Show agency attachment(s) DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service[Docket No. 00-108-10]Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose; Program StandardsAgencyAnimal and Plant Health Inspection Service, USDA.
Action Notice and request for comments.
Summary We are giving notice of changes to the Program Standards for the chronic wasting disease (CWD) herd certification program. The CWD herd certification program is a voluntary, cooperative program that establishes minimum requirements for the interstate movement of farmed or captive cervids, provisions for participating States to administer Approved State CWD Herd Certification Programs, and provisions for participating herds to become certified as having a low risk of being infected with CWD. The Program Standards provide optional guidance, explanation, and clarification on how to meet the requirements for interstate movement and for the Herd Certification Programs. Recently, we convened a group of State, laboratory, and industry representatives to discuss possible changes to the current Program Standards. The revised Program Standards reflect these discussions, and we believe the revised version will improve understanding of the program among State and industry cooperators. We are making the revised version of the Program Standards available for review and comment.
Dates We will consider all comments that we receive on or before March 31, 2014.
Addresses You may submit comments by either of the following methods:
•Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2006-0118-0401 . •Postal Mail/Commercial Delivery: Send your comment to Docket No. 00-108-10, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2006-0118 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.
For Further Information Contact Dr. Patrice Klein, Senior Staff Veterinarian, National Center for Animal Health Programs, Veterinary Services, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231; (301) 851-3435.
Supplementary Information Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy of cervids (members of Cervidae, the deer family) that, as of May 2011, has been found only in wild and captive animals in North America and in captive animals in the Republic of Korea. First recognized as a clinical “wasting” syndrome in 1967, the disease is typified by chronic weight loss leading to death. Species currently known to be susceptible to CWD via natural routes of transmission include Rocky Mountain elk, mule deer, white-tailed deer, black-tailed deer, sika deer, and moose.
On June 13, 2012, we published in theFederal Register(77 FR 35542-35571, Docket No. 00-108-8) an interim final rule (1) that made effective on August 13, 2012, a final rule published on July 21, 2006 (71 FR 41682-41707, Docket No. 00-108-3), with changes to the final rule as discussed in a previous proposal and in the interim final rule itself. This action established a voluntary herd certification program in 9 CFR part 55 for CWD in farmed or captive cervids. States that choose to participate must establish State Approved Herd Certification Programs in which States agree to perform tasks and meet requirements to ensure that the program is being effectively administered. Owners of deer, elk, and moose herds who choose to participate in the approved State programs must follow the program requirements for animal identification, testing, herd management, and movement of animals into and from herds.
The interim final rule also established a new part 81 containing interstate movement requirements designed to prevent the spread of CWD through the movement of farmed or captive deer, elk, or moose. The interim final rule set a compliance date of December 10, 2012, for the interstate movement provisions in 9 CFR part 81, to give States and producers time to come into compliance with the herd certification program requirements in 9 CFR part 55.
The regulations for the voluntary CWD herd certification program in 9 CFR part 55 establish minimum requirements for State and herd owner participation and allow States and herd owners to use any effective means to comply with those requirements. For example, participating States are required in § 55.23(a)(6) to effectively monitor and enforce State quarantines and State reporting laws and regulations for CWD. Each State may have different means of meeting that requirement. Similarly, herd owners participating in the voluntary program must, under § 55.23(b)(2), have fencing around their premises that is adequate to prevent ingress or egress of cervids; the regulations do not specify what type of fencing is necessary to meet this requirement, allowing our guidance to change based on scientific information and experience.
To facilitate State and herd owner participation in the voluntary herd certification program, the Animal and Plant Health Inspection Service (APHIS) made available in July 2012 a document titled “Chronic Wasting Disease Program Standards.” This document provided detailed descriptions ofsuggested methods for complying with the requirements in 9 CFR parts 55 and 81.
During the October 2012 U.S. Animal Health Association meeting, a resolution was passed asking APHIS to work with cervid industry stakeholders to revise the CWD Program Standards. Accordingly, we convened a group of State, laboratory, and industry representatives to receive their input on potential revisions. The group met from November 2012 to June 2013 to completely review the CWD Program Standards. The revised draft, which is based on those discussions, is intended to provide more detailed guidance to States and herd owners who are seeking to participate in the Federal CWD herd certification program. As we believe the collaborative process has been helpful in revising the CWD Program Standards, we plan to work with State, laboratory, and industry representatives to review the standards at least once a year.
We welcome public comment on this notice and the proposed revisions to the CWD Program Standards. After considering all comments, if no substantive changes to the CWD Program Standards are deemed necessary by the APHIS Administrator, the revised CWD Program Standards will be adopted as final 30 days after the close of the comment period for this notice. If substantive changes are deemed necessary, we will publish an additional document in theFederal Registerto discuss them; otherwise, the final version of the revised CWD Program Standards will be announced and made available on the CWD Web site.
Done in Washington, DC, this 20th day of December 2013. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013-31143 Filed 12-30-13; 8:45 am] BILLING CODE 3410-34-P Footnotes (1) To view the interim final rule and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2006-0118 .
Agency:Animal and Plant Health Inspection Service (APHIS)
Parent Agency:Department of Agriculture (USDA)
This rulemaking establishes a herd certification program and requirements for the interstate movement of farmed or captive deer, elk, and moose and authorizes the payment of indemnity, subject to availability of funds, for the depopulation of farmed or captive deer, elk, and moose that have been infected with, or exposed to, chronic wasting disease (CWD).
RIN:0579-AB35Impacts and Effects:NoneCFR Citation:9 CFR 55, 9 CFR 81Priority:Other Significant
APHIS-2006-0118-0100 Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose Singeltary comment submission as follows ;
Comment.View document:. APHIS-2006-0118-0096
Greetings APHIS et al,
I would kindly like to comment on ;
Docket ID APHIS-2006-0118 Docket Title Chronic Wasting Disease Herd Certification Program Document ID APHIS-2006-0118-0096
Document Title Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose
with great sadness, my comments are as follows ;
DUE to the likelihood of CWD transmission to humans as a zootic disease, and proven transmission of CWD to other species via the lab, and the highly environmental transmission routes of CWD, the threat that game farms pose to the wild is great.
RECENTLY, in the May 2009 CDC warns of this potential of prions to humans via CWD and Nutritional Supplements from ELK ANTLER VELVET.
ALSO RECENTLY, a multi-state recall of ELK MEAT PRODUCTS FROM A CWD POSITIVE ELK. (they are not recalling all this meat for the well being of the dead cwd positive elk.)
SOME of these game farms have proven to have a high infectious rate for CWD. Some as high as 79% infection rate.
A NEW 2nd strain of CWD i.e. (THE WISCONSIN STRAIN of CWD?), and what will this curtail i.e. as in transmission ?? we found out with BSE in cattle, that the atypical strains, some are more virulent in transmission.
FOR all these reasons, it is urgent to keep the failures of the CWD factory farming industry of 'big rack' deer and elk, to spreading to the wild.
I urge that 100% CWD testing of elk, deer, and all animals on game farms tested for CWD/TSE.
ANY positive should result in complete herd eradication.
ANY GAME farm with one positive CWD animal must be shut down for good due to the ramifications of environmental infection risk factors, and future infection there from, there of.
THE land there from, must be contained, and quarantined for 5 years, with no introduction of any game and or farm producing livestock for humans and or animals, and or crop production. Then a reevaluation of that farm/land and environmental risk factors there of must be done for a reassessment, before any use of that farm/land could go forward.
ANY and all water run off must be contained at owners expense.
ALL elk and deer and or any animal from game farms, must be identifiable and traceable, at all times.
THIS all should be mandatory, and regulated by the federal government, because the chance of different regulations, and lack of enforcement, state by state, would enhance the spreading of CWD.
WE must stop CWD before it spreads to all STATES, and until a validated 100% CWD TSE live test is available, one that can be used at birth, and until there is a way to completely decontaminate land that has been infected with the CWD agent, in my opinion, these draconian measures are the only plausible measures which i know of that can be taken, which might stop this spread of CWD to every state.
Comment from Terry Singeltary This is a Comment on the Animal and Plant Health Inspection Service (APHIS) Notice: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Chronic Wasting Disease Herd Certification Program
Subject: DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 –0500
From: "Terry S. Singeltary Sr."
i would kindly like to comment on; Docket 03D-0186FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability Several factors on this apparent voluntary proposal disturbs me greatly, please allow me to point them out;
Oral transmission and early lymphoid tropism of chronic wasting diseasePrPres in mule deer fawns (Odocoileus hemionus ) These results indicate that CWD PrP res can be detected in lymphoid tissues draining the alimentary tract within a few weeks after oral exposure to infectious prions and may reflect the initial pathway of CWD infection in deer. The rapid infection of deer fawns following exposure by the most plausible natural route is consistent with the efficient horizontal transmission of CWD in nature and enables accelerated studies of transmission and pathogenesis in the native species.
DEPARTMENT OF HEALTH & HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONApril 9, 2001 WARNING LETTER01-PHI-12CERTIFIED MAILRETURN RECEIPT REQUESTED
Brian J. Raymond, Owner Sandy Lake Mills 26 Mill Street P.O. Box 117 Sandy Lake, PA 16145
Dear Mr. Raymond:Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Sandy Lake, Pennsylvania, on March 23,2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) . Such deviations cause products being manufactured at this facility to be misbranded within the meaning of Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).Our investigation found failure to label your swine feed with the required cautionary statement "Do Not Feed to cattleor other Ruminants" The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
In addition, we note that you are using approximately 140 pounds of cracked corn to flush your mixer used in the manufacture of animal feeds containing prohibited material. This flushed material is fed to wild game including deer, a ruminant animal.Feed material which may potentially contain prohibited material should not be fed to ruminant animals which may become part of the food chain.The above is not intended to be an all-inclusive list of deviations fromthe regulations. As a manufacturer of materials intended for animalfeed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance withthe law. We have enclosed a copy of FDA's Small Entity Compliance Guideto assist you with complying with the regulation...
MAD COW FEED BAN FOR CERVIDS, even though science has shown that the oral route of the TSE prion to cervids is very sufficient ??
>>>FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required. <<<
Draft Guidance on Use of Material From Deer and Elk in Animal Feed; CVM Updates on Deer and Elk Withdrawn FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4
FDA has announced the availability of a draft guidance for industry entitled “Use of Material from Deer and Elk in Animal Feed.” This draft guidance document (GFI #158), when finalized, will describe FDA’s current thinking regarding the use in animal feed of material from deer and elk that are positive for Chronic Wasting Disease (CWD) or that are at high risk for CWD.
CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the cervidae animal family (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). TSEs are very rare, but are always fatal.
This draft Level 1 guidance, when finalized, will represent the Agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations.
Draft guidance #158 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained from the FDA Veterinarian.
Comments and suggestions regarding the document should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the Docket No. 03D-0186.
For questions regarding this guidance, contact Burt Pritchett, Center for Veterinary Medicine (HFV- 222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, E-mail: email@example.com. Additional copies of this guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at
Food and Drug Administration Center for Veterinary Medicine September 15, 2003
CONTAINS NON-BINDING RECOMMENDATIONS
Guidance for Industry1
Use of Material from Deer and Elk in Animal Feed
This guidance represents the Food and Drug Administration’s current thinking on the use of material from deer and elk in animal feed. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of applicable statutes or regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
Under FDA’s BSE feed regulation (21 CFR 589.2000) most material from deer and elk is prohibited for use in feed for ruminant animals. This guidance document describes FDA’s recommendations regarding the use in all animal feed of all material from deer and elk that are positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD. The potential risks from CWD to humans or non-cervid animals such as poultry and swine are not well understood. However, because of recent recognition that CWD is spreading rapidly in white-tailed deer, and because CWD’s route of transmission is poorly understood, FDA is making recommendations regarding the use in animal feed of rendered materials from deer and elk that are CWD-positive or that are at high risk for CWD.
CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the animal family cervidae (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer,
1 This guidance has been prepared by the Division of Animal Feeds in the Center for Veterinary Medicine (CVM) at the Food and Drug Administration.
CONTAINS NON-BINDING RECOMMENDATIONS
white-tailed deer, North American elk, and in farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease) in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans. There is no known treatment for these diseases, and there is no vaccine to prevent them. In addition, although validated postmortem diagnostic tests are available, there are no validated diagnostic tests for CWD that can be used to test for the disease in live animals.
Use in animal feed of material from CWD-positive deer and elk
Material from CWD-positive animals may not be used in any animal feed or feed ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act, animal feed and feed ingredients containing material from a CWD-positive animal would be considered adulterated. FDA recommends that any such adulterated feed or feed ingredients be recalled or otherwise removed from the marketplace.
Use in animal feed of material from deer and elk considered at high risk for CWD
Deer and elk considered at high risk for CWD include: (1) animals from areas declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that at some time during the 60-month period immediately before the time of slaughter were in a captive herd that contained a CWD-positive animal.
FDA recommends that materials from deer and elk considered at high risk for CWD no longer be entered into the animal feed system. Under present circumstances, FDA is not recommending that feed made from deer and elk from a non-endemic area be recalled if a State later declares the area endemic for CWD or a CWD eradication zone. In addition, at this time, FDA is not recommending that feed made from deer and elk believed to be from a captive herd that contained no CWD-positive animals be recalled if that herd is subsequently found to contain a CWD-positive animal. V. Use in animal feed of material from deer and elk NOT considered at high risk for CWD
FDA continues to consider materials from deer and elk NOT considered at high risk for CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with current agency regulations, 21 CFR 589.2000. Deer and elk not considered at high risk include: (1) deer and elk from areas not declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that were not at some time during the 60-month period immediately before the time of slaughter in a captive herd that contained a CWD-positive animal.
if i am not mistaken, it was the same email address. it was 3 or 4 weeks ago i wrote, as it is, i don't save 'sent' emails anymore, unless very important.
my main concern (besides the fact that a potential TSE has been in the USA cattle for some time, but the APHIS do not test to find), is that the CWD could very well be transmitting to humans, and i just did not see to much posted about it on OIE site.
Coming back to your question, Chronic Wasting Disease is not an OIE
why is this TSE (CWD) not listed and followed as with BSE ?'
Article 126.96.36.199. 1. Countries shall make available to other countries, through the OIE, whatever information is necessary to minimise the spread of important animal diseases and to assist in achieving better worldwide control of these diseases.
(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,
Subject: Written submission to House of Commons Science and Technology Committee inquiry
Thank you for your written submission to the House of Commons Science and Technology Committee inquiry on Blood, tissue and organ screening.
We will be in touch if we have any further questions.
From: Terry S. Singeltary Sr.
Sent: Monday, December 02, 2013 9:18 PM
To: CJDVOICE CJDVOICE Cc: bloodcjd bloodcjd
Subject: [BLOODCJD] A parliamentary inquiry has been launched today into the safety of blood, tissue and organ screening following fears that vCJD – the human form of ‘mad cow’ disease – may be being spread by medical procedures
Monday, December 02, 2013
*** A parliamentary inquiry has been launched today into the safety of blood, tissue and organ screening following fears that vCJD – the human form of ‘mad cow’ disease – may be being spread by medical procedures