WORLD AQUACULTURE and INTERNATIONAL HARMONIZATION for DRUGS AND BIOLOGICS
THE JOINT SUBCOMMITTEE ON AQUACULTURE WORKING GROUP ON QUALITY ASSURANCE IN AQUACULTURE PRODUCTION
FDA PUBLISHES ADEQUATE AND WELL-CONTROLLED STUDIES FINAL RULE
NATIONAL PET WEEK - MAY 3-9, 1998
This year's theme for National Pet Week is "People and Animals Need Each Other." Cosponsors are the Auxiliary to the American Veterinary Medical Association (AVMA), the AVMA, the American Animal Health Association (AAHA), and the North American Veterinary Technician Association.
According to a study conducted by the AVMA, almost 60 percent of all U.S. households own at least one companion animal, with cats and dogs being the most popular, in 45.7 percent of homes, but close behind are birds (14.5 percent), rabbits and ferrets (2.3 percent), guinea pigs, hamsters, gerbils (2.3 percent), and reptiles (1.5 percent). In addition, 6.3 percent of households own 55.6 million fish.
The FDA Veterinarian is proud to support the National Pet Week campaign and its goals. Animals play an important role in our lives and provide us with hours of companionship and unconditional love, but they remain dependent on us for their well-being. Scientific studies have shown that pet ownership can lower blood pressure and even reduce the threat of heart disease. As animals increase our quality of life it is important to remember that responsible pet ownership can be a long-term commitment which requires the time and money to provide necessary care. Ensure your pet's good health and longer life by scheduling regular veterinary visits, and by watching for common problems that could have a serious impact on your pet if not properly treated. For information concerning pet care, you may access the AVMA's Internet Web site at www.avma.org. The AAHA Web site is www.healthypet.com.
The following article provides information on dogs and provides suggestions for their care. Veterinarians may wish to duplicate this article and provide copies to their interested clients. As always, material which appears in the FDA Veterinarian is free of copyright and may be reproduced without permission.
DOG OWNERSHIP -- A LONG-TERM COMMITMENT
by Karen A. Kandra
As a loyal friend and guardian to your dog, you have certain responsibilities to provide food, shelter, and veterinary care to ensure your pet's health and safety. As dogs are "man's best friend," so are we "dog's best friend," and we should be willing to attend to their needs before our own. Dog ownership is a long-term commitment resulting in mutually rewarding companionships for both people and dogs.
GETTING ACQUAINTED
Whether you purchase a registered AKC dog from a reputable breeder, or rescue one from the animal shelter, it will be totally dependent on you for its care and well-being. It is important to build mutual trust and loyalty from the start, by spending as much time together, and training it to be responsive and obedient. The local humane society or dog club may offer obedience classes. A well-behaved dog will ensure a good relationship with your neighbors, and will be a joy to own.
Provide a warm, dry place for your pet to rest. Dogs adapt well to crates, as long as they are large enough to turn around. This will prevent unacceptable behavior, such as chewing furniture, and dogs seem to feel more secure in a small, close area where they can escape for peace and quiet.
Never leave two or more pets together unattended unless you have observed them frequently and are sure they are compatible. Be sure to take your dog outside often (at least three times a day) to urinate and defecate to avoid accidents, and always provide clean, fresh water. Dogs quickly adapt to a routine, and come to expect the same activities on a daily basis.
Unless you plan to raise puppies, it is important to spay (removal of ovaries and uterus) or neuter (removal of testicles) your dog. This will prevent objectionable behavior, such as roaming and fighting, and help your pet enjoy a longer, healthier life. In addition, spaying of females lowers the risk of mammary cancer.
Purchase a license if your city or town requires it, and attach it to the dog's collar, along with an identification tag containing your name and address in order to expedite finding a lost dog. Microchip I.D.'s are now available from your veterinarian.
It is a good idea to name a caretaker for your four-legged friend, in case of your death, or hospitalization, just as you would for a child.
FEEDING
There are endless choices in dog foods. It is important to choose specially formulated diets for growth, reproduction, or maintenance, depending on the dog's stage of life. Purchasing pet foods labeled as "complete and balanced" can help ensure that your dog's diet is nutritionally adequate. There are three types of commercial pet foods available today -- dry, semi-moist, and canned. As long as they are complete and balanced products, all three are equally nutritious and each has its own advantages and disadvantages. One advantage of dry food is its abrasive action which helps keep teeth clean. It is important to maintain a regular feeding schedule, and always provide fresh food and water with each feeding.
Obesity is a major problem with dogs in our society, since owners tend to feed table scraps in excess. Serious health problems may result from obesity. Extra weight puts a strain on the animal's heart, lungs, skeleton, and muscles, and lowers its resistance to disease. An occasional treat is fine, but many human foods can upset the dog's metabolism, and it is best to avoid bad feeding habits. Regular exercise and proper nutrition are both essential to maintain optimal weight and health.
HEALTH CARE Veterinary examinations are critical to a dog's health. It is important to keep a detailed medical history and establish a veterinary-client-patient relationship to ensure a long, healthy life for your dog. During the initial exam, your veterinarian will be able to establish a preventive health care program for your pet. Vaccination for rabies is basic to preventive health care, and required in most areas. Rabies is a deadly disease, transmitted by saliva, and frequently found in wild animals, such as skunks, foxes, and raccoons. For the health of yourself, your family and neighbors, and your dog, it is essential to keep the rabies vaccination up-to-date. Your veterinarian may recommend other vaccines, such as a combination of distemper, parvovirus, leptospirosis, hepatitis, coronavirus, or parainfluenza, depending on your dog's activities and expected travel. Parasite control is another area to discuss with your veterinarian. A stool sample can be tested for the presence of harmful parasites, such as ascarids (roundworms), whipworms, tapeworms and hookworms. Your veterinarian will prescribe treatment if necessary, and may recommend heartworm prevention medication following a negative blood test to determine the existence of heartworms. Many of the new heartworm preventatives also prevent some of the most common intestinal parasites. Flea control may also be discussed, as there are new products which may be prescribed by veterinarians to control or prevent flea infestation. Veterinarians may prescribe specific diets determined by your dog's needs, and a dental exam is always recommended, to detect periodontal disease, loose or abscessed teeth, receding gums, or other indications which require attention.
YOUR VETERINARIAN IS THE BEST SOURCE OF INFORMATION ABOUT ALL ANIMAL HEALTH MATTERS.
In a medical crisis situation, call your veterinarian immediately if you detect any of the following symptoms:
abnormal breathing
active bleeding
bone exposure
puncture to abdomen, chest, or neck
watery or bloody discharge
partial or complete paralysis
difficulty urinating
profuse vomiting or diarrhea
poison ingestion
bloated or tender abdomen
rectal temperature over 103 degrees F or under 99 degrees F
dehydration
abnormal color
disorientation
collapse
NEVER GIVE ASPIRIN OR ANY MEDICATION WITHOUT CONSULTING YOUR VETERINARIAN.
GROOMING
It is important to establish a grooming regimen with your dog. Whether a short- or long-haired variety, your dog will benefit from frequent brushing, which stimulates the coat and skin, and your house will be cleaner, since less shedding will occur. If you elect to clip your dog in the summer, keep in mind that there is a risk of sunburn, if he spends much time in the sun.
Bathing is only suggested on rare occasions, since frequent baths remove natural protective oils from the skin. If he is dirty, or shows evidence of fleas, a dog may be bathed in lukewarm water using mild shampoo. Rinse the soap thoroughly and towel dry.
During grooming sessions, look for parasites which cause your pet discomfort. Fleas are common, but can be controlled by commercial powders, sprays, collars, or dips. Contact your veterinarian for recommended treatment or prevention with long-lasting topicals or oral products. Ticks may be removed by saturating with alcohol, and carefully pulling off with tweezers. Mites are too small to detect, but symptoms include frantic scratching, biting, and chewing. Your veterinarian can help diagnose mites.
Eyes should be cleaned of any discharge with a soft cloth moistened with water or saline solution. Ear discomfort is indicated by scratching or head shaking. Infections can settle deep in the ear canal and should be treated by your veterinarian immediately.
Since dogs depend on their teeth for survival, the mouth should be examined periodically for signs of gum disease, and tartar accumulation. This should be a major part of the annual veterinary examination, and any problems should be addressed immediately.
Few dogs exercise on hard surfaces to keep their nails filed down, so it is your job to clip their nails, to keep them comfortable. Neglected nails may cripple a dog.
PREVENTION
Accidents can be prevented by thinking ahead and avoiding dangerous situations. Automobiles are the number one killer of dogs, so keep him leashed, or fenced in at all times. Invisible fencing is a popular alternative to traditional fencing styles.
Keep poisons out of reach. Many household plants are toxic to dogs, including poinsettias, ferns, philodendrons, dieffenbachia, and other varieties. Cleaning solutions such as detergents, bleaches, oven cleaners, etc. may pose hazards as well. Make sure bottle caps are tight and the rags used to apply these chemicals are stored safely out of reach. Treat animals like children and keep medicines locked up, and never leave candy, especially chocolate, where dogs may have access to it.
Outdoor hazards include windshield cleaners, antifreeze, weed killers, used motor oil and insecticides. Antifreeze has a sweet taste, and just a few drops can be fatal to your dog. Other hazards include rodenticides used to kill rats and mice. If any poisoning occurs, call your veterinarian immediately, and provide a sample of the poison with the labeling to aid in proper treatment. In an emergency, call the ASPCA National Animal Poison Control Center at 800-548-2423.
Keep sharp objects, i.e., knives and forks, carpet tacks, paper clips, etc., out of reach, in addition to children's toys or small objects which may become lodged in a dog's throat. Never leave a dog unattended on a balcony. A precocious pet may squeeze through the bars and fall, which could fatally injure him.
Avoid extremes in temperature. Of course, never leave a dog in a parked car in hot weather, even with the windows open, and never leave him outside without water and shade. Similarly, in frigid temperatures, bring him indoors, and be sure he always has shelter from wind, rain, and sun, even in mild temperatures.
OLD AGE
Dogs are considered "old" around eight or nine years, but many live into their mid-teens, with proper care and nutrition. Senior citizens have more needs, and require more attention. Their sight and hearing may diminish, and they will sleep more and move more slowly. Steps may become a hardship, so sleeping arrangements may need adjusting. They need to go out more often, as bladder control is usually weakened. They still need moderate exercise, frequent grooming, and appropriate nutrition. Since they may have fewer teeth, a soft diet may be necessary. It is especially important to avoid obesity, since it will affect your pet's quality of life. More frequent veterinary visits may be required to deal with tumors, arthritis, or heart disease. Some dogs require daily medications to treat the infirmities of old age. Together you and your veterinarian can have a positive influence on your dog's happiness and comfort for many years to come. The rewards of dog ownership will last a lifetime.
NEW COMMITTEE MEMBERS FOR VMAC
Five new members have been selected to join FDA's Veterinary Medicine Advisory Committee (VMAC). The new members are Vernon C. Langston, Ph.D., D.V.M., Robert E. Holland, D.V.M., Wanda M. Haschek-Hock, Ph.D., Janis Livingstone Cleland, D.V.M., and Richard R. Wood. They replace former members Sue Hudson Duran, Dr. Gary Koritz, Dr. Alice Wolf, and Dr. Nancy K. Jaax.
Dr. Langston is an expert in veterinary pharmacology. He is Associate Professor of Veterinary Medicine at Mississippi State University, College of Veterinary Medicine. He is Board-Certified as a Diplomate, American College of Veterinary Clinical Pharmacology. Previously, Dr. Langston served as the Chairman of the United States Pharmacopeia (USP) Drug Information Division Veterinary Advisory Panel, and as Executive Council of the American Academy of Veterinary Pharmacology and Therapeutics.
Dr. Holland is an Associate Professor in the Department of Large Animal Clinical Sciences, Michigan State University. Currently, he is the Animal Drug Coordinator for the North Central IR-4 Program, a project designed to facilitate approval of drugs for minor species. He is a widely respected expert in significant research devoted to minor uses of drugs.
Dr. Hasched-Hock is Professor and Head of the Department of Veterinary Pathobiology, College of Veterinary Medicine, University of Illinois. She is Board-Certified by the American College of Veterinary Pathologists, in addition to the American Board of Toxicology. Her research efforts have included toxicologic pathology as well as other research in the area of pathology.
Dr. Cleland is an outstanding small animal clinician. Among her accomplishments, she is Board-Certified as a Diplomate, American Board of Veterinary Practitioners in Companion Animal Medicine, is currently Editor for the Journal of the American Animal Hospital Association, and has recently served as a member of the Council on Biologic and Therapeutic Agents, American Veterinary Medical Association.
Mr. Wood is currently Executive Director of the Food Animal Concerns Trust (FACT), a non-profit organization that advocates better farming practices. Mr. Wood has a history of working with consumers and helping them respond to public policy on both the State and National level. Dr. Donald Lein remains the chairman of VMAC, and other members include Dr. Fred Angulo, Dr. Steven A. Barker, Dr. George Cooper, Dr. Oscar Fletcher, Dr. Diane Gerken, Dr. Ling-Jung Koong, and Dr. Keith Sterner. VMAC members normally serve four-year terms
JIFSAN TO PRESENT TSE WORKSHOP
The Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a shared endeavor of the Food and Drug Administration and the University of Maryland, will convene a workshop June 8-9, 1998, in College Park, Maryland, concerning transmissible spongiform encephalopathies (TSEs) with the collaboration of a number of government agencies and international organizations. The workshop will consider what is known and what is critical to learn about the potential risk of TSE transmission related to source materials, processing, and the use of end-products by animals and humans. The objective of the workshop is to define the state of current knowledge and to identify practical guiding principles for evaluating the risks posed by TSEs. Collaborators and sponsors include the Virginia-Maryland Regional College of Veterinary Medicine and international, academic, manufacturing, consumer, and governmental organizations. Workshop proceedings will be made available.
The workshop will consist of three interrelated activities. First, experts have been invited to make oral presentations on TSE risks related to source materials, processing, and end products. Second, an interactive web site and information resource currently under construction will enable participants and non-participants to learn what is known about TSEs and contribute data and concepts critical to the assessment of TSE risk. Third, registrants are encouraged to submit poster abstracts reporting on work related to the subject matter of the workshop. Authors whose abstracts are accepted by the program committee will be invited to present their work at a poster session/reception.
For TSE Workshop information, program and forms, visit their web site at http://www.life.
A PERSPECTIVE ON FDA FIELD WORK
by Frederick D. Doddy, V.M.D., M.S.
The author recently joined the Office of Surveillance and Compliance at the Center for Veterinary Medicine as a Veterinary Medical Officer. He began his Food and Drug Administration (FDA) career with the Office of Regulatory Affairs (ORA) as an FDA Field investigator (or consumer safety officer) in the Chicago District Office.
FDA Field investigators are employed by the Office of Regulatory Affairs (ORA) throughout the country and play a vital role in FDA serving as the primary "eyes and ears" of the Agency. ORA has approximately 160 Field offices located throughout the country. This is an essential part of the FDA surveillance and enforcement network which is responsible for protecting the public health and ensuring that products comply with the laws and regulations enforced by FDA.
The ORA Field organization is divided into five Regional Offices, which are managed by Regional Food and Drug Directors. Each Regional Office controls several District Offices. The structure of a District Office is not universal throughout the Agency. The Chicago District Office, which is part of the Central Region, is headed by a District Director. The District Director is supported by a Director of Investigations Branch, a Director of Compliance, a Public Affairs Specialist, Compliance Officers, Supervisory Investigators (or First-Line Managers), Investigators, Engineers, Inspectors, aides, and clerical support. The Chicago District Office has geographical responsibility for the entire State of Illinois. Consequently, it is necessary to have extensions of the District Office throughout the State. These strategically located extensions are called Resident Posts, which cover specific geographical areas or operations. For example, Chicago District has seven Resident Posts: Gurnee; Hinsdale; Mount Vernon; O'Hare (for import operations); Peoria; Rockford; and Springfield. This provides easy and rapid access to FDA-regulated industries throughout the State. Some Resident Posts are managed by supervisors; some by a Resident-in-Charge. Because there are only 21 Districts, some Districts are responsible for more than one State. Also, some Districts are affiliated with an FDA laboratory. In addition to Chicago, Illinois, there are District Offices located in the following cities: Atlanta, Georgia; Baltimore, Maryland; Buffalo, New York; Cincinnati, Ohio; Dallas, Texas; Denver, Colorado; Detroit, Michigan; Maitland, Florida; Lenexa, Kansas; Irvine, California; Minneapolis, Minnesota; Nashville, Tennessee; Stoneham, Massachusetts; New Orleans, Louisiana; Parsippany, New Jersey; Brooklyn, New York; Philadelphia, Pennsylvania; Alameda, California; San Juan, Puerto Rico; and Seattle, Washington.
The Investigations Branch in Chicago is organized into six teams under the following program areas: biologics; devices/radiological health; drugs (and cosmetics); foods; imports; and veterinary medicine (e.g., drugs, devices and feeds). (Veterinary biologics fall under the jurisdiction of the USDA.) The Branch's mission is to ensure industry compliance and maximize consumer protection. ORA work plans (or Field assignments) are developed on an annual basis with guidance provided by FDA headquarters and programs from each product-oriented Center, and are allocated to Districts commensurate to staffing. The product-oriented Centers are: 1) Center for Drug Evaluation and Research (CDER); 2) Center for Biologics Evaluation and Research (CBER); 3) Center for Food Safety and Applied Nutrition (CFSAN); 4) Center for Devices and Radiological Health (CDRH); and 5) Center for Veterinary Medicine (CVM). Additionally, Field assignments may originate from other Districts, special requests from headquarters, trade and consumer complaints, court orders, surveillance reports, or emergencies. These assignments consist of: 1) conducting domestic and foreign inspections of FDA-regulated industries; 2) conducting special investigations such as foodborne illnesses and adverse drug reactions; 3) collecting surveillance samples; 4) monitoring product recalls; 5) evaluating/assessing new product applications; 6) reviewing/examining/sampling imported products; 7) administering the Government-Wide Quality Assurance Program to assure safety of medical products purchased by the government; 8) providing training to industry representatives, consumer groups, and cooperating officials; 9) coordinating/cooperating with other regulatory agencies; and 10) enforcing the interstate Sanitation Travel Regulations. The work of the Field investigator is guided chiefly by the Federal Food, Drug, and Cosmetic Act (the Act)and Title 21 of the Code of Federal Regulations. The Public Health Service Act, Compliance Program Guidance Manuals, investigational guidance documents, and specific Center guidance are also used.
The scope of work for the Field investigator can be very broad, and varies from District to District. This is determined by the type and number of FDA-regulated industries in the District. Therefore, investigators are encouraged to select the program area(s) in which they have primary interest and would like to concentrate their efforts. For example, engineers generally select device team work; I focused on drug and veterinary assignments. The majority of my work assignments involved the Bioresearch Monitoring (BIMO) Program which includes clinical investigators, sponsors/monitors, good laboratory practices (GLPs), institutional review boards (IRBs), and contract research organizations. The commodities covered in the BIMO Program include human drugs, animal drugs, human biologics, devices, and food additives. The main objectives of the BIMO Program are: 1) to assure the integrity of scientific test data submitted to FDA to support approval of products; and 2) to determine that the welfare of human and animal research subjects are adequately protected. This permits FDA to make sound judgments regarding the safety and effectiveness of FDA-regulated products requiring premarket approval.
BIMO assignments originate from the product-oriented Centers and are forwarded to the District BIMO monitor who is responsible for the coordination and distribution of these assignments to appropriate District personnel. An inspection assignment is either announced (i.e., notification is given to the firm prior to the start of an inspection) or unannounced (i.e., notification is not given prior to the start of an inspection) depending on the type of BIMO, and the specific guidance provided in the assignment from the Center. An inspection can last from one or two days to several weeks, depending on its purpose and scope. While conducting assignments issued by a Center, the Field investigator may find it necessary to consult with Center personnel to resolve issues raised while conducting the Field assignment. Occasionally, Headquarters may send Center experts to the Field to assist in an inspection. The findings during inspection are documented accurately and factually in narrative form in reports called Establishment Inspection Reports (EIRs). Significant deviations (or deficiencies) from the Federal regulations observed during an inspection are also recorded on an FDA-483 (Inspectional Observations Form). FDA-483's are immediately releasable under the Freedom of Information Act. The EIRs provide historical information and are used to make administrative decisions. EIRs receive one of three classifications by a Field supervisor: 1) no action is indicated (NAI); 2) voluntary action is indicated (VAI); and 3) official action is indicated (OAI). Once endorsed by the District, a copy of the EIR is forwarded to the respective Center reviewer for a final endorsement. The original remains in District files.
Regardless of the type of assignment originating from a product-oriented Center, the coordination between the Center and the Field is generally similar. The coordinated efforts ensure that FDA-regulated products are safe and effective for their intended use(s).
WORLD AQUACULTURE and INTERNATIONAL HARMONIZATION for DRUGS AND BIOLOGICS
by Charles E. Eirkson III
Following is a summary of the International Harmonization of Aquaculture Drugs and Biologics and World Aquaculture Meetings, held February 15 - 19, 1998, in Las Vegas, Nevada.
Aquaculture International Harmonization Meeting
During the Aquaculture International Harmonization Meeting there were presentations by individuals representing or relaying their interpretations of various international organizations including the Food and Agriculture Organization of the United Nations (FAO), World Health Organization (WHO), Office International Des Epizooties (OIE), CVM, Organization for Economic Co-operation and Development (OECD), USDA, European Union (EU) and private industry. Dr. Albert Tacon of FAO presented information on the total aquaculture production, estimated at 28 million metric tons and 43 billion U.S. dollars annually. Ninety percent of the total is from Asia, consisting predominantly of lower-value herbivorous fish for mass market, while the developed countries produce higher value carnivorous species for selected markets. It was pointed out that the higher-value markets consume 450 Kg fish meal and 250 mg fish oil to produce 1 metric ton of fish (salmon). Dr. Michael Blackwell from CVM presented information on international efforts under CODEX Alimentarius Commission, Veterinary International Cooperation on Harmonization (VICH) and North American Free Trade Agreement (NAFTA). He also provided a summary of CVM's efforts under the minor use minor species (MUMS) policy to provide for approvals of drugs for aquaculture. Dr. Gudrum Gallhoff from the EU discussed the EU process for registration. There is a centralized process for approval at the EU level and a decentralized process for approval within member countries. At the decentralized level, MRL is still determined at the centralized level to provide for trade between EU countries. Additionally, all biotechnology products must go through the centralized process and all aquaculture products are required to go through a phase II ecotoxicity review. Dr. Alan Reilly from WHO discussed concerns about antibiotic resistance associated with aquaculture. He stressed that human medicine was the largest contributor but that there is a potential for problems from resistance development and transfer in aquaculture, especially in the tropical zones. He noted that some data (unspecified) demonstrates that resistance development from aquaculture in temperate zones is low. Dr. Rolf Nordmo of Vikan Research, Norway, discussed the GLP OECD/GD (92) process.
Dr. Michael Blackwell presented an in-depth discussion of VICH and its process. Dr. Raphaela le Gauvello of Stermor Aquaculture Health Consulting, France, discussed the EU requirements for aquaculture under the current ecotoxicity and food safety requirements. All aquaculture is currently phase II which requires environmental testing. She also expressed and confirmed that residue markers established for other species are now accepted for aquatic species. Dr. Mark Wood of the Animal Health Institute presented the U.S. animal health industry perspective of aquaculture markets by expressing that the cost of drug development is still not balanced by the available aquaculture market making development prohibitive. Dr. J. Brackett of Syndel Laboratories, Canada, expressed that there is a need for harmonization to reduce cost and that risk assessment should be the preferred approach in dealing with drug approval. Risk assessment could be used to identify low-risk uses and reduce regulatory requirements for those uses. Dr. Blackwell of CVM presented more details concerning CVM's MUMS proposal, specifically, the removal of disincentives for drug development, including improving enforcement for unapproved products, changes in standards for approval and assuring that existing approvals will not be jeopardized by minor use supplements.
Reports for the Education-Communication, Prioritization, Research, and Level Playing Field Committees were presented. The Education-Communication Committee reported that a web cite at aquaintharm-mg@usda was developed. The Prioritization Committee noted that there are approximately 27 products approved in Japan, 9 in Europe, 4 in Canada and 2 in the U.S. The Research Committee identified a lack of knowledge of basic fish anatomy and physiology. The Level Playing Field Committee reported that its membership had fallen and there is a need for producers and manufacturers to get involved. There is a critical need to cover areas of drug and biologic availability, open markets, and investment.
World Aquaculture Meeting
On Monday February 16, there were sessions on Aquaculture Engineering Society Fundamental Workshop, Aquaculture Drug Approvals Through Producer INADs, Biosecurity Measures that Reduce Risk for Aquatic Species in the Aquatic Animal Health and Clarifying the Department of Commerce's Role in the Development of U.S. Aquaculture. During the Engineering session, it became apparent that there is a critical need for separating and disposing of solids from recirculating systems. These solids require subsequent disposal and can present environmental issues. Data were also presented that biofilters are critical for proper control of nitrate and nitrite levels and that these systems can be damaged or destroyed with the presence of antibiotics in effluents. During the INAD session, the presentation on the Development of Data for Approval of Cypermethrin to Control Freshwater External Parasites was replaced with a presentation on a new (unidentified) fungicide and antimicrobial to be submitted for consideration at FDA by Grampian Pharmaceuticals. It is claimed that the product is a replacement for malachite green. During the session on Biosecurity Measures, the need to prevent microbial and viral contamination of aquaculture sites following formats used in the poultry industry was presented. The emphasis was on the prevention of disease to provide for successful aquaculture development. The session on Clarifying the Department of Commerce's Role in the Development of U.S. Aquaculture provided a public forum to facilitate communication on a new Department of Commerce strategic plan for supporting aquaculture through the year 2005. The plan stimulated a prolonged discussion with the representatives of the aquaculture industry. Apparently there is considerable difficulty between USDA and Commerce and within Commerce in promoting and supporting aquaculture in the U.S. The Department of Commerce has the difficult task of balancing the regulation and promotion of commercial fishing and aquaculture in a marine environment.
On Tuesday, February 17, during a session on the Environmental Impact of Shellfish Aquaculture, topics on environmental damage from collecting mollusk spats (larval stage) and the transmission of pathogens were covered. The collection of spats for transplant to culture operations reduces the wildstock populations; in some areas to the point of removing the necessary food-base for a number of predatory birds that feed on mollusks. The populations of the birds are reduced. Data were also presented on the transmission of Campylobacter spp. from mollusk culture facilities to nearby beaches. Apparently, birds which land on mollusk facilities pick up, on their feet, Campylobacter, and other pathogens and transport them to other areas. They have measured higher than expected pathogen numbers at public facilities where birds congregate. A session on Aquaculture Pond Soil Quality Management stressed the need for active and balanced microbial populations in the pond soil to maintain proper pond chemistry. The management of acidity, sulfate, and other biological and chemical factors are modulated by microorganisms in pond sediments. The removal of microbes could adversely affect sustainable production in ponds. The session titled "Aquaculture Drug Approval Process - A Success Story," indicated that drug approval provided a positive perspective of CVM's efforts at promoting the investigation and approval of drugs for use in aquaculture. It provided a good deal of information on the U.S. Fish and Wildlife Service experience in conducting investigations on a number of new animal drugs.
On Wednesday, February 18, sessions included a Forum on Sustainability, Shrimp Ecosystem Stability and General Contributed Papers. During the first two sessions, there was considerable discussion of the modification of lands for use in shrimp farming. Many terrestrial agricultural (rice) and forested (mangrove) ecosystems have been converted to shrimp production without planning and, subsequently, abandoned. The removal of previously productive rice plantations has caused adverse social, ecological and economic impacts in some areas. The removal of mangrove forests has also caused ecological and economic impacts in some areas. There are also cases where there are significant increases in economic and social benefits from shrimp farmers. The session focused on the need for better planning and, perhaps, regulation to control the siting of shrimp farms. During the session on General Contributed Papers, a talk entitled the "Effects of Tetracycline Use in Aquaculture on Microbial Communities" provided data on the use of chlortetracycline and tetracycline and the subsequent development of drug resistance in fresh and marine systems. For freshwater uses, drug resistant organisms were observed in effluent and sediment from the aquaculture facilities in California. The amount of resistance formation appeared to be correlated with the concentration and sorption of tetracycline. In a marine system, the amount of resistance could not be correlated with the concentration or sorption of tetracycline. There were higher levels of resistance than expected. It appears that the development of resistance from selective pressure in a marine system is different from a fresh water system.
On Thursday, February 19, a session on Shrimp Pond Ecosystem Stability discussed the need for settling basins or wetlands to treat effluents from shrimp ponds. Nutrient and suspended solids loads are high and settling basin or wetlands are needed to reduce loads entering into marine and freshwater systems. There was also a presentation on conducting an environmental assessment for siting a shrimp farm and on the restoration of shrimp ponds. T
he meeting provided attendees with valuable insight into the potential environmental impacts of aquaculture. It was recognized throughout the meeting that microbial communities are critical for maintaining the sustainability of aquaculture facilities and that these communities, and the benefits they provide, can be disrupted by the use of antimicrobial agents. In addition, drug use in aquaculture represents a hazard to ecosystems receiving effluents from aquaculture facilities. The development of antimicrobial resistance was also associated with the use of antibiotics in aquaculture facilities. Considerable evidence supports a need to adequately study the potential effects of aquaculture drug products on fresh, estuarine and marine ecosystems but also confirms that significant benefits are derived from the use of these products.
FDA APPROVES FIRST VETERINARY COMPETITIVE EXCLUSION PRODUCT
On March 13, 1998, FDA approved the first competitive exclusion (CE) product for animals in the U.S. CE products are made up of live bacteria that can be given to animals to establish normal gut-microflora, thereby helping to reduce or prevent the colonization of undesirable bacteria, including zoonotic pathogens. By populating the gut with normal microflora, thereby excluding undesirable bacteria, CE products may help reduce carcass contamination and the incidence of foodborne illness in humans. This first approved CE product, PREEMPT™, is approved for the early establishment of intestinal microflora in baby chicks to reduce Salmonella colonization. The use of PREEMPT™ establishes bacteria that are native to the intestinal tract, creating an environment in which organisms such as Salmonella are less likely to become established.
PREEMPT™ is a defined mixture of 29 bacteria originally obtained from healthy broiler chickens. A single spray of bacterial suspension will be administered to newly hatched chicks, at a dose of approximately 0.25 milliliter per chick. The bacteria on the chick's feathers are subsequently ingested through normal grooming (preening) behavior.
Reduction of Salmonella colonization in chickens is an important step in reducing Salmonella contamination in processed poultry products. While Salmonella colonization is generally not a problem for the chickens, it is a problem for humans who may develop salmonellosis through the ingestion of improperly cooked or handled Salmonella-contaminated chicken.
While the use of CE culture products in newly hatched chicks will help to reduce Salmonella colonization in chickens, such products alone will not eliminate salmonellosis in humans. Other measures, such as Hazard Analysis and Critical Control Point (HACCP) Systems are currently being implemented at poultry processing plants to further reduce Salmonella contamination in chickens. While the use of PREEMPT™ will help reduce one type of contamination, poultry must be properly handled and cooked to be safe.
This CE culture product was originally developed and tested by a USDA/Agricultural Research Service team at College Station, Texas. This specific culture is produced as PREEMPT™ under an exclusive licensing agreement between the USDA and MS BioScience.
During clinical studies, no adverse effects were observed in the chicks following PREEMPT™ administration. In addition since PREEMPT™ is a suspension of bacteria, there are no concerns regarding chemical residues in edible tissue from treated chickens. However, since this product consists of live bacteria, using antimicrobials in feed or drinking water along with PREEMPT™ would inhibit the survival and ultimate establishment of these organisms in the gut.
Michael A. Friedman, M.D., FDA's lead deputy commissioner said "This approval marks another successful step in the concerted effort FDA, USDA, and other government agencies have made to enhance the safety of the nation's food supply. FDA is committed to facilitating the development of any promising technology that can improve food safety at every stage -- from farm to table."
FDA GUIDANCE ON RUMINANT FEED RULES AVAILABLE
CVM has released four small entity compliance guides which explain in plain language how the new regulations prohibiting certain mammalian proteins from use in feed for ruminant animals apply to renderers, feed manufacturers, and livestock feeders. These new guides replace the single "Guidance for Industry -- Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide" (Guidance Document 60); breaking out the requirements for each of these particular groups.
The titles of these new guides are as follows:
Among other things, each guide contains a one-page summary of how to comply with the regulations (published in the June 5, 1997 Federal Register) that prohibit the use of certain protein products derived from mammals in feed for beef and dairy cattle and in other ruminant animals. FDA adopted the regulations to protect U.S. cattle herds from the establishment and amplification of bovine spongiform encephalopathy (BSE) through feed, which has been reported in Europe. The disease has never been detected in the U.S. Scientists believe cattle can develop the disease after consuming rendered byproducts from infected animals.
The guides are available through the CVM Internet Home Page or by calling the FDA Veterinarian. Additional information on complying with the rule may be obtained by contacting CVM's Division of Compliance, 7500 Standish Place, HFV-230, Rockville, MD 20855, 301-594-1726.
THE JOINT SUBCOMMITTEE ON AQUACULTURE WORKING GROUP ON QUALITY ASSURANCE IN AQUACULTURE PRODUCTION
by Kevin Greenlees, Ph.D.
Dr. Greenlees is a toxicologist on the Office of New Animal Drug Evaluation's Division of Human Food Safety Toxicology Team and currently co-chairs the Working Group on Quality Assurance in Aquaculture Production.
In the 1980s, Congress recognized the need to foster the growth and development of aquaculture in the United States. This led to the passage of the National Aquaculture Act of 1980 and National Aquaculture Improvement Act of 1985. A result of this legislation was the creation of the Joint Subcommittee on Aquaculture (JSA).
The JSA is a statutory committee that operates under the control of the National Science and Technology Council (NSTC) of the Office of Science and Technology Policy in the Office of the Science Advisor to the President. The JSA reports to the NSTC's Committee on Health, Safety & Food Research and Development, which is one of nine research and development (R&D) committees established by NSTC to prepare coordinated R&D strategies and budget recommendations for accomplishing national goals. The permanent chair of the JSA is the Secretary of Agriculture, who is currently represented by Dr. Meryl Brussard of USDA's Cooperative State Research, Education and Extension Service (CSREES). Other members of the JSA consist of those Federal Governmental agencies which affect aquaculture.
The work of the JSA is carried out by standing working groups and temporary task forces. One of the first groups was the Working Group for Quality Assurance in Aquaculture Production. Established in November of 1990 under the leadership of Mr. Gary Stefan of the FDA Center for Veterinary Medicine, the Working Group has provided a national forum to address drug, biologic, and pesticide use in aquaculture through education and in the coordination of related efforts in government, industry, and academia.
A key to the Working Group's success has been its broad membership, drawing on all parts of the aquaculture community. The Working Group includes representatives from Federal and State regulatory agencies, academia, major aquacultural trade and industry associations, private aquaculturists, and other members of the aquaculture community. Pharmaceutical industry and international government representatives have been frequent participants. With meeting attendance ranging from 25 to 100 people, and a mailing list of 150, the Working Group has provided a frank forum for the exchange of information between the regulators and the regulated industry.
Much of the early focus of the Working Group was in the development of quality assurance programs in the aquaculture community, and the implementation of quality assurance programs continues to be emphasized. A concentrated effort was made to learn from the established food animal production industries in the application of quality assurance programs to the growing aquaculture industry. The catfish producers were the first to establish a quality assurance program, and were soon followed by the trout producers. The hybrid striped bass producers have more recently developed a quality assurance program, and similar programs continue to spread throughout the aquaculture community. The recent implementation of the Hazard Analysis Critical Control Point (HACCP) programs for aquaculture by FDA and National Marine Fishery Service (NMFS) has emphasized the importance of quality assurance programs in all areas of food animal production.
The need to educate the developing aquaculture community about Federal regulatory requirements produced the 1992 booklet, "Federal Regulation of Drugs, Biologicals, and Chemicals Used in Aquaculture Production." A product of the Working Group, drawing on Federal and private member resources, the booklet was published by the National Agricultural Library. It was intended as "…a guide to Federal requirements associated with marketing and using these compounds. It provides a summary of Food and Drug Administration, Environmental Protection Agency, and Animal Plant Health Inspection Service regulations applicable to these compounds, as well as sources of contact for further information."
Two years later, the above publication was followed with the release of the 1994 booklet, "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture." Published by the Texas Agricultural Extension Service, this document provides detailed information on approved drugs, vaccines and pesticides for use in aquaculture. These documents, developed jointly with the regulatory agencies, have provided exceptional benefit to the aquaculture community.
The Working Group recognized that education is a process that creates the greatest impact when information flows in both directions. A concerted effort was made by the representatives of the aquacultural community to educate the Federal regulatory agencies. Presentations were provided on various aspects of modern aquaculture. Identification and prioritization of critical disease problems and aquaculture drugs for which new animal drug approvals were required led to the development of a prioritized list of drugs for which data could be sought to facilitate approvals. Compounds traditionally used by the aquaculture community were identified and submitted to CVM in order to determine their status as drugs, pesticides, or chemicals. Submitted compounds ranged from urea and tannic acid used to denature the adhesive component of fish eggs to ozone. These efforts served to educate the regulatory agencies on the needs of the aquacultural community, and allow the aquacultural community to clearly understand where it stood in relation to drug and pesticidal use.
The need to conduct investigational studies to gather data for the approval of drugs for aquaculture use led to the development, under the auspices of CVM, of investigational new animal drug (INAD) efforts by aquacultural facilities throughout the country. The Working Group became a focus for the aquacultural community's efforts to coordinate these varied studies, and was pivotal in the creation of a non-governmental INAD representative to coordinate the investigational efforts nationwide. The INAD coordinator position soon evolved into the position of the National Aquaculture New Animal Drug Coordinator, currently exceptionally served by Ms. Rosalie Schnick, formerly of the U.S. Fish and Wildlife Service. Ms. Schnick serves as a liaison for the aquaculture community to the pharmaceutical industry and the regulatory agencies.
More recently, the importance of world-wide aquaculture and its impact on aquaculture within the United States has been recognized. An international workshop on the harmonization of drugs and biologics for aquaculture was organized by the Working Group. The first workshop was held in 1997 as part of the World Aquaculture Society meeting in Seattle, Washington. Participants from countries representing every major continent except Africa attended the all-day session. A second workshop was held this year in Las Vegas in conjunction with the 1998 World Aquaculture Society meeting. Work continues to take advantage of the wealth of knowledge available globally in the advancement of aquaculture.
The Working Group for Quality Assurance in Aquaculture Production is currently co-chaired by Drs. Kevin Greenlees of FDA/CVM and Gary Jensen of USDA/CSREES. A five-year plan has been developed to take the Working Group into the next century. The "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture" is undergoing extensive revisions and the new edition is anticipated this year. Activity continues toward the international harmonization of aquaculture drugs and biologics. Efforts to coordinate the development of data for the approval of needed pharmaceutical and biological tools for the aquaculture industry with potential sponsors for the approved products continue to be a major effort. The Working Group continues to provide a unique forum for discussion and action while advancing the growth and development of U.S. aquaculture.
Quality Assurance Working Group for Aquaculture Production Five-Year Plan
Facilitate the funding and support for the NADA Coordinator from both the public and private sectors;
Continue to identify and prioritize drugs, chemicals, and biologics needed for diverse aquaculture species at two-year intervals;
Explore innovative strategies for funding the research needed to facilitate aquaculture drug approvals, chemical registrations, and biologic licensing;
Encourage the aquaculture community to assist in defining food/non-food fish, crop grouping, and/or life stages for drug-specific applications;
Evaluate the Aquaculture Pesticides Food Animal Residue Avoidance Databank (FARAD) for utilization, software accessibility, and funding;
Update and assist in distributing the educational publications: "Federal Regulation of Drugs, Biologicals, and Chemicals Used in Aquaculture Production" and "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture";
Monitor, evaluate, and discuss pending Federal legislation and regulations pertaining to aquaculture drugs, chemicals, biologics, and quality assurance;
Highlight vaccines as an important component of integrated "herd health" management programs and as a mechanism to reduce drug use; encourage vaccine development and licensing;
Continue to support the development and implementation of producer quality assurance programs for aquatic species; Continue to foster utilization of producer-based quality assurance programs together with processor-based Hazard Analysis Critical Control Point (HACCP) principles;
Use computer technology to create and maintain databases on the status of drug approvals, investigational new animal drug (INAD) exemptions and other pertinent aquatic health information to encourage and facilitate public access and review through the Office of the NADA Coordinator;
Foster international harmonization for the establishment of tolerance levels and for the processes needed for aquaculture drug approvals, chemical registrations, and biologic licensing;
Appraise the potential national and international market value for aquatic health products to encourage pharmaceutical, chemical, and vaccine industry involvement; and
Promote the participation of domestic and international agencies and producer groups in the activities of the Working Group on Quality Assurance in Aquaculture Production.
CVM COSPONSORS SYMPOSIUM AT AVMA CONVENTION
In conjunction with the annual meeting of the American Veterinary Medical Association (AVMA), a Food Safety Symposium will be presented on July 25, 1998, at the Baltimore Convention Center. Cosponsors include the American Veterinary Medical Association, the Center for Veterinary Medicine, Food and Drug Administration, the American Association of Food Hygiene Veterinarians, the American College of Veterinary Preventive Medicine, and the American Association of Public Health Veterinarians.
This symposium will offer a comprehensive review and analysis of emerging foodborne issues (i.e., residues, resistance, and emerging foodborne pathogens). The views of leaders from the public health sector, regulatory agencies, and medical practitioners will be presented. Moderators will direct panel discussions focusing on criteria for prevention and approaches for addressing and resolving these foodborne issues.
1998 AVMA PUBLIC HEALTH SECTION
FOOD SAFETY SYMPOSIUM -- POST-HARVEST: FOODBORNE DISEASE ISSUES
Presiding: Dr. Linda Tollefson -- Center for Veterinary Medicine
| 8: 30 a.m. | Salmonella enteritidis Dr. Fred Angulo |
| 9:00 a.m. | Salmonella typhimurium DT 104 Dr. Kathy Hollinger |
| 9:30 a.m. | E. Coli O157:H7 Changes in Epidemiology of Outbreaks Dr. Phyllis Sparling |
| 10:00 a.m. | BREAK |
| 10:15 a.m. | Campylobacter jejuni in Foods Dr. Sean Altekruse |
| 10:45 a.m. | The Issue of Residues and Human Health Dr. Joseph Paige |
| 11:15 a.m. | PANEL DISCUSSION |
| 11:45 a.m. | LUNCH BREAK |
AFTERNOON SESSION
Presiding: Dr. Leon Russell -- Texas A&M
| 1:00 p.m. | Food Safety Initiatives Dr. Marissa Miller |
| 1:30 p.m. | Antimicrobial Susceptibility Monitoring Dr. Paula Cray |
| 2:00 p.m. | HACCP as a Prevention Tool Dr. David Dreesen |
| 2:30 p.m. | BREAK |
| 2:45 p.m. | Use of Competitive Exclusion to Control Gut Colonization by Human Pathogens in Food Animals Dr. David Nesbit |
| 3:15 p.m | Microbial Risk Assessment Dr. Roberta Morales |
| 3:45 p.m. | Seminar Synopsis Dr. George Beran |
| 4:15 p.m. | ADJOURN |
CVM's Notice of Claimed Investigational Exemption (NCIE) Electronic Submissions Pilot Project has been extended until March 8, 1999. The purpose of the pilot project is to determine the practicality and feasibility of electronic submission and review as an alternative to the current paper-based processes. The CVM standardized NCIE form, Form FDA 3458 (1/98), may be submitted via either electronic transmission or hard copy. The form is available on the CVM Home Page on the Internet or by calling the FDA Veterinarian.
For further information about the pilot project, please contact Charles J. Andres, Ph.D., Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855 by telephone (301-594-2604) or e-mail (candres@bangate.fda.gov).
FDA PUBLISHES ADEQUATE AND WELL-CONTROLLED STUDIES FINAL RULE
In the March 5, 1998, Federal Register, FDA published a final regulation further defining "adequate and well-controlled studies." The purpose of this final rule is to further define "adequate and well-controlled" to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions. The rule implements, in part, the Animal Drug Availability Act of 1996, which amended the Federal Food, Drug, and Cosmetic Act to enable more efficient approval and more expeditious marketing of safe and effective animal drugs. The regulation is effective on April 6, 1998.
The Federal Register notice for this final rule is available for review or downloading on CVM's Internet Website. Paper copies are available from the FDA Veterinarian.
Questions about this rule may be directed to Herman M. Schoenemann, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1638.
FOOD ADDITIVE PETITION APPROVED
In the February 20, 1998, Federal Register, FDA announced that it is amending the food additive regulations to provide for the safe use of sodium stearate as an anticaking agent in animal feeds (FAP 2236). This action was taken in response to a food additive petition filed by Betty J. Pendleton. Additional information is included in Federal Register and from Dr. John P. Honstead, Center for Veterinary Medicine (HFV-222), FDA, 7500 Standish Place, Rockville, MD 20855, (301) 594-1728.
FDA DISTRICT DIRECTOR TO SPEAK AT AVMA
Mike Rogers, Director of FDA's Kansas City District Office, will present a talk titled "FDA Investigations -- A District Director's Perspective," at the AVMA Convention in Baltimore, Maryland. Mr. Rogers will discuss the FDA Field experience in implementing CVM's regulatory strategies, and the importance of collaboration between practitioners, veterinary associations and FDA in reducing threats to the public health. The talk is scheduled for 8:45 a.m. on Monday, July 27, 1998, during the section on Bovine Medicine.
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
These violations involved illegal residues of sulfadimethoxine in a cow and gentamicin in a cow.
John L. Draxler, JCJ Dairy, Hanford, CA, received a warning letter for offering a dairy cow for slaughter that contained illegal drug residues of gentamicin and penicillin and for using Tetracycline Hydrochloride Soluble Powder in a way that is not in conformance with its approved labeling.
A warning letter was sent to Frank J. Garcia, Jr., Frank R. Garcia & Sons Dairy, Tulare, CA, for offering a dairy cow for slaughter that contained illegal drug residues of gentamicin. The letter also stated that this firm has established a history of offering animals for sale for human use which have been found to be adulterated with drug residues.
Jose A. Matos and Jovina M. Matos, Merced, CA, received a warning letter for offering a cow for slaughter that contained illegal drug residues of sulfadimethoxine and for using oxytetracycline and tetracycline hydrochloride soluble powder in ways that are not in conformance with their approved labeling.
A warning letter was sent to Kars Tamminga, President, Fri-Tex Dairy, Inc., Waxahachie, TX, for offering dairy cows for slaughter with obvious symptoms of poisoning. The letter also said that FDA investigators found that the firm held animals under conditions which are so inadequate that diseased or sick animals bearing potentially harmful pesticide and drug residues are likely to enter the food supply. In addition, the letter stated that this firm has previously offered for slaughter dairy cattle with violative drug residues.
Company
Hoechst Roussel Vet
(NADA 140-843)
Generic and (Brand) Names
Narasin, Bambermycins and Roxarsone
Indications
Broiler chickens. To prevent coccidiosis, increased rate of weight gain, improved feed efficiency, and improved pigmentation.
Routes/Remarks
MEDICATED FEED: Provides for using approved single ingredient Type A medicated articles, Monteban (45 grams narasin activity per pound), Flavomycin (4 and 10 g bambermycins activity/lb), and 3-Nitro(45.4, 90, and 227g roxarsone/lb), to make Type C medicated broiler feed containing 54 to 72 g narasin, 1 to 2 g bambermycins, and 22.7 to 45.4g roxarsone/ton of feed.
Federal Register 3/18/98.
Company
Biopure Corp.
(NADA 141-067)
Generic and (Brand) Names
Hemoglobin Glutamer-200 (bovine) (Oxyglobin®) Rx
Indications
Dogs. For the treatment of anemia.
Routes/Remarks
INTRAVENOUS: Each 125 milliliter bag contains 13 grams per deco-liter of sterile, polymerized hemoglobin of bovine origin in modified Lactated Ringer's Solution.
Federal Register 3/10/98.
Company
Heska Corp.
(NADA 141-082)
Generic and (Brand) Names
Doxycycline Hyclate solution Rx
Indications
Dogs. For treatment and control of periodontal disease.
Routes/Remarks
SUBGINGIVAL: Solution to be applied by syringe to the periodontal pockets of the affected teeth. Do not use in dogs less than 1 year old. Do not use in pregnant bitches.
Federal Register 2/19/98.
Company
Fort Dodge Animal Health
(NADA 141-096)
Generic and (Brand) Names
Difloxacin Hydrochloride (Dicural®) Rx
Indications
Dogs. For managing diseases in dogs associated with bacteria susceptible to difloxacin. Federal law prohibits extralabel use of drug in food-producing animals.
Routes/Remarks
ORAL: Each tablet contains 11.4, 45.4, or 136 milligrams. Amount used is 5 to 10 mg per kilogram of body weight.
Federal Register 2/18/98.
Company
Fort Dodge Animal Health
(NADA 141-099)
Generic and (Brand) Names
Moxidectin (Cydectin ®)
Indications
Cattle. For treatment and control of infections and infestations of certain internal and external parasites.
Routes/Remarks
TOPICAL: Provides for a 0.5% solution as a pour-on for beef and non-lactating dairy cattle at 500 micrograms per kilogram body weight. Also establishes an ADI of 4 mg/kg/day and tolerance in cattle of 50 ppb inmuscle and 200 ppb in liver.
Federal Register 3/24/98.
Company
Novartis Animal Health U.S., Inc.
(NADA 141-029)
Generic and (Brand) Names
Desoxycorticosterone pivalate (Percorten-V®) Rx
Indications
Dogs. For replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
Routes/Remarks
INTRAMUSCULAR: Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
Federal Register 3/18/98.
Company
Alpharma, Inc.
(NADA 141-069)
Generic and (Brand) Names
Colistimethate sodium (First Guard ® Sterile Powder) Rx
Indications
1-3 day old Chickens. For control of early mortality associated with Escherichia coli organisms.
Routes/Remarks
SUBCUTANEOUS: The sterile powder is reconstituted in sterile saline or sterile water for injection in the neck of the chicks.
Federal Register 3/18/98.
ABBREVIATED NEW ANIMAL DRUG APPROVALS
Company
Hoffmann-LaRoche, Inc.
(ANADA 200-242)
Generic and (Brand) Names
Chlortetracycline, Bacitracin Methylene Disalicylate
Indications
Swine. For treatment of bacterial enteritis, bacterial pneumonia, increased weight gain, improved feed efficiency.
Routes/Remarks
MED FEED: ANADA 200-242 is a generic copy of Alpharma, Inc.'s NADA 141-059. Federal Register 3/3/98.
Company
Rhone-Poulenc Chemicals, Ltd.
(ANADA 200-237)
Generic and (Brand) Names
Isoflurane Rx
Indications
Horses and dogs. As an inhalant for induction and maintenance of general anesthesia.
Routes/Remarks
INHALANT: ANADA 200-237 is a generic copy of Ohmeda Pharmaceutical Products Div., Inc.'s NADA 135-773 (Aerrane®).
Federal Register 2/18/98.
Company
Company Western Chemical, Inc.
(ANADA 200-226)
Generic and (Brand) Names
Tricaine Methane- Sulfonate
Indications
Fish and other aquatic animals. In the water for anesthesia and tranquilization.
Routes/Remarks
TOPICAL: ANADA 200-226 is a generic copy of Argent Chemical Laboratories' NADA 42-427 (Finquel® ).
Federal Register 2/17/98.
SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS
Company
Hoffmann-La Roche, Inc.
(NADA 49-287)
Generic and (Brand) Names
Chlortetracycline (PfiChlor® 50, 70,100) CTC Type A Articles
Indications
Chickens, turkeys, sheep, calves, cattle, swine. For control and treatment of animal diseases susceptible to CTC, as well as weight gain and improved feed efficiency.
Routes/Remarks
MEDICATED FEED: The firm filed the supplemental application and labeling to reflect the concurrence with the conclusions of NAS/NRC DESI review and the subsequent FDA conclusions.
Federal Register 3/31/98.
Company
Hoffmann-La Roche, Inc.
(NADA 100-901)
Generic and (Brand) Names
Chlortetracycline (PfiChlor® 100S) CTC Type A Articles
Indications
Calves. For a calf milk replacer.
Routes/Remarks
MEDICATED FEED: The firm filed the supplemental application and labeling to reflect the concurrence with the conclusions of NAS/NRC DESI review and the FDA conclusions based on that review.
Federal Register 3/31/98.
Company
Pfizer, Inc.
(NADA 41-061)
Generic and (Brand) Names
Carbadox (Mecadox®)
Indications
Swine. For control of swine dysentery, control of swine enteritis, increased rate of weight gain, and improved feed efficiency.
Routes/Remarks
MED FEED: The supplement provides for a revised finite tolerance for residues of carbadox in edible swine tissue (30 ppb in liver)
Federal Register 3/19/98.
Company
Pfizer, Inc.
(NADA 55-099)
Generic and (Brand) Names
Amoxicillin Trihydrate and Clavulanate Potassium Tablets (Clavamox)
Indications
Dogs. For treatment of periodontal infections caused by susceptible strains of aerobic and anaerobic bacteria.
Routes/Remarks
ORAL, Tablets: The supplemental application revises the indications to include treatment of periodontal infections. Federal Register 3/18/98.
Company
Pfizer, Inc.
(NADA 55-101)
Generic and (Brand) Names
Amoxicillin Trihydrate and Clavulanate Potassium Suspension (Clavamox)
Indications
Dogs. For treatment of periodontal infections caused by susceptible strains of aerobic and anaerobic bacteria.
Routes/Remarks
ORAL, Suspension: The supplemental application revises the indications to include treatment of periodontal infections.
Federal Register 3/18/98.
Company
Elanco Animal Health
(NADA 140-929)
Generic and (Brand) Names
Tilmicosin Phosphate (Micotil ® 300 Inj.) Rx
Indications
Cattle, including preruminating (veal) calves. For treatment of cattle with bovine respiratory disease(BRD)associated with Pasteurella haemolytica.
Routes/Remarks
SUBCUTANEOUS: This supplement provides for the removal of the label warnings concerning injection in veal calves. Federal Register 2/17/98.
Company
Merial Ltd.
(NADA 128-409)
Generic and (Brand) Names
Ivermectin (Ivomec® Inj. 1%)
Indications
Cattle, Swine, Reindeer, and American Bison. For treatment and control of certain internal and external parasites.
Routes/Remarks
SUBCUTANEOUS: This supplemental NADA provides for use of 1% Ivermectin injection in American bison and a tolerance for residues of Ivermectin in edible tissues.
Federal Register 2/17/98.
Company
Elanco Animal Health
(NADA 95-735)
Generic and (Brand) Names
Monensin Pasture
Indications
Cattle. For increasing weight gain.
Routes/Remarks
MED FEED: This supplemental NADA incorporates the data from NADA 119-823 for a free choice feed. NADA 119-823 is withdrawn.
Federal Register 2/11/98.
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