May/June 2000 FDA Veterinarian Newsletter
This year the 20th anniversary of National Pet Week will be celebrated May 7-13, 2000. The theme, "Friends For Life" embraces the life-long commitment we make to our four-legged friends as valued family members. This special week is set aside by the American Veterinary Medical Association (AVMA), the Auxiliary to the AVMA, the American Animal Hospital Association, and the North American Veterinary Technician Association, Inc., to honor the animals that have been important to us at every stage of our lives.
Veterinary clinics across the country are sponsoring open houses, pet care educational programs, dog jogs, fun runs, photo contests, and fundraisers to benefit special animal-related causes.
It is important to remember that pets rely on us for regular veterinary check-ups, proper nutrition, dental care, exercise, and plenty of love and attention. The rewards of pet ownership will last a lifetime.
By Amey L. Adams, Ph.D.
The following article provides information on goats as pets. Veterinarians may wish to duplicate this article and provide copies to their interested clients. As always, material that appears in the FDA Veterinarian is free of copyright and may be reproduced without permission.
Goats as a species have been the object of ridicule and "bad press" for centuries. In ancient times, a community would lay their hands on a goat to symbolically transfer their sins to the animal, then send it out into the wilderness, carrying their sins away. Hence the origin of the term "scapegoat." In the New Testament, Christ tells his followers that he will separate the sheep from the goats, meaning the good from the bad, and the goats will be cast out into the darkness. From a more modern standpoint, goats are often perceived as a nuisance with bizarre appetites and destructive habits.
The truth about goats is that they are one of the most intelligent of domesticated species, rivaling the pig and the dog. That’s the good news. The bad news is that this intelligence, combined with curiosity and a highly active, energetic temperament, often causes problems for the owner, neighbors, and the animal itself. However, in an appropriate environment, goats can make excellent companion animals. They are noted to have highly individual personalities, and are capable of great affection and loyalty to their human caretakers. Goats can be trained to pull small carts, making them a fun and novel activity for children. Because of their small size and trainability, goats make an ideal 4-H project for younger children who might have difficulty handling larger farm livestock.
Multi-Purpose Animals
Although not economically important in the U.S., goats are a significant source of food, income, and draft power in many countries around the world. Goat milk and dairy products are an important commodity in Europe, and goat meat is highly prized in many African, Middle Eastern, and Caribbean countries. Here in the US, goat milk is sometimes recommended for the lactose-intolerant, and for many children who have difficulty digesting the fat and protein of cow’s milk. Angora goats produce mohair, and most goat breeds produce at least some cashmere, the soft fibers prized for sweaters. In much of the western US goats are being promoted as a low-cost, environmentally friendly biological control for weeds and brush which cattle and sheep do not consume.
Not for Everyone
Goats are considered farm livestock, and rightly so. Goats can be trained to walk on a leash and perform many of the tricks we might teach our dogs. It may even be possible to housebreak a goat. However, because of their high levels of activity, they require considerable space, much like a horse. This is true even of the diminutive Pygmy goat, which packs a lot of bounce in its small frame. Most domesticated goats originated in mountainous areas, and they retain their agility and propensity for climbing and jumping. Thus, you should not be surprised to find that your goat has leapt to the top of your kitchen table, or hopped over the backyard fence. Goats are highly social animals, and easily bored, so it is generally recommended that they be kept with other goats or other farm animals. Simple toys should be made available, such as a soccer ball or basketball, or even an empty (well-rinsed) bleach bottle tied to a stake or fence post.
Breeds
In the US there are approximately 10 major goat breeds; five dairy breeds, two meat breeds, two dwarf/pygmy breeds, and the mohair-producing Angora. Breed associations exist for all of the major breeds. To decide what breed would best fit your lifestyle, I recommend you contact your local cooperative extension agent or the breed associations.
The dairy breeds include Alpine, Saanen, Toggenburg, Nubian and La Mancha. The Alpine is often called "the Holstein of goats" because of its high milk production relative to other dairy breeds (roughly 10 to 12 lbs. milk per day). The Nubian or Anglo-Nubian is popular among owners who want a gentle pet as well as some milk for home consumption/cheese making.
The major meat-producing breed is the Boer goat, imported into this country from South Africa and New Zealand. The so-called "Spanish" goat is a dual-purpose goat whose ancestors most likely were brought from Spain in the 1500s. They are raised principally for meat, although many strains produce a substantial amount of cashmere. This is the breed most used by ranchers who want to clear brush and weeds from pasture land in the western US
Probably the most popular breed for pets is the Pygmy. Its small size (40-50 lbs.) makes it more appropriate for owners with very limited acreage, and it retains that "baby goat" appeal into adulthood. A less well-known small breed is the Nigerian or West African Dwarf goat. These goats are slightly larger than the Pygmy (approximately 60 lbs.), but still smaller than the full-size breeds, which can range between 95 to 225 lbs. Dwarf goats were originally bred as dairy goats in West Africa, and will also produce some milk for home use.
Goats Do Not Eat Tin Cans
One of the many myths surrounding goats is their peculiar appetite. However, one must distinguish between what the animal actually consumes, and what it might pick up out of mere curiosity. Goats, like small children, have a propensity for mouthing or "tasting" any new object they encounter. Choking is a hazard with goats for this very reason. On the other hand, they will readily consume paper, tree bark, and your prize roses, given the opportunity and/or inadequate space or alternative food sources.
Meeting the nutritional needs of pet goats is relatively easy. Good quality hay, such as alfalfa, combined with a source of minerals and vitamins (such as a salt lick appropriate for horses, cattle, or sheep), and access to good quality pasture is essential. Goats are considered mixed browsers/grazers, which is to say that they will eat grass and the leaves of bushes with equal appetite. For this reason, it is important to identify any toxic plants, such as rhododendrons, which may be on your property and take steps to prevent your goats from exposure to these plants. Adult pet goats generally do not require grain, except perhaps during winter months when green feed is less available. Because goats are ruminants, like cattle and sheep, grain feeding must be undertaken with care. Lower energy grains, such as crimped barley or oats, should be introduced slowly, one handful at a time, and fed only in very limited amounts to maintain the goat in good body condition. Goat pellets can be purchased for growing or lactating goats, which are specially formulated to meet their needs. Do not feed horse sweet-feed to your goats.
Billies or Nannies?
Another issue to consider when deciding to buy a goat is gender. Uncastrated male goats produce a strong, pungent and, to most people, unpleasant odor. Male goats, or bucks, also tend to be aggressive. Both of these less-than-desirable attributes are intensified during the breeding season, which for most goats runs from September to December or January. Buck goats can be castrated as early as 7 days old, which generally mitigates both these problems. Female goats, called does, do not have a noticeable odor, unless they are kept in unclean conditions. Generally speaking, does are even-tempered and affectionate when hand raised. However, I must again point out that goats are highly individual in their personalities. Female goats need only be bred if their milk is desired.
Whether you choose a male or female goat, it should be dehorned. Some strains of goats are born without horns, or polled. Horn buds appear a few days after birth in goats that are not polled. The easiest and most humane time to remove horns is during the first two-weeks of life. However, goats can be dehorned as adults. At any time, a veterinarian should perform this procedure.
Goat Health
For the most part, goats are hardy animals with broad tolerances for heat and cold. However, they must be provided with shelter from wind and rain. Young animals, in particular, are susceptible to pneumonia. In general, goats suffer from few diseases, but in rare cases may contract Brucellosis (Undulant Fever) and Tuberculosis from infected animals. The two major disease concerns in goats are Caseous Lymphadenitis (chronic abscesses) and Caprine Arthritis/Encephalitis (CAE). Both these diseases are infectious and may be transmitted in the milk. Caseous Lymphadenitis can be transmitted to humans. There is no treatment for either of these diseases. It is important, therefore, to ask for proof that the goat you are buying has been tested for both these diseases.
The most common health problem in goats is internal parasites. Internal parasites are ingested by goats grazing infected pasture. Depending on the severity of the infestation (generally referred to as parasite load) goats may show few or no signs of illness, or may suffer from a variety of signs such as weight loss (or failure to gain weight), dull and/or rough hair coat, and diarrhea. Goats, which appear to be "poor doers," i.e., consume large amounts of feed but still appear thin, may suffer from a heavy parasite load. You will need to consult with your veterinarian regarding appropriate parasite control programs.
Summary
Keeping a goat as a pet or 4-H project can be a fun and rewarding experience. Most goat owners are devoted to their animals and will readily expound on the joys of ownership. Goats are clean by nature, intelligent, affectionate, and versatile. They require little in terms of feeding and health care, but do require adequate space and lots of activity. With proper care and management, your goat should live 12 to 15 years. Goats are normally quite gentle, and so make an ideal introduction for children to farm animals. Goat milk is wholesome and, for some people, easier to digest than cow’s milk. For those who are inclined toward handcrafts, mohair and cashmere fiber are an added bonus of goat ownership. For additional information, contact your local cooperative extension office or public library. Also, a number of good information sources may be found on the web: Langston University’s goat extension, North Carolina State University, Purdue University, Texas A&M University, and many, many more.
In July 1999, Switzerland reported to the United States that it had found trace levels of diethylstilbestrol (DES) in two samples of U.S. beef. On July 13, the Swiss government published a press release that announced its DES findings in U.S. beef. The press release stated that the amounts detected were at low levels and did not pose an acute health threat.
Laboratory animal studies linked DES to cancer in the early 1970s, and FDA prohibited the use of DES in U.S. food-producing animals in 1979.
The FSIS' National Residue Plan stopped monitoring for DES in 1991, since no positive results or confirmable findings were found for several years. The last positive findings in the early 1970's led to two Department of Justice, FSIS, and FDA investigations and trials, in Wichita, Kansas and Syracuse, New York.
The FDA takes misuse of compounds of public health significance like DES very seriously. The Agency’s Center for Veterinary Medicine (CVM), which has the responsibility to investigate the misuse of drugs in food-producing animals, has carried out an intensive investigation during the past eight months. FDA inspectors have conducted on-farm investigations of animal producers and feedlots delivering animals to the establishment in question. They have investigated bulk drug re-packers, compounding pharmacies, and other points at which illegal diversions of drugs might be uncovered. FDA has thus far found absolutely no evidence of the diversion of DES to use in food animals.
In the meantime, FDA has learned that the Swiss government sent the two positive samples to a European Union (EU) reference laboratory for re-confirmation. The October 14, 1999, report from the EU reference laboratory states "...we must conclude that our analyses do not confirm the presence of DES in the samples submitted for analysis."
The investigation is still ongoing, but to this point, FDA has found no misuse of DES or evidence of its diversion to food-producing animals.
The FDA Veterinarian discussed the issue of antimicrobial resistance with Dr. Sharon R. Thompson, CVM's Associate Director for Veterinary Medical and International Affairs. Dr. Thompson is responsible for managing and coordinating national and international activities on antimicrobial resistance related to drug therapy in food animals. The following are questions and answers that came out of that discussion.
Q. FDA's CVM has stated that antimicrobial resistance is its number one priority. Why is FDA so concerned about the role that antimicrobial drug use in food-producing animals plays in the emergence of antimicrobial drug resistant bacteria? Isn't it true that much of the problem in humans is caused by antimicrobial use in human medicine?
A. The Center acknowledges that the bulk of the antimicrobial resistance problem in humans is due to human use of these products. FDA is co-chair with CDC and NIH of an Interagency Task Force on Antimicrobial Resistance that is working on the broad issue of antimicrobial resistance. The Task Force is developing a Public Health Action Plan to serve as a blueprint for Federal agencies to address antimicrobial resistance. A draft plan is being prepared based on input at a public meeting held in July 1999 and is expected to be released for public comment later this year. Most of the plan will deal with human drug issues, which represent the bulk of the human drug resistance problem. However, it is important to recognize that use of antimicrobials in food-producing animals is also of concern. For certain foodborne pathogens, animal use can be a major driver of the resistance that is seen in human medicine. In industrialized countries, the foodborne pathogen Salmonella is infrequently transferred from person to person. In these countries, epidemiological data have demonstrated that a significant source of antibiotic resistant foodborne infections in humans is the acquisition of resistant bacteria from animals via food.
This is not a new issue; we have been concerned about it for about 30 years. FDA first called for several restrictions on antimicrobial use in feed in 1977. That proposal generated several studies and reports. In 1988, the Institute of Medicine (IOM) again reviewed current information about antibiotic resistance. The Committee found a considerable amount of indirect evidence implicating both subtherapeutic and therapeutic use of antimicrobials as a potential human health hazard, but did not find data demonstrating that use of subtherapeutic penicillin or tetracycline directly caused a human to die from salmonellosis. The Committee strongly recommended further study of the issue.
In the early 1990s, several scientists expressed concern that the approval of fluoroquinolones for use in food-producing animals in the U.S. would result in fluoroquinolone resistant foodborne disease in humans. Since then, reports have identified a relationship between the approval of fluoroquinolones for therapeutic use in food-producing animals and the development of fluoroquinolone resistance in Campylobacter in animals and humans. This and other recent epidemiological evidence has highlighted concerns over the human health impact of resistant bacteria acquired from animals via food. As a result of this new evidence, CVM believes that we must address this issue now.
Q. What is CVM doing to address the issue of antimicrobial resistance caused by the use of these drugs in food-producing animals?
A. This is a very complex issue, and the Center has a multi-pronged strategy to address it as follows:
Revising our regulatory approach
Guidance for Industry #78 -- "Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals"
[ pdf ] [ htm ]This guidance states that FDA believes it is necessary to consider the potential human health impact of the microbial effects associated with all uses of all classes of antimicrobial new animal drugs intended for use in food-producing animals when approving such drugs. This guidance document was finalized December 1999.
Framework document -- "A Proposed Framework For Evaluating And Assuring The Human Safety Of The Microbial Effects Of Antimicrobial New Animal Drugs Intended For Use In Food-Producing Animals"
[ pdf ]
The Framework Document is a conceptual outline of how antimicrobials intended for use in food-producing animals might be regulated.
The Framework Document states FDA’s position that the regulatory system for antimicrobials used in food-producing animals should be modified to address microbial safety concerns. The assessment of microbial safety envisioned in the Framework Document involves a qualitative risk assessment, with the characterization of the risk to include the definition of the hazard and the exposure. The document goes on to articulate the need to determine acceptable levels of resistant bacteria in animal products (thresholds) to ensure that the effectiveness of human antimicrobials would not be compromised.
Risk Assessment
To better estimate the risks posed from the use of antimicrobials in food animals, the Food and Drug Administration’s Center for Veterinary Medicine (CVM) conducted a quantitative risk assessment that modeled the human health impact of fluoroquinolone resistant Campylobacter infections associated with the consumption of chicken.
The draft risk assessment model assumes that resistant bacteria pass through the food supply, infect humans, and are treated in the same manner as susceptible bacteria. The health risk associated with antimicrobial resistant bacteria represents an incremental increase in risk to consumers because resistance to an antimicrobial used in human medicine can compromise the effectiveness of therapy. Using this approach, the incremental human health impact of resistant foodborne disease can be determined without assessing all the factors influencing the cause of the foodborne illness itself.
CVM has contracted for a second risk assessment to examine the indirect transfer of resistance from animals to humans. For this risk assessment, CVM will be modeling the impact of virginiamycin resistance in Enterococcus faecium in animals on the ability to treat E. faecium in humans with the recently approved human antimicrobial, Synercid.
In the April 19, 2000, Federal Register, the Agency requested input from the public on the appropriate design of a risk assessment model, and on the data that should be considered or generated to support the risk assessment. Once the feasibility study is completed, CVM will know whether sufficient data exist to support the risk assessment or whether additional data need to be generated.
The results of CVM’s risk assessments on antimicrobial resistant bacteria will guide risk managers toward more informed decisions regarding the public health impacts of antimicrobial drugs approved for use in food-producing animals. Although each model will address the specific problem outlined, the model generated may be generalized as a guide for future quantitative risk assessments for other antimicrobial products for which transfer of resistance from animals to humans is an issue of public health concern.
Consulting with our stakeholders
We need public input on this complex issue and are using various ways to obtain this input as follows.
- Veterinary Medicine Advisory Committee (VMAC) Meeting, January 25-26, 1999. The focus of the meeting was to discuss a proposed framework on how to evaluate the potential public health risk from microbial effects associated with the use of antimicrobials in food-producing animals.
- General Public Meeting -- October 4, 1999. This meeting provided an opportunity for stakeholders to give input to CVM on the appropriate issues, experts and agenda items to be included in subsequent workshops related to antimicrobial resistance.
- First Workshop -- December 9-10, 1999. This workshop focused on issues related to risk assessment and the establishment of resistance thresholds in food-producing animals.
- Second Workshop -- February 22-24, 2000. This workshop was held to discuss the appropriate designs for pre-approval studies to evaluate the microbial effects of antimicrobial drugs intended for use in food-producing animals.
- Third Workshop -- Fall 2000. CVM is in the process of planning a workshop on thresholds (levels of resistant bacteria in animal products.)
Improving the monitoring of resistance/surveillance
In 1996, the FDA, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA) created the National Antimicrobial Resistance Monitoring Program -- Enteric Bacteria (NARMS). NARMS was created to prospectively monitor changes in antimicrobial susceptibilities of zoonotic enteric pathogens from human and animal clinical specimens from healthy farm animals and from carcasses of food-producing animals at slaughter.
NARMS is designed to provide descriptive data on the extent and the temporal trends of antimicrobial susceptibility in Salmonella and other enteric organisms from the human and animal populations; to provide timely information to veterinarians and physicians; to prolong the life span of approved drugs by promoting the prudent use of antimicrobials; and to identify areas for more detailed investigation.
NARMS has been expanded each year since its inception. Now, NARMS is monitoring susceptibilities of Salmonella and E. coli isolates to 17 antimicrobial drugs and Campylobacter isolates to eight antimicrobial drugs (azithromycin, chloramphenicol, ciprofloxacin, clindamycin, erythromycin, gentamycin, nalidixic acid, and tetracycline). Animal isolate testing is conducted at USDA’s Agricultural Research Service Russell Research Center. Human isolate testing is conducted at CDC’s National Center for Infectious Diseases Foodborne Disease Laboratory.
Conducting research
FDA's CVM has initiated intramural, extramural, and collaborative research efforts to investigate factors associated with development, dissemination, and persistence of bacterial antibiotic resistance in both the animal production environment and food supply. Both the Agricultural Research Service and the Cooperative State and Research, Education, and Extension Service of the U.S. Department of Agriculture are considering or engaged in research on critically important environmental, mitigation, and product issues relating to the development of resistance to antimicrobials.
Scientists in CVM’s Office of Research are currently conducting or are participating in projects specifically targeted to gather data on such issues as: (1) the background level of bacterial antibiotic resistance that currently exists in retail animal-derived food products; (2) the development and persistence of bacterial antibiotic resistance from aquaculture and animal production environments; (3) characterization of mechanisms of resistance dissemination and transfer among pathogenic and commensal bacteria associated with food-producing animals and aquaculture environments; (4) determining the roles that animal feeds and feed commodities play in the dissemination of antibiotic resistance and pathogen carriage; and (5) co-selection of antibiotic resistance phenotypes associated with the use of sanitizers and other antimicrobials in animals. In addition, CVM is a contributing laboratory to CDC’s PulseNet molecular fingerprinting network involved in the molecular epidemiology of foodborne outbreaks. The CVM laboratory provides the only source of data on animal associated bacterial pathogens into the PulseNet system.
Supporting efforts for judicious use/education
Q. How does the Center respond to some scientists, consumers, and others who believe all feed use/production use of antimicrobials in food-producing animals should be banned immediately? Why is our approach different from that in some other countries, particularly in Europe?
A. Our approach is different for two main reasons:
Differences in the law
In Europe, laws regulating therapeutic animal drugs differ from laws regulating animal drugs used for growth promotion. These different laws come under different agencies, and this separation makes it easier for the European governments to take different actions on these drugs based on their usage. Thus, the same drug could be approved for use for therapeutic purposes, but prohibited for use in feeds for growth promotion. U.S. law does not separate drugs based on their usage. Also, these drugs are regulated by the same government agency -- FDA's CVM.
Differences due to the way we view scientific evidence
In the U.S., we believe it does not make scientific sense to separate therapeutic and production uses of drugs. For example, we have evidence that fluoroquinolone products used therapeutically can have an effect on resistance. Our Framework document explains how we believe the antimicrobial drugs should be evaluated -- on the basis of importance of the drug or related drug to human medicine and on the potential exposure of humans from resistant bacteria originating from animals. We believe it is appropriate to evaluate risk from all antimicrobial drugs equally. CVM starts with the premise that any product is potentially approvable, but we must evaluate the risks of that proposed use.
Q. How does CVM respond to food animal producers and others who are concerned that the Center is making it too difficult for them to obtain the antimicrobials they need by slowing or making harder for these products to be approved for use?
A. The Center must have adequate data on microbial effects to answer any safety concerns from the sponsors, or antimicrobial products cannot be approved. We acknowledge that there is a delay/slowing in the process as we are working out our regulatory approach. Antimicrobial resistance caused by drug use in food-producing animals is a complex scientific and policy issue requiring a science-based regulatory approach that takes time to finalize. Our approach is to balance the goals of protecting public health and making safe and effective drugs available for animal use.
Q. What about regulation of antimicrobial products that are already on the market? Will the Center reevaluate their safety based on the concepts of the Framework document?
A. Once we finalize our approach to the regulation of antimicrobials used in food-producing animals, we will look at all approved products, and prioritize our evaluation of them on the basis of any public health concern. As mentioned above, we have already initiated a second risk assessment that will model the impact of virginiamycin resistance in Enterococcus faecium in animals on the ability to treat E. faecium in humans with the human antimicrobial, Synercid. Virginiamycin has been an approved veterinary product for about 25 years.
Q. What is CVM's timetable for implementing the concepts in the Framework document?
A. The Center cannot commit to a specific timetable. This is the Center's highest priority area, and we are working as quickly as we can. But, we need to obtain public input before we finalize our regulatory approach on this complex issue, and the resolution of some aspects may require notice and comment rulemaking.
FDA RESPONDS TO CITIZEN PETITION ON BST
On April 20, 2000, FDA responded to a Citizen Petition (Docket No. 99P-4613) from Mr. Robert Cohen concerning Posilac®, the only FDA-approved recombinant bovine growth hormone (rbGH) product for increasing milk production in dairy cattle. FDA's Center for Veterinary Medicine (CVM) approved Monsanto Company's rbGH product, Posilac in November 1993 after a comprehensive review of the product's safety and efficacy, including human food safety.
The petition requested that FDA rescind the approval of Posilac, and immediately remove it from the market based on "new evidence" that the product poses "serious health consequences for human consumers." Later, Mr. Cohen amended this petition, most recently on December 2, 1999. As amended, the petition raised three primary issues in support of the request for withdrawal of Posilac. These issues are as follows: (1) that a recently reported increase in serum levels of insulin-like growth factor-1 (IGF-I) in humans following milk consumption represents absorption of dietary IGF-I, invalidating a basic premise of FDA's safety assessment and proving that IGF-I in milk represents a hazard to human health; (2) that Monsanto changed the manufacturing process for rbGH after the studies supporting the New Animal Drug Application (NADA) were completed, thereby invalidating the research used to support the approval; and (3) that the 90-day toxicology study and/or the information derived from the additional 90 days of the study demonstrate both that rbGH is absorbed and that it is not safe.
In response to Mr. Cohen's petition, the Agency stated that these arguments do not demonstrate any human food safety issue related to the use of Posilac. Therefore, the petition requesting withdrawal of the approval of Posilac was denied.
An electronic copy of FDA's response to Mr. Cohen's petition is available on the Internet Home Page of FDA's Center for Veterinary Medicine. Readers who do not have access to the Internet, may file a Freedom of Information (FOI) request for this response to: Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. FOI requests also may be sent via fax to: (301) 443-1726.
By H. E. Ekperigin, D.V.M., M.P.V.M., Ph.D.
This information was presented on March 1, 2000, at the departmental/graduate program seminar of the Virginia-Maryland Regional College of Veterinary Medicine, Maryland Campus, University of Maryland, College Park, Maryland.
Foodborne Diseases and Animal and Public Health
Foodborne illnesses occur worldwide. They can be caused by microbes like Salmonella or by chemical substances like mycotoxins. Salmonella are enteric bacteria that cause a significant proportion of foodborne illnesses. There are over 2,000 serologically distinct types (serotypes) of Salmonella. Expressions of the illnesses caused by Salmonella range from mild to severe diarrhea to anorexia, fever, nervous and respiratory signs, abortion, depression, shock, and death.
Mycotoxins are toxic secondary metabolites produced by fungi. They can be quite toxic to susceptible human beings and animals ingesting the mycotoxins. Expressions of toxicity in affected individuals can range from death to skin lesions or signs and symptoms of hepatotoxicity, nephrotoxicity, neurotoxicity, or genotoxicity. Mycotoxins are also carcinogenic, mutagenic, or teratogenic and can have adverse effects on the immune system. There are more than 300 known mycotoxins, and a large proportion of the world’s cereal grains is estimated to be contaminated with one or more mycotoxins.
Thus, foodborne illnesses can have severe negative impacts on human and animal health, and be fatal. The resultant economic losses can be quite significant. In the United States (U.S.), 76 million cases of foodborne illnesses are estimated to occur annually, and to result in 325,000 hospitalizations and 5,000 deaths. Economic losses due to medical expenses, lost production, and loss of life have been estimated to be as much as $35 billion. Such statistics can generate a lot of interest, attention, and concern as indicated in recent years in the U.S. by the relatively large number of reports of food-borne illnesses in the news media, and the initiation of major programs by government agencies to combat the problem.
CVM’s Role in Food Safety
One important way in which CVM contributes to human food safety is by working to ensure that feeds consumed by or intended for consumption by animals are safe for the animals, and do not pose a hazard to human health. CVM’s statutory responsibilities in this area include oversight over food additives and other substances that are added to feeds for one purpose or the other.
Feeds can be important sources of pathogenic microbes, microbial toxins, and toxic chemicals for food animals. Food animals, in turn, can be a source of microbial infections and toxicants for humans. Several recent examples have demonstrated the potential for contaminated feeds to have a severe negative impact on animal and human health, and the economy. One recent example is an outbreak of human Salmonellosis in Canada that was linked to Salmonella present in pig ear chews and other pet snacks. Another is an outbreak of aflatoxicosis in Texas that resulted in the death of about 30 dogs and was attributed to the inclusion of moldy corn in foods consumed by the dogs. In another well-known example, outbreaks of animal and human encephalopathies in Britain were linked to the consumption of rendered ruminant protein by cattle and the subsequent consumption by humans of food products from these cattle. A more recent incident involved the occurrence, in Belgium, of dioxin toxicosis in chickens and other food-producing animals ingesting dioxin-contaminated feed. The cost to the Belgian economy has been estimated at more than $750 million.
Thus, while feeds primarily serve as sources of nutrients for animals, they can also be important vehicles for transmission of foodborne illnesses to animals and humans.
Collaborative Research
CVM recently conducted nationwide surveys of feed ingredients to determine the extent of their contamination by Salmonella. The results indicate that the levels of contamination are fairly high for all feeds, and unexpectedly high for feeds of plant origin. When considered along with the recent spate of reports of outbreaks of human Salmonellosis and E. coli infections that were linked to the consumption of contaminated vegetables (lettuce, cantaloupe, radish, clover sprouts, and alfalfa sprouts), these results indicate that contamination of vegetables or feeds of plant origin by enteric pathogens probably occurs through routes other than the commonly speculated route of casual, incidental contact by handlers, etc.
Several million tons of poultry litter or manure are generated annually by poultry farms. A substantial proportion of the litter or manure is estimated to be disposed of by spreading on croplands. Salmonella and E. coli have been recovered from litter or manure for up to 120 days after the removal of poultry flocks that were raised on the litter, or produced the manure. Salmonella and E. coli have also been shown to survive in litter or manure-treated soils for up to 2 months. The results of our own preliminary studies show that Salmonella and E. coli can survive in litter or manure-treated soils for up to 90 days - a time frame that can comfortably accommodate the life span of many crops.
Based on the foregoing, we developed the hypothesis that the use of poultry litter or manure as a fertilizer for croplands can cause crops grown on such litter/manure-treated lands to become contaminated with Salmonella, and proposed research to test the hypothesis. The research basically will consist of experiments designed to isolate Salmonella and E.coli from litter/manure, litter/manure-treated soils, and crops grown on litter/manure-treated soils. The genetic relationships between various isolates will then be determined.
The United States Department of Agriculture has approved a proposal for funding a three-year study to conduct research on this hypothesis. A multi-disciplinary team of four scientists, including the author, and Drs. Morant, Nagaraja, and Oscar will implement the research. Dr. Mervalin Morant, the Co-Principal Investigator is an Associate Professor of Plant Pathology at the University of Maryland Eastern Shore. Her research interests include using poultry litter/manure to control plant nematodes.
Dr. Kakambi Nagaraja is a Professor of Veterinary Medicine at the University of Minnesota. His research interests and expertise include the genetic "finger-printing" of enteric pathogens.
Dr. Tom Oscar heads USDA’s Center of Excellence for Poultry Food Safety Research, at the University of Maryland Eastern Shore. His expertise includes risk assessment, and the development and use of computer simulations.
The grant allows for the hiring of a post-doctoral research fellow who will be responsible for the day-to-day implementation of the research.
Summary
In summary, foodborne illnesses can have a severe impact on animal and public health. Food animals are a source of microbial infections and toxicants for humans, and feeds can be important sources of pathogenic microbes, microbial toxins, and toxic chemicals for food animals.
FDA’s Center for Veterinary Medicine contributes to human food safety in one important way, among others, by working to ensure that feeds consumed by or intended for consumption by animals are safe for the animals, and do not pose a hazard to human health.
The discovery of a relatively high level of contamination of feeds of plant origin by Salmonella, and reports of contaminated vegetables causing human Salmonellosis and E. coli infections, indicate the possible existence of significant gaps in our knowledge of the epidemiology of foodborne illnesses. Research was proposed to close some of those gaps in knowledge by investigating whether pathogens shed in poultry manure can be transferred to crops (foods and feeds) grown on lands fertilized with the manure. The United States Department of Agriculture has approved the proposal, and will fund a three-year study.
References available upon request from the FDA Veterinarian.
THE ROLE OF THE OMBUDSMAN IN CVM
By Marcia K. Larkins, D.V.M.
Definition of an Ombudsman
Ombudsman is a Scandinavian term meaning literally "administrative man." It describes a special kind of grievance-handling official -- one who investigates citizen’s complaints against administrative agencies.
An ombudsman is an individual who is skilled in dealing with reported complaints, operating in a neutral and confidential role, to help achieve equitable solutions. Although the terms are frequently used interchangeably, ombudsman generally refers to a function while ombudsperson or practitioner refers to the individual performing the function. The ombudsperson is a designated neutral who reports to the top of an agency/organization outside of normal management channels. This distinction helps to preserve the independence and contributes to the overall effectiveness of the function. The two basic types of ombudsman are the classical ombudsman and the organizational ombudsman. The organizational ombudsman is the more prevalent of the types defined below, and in practice, has the most functions that any dispute resolution practitioner can have.
The classical ombudsman is a function that is created by law and appointed by legislative bodies. Classical ombudspeople receive complaints about the administrative acts of government agencies. They may have jurisdiction over all agencies or only certain agencies of a local or state government. They may also "specialize" by focusing on the needs of a defined population such as the elderly or the disabled. Classical ombuds practitioners can do formal investigations and have subpoena power. They make recommendations to an agency that they have investigated and can publish public reports that include the findings on whether a complaint is justified. There are strong legal safeguards in place to preserve their independence and the confidentiality of their records.
The organizational ombudsman is a complaint-handler and dispute-resolver, communications channel, confidential and informal information resource, and a person who helps an organization work for change. The organizational ombudsperson helps to achieve resolution and then helps an organization to avoid reoccurrence of the same problems. This aspect of the ombudsman function differs from that of a formal mediator who leaves after a dispute has been resolved. Public and private institutions, agencies and corporations employ organizational ombudspeople. They are further classified as being either "internal" or "external." An internal ombudsperson is an employee of the organization who is paid to be neutral, whereas the external ombudsperson is a service provider by contract. Otherwise the function is the same.
What an Organizational Ombudsman Does
An organizational ombudsperson may serve internal staff or customers of the organization or both. He or she helps to find solutions to problems and concerns expressed by customers, that meet the needs of both the customer and the organization. Ombudsman intervention is accomplished through informal investigation, shuttle diplomacy or third party intervention and informal mediation. Rather than choosing for a complainant how a complaint will be handled, the ombudsperson thinks of options or helps the complainant develop new options.
Additionally, the organizational ombudsperson 1) provides feedback to the organization on issues, 2) acts as a safety-net for those issues that are not addressed through normal channels and 3) serves as an "early warning" channel for new issues by identifying trends, thus allowing the organization to be proactive. For example, the ombudsperson might notice a pattern or multiple incidents of the same kind, which may indicate an organizational need for a new policy, or procedure or structure. While the ombudsperson is not a decision-maker, he or she does make insightful recommendations that can help effect positive change in the organization.
The ombuds practitioner is a point of contact who provides information about an organization to callers by 1) advising them on how the system works and how they can best access it, 2) clarifying the meaning of and/or providing them with a copy of a policy and 3) providing or helping them to find information (names, phone numbers, etc.) that enables them to go directly to the person who can best address their concern, or resolves their problem in one or two contacts. Due to the protection provided by the practice of confidentiality, the ombudsperson may also serve an important role in receiving information from callers that is useful to an organization. Typically, organizational ombudspeople do not answer questions or voluntarily disclose information regarding anyone that they may have spoken to, and maintain that privacy unless they have permission to do so, for the purpose of informal dispute resolution.
It should be noted that the CVM Ombudsman does not intervene for or replace the functions of the Equal Employment Opportunity (EEO) program or the National Treasury Employees Union (NTEU). The issues that are handled by the Ombudsman whether initiated internally or externally, involve disputes over science and/or policy decisions and the administrative procedures used in making those decisions.
Knowledge and Skills of the Organizational Ombudsman
An organizational ombudsperson should know the values and ethics and the policies and procedures of an organization, and should understand the structure, processes and resources within that organization. For example, about 3 years ago the National Institutes of Health (NIH) appointed its first Ombudsman and Director of the Center for Cooperative Resolution based on his scientific background, personal qualities and his familiarity with the NIH research environment.
The ombudsman function requires skills that include being able to listen impartially to a complainant, being sensitive to fairness and being able to work with others to resolve the dispute. A publication put out by The Ombudsman Association (TOA) on organizational ombudsmen states that "The cost effectiveness of good communications, of raising problems on a timely basis, and of fair conflict management should be understood and communicated by ombuds practitioners." The ombudsperson should also have a good working knowledge of the regulations and guidance documents relevant to the organization and to its customers including those involving dispute resolution.
The ombudsperson can enhance his or her skills and knowledge through personal experience in an organization and from training courses, conferences and workshops sponsored by professional organizations. The Ombudsman Association (TOA) is a non-profit organization that provides a forum for practicing organizational ombudspeople while the United States Ombudsman Association (USOA) is for classical ombuds practitioners. The knowledge and experiences shared in discussions with other ombudspeople can also provide valuable information, insight and professional support. The Coalition of Federal Ombudsmen (CFO) is based in Washington D.C. and meets every two months. The membership includes the FDA and many other organizations such as the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), the U.S. Secret Service, the U.S. House of Representatives, the Federal Deposit and Insurance Corporation (FDIC), the Securities and Exchange Commission (SEC), U.S. Customs Service, the Department of Energy (DOE), the Federal Reserve, the Bureau of Alcohol, Tobacco and Firearms (ATF) and the Capitol Police.
The Role of the Organizational Ombudsman in the FDA
The role of an ombudsman within an organization will depend on the culture of that organization. In order to be effective, the ombudsman must 1) have the support of top management, 2) have access to any individual manager within the organization, 3) act and be perceived as neutral, and 4) be able to offer confidentiality and anonymity to those who contact him or her for informal problem resolution.
Ombudsmen employed by federal government agencies are classified as internal organizational ombudsmen. The significance of this function within FDA is demonstrated by the existence of the Office of the Ombudsman (OO) in the Office of the Commissioner. The Office is staffed with a Chief Ombudsman, a Deputy Ombudsman, and two staff lawyers serving as Regulatory Counsels. The function of this Office is defined in the Federal Register publication dated February 27, 1997 (Vol. 62 No.39) which states:
"The Ombudsman reports directly to and acts on behalf of the FDA Commissioner in investigating and resolving issues and problems that affect products under FDA’s jurisdiction. The office was created to investigate industry complaints about FDA’s regulatory processes, identify deficiencies about those processes, respond to problems affecting a product under FDA’s jurisdiction, and ensure that FDA policy is fairly and evenly applied throughout the agency. The Ombudsman also mediates disputes or issues between FDA and the regulated industry that have not been resolved through other means."
The Ombudsman’s Office receives and handles external complaints about the review process primarily from private industry. The Office is there to assure that the process by which decisions are made in the Centers is legal. The Chief Ombudsman is also the product jurisdiction officer and is authorized to determine whether the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health (CDRH) has primary responsibility for premarket review and regulation of combination products based on their established informal intercenter agreements. For products where the Center with primary jurisdiction is either unclear, not covered in the formal intercenter agreements, or in dispute [as per 21 CFR §3.7(a), and §5.32], the Chief Ombudsman works with the Centers to get a consensus before making a final decision on requests for designation on product jurisdiction.
Three other Centers (CDER, CBER and CDRH) have ombudsmen in place to handle dispute resolution including appeals. One quarter of the disputes handled by CDER’s Ombudsman originate internally and three quarters are initiated externally. Those handled by the CBER and CDRH Ombudsmen are all external. The contact for appeals at the Center for Food Safety and Applied Nutrition (CFSAN) is the Industry Activities Staff, as it does not have an ombudsman. The Office of the Ombudsman supports the Center ombudsmen but reserves certain functions to that Office such as 1) inter-Center inconsistencies and coordination issues, 2) issues that have gone through the Center Director and the complainant seeks further agency review and 3) when the caller or complainant has reasonable concerns about raising an issue with the Center. Public awareness of and accessibility to the FDA Ombudsmen in OO, CDER and CBER are enhanced by information provided via web pages linked to their respective agency and Center home pages.
Current Issues Regarding Federal Organizational Ombudsmen
Confidentiality and record retention are 2 issues that are currently undergoing some scrutiny with regard to the rights and responsibilities of organizational ombudsmen employed by the federal government. The Office of the Ombudsman has taken the lead on examining the meanings and implications of both issues. The role of the federal ombudsman in light of the current regulations for dispute resolution and for record keeping has been discussed within FDA between the Office of the Ombudsman, the Office of the Chief Counsel, and the FDA Center ombudsmen. These issues are also being discussed in meetings of the Coalition of Federal Ombudsmen as to how they apply to all federal ombudsmen.
Confidentiality:
One of the ombudsman’s most important tools is the ability to assure the confidentiality of any dispute resolution communication. The Ombudsman Association’s (TOA) publication for organizational ombudspeople explains that they do not do formal investigations, keep formal case records or appear as witnesses in judicial or quasi-judicial proceedings in order to safeguard both the practice and appearance of neutrality and confidentiality. The Code of Ethics for TOA states:
"The ombudsman as a designated neutral, has the responsibility of maintaining strict confidentiality concerning matters that are brought to his or her attention unless given permission to do otherwise. The only exceptions, at the sole discretion of the ombudsman, are where there appears to be imminent threat of serious harm."
The conditions imposed on federal ombudsmen with regard to confidentiality prevents them from exercising strict adherence to TOA’s Code of Ethics and thereby denies them the right to full member status. They can apply for Associate status as long as they are willing to support and affirm the Code of Ethics. They cannot however, serve on the Board of Directors nor can they vote.
Generally, the right of the ombudsperson or designated neutral, to maintain confidentiality with regard to any form of communication with a complainant, and any records generated during a dispute or controversy is protected by the Administrative Dispute Resolution Act (ADRA). The recently amended ADRA now includes "the use of ombuds" in its definition of "alternative means of dispute resolution" as a procedure that is used to resolve issues in controversy. It also clarifies [as per 5 U.S.C. ( United States Code) §574(j)] that dispute resolution communications are not releasable under the Freedom of Information Act (FOIA). ADRA confidentiality protection for FDA ombudsmen however, is still unclear and open to interpretation regarding requests from Congress for access to information. A Congressional Research Service (CRS) Report for Congress (dated April 7, 1995) refers somewhat to this issue in that one section of the document (entitled the Effect of Statutory Prohibitions on Public Disclosure on Congressional Access) states:
"Upon occasion Congress has found it necessary and appropriate to limit its access to information it would normally be able to obtain by exercise of its constitutional oversight prerogatives. But where a statutory confidentiality or non-disclosure of information is not explicitly applicable to Congress, the courts have consistently held that agencies and private parties may not deny Congress access to such information on the basis of such provisions."
The document sites a couple of cases as examples to support the second statement. However, further research would have to be done to determine the best way to distinguish ADRA from the statutes at issue in these cases. There have not been any cases within FDA to date that required a direct interpretation of the ADRA provision.
Record Retention:
Under 21 CFR §10.70, documentation of significant FDA decisions on any matter under Federal law must be provided in an administrative file. However, communications that are made with regard to an informal dispute resolution are not "records" within the meaning of 44 U.S.C. 3301 and are therefore not submitted to or received by an ombudsman under Federal law. FDA ombudsmen may destroy certain informal dispute resolution communications when the dispute is resolved.
According to TOA, most organizational ombudspeople who serve internal staff and students look into problems much less formally, and never or almost never write a case report. However, the Association also acknowledges that all practicing ombudspeople do not follow this criterion, and that in fact, probably no statement about ombudspeople is true for all practitioners. Evidence of this is demonstrated even within the FDA as case records and files are not retained by all of the current ombudsmen. This practice complies with TOA’s Standards of Practice under section 3.3 which states:
"An ombudsman keeps no case records on behalf of the organization. If an ombudsman finds case notes necessary to manage work, the ombudsman should establish and follow a consistent and standard practice for the destruction of any such written notes."
Conclusion
The ombudsperson operates independently within an organization not only to investigate problems and provide options, but to follow-up on resolutions to determine if they were effective and to track or monitor issues to determine if repetitive patterns exist and advise management accordingly. The ombudsperson provides neutral facilitation for an appeals process by serving as the point of contact for all of the parties involved. Equally as important is the overall purpose of an organizational ombudsman, which is to foster values and decent behavior with respect to fairness, equity, justice, equality of opportunity and respect. These qualities are particularly relevant to CVM in light of the Center’s present quest to achieve goals that include behavioral and systems values, which will contribute to establishing it as a High Performance Organization (HPO).
Dr. Marcia Larkins became CVM's new and first Ombudsman in November of 1999. She gained experience by acting in this role beginning in 1997. Prior to this she held positions in the Center as a veterinary reviewer for 11 years from 1973 to 1984 and as a Branch Chief/Team Leader for 13 years from 1984 to 1997 in the Division of Drugs for Non-Food Animals.
ADSA - ASAS Joint Meeting -- Baltimore 2000 "From Research to Innovation"
The American Dairy Science Association (ADSA) and the American Society of Animal Science (ASAS) announce their annual national meeting to be held jointly at the Baltimore Convention Center from July 24-28, 2000. The five-day meeting will consist of presentations of scientific information, special symposia and invited speakers in the area of dairy and animal research as it relates to animal agriculture. In addition, the national meeting offers commercial exhibits.
The pre-registration deadline is July 1, 2000, however, registrations will be accepted at the door. The registration cost of the five-day meeting is $250 for society members and $400 for non-members. Graduate and undergraduate costs range from $0-30 depending on member status. For further information, please visit the event web site at http://www.baltimore.org/
On March 10, 2000, FDA announced that Clinipad Corp. of Rocky Hill, Connecticut, initiated a voluntary recall of its antiseptic sterile skin preparations because of a potential for bacterial contamination. The company had confirmed bacterial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa and Stenotrophomonas maltophilia (recalled in December 1999), and therefore, cannot assure the sterility of products labeled and sold as sterile.
These organisms can cause skin, wound, or other infections that may be serious or life-threatening in some cases.
The nationwide recall of the Clinipad sterile-products line includes Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic Products, as well as Sterile Cliniguard Protective Dressing Labeled as "sterile," manufactured since Jan. 1, 1997. The products (swabsticks, prep pads, towelettes, ointments and pouches, as well as protective dressings) are distributed under the names: Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical Corp., and Rauscher. They are sold separately or packaged in various institutional kits and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies and are used to control and prevent infection.
All lots of the sterile products line involved in the recall have a lot number beginning with 7, 8, 9, or 0, and are labeled as "sterile" on the unit of use packaging, or "sterile unless opened or damaged." The lot numbers are also found on the shipping carton or its label.
Health professionals and consumers who have these products can obtain more information about the recall from FDA's MedWatch Website. Also, consumers with questions may contact the Clinipad Corporation at 860-571-0100.
The Center for Veterinary Medicine is pleased to announce that FDA and the Veterinarian has been revised and reprinted. The new version reflects changes brought about by the implementation of the Animal Medicinal Drug Use Clarification Act and the Animal Drug Availability Act. Extra-label use of drugs and Veterinary Feed Directives are just a few of the changes in the amended booklet, which explains the Federal Food, Drug, and Cosmetic Act as it applies to veterinarians. Free single or bulk copies are available by contacting Joanne Kla at the Center for Veterinary Medicine (301-827-6507). The revised publication will also be posted on our website.
The Food and Drug Administration (FDA) announced in the March 14, 2000, Federal Register, the availability of a final guidance for industry (#91) entitled "Stability Testing for Medicated Premixes" (VICH GL8.) This guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
Guidance #91 on stability testing is an annex to the parent VICH guidance entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products." Guidance document #91 addresses the recommendations for stability testing of veterinary medicinal Type A medicated articles (referred to as medicated premix drug products in the final guidance) intended for submission for approval to the European Union, Japan, and the United States.
This guidance represents current thinking and does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use alternative methods as long as they satisfy the requirements of the applicable statute and regulation.
Copies of this document may be obtained from CVM's Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Interested persons may submit written comments and suggestions on the guidance document at any time, to Dr. Carol Haley, Policy and Regulations Team (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. Comments should be identified with the full title of the guidance document and with Docket number 99D-2249.
Further information about this guidance document is contained in a March 14, 2000, Federal Register notice. Information on guidance document #91 is also available from William G. Marnane (HFV-140), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6966.
Further information on VICH is available from Dr. Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798 or from Dr. Robert C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, 301-594-5903.
The Food and Drug Administration (FDA) has issued a final order permanently debarring Premchand Girdhari, Eau Claire, WI, from providing services in any capacity to a person who has an approved or pending drug product application. FDA based this order on a finding that Mr. Girdhari was convicted of two felonies under Federal law relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act (the Act). This is the first debarment resulting from violations of the Act involving veterinary drugs.
The factual basis underlying Mr. Girdhari's debarment relates to his 1991 guilty plea to making false statements and distributing adulterated drugs with the intent to defraud and mislead in violation of the Act. Mr. Girdhari is the President of Radix Laboratories, Inc., a firm that manufactured a variety of animal drugs. He marketed the drug "Antihistamine (2%),'' which was adulterated under the Act because it was not the subject of the necessary FDA approvals nor was it manufactured in conformity with good manufacturing practice. He also knowingly and willfully made a false statement related to FDA's regulation of the injectable animal drug, "Cal-Plex.''
Section 306(a)(2) of the Act mandates debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the Act.
Additional information about this debarment is contained in the January 21, 2000, Federal Register and from Richard L. Arkin, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0141, FAX 301-827-5510.
On April 3, 2000, Arie C. Van Leeuwen, owner and operator of a dairy farm in Modesto, California, was sentenced to four years probation, including 12 months home detention. U.S. District Court Judge Robert E. Coyle also ordered Van Leeuwen to pay a $100,000 fine. In addition, he was ordered to pay $100,000 civil penalty in a related State suit pending in the Stanislaus County Superior Court.
The Court also ordered Van Leeuwen to permanently refrain from any decision-making activities pertaining to the Van Leeuwen Dairy or any other dairy. He is also prohibited from participating or aiding in the following activities: custody, sale, consignment, or transport of any animals; the purchase or use of any drugs in animals; and keeping records pertaining to dairy operations.
In January 2000, Van Leeuwen pled guilty to a three-count Information charging him with introduction into interstate commerce of adulterated food with intent to defraud and mislead in violation of 21 U.S.C. sections 331(a) and 333(a)(2), a felony. He also pled guilty to two counts of criminal contempt, in violation of 18 U.S.C. section 401(3). Information about the guilty plea is contained in the March/April 2000 FDA Veterinarian (page 14.)
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
These violations involved illegal residues of gentamicin in cows, oxytetracycline and gentamicin in a cow, sulfadimethoxine in a dairy cow, gentamicin and penicillin in cows, and penicillin in a dairy cow,
Warning letters were also sent to the following firms/individuals that had a history of offering animals for sale for human food which were adulterated with drug residues. These warning letters stated that these individuals/firms had offered animals for slaughter that contained illegal drug residues:
These violations involved illegal residues of oxytetracycline in a dairy calf and penicillin in a dairy cow.
A warning letter was sent to Richard and James Kopwitz, Burlington, WA, for violations from Good Manufacturing Practices (GMPs) for medicated feeds.
A warning letter was sent to Merle R. Ressler, Richard L. Thompson, and Amos S. Fisher, Fisher and Thompson, Leola, PA for the illegal purchase, holding, and sale of veterinary prescription drugs. The letter stated that their firm failed to establish controls to assure that prescription veterinary drugs are sold only upon a valid veterinarian/client/patient relationship.
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Company |
Generic and Brand Names |
Indications |
Routes/Remarks |
|
Koffolk, Inc. |
Nicarbazin (Nicarb®) Bacitracin Zinc (Baciferm®) |
Broiler chickens. For prevention of coccidiosis and for increased rate of weight gain and improved feed efficiency. |
MEDICATED FEED: The NADA provides for using approved nicarbazin and bacitracin zinc Type A medicated articles to make combination Type C medicated broiler. Feed continuously as a sole ration. Do not feed to laying hens in production. Discontinue medication 4 days before marketing the birds for human consumption. Federal Register: 03/07/00 |
|
Novartis Animal Health US, Inc. |
Milbemycin oxime (Milbemite™) Rx |
Cats and kittens above 8 weeks of age. To treat ear mite infestations. |
OPHTHALMIC AND TOPICAL: The NADA provides for use of one 0.25 ml tube per ear as a single treatment. This approval qualifies for 3 years of marketing exclusivity. Federal Register: 03/15/00 |
|
Company |
Generic and Brand Names |
Indications |
Routes/Remarks |
|
Med-Pharmex, Inc. |
Triamcinolone acetonide (Medalog) Rx |
Dogs. For topical treatment of allergic dermatitis and summer eczema. |
OPHTHALMIC AND TOPICAL: The cream is a generic copy of Fort Dodge Animal Health's NADA 46-146 (Vetalog®). Federal Register: 03/30/00 |
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Company |
Generic and Brand Names |
Indications |
Routes/Remarks |
|
Hoechst Roussel Vet |
Trenbolone Acetate and Estradiol (Revalor®-200) |
Beef Cattle. For increased rate of weight gain and improved feed efficiency. |
IMPLANTATION: The supplemental NADA provides for use of a higher dose ear implant for steers fed in confinement for slaughter. The implant contains 10 pellets with 200 milligrams trenbolone acetate and 20 mg estradiol. This supplemental NADA qualifies for 3 years of marketing exclusivity. Federal Register: 02/29/00 |
|
Pennfield Oil Co. |
Chlortetracycline (CTC) |
Swine. For treatment and control of bacterial enteritis and bacterial pneumonia. |
ORAL: The supplemental NADA provides for a zero-day slaughter withdrawal period after use of CTC powder in swine drinking water for treatment and control of disease. Federal Register: 02/29/00 |
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