results in accordance with section 702 of the act; (6) be able to identify and quantify improvements to the existing State/ territory/tribal BSE/ ruminant feed ban program or developing new programs (i.e., personnel hiring, personnel training, equipment upgrades, increase in inspections conducted) in the mid-year

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report as a result of the cooperative agreement; (7) conduct outreach educational activities and materials as needed to further and enhance the industries knowledge and compliance with ruminant feed ban. Please visit http://www.grants.gov to view the full version of this Request for Applications (RFA). FDA urges applicants to read the full version RFA in its entirety prior to submitting application packets. The events of September 11, 2001, reinforced the need to enhance the security and safety of the U.S. food supply. Congress responded by passing the Bioterrorism Act which President Bush signed into law on June 12, 2002. The Bioterrorism Act is divided into the following five titles: (1) Title I-- National Preparedness for Bioterrorism and Other Public Health Emergencies; (2) Title II--Enhancing Controls on Dangerous Biological Agents and Toxins; (3) Title III--Protecting Safety and Security of Food and Drug Supply; (4) Title IV--Drinking Water Security and Safety; and (5) Title V--Additional Provisions Subtitle A of Title III--Protection of Food Supply, Section 311-- Grants to States for Inspections, amends the act by adding section 909 to authorize the Secretary of Health and Human Services to award grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities under section 702 of the act. The grant funds are only available for the costs of conducting these examinations, inspections, investigations, and related activities. Toward these ends, ORA is offering these cooperative agreements to State/ territorial/tribal governments for them to develop, new or enhance the capability of, their existing BSE/ruminant feed ban programs and assist in an increased surveillance presence throughout the commercial feed channels to prevent the introduction or amplification of BSE in the United States. State/territorial/ tribal inspections are based on a determination of compliance of firms with the ``Animal Proteins Prohibited In Ruminant Feeds'' regulation, (21 CFR 589.2000), as well as any subsequent regulations and guidance applicable to the BSE/ruminant feed ban. This regulation is designed to prevent the establishment and amplification of BSE through animal feed, by prohibiting the use of certain proteins derived from mammalian tissue in the feeding of ruminant animals. The regulation affects renderers, protein blenders, commercial animal feed manufacturers, distributors (including retailers), transporters of animal feed and feed ingredients, on-farm animal feed mixers, and ruminant feeders. Based on the need to control the entry and spread of this disease, the agency has set a goal to assist in the development of new, or the enhancement of existing, State/territory/tribal BSE/ruminant feed ban programs to help meet compliance with the regulation.

II. Project Goals, Definitions, and Examples

The goal of FDA's ORA Cooperative Agreement Program is to enhance, complement, develop, and improve State/territory/tribal feed safety and surveillance programs. This will be accomplished through the provision of funding for additional equipment, supplies, funding for personnel, training in current FDA approved feed testing methodologies, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, and analysis of surveillance samples and State/territorial/tribal compliance inspections. This will also require extensive cooperation and coordination with FDA District Offices to minimize duplication of inspections. These cooperative agreements will be made to either fund the development of new State/territory/tribal BSE/Ruminant Feed Ban programs or to enhance existing State/territory/tribal BSE/ruminant feed ban programs for the funding of items such as: Supplies, lab equipment, surveillance, sample collection, personnel, for the provision of training in current inspectional and analytical methodology, for the analysis of feed and feed products, and BSE/ ruminant feed ban inspections. Successful applications will be selected for funding to ensure a broad geographic distribution of the program. Size of the existing or new State/territory/tribal program and number of facilities to be covered under the cooperative agreement will also be a determining factor. These cooperative agreements are not to fund licensed medicated feed or routine feed safety good manufacturing practices (GMP) inspections that are unrelated to the ruminant feed ban. These awards may be only used for the development of new State/ territory/tribal BSE/ruminant feed ban programs or to enhance and supplement existing State/ territory/tribal BSE/ruminant feed ban program funding. States with current BSE/ruminant feed ban contracts from FDA can maintain these contracts for BSE/ruminant feed ban inspections at the discretion of the State and FDA. However, the facilities and work covered under the contract cannot be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement.

III. Reporting Requirements

A final Program Progress Report and a final Financial Status Report (FSR) (SF-269) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award. In addition, the grantee must file an invention statement and disposition of equipment statement within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award. An original and two copies of each report shall be submitted to Marc Pitts, Grants Management Office (see ''). The program progress report should include: (1) Status report on the installation and operational readiness of any analytical equipment that is purchased; (2) status report on the hiring and training of State/territorial/tribal laboratory personnel; (3) copies of the inspection report on the firms for which Ruminant Feed Ban Inspection checklists were completed including general assessment of compliance status; (4) summary report on the facility inventory that is maintained in the State/territory/ tribal government; (5) status report on the hiring and training of personnel to conduct the inspections; (6) report on feed sample descriptions and subsequent analytical results; (7) where the examinations, inspections, or investigations and related activities undertaken under section 702 of the act result in a State/territorial/ tribal enforcement action, a summary report of the follow up actions and final resolution of the findings; (8) summary of improvements (identify and quantify) in the overall State/territory/tribal BSE/ ruminant feed ban program resulting from the cooperative agreement; and (9) provide copies of all completed BSE/ruminant feed ban checklists and sample results as a part of the quarterly program progress report to the FDA Project officer or designated office. A Mid-Year Progress Report is also required no later than 90 days after the close of the budget period. The Mid-Year Progress Report should cover 6 months of activity including all criteria listed in the previous paragraph. Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least semi- annually by the project officer. Project monitoring may also be in the form of telephone conversations between the project

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officer/grants management specialist and the principal investigator. When multiple years are involved, awardees will be required to submit the PHS Non-Competing Grant Progress Report SF-424 (5161) application http://www.hhs.gov/forms/PHS-5161-1.pdfannually and financial statements as required in the DHHS Grants Policy Statement. Reports must be submitted 2 months prior to the next budget period start date. The Progress Report should include a report of the previous meeting supported by the current grant, as well as a full description of the next planned meeting.

IV. Mechanism of Support

A. Award Instrument

This funding opportunity will use the Research Demonstration Cooperative Agreements (U18) award mechanisms. This funding opportunity uses just-in-time budget concepts. It also uses the nonmodular budget format. Applicants must complete and submit a detailed categorical budget the SF-424 application. These agreements will be subject to all applicable policies and requirements that govern the grant programs of PHS, including 45 CFR part 92 and the PHS Grants Policy Statement. Equipment purchased under this cooperative agreement is subject to the requirements of 45 CFR part 92.31, ``Real property.'' Applicants must adhere to the requirements of this Notice. Special Terms and Conditions regarding FDA regulatory requirements and adequate progress of the study may be part of the awards notice. PHS strongly encourages all cooperative agreement recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

B. Eligibility

This cooperative agreement program is only available to State/ territory/tribal agency feed/BSE regulatory programs that undertake inspections and related activities under section 702 of the act and who are currently not funded under this cooperative agreement.

C. Length of Support

It is anticipated that FDA will fund these grants at a level requested but not exceeding $250,000 total direct plus indirect costs for the first year. An additional year (1) of support up to approximately $250,000 (direct plus indirect costs) per year will be available, depending upon fiscal year appropriations and successful performance. The length of support will also depend on the nature of the project.

D. Funding Plan

Federal funds are currently available from FDA for this program. However, continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined annually by FDA procedures, the receipt of a noncompeting continuation application, final yearly report and the availability of Federal funds. An estimated amount of $1 million is available in FY 2008. The number of projects funded will depend on the quality of the applications received and is subject to availability of Federal funds to support the projects.

V. Review Procedure and Criteria

All applications submitted in response to this request for applications (RFA) will first be reviewed for responsiveness by grants management and program staff. Responsiveness is defined as submission of a complete application packet on or before the required submission date as listed in the previous paragraphs. If applications are found to be nonresponsive, they will be returned to the applicant without further consideration. Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts. Applicants are strongly encouraged to contact FDA to resolve any questions regarding criteria before the submission of their application. All technical or programmatic questions must be directed to the ORA program staff (see ADDRESSES). All administrative or financial questions must be directed to the Grants Management Staff (see ADDRESSES).

VI. Submission Requirements

FDA is accepting new applications for this program electronically via http:www.grants.gov (Grants.gov). To download the SF424 application forms for this Funding Opportunity Announcement (FOA), link to ``Apply for Grants'' and follow the directions provided on that site. A one- time registration is required for institutions at Grants.gov, link to ``Get Registered.'' The application receipt date is July 30, 2008. Your organization will need to obtain a Data Universal Number System (DUNS) number as part of the Grants.gov registration process. The DUNS number is a 9-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. The Dunn and Bradstreet number can be obtained by calling: 866-705-5711 or through the Web site at http://www.dnb.com/us/ . The applicant must also register in the Central Contractor Registration (CCR) database in order to be able to submit the application. Information about the CCR is available at http:// www.ccr.gov or under the ``Organization Registration'' page of Grants.gov at:http://www.grants.gov/applicants/organization_ registration.jsp

VII. Method of Application

A. Submission Instructions

The SF-424 (5161) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov (link to ``Apply for Grants '') includes all applicable components, required and optional.

B. Format for Application

A completed application in response to this FOA includes the data in the following components: The face page of the application should indicate ``Response to Ruminant Feed Ban Support Project RFA-FDA-08-008.'' For information that should be addressed in the application, please see the full version of this RFA at http://www.grants.gov.

VIII. Legend

Unless disclosure is required by the Freedom of Information Act (FOIA) as amended (5 U.S.C. 552), as determined by the Freedom of Information (FOI) officials of the U.S. Department of Health and Human Services (HHS) or by a court, data contained in the portions of an application which have been specifically identified by page number, paragraph, etc., by the applicant as containing restricted and/or proprietary information shall not be used or disclosed except for evaluation purposes.

Dated: July 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-15561 Filed 7-8-08; 8:45 am]

BILLING CODE 4160-01-S



http://edocket.access.gpo.gov/2008/E8-15561.htm




Greetings,


================================================================

The events of September 11, 2001, reinforced the need to enhance the security and safety of the U.S. food supply.
Congress responded by passing the Bioterrorism Act which President Bush signed into law on June 12, 2002.
The Bioterrorism Act is divided into the following five titles: ...snip...end

================================================================


OH 'p l e a s e' give me a break, blame everything from katrina to housing market crash to global warming on the damn terrorist or 9/11/2001,
when the one to blame is the industry itself. the terrorist did not, and do not continue to violate the 8/4/97 ruminant-to-rumimant feed ban rule here in the USA.
show me the terrorist in the following ;


2008 Central Connecticut Cooperative Farmers Association 5/13/08 New England District Office Animal Protein Feed/Equine/Adulterated



http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm



Tuesday, July 1, 2008 Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs



http://madcowfeed.blogspot.com/2008/07/missouri-firm-recalls-cattle-heads-that.html



http://www.fsis.usda.gov/News_&_Events/Recall_021_2008_Release/index.asp



Texas Firm Recalls Cattle Heads That Contain Prohibited MaterialsRecall Release CLASS II RECALL FSIS-RC-020-2008 HEALTH RISK: LOW
Congressional and Public Affairs (202) 720-9113 Peggy Riek WASHINGTON, June 26, 2008



http://www.fsis.usda.gov/News_&_Events/Recall_020_2008_Release/index.asp



Thursday, June 26, 2008 Texas Firm Recalls Cattle Heads That Contain Prohibited Materials



http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html



Tuesday, May 27, 2008 FDA BSE/Ruminant Feed Inspections Firms Inventory Report Texas Legend Ranch OAI 05/10/2008



http://madcowfeed.blogspot.com/2008/05/fda-bseruminant-feed-inspections-firms.html




2007

In 2007, in one weekly enforcement report, the fda recalled 10,000,000+pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that mostof it was fed out ; 10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007 Date: March 21, 2007 at 2:27 pm PST REASON Blood meal used to make cattlefeed was recalled because it was cross-contaminated with prohibited bovinemeat and bone meal that had been manufactured on common equipment andlabeling did not bear cautionary BSE statement. VOLUME OF PRODUCT IN COMMERCE 42,090 lbs. DISTRIBUTION WI REASON Products manufactured from bulk feed containing blood meal that wascross contaminated with prohibited meat and bone meal and the labeling didnot bear cautionary BSE statement. VOLUME OF PRODUCT IN COMMERCE 9,997,976 lbs. DISTRIBUTION ID and NV END OF ENFORCEMENT REPORT FOR MARCH 21, 2007



http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html



2006

Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,TN, AND WV Date: September 6, 2006 at 7:58 am PST snip... see listings and references of enormous amounts of banned mad cowprotein 'in commerce' in 2006 and 2005 ; see full text ; 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



SPECIFIED RISK MATERIALS SRMs



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



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



http://madcowfeed.blogspot.com/





Docket Management Docket: 02N-0273 - Substances Prohibited From Use inAnimal Food or Feed; Animal Proteins Prohibited in Ruminant FeedComment Number: EC -10Accepted - Volume 2http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.htmlPART 2http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html


2003D-0186Guidance for Industry: Use of Material From Deer and Elk In Animal FeedEMC 7Terry S. Singeltary Sr.Vol #:1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm



01N-0423 Substances Prohibited from use in animal food/Feed RuminantAPE 5 National Renderers Association, Inc. Vol#: 2APE 6 Animal Protein Producers Industry Vol#: 2APE 7 Darling International Inc. Vol#: 2EMC 1 Terry S. Singeltary Sr. Vol#: 3


http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm



suppressed peer review of Harvard study October 31, 2002


http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf



[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of BovineSpongiform Encephalopathy (BSE)


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



[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
03-025IFA 03-025IFA-2 Terry S. Singeltary Page 1 of 17 9/13/2005


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




THE 8/4/97 FAILED, partial, and voluntary, ruminant-to-ruminant feed ban was just that, and blaming it on the terrorist will not make it any better, and or handing out a million bucks in some bogus awarding program. IF they have not got it right by now, giving away a million bucks, or 100 million bucks will not solve the continued, blatant, disregard of the original partial and voluntary 8/4/97 mad cow feed ban. AS long as it is voluntary, the USA will still be feeding cows to cows, thus, the mad cow agent will continue to spread. i really don't understand this? it seems to be another fema-like pay out $$$ one million dollars, divided 4 ways, to award whom, for what ??? for something that was nothing more than ink on paper in the first place, something that was never enforced, and under the circumstances then and now, still cannot be enforced. ...


=====================================================================


The goal of enhancing their feed/BSE safety programs is to increase State, territory, and tribal inspections under section 702 of the Federal Food, Drug, and Cosmetic Act (act) (21 U.S.C. 372) of renderers, protein blenders, and feed mills that manufacture animal feeds and feed ingredients, and inspections of salvagers of food and feed, and transporters of animal feed and feed ingredients utilizing materials prohibited under the ruminant feed ban. Finally, the Feed Ban Support Project funds are intended to supplement, not replace, State funding for program improvement. The following are seven key project areas identified for this effort: ...snip...end


=====================================================================


WE are still floundering on mad cow feed regulations that were put in place in August of 1997. this is nothing more than a band aid approach to something that needs tourniquets. ...TSS



ON THE OTHER HAND, i tried to warn them about biological AND OR PRIONIC 'suitcase bombs' in 2002 ;


# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of 2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -TSS 1/27/03 (0) Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of FoodFacilities, Section 305 Comment Number: EC-254 [TSS SUBMISSION]

Subject: Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of 2002;Date: Mon, 27 Jan 2003 15:54:57 -0600From: "Terry S. Singeltary Sr." To: regulations@aphis.usda.gov
Docket No: 02-088-1

Title: Agricultural Bioterrorism Protection Act of 2002;Possession, Use, and Transfer of Biological Agents and Toxins



http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=fr13de02-15.pdf



Greetings,



i would like to kindly submit to this docket and warn ofthe potential for biological 'suitcase bombs' from civilian air-traffic populations from known BSE/FMD and other exotic animal disease pathogens coming into the USA.


please be warned;


Date: Thu, 21 Mar 2002 08:42:56 -0800
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: USA SEALED BORDERS AND THE ''USCS'' (unspecified species coding system) MORE POTENTIAL B.S.eee

Change in Disease Status of Greece With Regard to Foot-and-Mouth

[Federal Register: March 21, 2002 (Volume 67, Number 55)]
snip...
Under Sec. 94.11, meat and other animal products of ruminants and swine, including ship stores, airplane meals, and baggage containing these meat or animal products, may not be imported into the United States except in accordance with Sec. 94.11 and the applicable requirements of the U.S. Department of Agriculture's Food Safety and Inspection Service at 9 CFR chapter III.

snip...

From an economic standpoint, the proposed rule would have little or no impact on U.S. animal stock and commodities. There are two reasons. First, the proposed rule would not remove other disease-based restrictions on the importation of ruminants or swine (and certain meat and other products from those animals) from Greece into the United States. Because bovine spongiform encephalopathy is considered to exist in Greece, the importation of ruminants and meat, meat products, and certain other products of ruminants that have been in Greece is prohibited.
snip...


http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-6837-filed


========================


What are the U.S. imports of affected animals or animal products from the country?
Very few products that would be of risk for transmission of BSE were imported into the US from Greece during 2000 or 2001 (January - April). Due to the above mentioned import ban, no live ruminants, ruminant meat, meal made from ruminants, or other high risk products from ruminants were imported from Greece during this time period. In 2001 (January - April), 3000 kg of enzymes and prepared enzymes and 5 kg of medicants containing antibiotics for veterinary use were imported. The data do not provide a species of origin code for these products, therefore they may not contain any ruminant product.

Sources: World Trade Atlas

What is the level of passenger traffic arriving in the United States from the affected country?

Approximately 185,000 direct flights from Greece arrived to US airports in fiscal year 2000. Also, an unknown number of passengers from Greece arrived via indirect flights.
Under APHIS-PPQ's agriculture quarantine inspection monitoring, 584 air passengers from Greece were sampled for items of agricultural interest in fiscal year 2000. Of these passengers, 14 carried meat (non-pork) items that could potentially transmit pathogens that cause BSE; most passengers carried from one to two kilograms (kg) of meat, although one passenger in November 1999 carried 23 kg of meat in a suitcase. Florida, Massachusetts, and New York were the reported destinations of these passengers. None of the passengers with meat items reported plans to visit or work on a ranch or farm while in the US.

Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base


http://www.aphis.usda.gov/vs/ceah/cei/bse_greece0701.htm


Greetings list members,


i just cannot accept this;


> 23 kg of meat in a suitcase (suitcase bomb...TSS)

> The data do not provide a species of origin code for these

> products, therefore they may not contain any ruminant product.

what kind of statement is this?
how stupid do they think we are?

it could also very well mean that _all_ of it was ruminant based products !

Terry S. Singeltary Sr., Bacliff, Texas USA

What is the level of passenger traffic arriving in the United States from Slovenia?

There were no direct flights from Slovenia to the US in fiscal year 2000.
APHIS-PPQ’s agriculture quarantine inspection monitoring sampled 27 air passengers from Slovenia for items of agricultural interest in fiscal year 2000. One of these 27 passengers was carrying two kilograms of a meat item that could potentially harbor pathogens that cause BSE. This passenger arrived to Elizabeth, New York, in June 2000 and declared no intention to visit a farm or ranch in the US.

Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base

http://www.aphis.usda.gov/vs/ceah/cei/bse_slovenia1101.htm

What is the level of passenger traffic arriving in the United States from the affected country?
A total of 45,438 passengers arrived in the US on direct flights from the Czech Republic in fiscal year 2000. It is likely that additional passengers originating in the Czech Republic traveled to the US on non-direct flights.

As part of APHIS-PPQ’s Agriculture Quarantine Inspection Monitoring, 238 air passengers from the Czech Republic were inspected for items of agricultural interest in fiscal year 2000. Of these, 10, or 4.2%, were found to be carrying a total of 17 kg of items that could potentially present a risk for BSE. None of the passengers with items reported plans to visit or work on a farm or ranch while in the US.

Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base


http://www.aphis.usda.gov/vs/ceah/cei/bse_cz0601.htm


What are the US imports of affected animals or animal products from Austria?


Between 1998 and June 2001, US imports from Austria included goat meat, animal feeds, and sausage. The sausage and animals feeds were from unspecified species.


Source: World Trade Atlas


snip...


What is the level of passenger traffic arriving in the United States from Austria?
A total of 168,598 passengers on direct flights from Austria arrived at US airports in fiscal year 2000. An undetermined number of passengers from Austria arrived in the US via indirect flights.


Under APHIS-PPQ’s agricultural quarantine inspection monitoring, 565 air passengers from Austria were sampled for items of agricultural interest in fiscal year 2000. Ten (10) of these passengers, or 1.7 percent, carried a total of 23 kg meat (non-pork) items that could potentially harbor the pathogen(s) that cause BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the US.


Source: US Dept. of Transportation; APHIS-PPQ


http://www.aphis.usda.gov/vs/ceah/cei/bse_austria1201.htm


Greetings FDA and public,


if you go to the below site, and search all BSE known countries and check out their air traffic illegal meat they have confiscated, and check out the low number checked, compared to actual passenger traffic, would not take too much for some nut to bring in FMD/TSEs into the USA as a 'suitcase bomb'.


[[Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.]]


IF they were to have questioned the terrorist that bombed the Twin Towers with jets, if they were to have questioned them at flight school in the USA, i am sure that they would have said they did not intend to visit the Twin Towers as a flying bomb either. what am i thinking, they probably did ask this? stupid me.


[[In 1999 a small amount of non-species specific meat and offal was imported and a small amount of fetal bovine serum (FBS) was also imported. FBS is considered to have a relatively low risk of transmitting BSE.]]


more of the USA infamous 'non-species coding system', wonder how many of these species are capable of carrying a TSE?


snip...


A total of 524,401 passengers arrived on direct flights to the U.S. from Israel in fiscal year 2000. This number does not include passengers who arrived in the U.S. from Israel via indirect flights.
Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.


http://www.aphis.usda.gov/vs/ceah/cei/bse_israel0602.htm


Source: U.S. Department of Transportation and APHIS-PPQ Agricultural Quarantine Inspection data base.


What is the level of passenger traffic arriving in the United States from Japan?


Approximately 6.84 million passengers on 29,826 direct flights from Japan arrived at US airports in fiscal year 2000. An undetermined number of passengers from Japan arrived in the US via indirect flights.


Under APHIS-PPQ's agriculture quarantine inspection monitoring, 801 air passengers from Japan were sampled for items of agricultural interest in fiscal year 2000. Of these 801 passengers, 10 carried meat (non-pork) items that could potentially harbor the pathogen(s) that cause BSE; most passengers carried an average of 1.7 kilograms of meat. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the US.


Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base


http://www.aphis.usda.gov/vs/ceah/cei/bse_japan0901.htm


What is the level of passenger traffic arriving in the United States from the affected country?


A total of 3.3 million passengers arrived in the US on direct flights from Germany in 1998, although many of these passengers would not have originated in Germany. As part of APHIS-PPQ's Agriculture Quarantine Inspection Monitoring, 8,247 air passengers from Germany were inspected for items of agricultural interest. Of these, 198, or 2.3%, were found to be carrying a total of 304 kg of items that could potentially present a risk for BSE. Thirty (30) of the passengers with items reported plans to visit or work on a farm or ranch while in the US. Reported destination states of these 30 passengers were CA, CO, DE, FL, LA, MT, OH, VA, and WY.


Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base


http://www.aphis.usda.gov/vs/ceah/cei/bse_germany1200e.htm


search archives at bottom of page of each BSE Country;


http://www.aphis.usda.gov/vs/ceah/cei/iw_archive.htm


more on non-species coding system and TSEs and potential'suitcase bombs';


To: Bovine Spongiform EncephalopathySubject:
Re: POLAND FINDS 4TH MAD COW CASE/USA IMPORTS FROM POLAND/non-species coding system strikes againReferences: <3dc198e3.8090704@wt.net>Content-Type: text/plain; charset=ISO-8859-1; format=flowedContent-Transfer-Encoding: 8bitX-Virus-Scanner: Found to be clean


Greetings again List Members,


let me kick a madcow around here a bit.


on the imports from Poland and the infamous USA'non-species' coding system.
the USDA/APHIS states;


> During the past four years (1998 - 2001), US imports from
> Poland included non-species specific animal products
> used in animal feeds and non-species specific sausage and offal
> products (Table 3). Given US restrictions on ruminant product
> imports, these US imports should not have contained ruminant
> material.


NOW, if you read Polands GBR risk assessment and opinionon BSE, especially _cross-contamination_, it states;



ANNEX 1

Poland - Summary of the GBR-Assessment, February 2001

EXTERNAL CHALLENGE STABILITY INTERACTION OF EXTERNALCHALLENGE AND STABILITY

The very high to extremely high externalchallenge met a very unstable system andcould have led to contamination ofdomestic cattle in Poland from 1987onwards.
This internal challenge again met the stillvery unstable system and increased overtime.
The continuing very high externalchallenge supported this development.
Not OKMBM-bansince 1997,but no feedcontrols.Reasonably OKHeat treatmentequivalent to133°C / 20min / 3bar standards, butno evidenceprovided oncompliance.
Not OK.No SRM-ban,SRM arerendered andincluded incattle feed.

BSE surveillance:
Not sufficient before2001.

Cross-contamination:
Lines for ruminantand non-ruminantfeed in feed-mills onlyseparated in time andno analytical controlscarried out.Likely present since 1987 and growing.

see full text and ANNEX 1 at;

http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf



so in my humble opinion, the statement by the USDA/APHISthat ''these US imports _should_ not have contained ruminantmaterials, is a joke. a sad joke indeed.


* POLAND BSE GBR RISK ASSESSMENT


http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf


BSE ISRAEL change in disease status, AND THE DAMN NON-SPECIES CODING SYSTEM $$$
Subject: BSE ISRAEL change in disease status, AND THE DAMN NON-SPECIES CODING SYSTEM $$$Date: November 1, 2002 at 8:03 am PST
[Federal Register: November 1, 2002 (Volume 67, Number 212)]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. 02-072-2]
Change in Disease Status of Israel Because of BSE
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Affirmation of interim rule as final rule.
-----------------------------------------------------------------------
SUMMARY: We are adopting as a final rule, without change, an interim rule that amended the regulations by adding Israel to the list of regions where bovine spongiform encephalopathy exists because the disease had been detected in a native-born animal in that region. The effect of the interim rule was a restriction on the importation of ruminants, meat, meat products, and certain other products of ruminants that had been in Israel. The interim rule was necessary to help prevent the introduction of bovine spongiform encephalopathy into the United States.
EFFECTIVE DATE: The interim rule became effective on June 4, 2002.
FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Chief Staff Veterinarian, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE).In an interim rule effective June 4, 2002, and published in the Federal Register on July 18, 2002 (67 FR 47243-47244, Docket No. 02-072-1), we amended the regulations in Sec. 94.18 (a)(1) by adding Israel to the list of regions where BSE exists due to the detection of BSE in a native-born animal in that region.Comments on the interim rule were required to be received on or before September 16, 2002. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.This action also affirms the information contained in the interim rule concerning Executive Orders 12866 and 12988 and the Paperwork Reduction Act.Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.
Regulatory Flexibility Act
This action affirms an interim rule that amended the regulations by adding Israel to the list of regions where BSE exists. The effect of the interim rule was a restriction on the importation of ruminants, meat, meat products, and certain other products of ruminants that had been in Israel. The interim rule was necessary to help prevent the introduction of BSE into the United States.The following analysis addresses the economic effects of the interim rule on small entities, as required by the Regulatory Flexibility Act.The interim rule's restrictions on the importation of ruminants and ruminant products and byproducts from Israel are not expected to have a significant impact on a substantial number of small entities due to the fact that the restricted items are either not imported from Israel or are imported in very small amounts. There are three categories of imports that may be affected, but Israel's share of U.S. imports is small in each case.The first category of affected imported commodities is ``Meat and edible meat offal, salted in brine, dried or smoked; edible flours and meals of meat or meat offal.'' Average total yearly imports of these products by the United States over the 3-year period 1999-2001 were valued at $24.6 million. Imports from Israel in 1999 were valued at $26,000. No imports of these products from Israel were reported for 2000 or 2001.The second category of affected commodities is ``Preparations of a kind used in animal feeding.'' Average total yearly imports of these products, 1999-2001, were valued at $93.5 million. Imports from Israel had an average yearly value over this period of about $76,000.The final category of affected commodities is ``Other prepared or preserved meat, meat offal or blood.'' Average yearly imports of these products, 1999-2001, were valued at $101.2 million. Imports from Israel had an average yearly value over this period of about $2.7 million.It is apparent that Israel is a minor supplier to the United States of the ruminant products and byproducts affected by the BSE-related restrictions resulting from the interim rule. Therefore, we do not expect that the interim rule's restrictions on ruminants and ruminant products and byproducts from Israel will substantially affect any U.S. importers, large or small, of those commodities.Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS
Accordingly, we are adopting as a final rule, without change, the interim rule that amended 9 CFR part 94 and that was published at 67 FR 47243-47244 on July 18, 2002.
Authority: 7 U.S.C. 450, 7711-7714, 7751, 7754, 8303, 8306, 8308, 8310, 8311, and 8315; 21 U.S.C 136 and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 28th day of October, 2002.Bobby R. Acord,Administrator, Animal and Plant Health Inspection Service.[FR Doc. 02-27812 Filed 10-31-02; 8:45 am]BILLING CODE 3410-34-P


http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-27812-filed


greetings List members,


MORE OF THE INFAMOUS USA NON-SPECIES CODING SYSTEM.
as long as the exporting country and the importing country know not what they are exporting (play dumb/stupid), this non-species coding system allows potential BSE/TSE materials to be imported and exported freely and legally...


TSS


What are the U.S. imports of affected animals or animal products from Israel ?


The U.S. imported no live ruminants or ruminant meat from Israel since 1999. In 1999 a small amount of non-species specific meat and offal was imported and a small amount of fetal bovine serum (FBS) was also imported. FBS is considered to have a relatively low risk of transmitting BSE. Other imports from Israel during the period 1998-2001 included non-species specific preparations used in animal feeds and other non-food products of unspecified animals. For the category "preparations used in animal feeding, NESOI" that was imported into the U.S., it is possible that bovine meat or bovine byproducts could have been included in this category. However, the US Food and Drug Administration prohibits feeding of meat-and-bone meal to ruminants in the U.S.
HS Code
Description
Unit
1998
1999
2000
2001
Feed - non species specific
Total
45,030
48,000
50,649
43,000
2309909500
Preparations Used in Animal Feedings, NESOI
KG
45,030
48,000
50,649
43,000
Meat & offal- non species specific
Total
5
0
0
0
300110
Dried Organs
KG
5
0
0
0
Other animal products - ruminants
Total
24
0
0
0
3002100040
Fetal Bovine Serum (FBS)
KG
24
0
0
0
Source: World Trade Atlas
What is the level of passenger traffic arriving in the United States from Israel?
A total of 524,401 passengers arrived on direct flights to the U.S. from Israel in fiscal year 2000. This number does not include passengers who arrived in the U.S. from Israel via indirect flights.
Under APHIS-PPQ?s agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.
Source: U.S. Department of Transportation and APHIS-PPQ Agricultural Quarantine Inspection data base.


http://www.aphis.usda.gov/vs/ceah/cei/bse_israel0602.htm


TSS


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



Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305Comment Number: EC -254 Accepted - Volume 11



http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/02n0276/02N-0276-EC-254.htm



Comment Submitted Comment Receipt Thank you. Your comment on Document ID: APHIS-2007-0033-0001 has been sent. Your comment tracking number is 8027c28d. Once the agency has posted your comment, you can find it by clicking on Advanced Search and selecting Document Search. When you see the Advanced Search - Document screen, type your tracking number in the Comment Tracking Number field and click Submit. If you wish to retain a copy of the receipt, use the following link to print a copy for your files. Print


http://www.regulations.gov/fdmspublic/component/main
http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm




July 8, 2008, 1:56PM
Ex-official: Cheney wanted climate change report altered
By H. JOSEF HEBERTAssociated Press

WASHINGTON — Vice President Dick Cheney's office pushed for major deletions in congressional testimony on the public health consequences of climate change, fearing the presentation by a leading health official might make it harder to avoid regulating greenhouse gases, a former EPA official maintains.
When six pages were cut from testimony on climate change and public health by the head of the Centers for Disease Control and Prevention last October, the White House insisted the changes were made because of reservations raised by White House advisers about the accuracy of the science.
But Jason K. Burnett, until last month the senior adviser on climate change to Environmental Protection Agency Administrator Stephen Johnson, says that Cheney's office was deeply involved in getting nearly half of the CDC's original draft testimony removed.
"The Council on Environmental Quality and the office of the vice president were seeking deletions to the CDC testimony (concerning) ... any discussions of the human health consequences of climate change," Burnett has told the Senate Environment and Public Works Committee. ...SNIP...END...TSS



http://www.chron.com/disp/story.mpl/hotstories/5876800.html




Wednesday, July 9, 2008



Ex-official: Cheney wanted climate change report altered



http://sciencebushwhacked.blogspot.com/2008/07/ex-official-cheney-wanted-climate.html




Tuesday, April 29, 2008
Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency
please see full text ;



http://sciencebushwhacked.blogspot.com/




Wednesday, April 30, 2008
Health group urges overhaul of US food safety system Calling the US food safety system antiquated and disjointed, a public health advocacy group today urged a major overhaul to make the system stronger, more coherent, and better attuned to today's major threats.


http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/apr3008tfah.html



Thu Dec 6, 2007 11:38
FDA IN CRISIS MODE, AMERICAN LIVES AT RISK



http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html




FDA SCIENCE AND MISSION AT RISK



http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf




Final Environmental Impact Statement for the Galveston National Laboratory for Biodefense and Emerging Infectious Diseases Research Facility in Galveston, Texas February 2005
Appendix H: Comments and Responses on the Draft GNL EIS Singeltary, Sr. Terry S., (G6) Comment Response G6-1 Page 1 of 14 H-68 through H-81



http://www.epa.gov/EPA-IMPACT/2005/April/Day-11/i7249.htm






USDA DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM


http://downercattle.blogspot.com/



Sunday, June 29, 2008

South Korea bans rallies against US beef imports


June 29, 2008, 1:07PM South Korea bans rallies against US beef imports


http://usdavskorea.blogspot.com/2008/06/south-korea-bans-rallies-against-us.html



USDA VS KOREA typical or atypical BSe



http://usdavskorea.blogspot.com/


still disgusted in sunny Bacliff, Texas. ...

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

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