??? Use of Autogenous Vaccine in the Treatment of Caseous Lymphadenitis (CL/CLA) in Goats

USE OF AUTOGENOUS VACCINE
IN THE TREATMENT OF
CASEOUS LYMPHADENITIS (CL/CLA) IN GOATS

By Susan M. Straumann

©Copyright Susan M. Straumann 2009




FIGURE 1. Would You Guess This Goat Has Had CL For Years?



The Good News

Despite what you have no doubt read or heard from all the naysayers,
Caseous lymphadenitis (CL/CLA) in a goat that is already infected IS treatable.

The on-farm treatment is, in fact, EASY.



The Not-So-Good (But Not Bad) News

The treatment is NOT a cure. Treatment must be continued permanently on an ongoing basis
without interruption for the life of the infected animal in order to control CL-related symptoms.

Some expense is involved in the treatment.

The USDA regulations which are applicable to the treatment require, at times,
some personal determination and persistence.



TABLE OF CONTENTS

Since in some cases concepts presented in later sections of this website build upon concepts presented in earlier sections, the material on this website is most effective when all sections are read from start to finish in the order presented, as opposed to reading individual sections out of sequence and out of context.

Section 1.0: Introduction
Section 2.0: Goals of this Website
Section 3.0: Intended Audience
Section 4.0: Woefully Necessary Legal Disclaimers
Section 5.0: Treatment of CL
        Section 5.1: Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences
                Section 5.1.1: Necessary Medical Definitions
                Section 5.1.2: Capturing the Bacteria Needed For Isolate and Vaccine Development
                Section 5.1.3: Use of Your Autogenous Vaccine
        Section 5.2: Applicable USDA Regulations
                Section 5.2.1: One-Time, One-Year Isolate Extension
                Section 5.2.2: Permanent Isolate Extension
Section 6.0: Miscellaneous
        Section 6.1: Is CL contagious between species? Can a person become infected from a CL-infected animal?
        Section 6.2: What is the persistence of the CL-causing bacteria in the farm environment?
        Section 6.3: Can stress negatively affect my CL-infected goat?
Section 7.0: Points of Contact
Section 8.0: Related Websites
Section 9.0: Special Thanks
Section 10.0: Permitted Use of Copyrighted Material
Section 11.0: MAKE A DONATION


1.0 INTRODUCTION

What is Caseous lymphadenitis? Caseous lymphadenitis (CL or CLA) is an infectious disease of goats caused by Corynebacterium pseudotuberculosis bacteria. The primary symptom of CL in infected animals is development of internal and external pus-filled abscesses. The Corynebacterium pseudotuberculosis bacteria are typically well encapsulated within an abscess, making the bacteria inaccessible to antibiotics and treatment of the disease using antibiotics largely ineffective. Internal abscesses can negatively affect the health and function of the infected animal???s critical organs, resulting in chronic failing health and potentially the animal???s death. Bacteria coughed out by animals with internal lung abscesses and pus from external abscesses carry the persistent Corynebacterium pseudotuberculosis bacteria to other animals and the farm environment, leading to a long-term CL control problem on the infected farm that is difficult and expensive to eradicate.



FIGURE 2. My goat Picasso's first CL abscess, December 2006

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2.0 GOALS OF THIS WEBSITE

It is my sincere hope that the information on this website will:

  • Dispel the myth that proliferates numerous websites, caprine publications, and veterinary publications that there is no successful treatment for CL, causing needless panic and hopelessness in dealing with CL in the farm environment.

  • Provide a specific working knowledge, including related USDA regulations, of how to treat a CL-infected goat so that the occurrence of future CL-related symptoms is virtually eliminated, giving both the animal and the owner better quality of life, and providing an alternative to euthanasia, the most commonly used method of controlling the spread of CL in the farm environment.

  • Improve the health and quality of life of CL-infected goats by precluding the formation of future abscesses, and in so doing precluding the health problems and potential loss of life that are often the direct result of the formation of such abscesses.

  • Facilitate potential advances in CL research.
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    3.0 INTENDED AUDIENCE

    My feeling is that the information on this website would be of interest to anyone who is currently dealing with CL (caprine or non-caprine) in a farm or research environment, or has the potential to do so in the future.

    Owners of CL-infected pet goats, operators of farm animal rescues, and farm veterinarians would probably be most directly able to apply the information on this website as it is currently presented with minimal adaptation.

    Some adaptation of the information on this website may be needed for application to a commercial environment. Adaptation to a commercial environment is not specifically addressed on this website. However, the points of contact provided in Section 7.0, Points of Contact could potentially be of valuable assistance to commercial enterprises for this purpose.

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    4.0 WOEFULLY NECESSARY LEGAL DISCLAIMERS

  • I, Susan M. Straumann, the author, have taken great care in the preparation of the information on this website; however, the information represents my opinions only based on my personal experience as a recreational owner of a goat that is infected with CL. I am not a veterinarian, nor do I have any formal veterinary training whatsoever. I am simply documenting on this website what I have observed and experienced firsthand to work to control CL symptoms in my CL-infected goat, Picasso, in the hopes that this information will be of benefit to other CL-infected goats and their owners.

  • Based on the excellent response my CL-infected goat Picasso has had to the treatment described on this website, it is my belief that he is infected with a single strain of goat CL. I cannot guarantee that a goat infected with a different strain of goat CL will respond to treatment as well as my goat has. In addition, information on this website will need to be adapted for use in goats infected with multiple strains of goat CL or in a farm environment where multiple strains of CL are known to exist.

  • While I have learned a great deal in recent years regarding successful treatment of my CL-infected goat, as I gain additional experience and knowledge, I cannot rule out the possibility that I may change my position in the future from what I believe to be reasonable information documented on this website today.

  • It is quite possible that the information on this website is relevant to the treatment of CL-infected animals other than goats (the farm animal rescue, Farm Sanctuary, for example, successfully uses a similar treatment approach to that discussed on this website in their herd of CL-infected sheep). However, my experience is with the care and treatment of CL-infected goats only, and so I cannot directly speak to the relevance of the information on this website to the treatment of CL in other animal species.

  • If anything stated on this website differs from the content of 9 CFR Part 113.113, Autogenous Biologics, the portion of the Code of Federal Regulations which applies to the treatment approach discussed on this website, in all cases 9 CFR Part 113.113, being legal USDA policy, supercedes anything stated on this website.

  • The information on this website is being provided free of charge as a public service intended for the betterment of the quality of life of CL-infected goats and their owners. Use of the information on this website is entirely at your own risk, and no warranty is implied nor liability assumed on the part of the author in any way through your voluntary use of the information provided.
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    5.0 TREATMENT OF CL

    The goal of the treatment described in this section is to prevent new CL abscesses from forming in an infected goat, thereby limiting the long-term negative health effects of CL on the infected animal, as well as exposure of uninfected animals and the farm to the CL-causing bacteria, Corynebacterium pseudotuberculosis, which lives in the pus within CL abscesses.

    It is my understanding from conversations I have had with the farm animal rescue Farm Sanctuary, which uses a treatment method similar to that described below in their CL-infected goat and sheep herd, that they have observed some newly rescued farm animals that were suffering severe negative health effects from CL obtain some benefit and improvement from receiving the treatment. However, for the most part, the treatment is most effectively used to prevent future abscesses from forming, as opposed to treating an existing abscess or health damage that has already occurred. In addition to the treatment regimen described on this website, a farm veterinarian should be consulted to obtain potential additional recommendations for conventional treatment with regard to past and present abscesses and related detrimental health effects.

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    5.1 Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences

    CL is popularly considered untreatable, but that is simply not the case.

    The vast majority of future CL abscess formations in a CL-infected goat can be prevented by periodically inoculating the infected animal with a custom-made CL vaccine developed from the specific strain of Corynebacterium pseudotuberculosis bacteria with which the goat is infected.

    It is seemingly illogical and counterintuitive to use a vaccine to treat disease in an infected individual. Ordinarily, vaccines are used to prevent disease in an uninfected individual (the custom CL vaccine can and should, of course, be used for this more typical purpose as well). Perhaps that is why this CL vaccine treatment approach is little known, and where known, is often regarded with skepticism by veterinarians.

    This section, Section 5.1, will discuss how such a custom CL vaccine is developed and used for the treatment of CL, and then later, in Section 5.2, Applicable USDA Regulations, the USDA regulations that relate to these types of vaccines will be discussed in order to ensure the custom CL vaccine is available on a long-term, consistent, and uninterrupted basis to CL-infected animals that require treatment, as well as uninfected animals that require protection from infection.

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    5.1.1 Necessary Medical Definitions

    Below are some fundamental and necessary medical definitions from the online Merriam-Webster's Medical Dictionary that relate to the custom CL vaccine treatment discussed on this website. For simplicity, only the definition or part of a definition relevant to this discussion has been included here. The links to the full online definitions are provided if a more expanded definition is desired.

    These concepts need not be understood in their entirety from the provided definitions here alone. Rather, the definitions are provided here to serve as an introduction to the concepts only . The terms will be used in context in further discussion below, where their meaning should become clearer.

  • autogenous: "Originating or derived from sources within the same individual" (Complete Merriam-Webster's Medical Dictionary definition of autogenous).

  • strain: "A group of presumed common ancestry with clear-cut physiological ... distinctions " (Complete Merriam-Webster's Medical Dictionary definition of strain).

  • isolate: "... A strain that has been isolated (as from diseased tissue, contaminated water, or the air); also : a pure culture produced from such an isolate" (Complete Merriam-Webster's Medical Dictionary definition of isolate).

  • vaccine: "A preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that is administered to produce or artificially increase immunity to a particular disease" (Complete Merriam-Webster's Medical Dictionary definition of vaccine).
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    5.1.2 Capturing the Bacteria Needed For Isolate and Vaccine Development

    Vaccines are made from a pure sample of virus or bacteria. Because the virus or bacteria needs to be separated (isolated) from all other types of virus and bacteria in order to be used for vaccine production, the sample of the virus or bacteria used for vaccine production is called an isolate. You must have an isolate before you can make vaccine. CL vaccine is typically made from killed bacteria, specifically, the bacteria which causes CL, Corynebacterium pseudotuberculosis.

    There are many varieties, or strains, of Corynebacterium pseudotuberculosis bacteria. There are Corynebacterium pseudotuberculosis bacteria that infect goats. There are Corynebacterium pseudotuberculosis bacteria that infect sheep. There are Corynebacterium pseudotuberculosis bacteria that infect horses. And so on. For a particular species of animal, there are even multiple varieties, or strains, of Corynebacterium pseudotuberculosis bacteria that infect that species. There are over 20 strains of Corynebacterium pseudotuberculosis bacteria that infect goats. The first goal in establishing a successful vaccine-based CL treatment program is to capture a sample of the specific strain of Corynebacterium pseudotuberculosis bacteria with which the goats to be treated are infected. This is commonly referred to as harvesting the bacteria.

    The Corynebacterium pseudotuberculosis bacteria are found in the pus of an active CL abscess. Therefore, an active external CL abscess is needed in order to start a vaccine-based treatment program. When one of the CL-infected animals has an active external abscess, contact a farm veterinarian to either lance and extract the pus from the active abscess or surgically remove it as a unit. Once a pus sample has been obtained, the farm veterinarian should send the sample to a custom vaccine manufacturer, where the pus sample will be tested for the presence of Corynebacterium pseudotuberculosis bacteria. If Corynebacterium pseudotuberculosis bacteria are detected, the lab will separate (isolate) the Corynebacterium pseudotuberculosis bacteria from the pus and develop it into an isolate suitable for vaccine production. It may take more than one attempt to successfully capture Corynebacterium pseudotuberculosis bacteria. Once the vaccine laboratory has the Corynebacterium pseudotuberculosis bacteria in isolate form, an order can be placed by the farm veterinarian with the vaccine manufacturer for the first batch of CL vaccine to be custom made for the infected farm. Because the CL vaccine for the farm's goats is manufactured from bacteria from the farm's goats, the vaccine is called autogenous vaccine.

    For the purpose of treating an animal already infected with CL, it is critical that CL vaccine is used that is manufactured from an isolate of the specific strain of Corynebacterium pseudotuberculosis bacteria with which the animal to be treated is infected.

    The best way to guarantee you treat your CL-infected animals with the most effective CL vaccine possible (and maximize protection of your uninfected animals from infection) is to capture a pus sample from one of the CL-infected animals on your farm and manufacture your CL vaccine from a bacterial isolate derived from that pus sample. Using over-the-counter CL vaccine (whenever one becomes commercially available specifically for goats) or autogenous CL vaccine developed for a friend or neighbor's herd (unless your animals have had direct or indirect physical contact with your friend or neighbor's CL-infected animals) will probably not give you good control of CL on your farm unless by sheer dumb luck the vaccine happens to have been manufactured from an isolate of the same strain of the bacteria that is on your farm.

    Note 1:

    If you have multiple strains of Corynebacterium pseudotuberculosis bacteria on your farm, to get good CL control you will ultimately need to obtain a pus sample containing each strain, so that an isolate for each strain can be developed at the vaccine lab for inclusion of each strain in your autogenous CL vaccine. If you have new animals frequently arriving at your farm (or if one of your animals came from a farm where new animals were frequently arriving), there is a good possibility that you could have multiple strains of Corynebacterium pseudotuberculosis bacteria on your farm. Based on the excellent response my CL-infected goat Picasso has had to treatment with my farm's autogenous CL vaccine, it is my belief that he is infected with a single strain of goat CL, and that I have a single bacterial strain on my farm. Farm Sanctuary has extensive experience in the use of autogenous CL vaccine in a farm environment where there are multiple strains of Corynebacterium pseudotuberculosis present. If you suspect you may have multiple strains on your farm (for example, if you aren't getting good treatment results from an autogenous CL vaccine manufactured from a single isolate from your farm), you may consider seeking additional advice from Farm Sanctuary regarding the handling of multiple strains. Contact information for Farm Sanctuary is provided in Section 7.0, Points of Contact.

    Note 2:

    It is possible over time for bacteria to naturally evolve from its current strain into a new strain, necessitating reharvesting of bacteria and development of a new isolate for the newly evolved strain. After over two years of being treated with my farm's autogenous CL vaccine, my CL-infected goat Picasso remains free of any detrimental CL health effects. Therefore, to date I am continuing to use my original Corynebacterium pseudotuberculosis isolate for vaccine production. I am, however, always vigilant for any sign of a decrease in the effectiveness of my current autogenous CL vaccine's ability to control Picasso's CL, which could indicate that the current strain of Corynebacterium pseudotuberculosis on my farm may have evolved into a new strain. If at some point in the future Picasso again begins to develop abscesses, I will consider reharvesting and updating my vaccine at that time.

    Note 3:

    I use MVP Laboratories in Omaha, Nebraska for my autogenous CL vaccine production. Isolate development, a batch of autogenous CL vaccine, and 2-day shipping using MVP Laboratories will cost approximately $850. Shipping costs will vary with the size of your order, but at MVP the cost of a batch of vaccine is the same no matter how many vials are ordered or what size they are. MVP Laboratories, upon request, can produce vials of vaccine as small as 20 ml. This is of importance to me, since I have a small number of goats on my farm. The larger minimum vaccine vial sizes which other labs often produce are more appropriate for larger herds. Long-term storage and re-use of a vaccine vial once its sterile seal has been pierced by a hypodermic needle are not recommended medical practices, so in addition to cost, also consider the availability of the most appropriate vaccine batch size and vial size for your farm when selecting an autogenous vaccine laboratory. U.S. residents should check with your state's Department of Agriculture to see if there are any regulations specific to your state that may influence your selection of an autogenous vaccine lab (Non-U.S. residents should check for the existence of applicable regional statutes in your country of residence). For example, it is my understanding from conversations I have had with PHL Associates, an autogenous vaccine manufacturer in Davis, California, that for isolates originating in California, California state law permits use of an isolate for three years, one year longer than the two-year limit permitted under Federal regulations (discussed in Section 5.2, Applicable USDA Regulations). Therefore, California residents may wish to consider using an autogenous vaccine laboratory within the state of California in order to take advantage of this. All autogenous vaccine laboratories in the U.S. are licensed by the USDA.

    Note 4:

    It is worthwhile to have your autogenous vaccine lab run an Antibiotic Susceptibility Test (sometimes also called an Antibiotic Sensitivity Test) using your isolate to determine the antibiotics to which your particular Corynebacterium pseudotuberculosis strain is most responsive. It is an inexpensive test, and this is critical information for your farm veterinarian to have on hand in the event there is a need to treat a CL-related infection with antibiotics at some point in an animal's life. Antibiotics in general are not an effective means to treat CL, but if the occasion arises when antibiotics must be used, your farm veterinarian will know the most effective antibiotics to use against the specific CL strain on your farm.

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    5.1.3 Use of Your Autogenous Vaccine

    Once your farm veterinarian receives your first batch of custom, strain-specific autogenous CL vaccine for your farm, you are ready to begin your vaccine-based CL treatment program. Before we get into details regarding how to administer the vaccine to a CL-infected animal, the following points must be made:

  • The use of autogenous vaccine for the control of CL-related symptoms in CL-infected animals is a treatment for CL; it is not a cure for CL. Life-long routine vaccination of the CL-infected animals with the vaccine is required to maintain good control of CL symptoms.

  • The use of autogenous vaccine for the control of CL-related symptoms in CL-infected animals prevents most, but not necessarily all, future CL abscesses. CL-infected animals may still get occasional abscesses from time to time (particularly during the beginning months of your vaccination program when the goat's immune system is still developing antibodies as a result of being vaccinated), but the frequency of abscess occurrences should be greatly reduced. If not, it's probable you have one or more Corynebacterium pseudotuberculosis strains on your farm which are not yet included in your current vaccine.

  • As veterinary practices go, it is counterintuitive to vaccinate an animal that is already infected with the disease a vaccine is designed to prevent. I had two veterinarians - a farm veterinarian and a veterinarian from an autogenous vaccine lab - tell me that use of autogenous CL vaccine in an animal already infected with CL would produce no positive benefit and would be a waste of my money. Don't be surprised if you encounter skepticism about the treatment approach from within the veterinary community. With the exception of the periodic vaccinations he receives, my CL-infected goat Picasso lives a normal, healthy goat life. His quality of life is excellent, and so is mine. I am so glad I ignored all the naysayers!

  • The Autogenous CL Vaccine Treatment Regimen Used on My Farm

    The life-long autogenous CL vaccine control and treatment program used on my farm is provided below. Note that the dosage, method, and frequency of vaccination of CL-infected animals on your farm may vary from that described below based on the recommendations of the specific laboratory developing your autogenous CL vaccine, as well as those of your farm veterinarian.

  • Initially vaccinate the CL-infected goat subcutaneously with 2 ml of autogenous CL vaccine.

  • Boost the CL-infected goat 3-4 weeks after the initial vaccination with an additional 2 ml subcutaneous vaccination.

  • Routinely re-boost the CL-infected goat with an additional 2 ml subcutaneous vaccination every 3-4 months throughout the goat???s lifetime.
  • The only side effect of the use of the autogenous CL vaccine that I have ever observed is localized swelling at the vaccination site. In my goat Picasso, the swelling is fairly significant, and lasts as long as 7-12 months. In my goat Esmeralda, the swelling is much less, and lasts about 21 days. Since the swelling at the vaccination sites in some goats can last for as much as a year, it is a good idea to make a record of the location of each vaccination site, so that local vaccination-related reactions can be differentiated from an actual CL abscess occurrence (since both look like lumps).

    Uninfected animals should also be routinely protected from infection using the same autogenous CL vaccine. Vaccine laboratory and farm veterinarian recommendations for routine vaccination of uninfected animals living on a farm where CL is known to be present should be followed. For simplicity, my farm veterinarian revaccinates my infected and uninfected animals on the same vaccination schedule (described above).

    As you can see, it's fairly trivial to implement an autogenous CL vaccine treatment program, and while it is not a cure, the use of autogenous vaccine helps reduce the frequency, size, and growth rate of CL abscesses that occur dramatically, improving the quality of life for both goats and goat owners alike, and minimizing exposure of the farm to CL-causing Corynebacterium pseudotuberculosis bacteria.

    The next section, Section 5.2, Applicable USDA Regulations, discusses in detail the USDA regulations that relate to autogenous vaccines. In order to ensure an uninterrupted supply of your farm's vaccine for your CL-infected and uninfected animals, anyone considering starting an autogenous CL vaccine treatment program should become thoroughly familiar with these USDA regulations.

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    5.2 Applicable USDA Regulations

    Non-U.S. Residents: USDA of course stands for the United States Department of Agriculture. Those of you outside of the U.S. will need to contact the appropriate government agency in your country to determine what national regulations may apply to your isolate and your autogenous vaccine. There may also be regional and local regulations that may affect your isolate and your vaccine.

    U.S. Residents: In addition to USDA regulations discussed in this section, some state regulations in the home state of your vaccine lab may also be relevant to your isolate and your autogenous vaccine; ask your vaccine lab regarding state-specific isolate and vaccine regulations that may affect you. Also, since your farm veterinarian is licensed by your state, there may possibly be some state regulations in your home state that may be relevant to your isolate and your vaccine; ask your farm veterinarian regarding state-specific isolate and vaccine regulations that may affect you. Also contact your state's Department of Agriculture to determine if there are other state-specific regulations that may apply.

    In order to most effectively use the autogenous CL vaccine treatment approached described above in Section 5.1, Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences, you need to have a basic working knowledge of the USDA regulations that apply to autogenous vaccines. More specifically, you need to be aware that the isolate from which your autogenous vaccine is produced has an expiration date which you must be proactively involved in extending if you wish to have an uninterrupted supply of your vaccine continuously available for the treatment of your CL-infected animals and the protection of your uninfected animals.

    The USDA regulation that defines the law with regard to isolates and autogenous vaccines is 9 CFR Part 113.113, Autogenous Biologics, where CFR stands for Code of Federal Regulations. A link to the complete text of 9 CFR Part 113.113 has been included in Section 8.0, Related Websites. As a USDA-licensed entity, your vaccine lab is very familiar with this Federal regulation, but it is worthwhile for you to have a fundamental knowledge as well.

    The only parts of 9 CFR Part 113.113 that will be discussed on this website are the parts that relate to ensuring your isolate expiration date gets extended so that the isolate will be available for autogenous CL vaccine production. For any questions you may have related to anything else in 9 CFR Part 113.113, contact your autogenous vaccine lab. If after consulting with your vaccine lab you still need or would like additional information, you can contact the USDA Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB), which is the body within the USDA that is responsible for inspection, compliance, licensing, and policy related to 9 CFR Part 113.113 and autogenous biologics. Contact information for the USDA APHIS CVB is provided in Section 7.0, Points of Contact, and a link to its website is provided in Section 8.0, Related Websites.

    The isolate expiration date differs from (is typically shorter than) the expiration date of the vials of autogenous CL vaccine manufactured from the isolate. 9 CFR Part 113.113 requires the vials of vaccine produced from an isolate to have an expiration date not exceeding 18 months. 9 CFR Part 113.113 requires an isolate to expire 15 months from the date of isolation or 12 months from the date of the isolate's first use in vaccine production, whichever comes first. Since the purpose of developing the isolate in the first place was to produce vaccine from it, more than likely it is the 12-month isolate expiration date that will apply to your isolate. If you do not proactively extend the isolate expiration date, the isolate will expire before your first batch of vaccine does, and you will not be able to produce a second batch of vaccine from the isolate when the first batch of vaccine expires. Ask your vaccine lab what the exact date is when your isolate will expire, as well as when the lab recommends submission of paperwork to the USDA to extend the date. Keep in mind that vaccine lab personnel are very busy and deal with many isolates over the course of a year; do not count on your vaccine lab to remind you when it's time to extend your isolate.

    As opposed to extending an isolate's expiration date, some people consider it preferable to allow an isolate to expire and to reharvest bacteria for a new isolate as described in Section 5.1.2, Capturing the Bacteria Needed For Isolate and Vaccine Development. Reharvesting has the advantages of relative ease, low cost, and obtaining a sample of the "latest" version of the Corynebacterium pseudotuberculosis bacteria that may have naturally evolved on your farm for use in your next batch of autogenous CL vaccine. Reharvesting has the disadvantages of allowing nature and USDA regulations to dictate what isolates are available for use in your vaccine, and risking re-exposure of your farm to CL, since an active external CL abscess is needed in order to reharvest. Reharvesting is also painful for the goat from which new pus is to be acquired, since it requires lancing of the abscess so that pus can be collected.

    In order to give you an understanding of all your options related to isolate expiration date extension, the specific process involved in extending your isolate will be discussed in detail in Section 5.2.1, One-Time, One-Year Isolate Extension, and Section 5.2.2, Permanent Isolate Extension. With this information, you can then decide what options you do and do not want to pursue for your farm. In addition, for those of you who suspect you may have multiple strains of CL on your farm, I would also suggest you contact Farm Sanctuary, which uses autogenous CL vaccine to treat its CL-infected goat and sheep herd, and has multiple known strains of CL on its New York and California farms. Farm Sanctuary may be able to give you additional advice regarding management of isolates and autogenous vaccine for multiple strains of CL. Contact information for Farm Sanctuary is provided in Section 7.0, Points of Contact, and its website is provided in Section 8.0, Related Websites.

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    5.2.1 One-Time, One-Year Isolate Extension

    In Section 5.2, Applicable USDA Regulations, it was discussed that 9 CFR Part 113.113 requires an isolate to expire 15 months from the date of isolation or 12 months from the date of the isolate's first use in vaccine production, whichever comes first, and that since the purpose of developing the isolate was to produce vaccine from it, more than likely it is the 12-month isolate expiration date that will apply to your isolate. With permission from the USDA, however, the use of the isolate for vaccine production can be extended for up to 24 months from the date of isolation. Assuming the date of isolation and first-use dates are in relatively close proximity, in effect the extension provides about an extra year in which the isolate can be used for vaccine production.

    Extending the use of the isolate to 24 months from the date of isolation is an easy, straightforward process. Your vaccine lab will send a form entitled Request For Authorization To Produce Additional Serials (or something equivalent) to your farm veterinarian. Your farm veterinarian fills out the form, essentially providing justification to the USDA as to why continued availability of the isolate for vaccine production is needed. Justification derives from the fact that you are using the autogenous CL vaccine made from your isolate for long-term treatment of CL-infected animals, as opposed to a more traditional strictly preventative use of the vaccine in uninfected animals. The form is then returned by your farm veterinarian to your vaccine lab, which then formally submits the extension request to the USDA (specifically to the USDA APHIS Center For Veterinary Biologics Inspection and Compliance Unit [CVB-IC]).

    In general the paperwork for this extension process should be started about two months before your isolate's effective expiration date, but check with your specific vaccine lab to see how much lead time before expiration of your isolate that they recommend to start this process. Keep in mind that vaccine lab personnel, your farm veterinarian, and USDA personnel are all busy people, so allow time for that fact. Given the straightforward nature of the paperwork and process for extending use of the isolate for up to 24 months from the date of isolation, with proper planning the extension can be accomplished with little difficulty.

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    5.2.2 Permanent Isolate Extension

    From the date of isolation up to 24 months from the date of isolation, regulation of your isolate falls under the control of the USDA APHIS Center For Veterinary Biologics Inspection and Compliance Unit (CVB-IC). After 24 months from the date of isolation, regulation of your isolate moves to the USDA APHIS CVB Policy, Evaluation, and Licensing Unit (CVB-PEL). Therefore, extending use of your isolate beyond 24 months from the date of isolation is handled by CVB-PEL. Extension of your isolate beyond 24 months, if granted by CVB-PEL, is a permanent extension. Once granted, the extension permits the isolate to be used indefinitely.

    Without question, obtaining a permanent extension is more challenging than the simple submission of a request form to the USDA, as was necessary to obtain the initial one-year extension of the use of your isolate as described in Section 5.2.1, One-Time, One-Year Isolate Extension. To obtain a permanent extension, 9 CFR Part 113.113 requires formal testing to be conducted. It is my hope that one day 9 CFR Part 113.113 will be modified to exclude from this testing autogenous CL vaccine users who have no intention of selling their vaccine, as it my opinion that the formal testing requirement deters most autogenous CL vaccine users from seeking isolate extension past 24 months, and is, therefore, counterproductive to the control of CL, since reharvesting bacteria for a new isolate requires an active external CL abscess, which risks re-exposure of both the farm and the animals on it to CL. Unfortunately, at this point in time, whether you are a pet goat owner, non-profit farm rescue, small family business, or large corporation you are required to conduct formal testing to extend use of your isolate past 24 months from the date of isolation. Fortunately, within the scope of current regulations, CVB-PEL has some flexibility in defining the nature and extent of formal testing that needs to be conducted.

    My vaccine lab initially told me that to conduct the formal testing required to extend the use of my isolate past 24 months from the date of isolation would cost tens of thousands of dollars. I was heartbroken. My beloved CL-infected goat, Picasso, had responded so well to the autogenous CL vaccine treatment described in Section 5.1.3, Use of Your Autogenous Vaccine, and in every way was enjoying the same quality of life that a goat that is not infected with CL enjoys. And now, because of a USDA regulation, Picasso was going to be robbed of what is, in my opinion, the only available effective treatment for CL. It was in this state of complete desperation that in January 2009 I wrote to the USDA APHIS CVB, explaining in my letter:

  • The autogenous CL vaccine treatment approach I was using

  • The great success I had experienced using the treatment to control CL on my farm

  • My desire, based on that success, to extend use of my isolate beyond 24 months from the date of isolation so I could continue long-term treatment of CL-infected animals and protect my farm from re-exposure to CL

  • The fact that I simply couldn't financially afford the tens of thousands of dollars my vaccine lab told me was required to run the regulation-required formal testing to extend my isolate beyond 24 months from the date of isolation

  • My opinion that, by requiring such costly testing, the regulation discouraged autogenous CL vaccine users from extending their isolates beyond 24 months from the date of isolation, ultimately ensuring the supply of autogenous CL vaccine made from the isolates would be interrupted, thereby making the regulation counterproductive to the control of CL

  • My animals and my farm were being put at risk for re-exposure to CL as a direct result of the cost of the regulation-required testing
  • The truth is, at the time that I wrote to the USDA, I considered it an exercise in futility, an act of final desperation. I needed to know in my heart that I had tried everything in my power to preserve Picasso's good health and quality of life, so I didn't have to watch him suffer the ill effects of a disease that I had successfully controlled in his body for years. I held out little hope that the USDA would even hear my plea, much less help me. I couldn't have been more wrong. I cannot speak highly enough of the response I received from the CVB. CVB personnel facilitated a teleconference between the CVB, my vaccine lab, and myself. They helped to devise a scaled-down test regimen that would meet the letter of regulatory law, but which I could afford to conduct. In short, they found a cost-effective way for me to extend use of my isolate permanently, for Picasso to continue to get his life-preserving autogenous CL vaccine, and for my farm to not be needlessly re-exposed to CL.

    Before you give up on seeking permanent extension of the use of your isolate because of what you have heard from your vaccine lab, your friends, or your other associates, write the CVB and give them an opportunity to work with you and your vaccine lab. They may or may not be able to find a solution for your specific situation that both you and your vaccine lab consider satisfactory, but it is my opinion that the personnel at the CVB are some of the finest individuals I have ever encountered, and that they will make every effort in their power to work with you to find an affordable way for you to conduct the formal testing required to renew your isolate permanently.

    Even though it may appear contrary to formal test methodology your vaccine lab was required to use in the past under 9 CFR Part 113.113, your vaccine lab, as a USDA-licensed entity, will follow whatever guidelines the CVB sets forth for use in your formal test, so if you are interested in pursuing permanent extension of the use of your Corynebacterium pseudotuberculosis isolate, in my opinion, the CVB is the place to start (CVB-PEL specifically). USDA APHIS CVB points of contact are provided in Section 7.0, Points of Contact.

    Dr. Brian Erdahl of USDA APHIS CVB-PEL informed me that I was the first individual (non-business) in USDA history to pursue, and be granted, a permanent isolate extension. If I can do it, you can do it.

    Note: USDA regulations require autogenous vaccine laboratories to remove expired isolates from their licensed premises. This is accomplished by some vaccine labs by destroying the isolate. However, this need not be the case. If you wish to pursue a permanent isolate extension, and your isolate will expire prior to the completion of formal testing, you can request your vaccine lab to temporarily move your expiring isolate to off-site unlicensed storage. Autogenous vaccine labs routinely do this, and will ordinarily have such a storage facility already identified. After successful completion of formal testing and being granted a permanent isolate extension, your vaccine lab is then permitted to move your isolate back to its licensed premises, so that it available for future vaccine production.

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    6.0 MISCELLANEOUS

    This section discusses a variety of CL-related topics which my experience has shown me to be largely misrepresented within the goat community.

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    6.1 Is CL contagious between species? Can a person become infected from a CL-infected animal?

    I have read in numerous places on the Internet that CL is contagious between animal species, even to people. This often directly results in a sense of complete fear and panic when CL first appears on a farm. I know it did for me. When I discovered Picasso had CL, and read on the Internet that it was contagious to other species, including people, I thought that Picasso, all the other animals on my farm, and I were all going to die from it.

    Here's what I know:

  • My farm veterinarian, Dr. Richard Decktor, told me that in all his decades of farm veterinary practice, he has never seen a single case where a CL-infected animal infected an animal outside of its species. He felt that if it were true that a CL-infected animal could infect an animal outside of its species, he would have seen a case of it, and he hasn't, not a single one.

  • Susie Coston, National Director of Farm Sanctuary, has dealt with CL for years managing Farm Sanctuary's CL-infected goat and sheep herd. She told me that of all the people she knows that work with CL on a day-to-day basis, she doesn't know of a single person who has become infected with CL as a result of contact with a CL-infected animal.

  • In my own personal experience on my farm, neither I nor any of the other animal species on my farm (dog, cats, horses) have caught Picasso's CL, despite the fact that I and all the animals are in direct day-to-day contact with Picasso:

  • I have never made any effort to disinfect any part of my farm (with the exception of the inside of the shed used to house my unvaccinated test goat during formal testing for my permanent isolate extension).

  • I pet, hug, and kiss Picasso every day.

  • The animals share corrals, grazing areas, waterers, and occasionally feed buckets (when someone filches someone else's food when I'm not looking).
  • So if CL were truly contagious between species, why haven't people with extensive experience with CL in a real farm environment seen examples of it?

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    6.2 What is the persistence of the CL-causing bacteria in the farm environment?

    I have read in numerous places on the Internet that Corynebacterium pseudotuberculosis, the CL-causing bacteria, can survive (persist) for years on a farm.

    I read a goat-based Corynebacterium pseudotuberculosis persistence veterinary study using infected pus on common barnyard materials:

    Survival of Corynebacterium pseudotuberculosis in axenic purulent exudate on common barnyard fomites, by J.L. Augustine and H.W. Renshaw, 1986, American Journal of Veterinary Research 47(4):713-715.

    Table 1 in the article documents overall results from this persistence study and leads to the following conclusions for the temperature range and materials used in the study:

  • Corynebacterium pseudotuberculosis that causes CL in goats persists for several months (not years) in the farm environment.

  • Corynebacterium pseudotuberculosis that causes CL in goats in general appears to be more persistent at colder temperatures than at warmer temperatures.
  • That said, I feel the above-referenced study falls short in two areas:

  • A wider temperature range needed to be covered, particularly at colder temperatures.

  • One of the most common farm transmission mediums of Corynebacterium pseudotuberculosis, soil, needed to be covered.
  • Based on this one study at least, it does not appear that claims of the bacteria persisting for years in the farm environment are valid, and that the greater likelihood is that the farm environment is being constantly re-exposed/re-infected by CL-infected animals on the farm, as opposed to the original bacteria to which the farm was exposed actually persisting for years. However, I would like to see additional information on this topic for the study areas that I cited above as lacking before I feel comfortable reaching any definitive conclusion.

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    6.3 Can stress negatively affect my CL-infected goat?

    The autogenous vaccine treatment described in Section 5.1, Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences, uses the vaccine to stimulate the CL-infected animal's immune system against the CL bacteria with which its body is infected. Therefore, in my opinion, anything that has the potential to negatively affect the goat's immune system will also potentially negatively affect your control of its CL. Conversely, anything that has the potential to positively affect the goat's immune system will also potentially positively affect your control of its CL.

    For example:

  • Numerous studies in people have shown that stress, depression, and anxiety all negatively affect the immune system (just Google "stress immune system" and you'll have enough reading to keep you busy for quite a while). Changes in the CL-infected animal's environment can cause it stress and anxiety, potentially negatively affecting its immune system; for example, a move to a new environment, introduction of a new animal to the farm, noise from a construction project at or nearby to the farm, etc. Similarly, it would be reasonable to conclude that the opposite is also true - that love and happiness positively affect the animal's immune system.

  • Good nutrition and veterinary care positively affect the immune system by keeping the overall body in which the immune system must function healthy.
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    7.0 POINTS OF CONTACT

  • For any questions, comments, or other feedback you may have regarding anything discussed on this website, please feel free to contact me:

    Sue Straumann
    Shambhala Farm
    sstrauma@voicenet.com

  • For information regarding autogenous CL vaccines and placing an order for autogenous CL vaccine with MVP Laboratories:

    Mike Murphy
    Vice-President of Sales and Customer Services
    MVP Laboratories, Inc.
    4805 G Street
    Omaha, NE 68117
    1-800-856-4648
    mikem@mvplabs.com

  • For information about pursuing permanent isolate extension through MVP Laboratories:

    Jack McGonigle
    USDA Liaison
    MVP Laboratories, Inc.
    4805 G Street
    Omaha, NE 68117
    1-800-856-4648
    jackm@mvplabs.com

    Dr. Jeff Kula
    Technical Services Veterinarian
    MVP Laboratories, Inc.
    4805 G Street
    Omaha, NE 68117
    1-800-856-4648
    jeffk@mvplabs.com

  • For information regarding current USDA regulations and the application of those regulations to the use of autogenous vaccines (in particular to the seeking of permanent isolate extension):

    Note: If you are in the process of pursuing permanent isolate extension, be aware that the only legally binding contact with the USDA is that conducted by your vaccine lab's USDA liaison in writing to the USDA, and the USDA's contact in writing to the vaccine lab's USDA liaison.

    Dr. Richard E. Hill, DVM
    Director, Center for Veterinary Biologics
    USDA APHIS Veterinary Services
    510 South 17th Street, Suite 104
    Ames, IA 50010
    1-515-232-5785
    rick.e.hill@aphis.usda.gov

    Dr. Byron Rippke, DVM
    Director, Policy, Evaluation, and Licensing
    Center for Veterinary Biologics
    USDA APHIS Veterinary Services
    510 South 17th Street, Suite 104
    Ames, IA 50010
    1-515-232-5785
    byron.e.rippke@usda.gov

    Mr. Steven Karli
    Director, Inspection and Compliance
    Center for Veterinary Biologics
    USDA APHIS Veterinary Services
    510 South 17th Street, Suite 104
    Ames, IA 50010
    1-515-232-5785
    steven.a.karli@usda.gov

    Dr. Brian Erdahl, DVM
    Licensor/Reviewer, Policy, Evaluation, and Licensing
    Center for Veterinary Biologics
    USDA APHIS Veterinary Services
    510 South 17th Street, Suite 104
    Ames, IA 50010
    1-515-232-5785
    brian.j.erdahl@aphis.usda.gov

  • For information regarding Farm Sanctuary's use of autogenous CL vaccine in its CL-infected goat and sheep herd (in particular to the use of autogenous CL vaccine in a farm environment where multiple strains of Corynebacterium pseudotuberculosis are present):

    Susie Coston
    National Shelter Director
    Farm Sanctuary
    PO Box 150
    Watkins Glen, NY 14891
    1-607-583-2225, Ext. 262
    scoston@farmsanctuary.org

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    8.0 RELATED WEBSITES

    Websites related to the use of autogenous CL vaccines:

  • MVP Laboratories, Inc.

  • Complete Text of 9 CFR Part 113.113, Autogenous Biologics
    (Scroll down to the "Inactivated Bacterial Products" section and click on "?? 113.113 Autogenous biologics")

  • USDA Animal and Plant Health Inspection Service (APHIS)

  • USDA APHIS Center for Veterinary Biologics

  • Farm Sanctuary
  • Other Shambhala Farm websites:

  • Shambhala Farm

  • Blind Horse Care, Training, and Riding
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    9.0 SPECIAL THANKS

    I would like to express my sincere thanks to the following individuals who have had a significant role in the continued good health of my CL-infected goat, Picasso:

  • Susie Coston, National Director of Farm Sanctuary, Watkins Glen, NY. Thank you, Susie, for the many times when you coached me in Farm Sanctuary's use of autogenous vaccines in its own CL-infected goat and sheep herd, so that Picasso and CL-infected animals like Picasso have an opportunity to lead a happy, normal life.

  • Dr. Brian Erdahl, DVM, USDA APHIS Veterinary Services, CVB-PEL, Ames, IA, USDA Licensor/Reviewer for MVP Laboratories. Thank you for your time, energy, and unending patience in working with me and MVP Laboratories guiding and overseeing the first-ever immunogenicity test conducted by an individual pet owner, so that the isolate used to make Picasso's CL vaccine was permanently extended, assuring the long-term, uninterrupted supply of his life-saving autogenous CL vaccine. You are, without question, a jewel within the USDA who brings to mind all that is good about this country and its Government.

  • The administrators of the USDA APHIS Veterinary Services, Center for Veterinary Biologics, Ames, IA. Thank you for providing me a cost-effective solution to pursue isolate extension, and for making Dr. Erdahl available to me and MVP Laboratories to help us through the related immunogenicity test:

  • Dr. Richard Hill, DVM, Director, Center for Veterinary Biologics (CVB), USDA APHIS Veterinary Services
  • Dr. Byron Rippke, DVM, Director, Center for Veterinary Biologics Policy, Evaluation, and Licensing (CVB-PEL), USDA APHIS Veterinary Services
  • Mr. Steven Karli, Director, Center for Veterinary Biologics Inspection and Compliance (CVB-IC), USDA APHIS Veterinary Services
  • Mike Murphy, Vice-President of Sales and Customer Services, MVP Laboratories, Omaha, NE. Thank you for your patience, knowledge, and assistance through the years placing Picasso's autogenous CL vaccine orders and answering my innumerable questions regarding use of the vaccine and the USDA regulations related to the vaccine.

  • Dr. Jeff Kula, Technical Services Veterinarian, and Jack McGonigle, Executive Vice-President, MVP Laboratories, Omaha, NE. Thank you both for going through the immunogenicity test process with me on behalf of my goat Picasso. I simply can't thank you both enough for all your time, effort, and expertise.

  • Mary Lou Chapek, owner, MVP Laboratories, Omaha, NE. Thank you for making so much of Jack McGonigle's and Dr. Kula's time available to support my immunogenicity test.

  • All the individual employees of MVP Laboratories behind the scenes who are responsible for producing the consistently excellent autogenous CL vaccine which preserves my goat Picasso's quality of life and good health. Thank you for your daily dedication to excellence in vaccine production.

  • Dr. Sharon Hietala of the University of California-Davis California Animal Health and Food Safety Laboratory, and Dr. Hendrik-Jan Roest of the Central Veterinary Institute of Wageningen, Netherlands, for your support analyzing, reverifying, and interpreting diagnostic test results for my immunogenicity study.

  • Dr. Richard Decktor, DVM, Decktor Veterinary Hospital and Clinic, Woodstown, NJ, Picasso's farm veterinarian. Thank you for your indispensible support and advice throughout Picasso's treatment with his autogenous CL vaccine, and for being the conducting veterinarian for the immunogenicity testing required to obtain the permanent extension of Picasso's isolate.

  • Lisa Swift, Veterinary Technician, Decktor Veterinary Hospital and Clinic, Woodstown, NJ. Thank you for all the extra effort you did on behalf of Picasso during my immunogenicity study.

  • My wonderful neighbors, the Woodsides, who are always ready to lend a hand in any way necessary. Thank you for taking time out of your Saturday evening to come over and help me get the test goat for my immunogenicity study, Esmeralda, safely settled in here on my farm prior to the start of my immunogenicity test. I am so blessed to have neighbors like you.

  • The individuals and organizations who so generously made donations to Shambhala Farm that were used toward veterinary expenses and the purchase of the isolation shed for the formal testing required to obtain permanent isolate extension for Picasso.
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    10.0 PERMITTED USE OF COPYRIGHTED MATERIAL

    All text and photographs on this website are copyrighted by the author, but may be freely reproduced for strictly non-profit purposes. Any intended for-profit use of the material on this website must be expressly approved in advance of use in writing by the author.

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    11.0 MAKE A DONATION

    Donations to help offset the cost of the care, feeding, and housing of the animals here at Shambhala Farm, and to maintain this website, are greatly appreciated. Please note that Shambhala Farm is not a 501(c)3 non-profit organization. As such, your donations are not tax deductible. I am simply one person who is trying to make the world a better place for hard-to-place animals whom no one wanted because of their special needs, but who deserve a loving, permanent home (and have found one here). I also try to disseminate through this website and the Shambhala Farm website any valuable information which I have learned through the care and treatment of these special needs animals, so that other people and animals can benefit.

    Please help as little or as much as you can. All contributions are appreciated.

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    Last Updated: October 10, 2009