GUIDE TO DRUG, VACCINE, AND PESTICIDE USE IN AQUACULTURE

The information in this document is primarily aimed at USA Aquaculture.  However, most of the information and recommendations have applicability wherever fish are raised.

The GUIDE TO DRUG, VACCINE, AND PESTICIDE USE IN AQUACULTURE is available in printed form from the Aquaculture Information Center, National Agricultural Library, U.S. Department of Agriculture, 10301 Baltimore Blvd., Rm. 304, Beltsville, MD 20705; 301/504-5558 (telephone) or aic@nalusda.gov (Internet-mail). The guide is also available from state Cooperative Extension Services, state Sea Grant Marine Advisory Services, and national aquaculture associations.

Educational programs conducted by the Texas Agricultural Extension Service and the Cooperative Extension System serve people of all ages regardless of socioeconomic level, race, color, sex, religion, disability, or national origin.  Mention or display of a trademark, proprietary product, or firm in the text or tables does not constitute an endorsement or imply preference by any federal agency or program or by The Texas A&M University. It is the reader's responsibility to read and follow label directions.

Contents

PREFACE

The GUIDE TO DRUG, VACCINE, AND PESTICIDE USE IN AQUACULTURE has been prepared by the Working Group on Quality Assurance in Aquaculture Production, which was established by the Federal Joint Subcommittee on Aquaculture in November 1990. This publication provides current information on federally approved uses of drugs, vaccines, and pesticides in aquaculture production and in aquatic sites. Sources of additional information and assistance are also presented.

The Working Group on Quality Assurance in Aquaculture Production provides a national forum for addressing drug, biologic, and pesticide use in aquaculture. This is accomplished through education and the coordination of related efforts in government, industry, and academia. The Working Group, Co-Chaired by Gary Jensen of USDA/CSREES and Kevin Greenlees of the FDA Center for Veterinary Medicine, is composed of representatives of the following agencies and organizations:

ACKNOWLEDGMENTS

The printing of this publication was supported by contributions from the following organizations and agencies:

American Feed Industry Association
American Tilapia Association
Catfish Farmers of America
National Aquaculture Association
National Aquaculture Council
U.S. Department of Agriculture
Animal and Plant Health Inspection Service
Extension Service
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
U.S. Department of the Interior
Fish and Wildlife Service
U.S. Trout Farmers Association

Special appreciation is expressed to Gary Jensen, USDA/CSREES, and Wendell Lorio, Louisiana Cooperative Extension Service, for compiling the guide. The assistance of the following individuals in providing information and obtaining agency approval clearances is also acknowledged: Antonio Bravo, Environmental Protection Agency; Althaea Langston, USDA Animal and Plant Health Inspection Service; Gary Stefan, FDA Center for Veterinary Medicine; and Kim Young, FDA Center for Food Safety and Applied Nutrition. Rosalie Schnick, U.S. National Biological Survey, contributed valuable comments and suggestions. Marjorie Harter, editorial consultant; Frances Gould, Louisiana Cooperative Extension Service; and Tracy Martin, USDA Extension Service are acknowledged for their efforts in the development of the guide.

The following persons are recognized for their critical review of this publication:

B.T. Alford,Nathan Birnbaum, Antonio Bravo, Marty Brunson, James Davis, Larry Dorman, John Ewart, Mike Freeze, Susan Homire, Gary Jensen, Kenneth Kasweck, Althaea Langston, George Lewis, Wendell Lorio, Brian Lynch, John R. MacMillan, Joe McCrarenHugh Mitchell, Joseph Morris, George Nardi, John Nickum, Paul Norton, Paul Olin, Bradley Powers, Robert Ringer, Rosalie Schnick, Darrell Scovell, R. Oneal Smitherman, Gary Stefan, Curt Stutzman, Steve Sundlof, Pete Taylor, Hugh Warren, Curry Woods III, and Kim Young

Appreciation is also expressed to James Davis, Texas Agricultural Extension Service, and Edna Smith, Department of Agricultural Communications, The Texas A&M University, who provided valuable assistance in the printing of the guide.

INTRODUCTION

The aquaculture industry in the United States has grown considerably in recent years and is now recognized as a significant supplier of food products for U.S. consumers. Aquaculture also provides aquatic stocks for recreational fishing, the restoration of threatened and endangered species, and wild stock enhancement, as well as for the bait, aquarium, and ornamental fish trades. To ensure the safety of aquatic food products, the integrity of the environment, the safety of target animals, and the safety of persons who administer various compounds, it is critical that all regulated products be used correctly and responsibly.

The implementation of aquacultural quality assurance programs that are industry developed and driven also is important for U.S. producers and the entire U.S. aquaculture industry, regardless of type of system, location, size of operation, and species grown. Private and public aquacultural producers should use best management practices to provide consumers with safe, wholesome food products and to minimize the use of federally regulated products.

On some occasions, various drugs, disinfectant, pesticides, and veterinary biologics are needed to ensure the health, productivity, and well-being of cultured aquatic stocks and to maintain production efficiency. These regulated products must be used in a manner to avoid risks to public safety and animal health or potential loss of consumer trust.

IT IS THE RESPONSIBILITY OF EVERYONE USING, PRESCRIBING, AND/OR RECOMMENDING THE USE OF REGULATED PRODUCTS TO KNOW WHICH PRODUCTS LEGALLY CAN BE USED UNDER FEDERAL, STATE, AND LOCAL REGULATIONS. Regulated- product uses may vary with different sites, life stages, and conditions.

This guide presents information that can assist U.S. aquacultural producers in providing high-quality, wholesome products. Information is included on drugs, pesticides, vaccines, and other veterinary biologics that currently may be used in commercial or noncommercial aquacultural production.

The reader is encouraged to note the information presented in the Appendixes. Appendix A is concerned with FDA-regulated drugs for use in aquaculture. In Appendix B, EPA-registered pesticides for aquatic sites are listed. USDA-licensed biologics for fish are presented in Appendix C. Readers may find the glossary of common terms listed in Appendix D a handy reference. For sources of further information and assistance, see Appendix E. Appendix F lists sponsors, registrants, licensees, and permittees for the federally regulated products included in the guide.

Although food additives and color additives are used in aquaculture, they are not the focus of this publication. More information on these products may be obtained by contacting governmental agencies or other sources of assistance listed in Appendix E.

Electronic Access

The guide can be accessed electronically via Internet using the Aquaculture Network Information Center (AquaNIC) of the Purdue Cooperative Extension Service and the Purdue University libraries. For details, contact AquaNIC at 317/494-6264 (telephone); 317/494-9347 (fax); or lswann@hub.ansc.purdue.edu (Internet e-mail).

Updating the Guide

New information on the regulatory status of products listed in the guide will be provided biennially. To facilitate the updating process, it is suggested that this publication be bound in a three-ring binder.

As updated information becomes available, replacement pages will be distributed. Each new page should be inserted into the binder to replace the former one. The date of each original page appears just above the page number. Replacement pages will also be dated appropriately.

The electronic version of the guide will be updated as changes occur. Individuals wishing updates on specific products may also contact the Food Animal Residue Avoidance Databank (FARAD) Regional Access Centers listed in Appendix E.

REGULATORY AGENCIES

Several federal and state agencies are involved in regulating the aquacultural use of drugs, vaccines, pesticides, and other products. Each federal agency has specific responsibilities, mandated by Congress, to regulate the products under its respective jurisdiction.

U.S. Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for ensuring the safety, wholesomeness, and proper labeling of food products; ensuring the safety and effectiveness of human and animal drugs; and protecting consumers from economic fraud. The Federal Food, Drug, and Cosmetic Act (FFDCA), the basic food and drug law of the United States, includes provisions for regulating the manufacture, distribution, and use of new animal drugs and animal feed. This law applies to public agencies and organization as well as to private industry.

FDA's regulatory programs are intended to ensure compliance with existing laws. Enforcement activities include actions to correct and prevent violations, remove illegal products or goods from the market, and punish offenders. The testing of domestic and imported aquacultural products for drug and pesticide residues is part of these enforcement activities. The range of enforcement action includes warning letters, seizures, injunctions, and criminal prosecution. FDA's field offices are responsible for initiating and recommending regulatory action. These field offices use guidance provided by FDA headquarters, including the various FDA Centers, to determine whether violations have occurred and, if so, what enforcement action is warranted.

Center for Veterinary Medicine

FDA's Center for Veterinary Medicine (CVM) regulates the manufacture, distribution, and use of animal drugs. CVM is responsible for ensuring that drugs used in food-producing animals are safe and effective and that food products derived from treated animals are free from potentially harmful residues. CVM approves new animal drugs based on data provided by a sponsor (usually a drug company). To be approved, an animal drug must be effective for the claim on the label and safe when used as directed for (1) treated animals, (2) persons administering treatment, (3) the environment, including non target organisms, and (4) consumers. CVM establishes tolerances and withdrawal periods as needed for all drugs approved for use in food-producing animals. CVM has the authority to grant investigational new animal drug (INAD) exemptions so that data can be generated to support the approval of a new animal drug.

Center for Food Safety and Applied Nutrition

FDA's Center for Food Safety and Applied Nutrition (CFSAN) conducts research on and develops standards for the composition, quality, nutrition, labeling, and safety of food, food additives, and color additives. The Center's responsibilities include domestic and imported seafood inspection and the development of seafood policies, standards, and programs, along with seafood research and educational activities. One ongoing program involves the annual pesticide and contaminant sampling of food items, including domestic and imported aquacultural products. CFSAN also reviews and approves industry petitions for the safe use of food and color additives. The Center's Office of Seafood has proposed mandatory seafood inspection regulations for the nation's seafood processors and seafood importers based on Hazard Analysis Critical Control Points (HACCP) principles. This is important for producers because the first critical control point is the quality of the raw product.

U.S. Environmental Protection Agency

The Environmental Protection Agency (EPA) is responsible for registering or licensing all pesticides used in the United States under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA requires that EPA register pesticides for specific uses, provided that the use does not pose an unreasonable risk to human health or the environment. Any pesticide sold or distributed in the United States must be registered by EPA. Places or establishments where pesticides are produced or formulated are also subject to registration.

In addition, EPA sets tolerances or maximum legal limits for pesticide residues in food commodities and animal feed under the Federal Food, Drug, and Cosmetic Act. The purpose of the tolerance program is to ensure that consumers are not exposed to harmful pesticide residues in food.

EPA is required by law to reregister those pesticides registered prior to 1984 in order to reflect changing registration standards that are critical to the protection of human health and the environment. Products regarded as pesticides include algicides, disinfectants, fish toxicants, and herbicides.

Animal and Plant Health Inspection Service

The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture regulates all veterinary biologics produced in, shipped into, or exported from the United States. This includes vaccines, non drug biological therapeutants, and test kits for the diagnosis of disease. It is unlawful to prepare, sell, barter, or exchange worthless, contaminated, dangerous, or harmful veterinary biologics, or to ship unlicenced veterinary biologics for experimental use in animals. States may impose additional requirements on the use of veterinary biologics. For example, APHIS requires that conditional state approval for distribution of products be obtained before APHIS authorizes field trials with experimental products, or before a conditionally licensed product is marketed in the state.

An extensive inspection program involves the monitoring of manufacturing site activities; the testing and release of product batches; and the monitoring of veterinary biologics after licensing to ensure that they are pure, safe, potent, and effective. Every batch of a product produced in the United States or offered for importation is tested by the manufacturer. In addition, samples are sent to APHIS, and each batch is subject to general and/or specific testing by APHIS to ensure that high quality is maintained.

Interagency Jurisdiction

FDA and EPA have some areas of mutual regulatory responsibility. A memorandum of understanding sets forth the responsibilities of each agency under FFDCA and FIFRA. The memorandum also provides guidance in the area of aquaculture, particularly as to which agency has jurisdiction over a particular substance for its intended use.

EPA has jurisdiction over disinfectants, sanitizers, and aquatic treatments used solely for the control of algae or bacterial slime and over any other aquatic treatments used solely for pest control that do not include claims for control of parasites or diseases of fish. EPA or a delegated state regulatory agency also regulates the National Pollutant Discharge Elimination System (NPDES) permit, which allows the discharge of drugs or pesticides into receiving waters.

FDA has jurisdiction over new animal drugs, including products intended to treat or prevent parasites or diseases of fish, anesthetize aquatic species, and alter the sex or regulate the reproduction of aquatic species. FDA has taken the position that if a pesticide registered by EPA for aquaculture or aquatic site use is being used properly (i.e., the labeled conditions in fact exist in the facility or site at the time the pesticide is used, and the compound is not misused under FIFRA), FDA will not object to that proper use even though the pesticide may have a secondary therapeutic benefit.

State Regulatory Agencies

State Departments of Agriculture or other designated state agencies may also register federally approved pesticides to permit their legal distribution and sale within a state or territory. States may have additional regulatory requirements, including additional data and/or additional restrictions on use and licensing. These requirements can affect the distribution and use of pesticides that are purchased from a distributor in one state for intended use in another. States can also issue Experimental Use Permits for a pesticide with an EPA-approved state plan and can provide registration for additional uses of federally registered pesticides to meet special local needs.

Some states license or impose additional regulations on the use of certain veterinary biologics. Some states may not allow the use of specific products or may require that they be administered only by licensed veterinarians. States also participate in the approval of field trials of veterinary biologics in their respective jurisdictions and in the experimental use of certain veterinary biologics.

The use of a drug under an investigational new animal drug (INAD) exemption may require approval by a state agency to comply with any local, state, and/or regional EPA discharge regulations. Discharge approval is intended to ensure that the possible impacts of a discharge (effluent) containing a specific compound or its residues are addressed.

USE OF FEDERALLY REGULATED PRODUCTS

The proper use of regulated products in aquacultural production, handling, and processing promotes human, target organism, and environmental safety; ensures to the greatest extent possible the effectiveness of the products used; reduces overuse, expense, and possible undesirable side effects; and prevents illegal residues in edible products available for human consumption. Food safety and quality are critical factors that influence the long-term development and economic competitiveness of all food production.

Public perception of the safety of food is also very important. Through the proper use of regulated products, the U.S. aquaculture industry can benefit while ensuring public trust and consumer confidence in the safety of U.S. aquacultural products in domestic and international markets.

Safety Considerations

Producers need to establish systems and adopt controls in production and processing that ensure the proper use of regulated products. Producers should evaluate the need for the products carefully and should use them on a schedule to maximize product effectiveness and minimize the amount of the product used. They should also keep detailed chronological records of treatment and of the amounts of the product used.

USERS SHOULD NOT MIX DIFFERENT REGULATED PRODUCTS UNLESS THIS IS SPECIFICALLY RECOMMENDED ON THE PRODUCT LABEL. Combining products can have many--mostly undesirable--effects. One or both products can be inactivated, and chemical reactions can produce harmful gases or other reaction products and by-products--some of them toxic.

Applicators and persons near treatment areas can be affected by various regulated products through contact, exposure to evaporated material in the air, or exposure to dusts or aerosols. Treated waters or airborne drift can carry restricted products to distant locations, where the products may affect non target organisms and sites.

Accidental self-injection of some veterinary biologics and injectable drugs can cause local tissue reactions, allergic reactions, or infections. Use of common sense and strict compliance with product label directions can minimize undesirable effects in humans, non target plants and animals, and the environment. Seek professional advice when in doubt.

The Product Label

ALWAYS READ AND UNDERSTAND THE PRODUCT LABEL BEFORE USING ANY COMPOUND. Label directions and information are important for two reasons. First, they describe the conditions of use under which the product can be expected to be effective and safe. Second, labels for approved products describe uses allowed by law. Any departure from the directions and conditions on the product label or on special state labels could mean a violation of law.

The product label and package inserts provided with regulated products present information on proper storage, mixing, dosage, and administration; date of expiration; diluting or reconstituting the product; safe disposal of the unused product and product containers; and withdrawal times. Pesticide labels list precautionary statements on environmental, physical, and chemical hazards. Pesticide toxicity is identified by signal words on the product label. The terms "danger" and "poison" are used with the most toxic products, whereas "warning" and "caution" are associated with those that are less toxic. The label also identifies restricted use pesticides (RUP).

Prescribed aquatic-use information is usually not found on the product labels of those substances determined by FDA to be unapproved new animal drugs of low regulatory priority (LRP). These compounds are listed in Appendix A (Table 2), as are the specific treatment rates and uses allowed by FDA. Generally, LRP substances are not marketed specifically for aquaculture use.

Economic Considerations

Drugs, pesticides, and vaccines are used to control or prevent specific diseases, water quality conditions, and pest (e.g., weed) or stress problems. THESE TREATMENTS SHOULD BE USED ONLY WHEN NEEDED. Each treatment has an economic value in terms of treatment cost and expected economic benefit. The proper use of regulated products, some of which are quite costly, can be important in preventing significant economic losses. Such losses are more likely to occur if the actual problem is incorrectly diagnosed, if precautions for treatment are ignored, or if treatments are improperly applied.

The use of best management practices in aquatic animal husbandry and water quality maintenance can reduce the use of regulated products and thereby increase profitability. Higher production based on increased dependence on chemicals does not necessarily mean higher profits. Such short-term goals may lead to long-term problems.

Using regulated products at less than the concentrations or dosages specified on the label can cause the treatment to be ineffective or only partially effective. For example, water quality may not be sufficiently improved, pests may not be controlled, vaccines may not protect adequately, and resistant strains of disease organisms may develop.

Using these compounds at concentrations or in dosages greater than those specified on the label (overdosing or over treating) wastes the product and can cause unwanted side effects, including stress and toxicity problems in aquatic stocks and non target organisms as well as environmental damage. Persons applying regulated products should recognize their legal responsibility for any harm to non target aquatic and non aquatic species and for off-site damage.

Legal Options for Obtaining Drugs

According to the Federal Food, Drug, and Cosmetic Act, a drug is defined as an article which is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; an article (other than food) intended to affect the structure or any function of the body of man or other animals; or an article which is recognized in official drug compendia. A new animal drug is a drug intended for animals which is not generally recognized by qualified experts as safe and effective for the uses recommended on the label. NEW ANIMAL DRUGS ARE CONSIDERED ADULTERATED, AND THEREFORE IN VIOLATION OF THE LAW, UNLESS THEY HAVE BEEN APPROVED BY FDA OR ARE THE SUBJECT OF AN INAD EXEMPTION.

At present, no drugs used in aquaculture are considered by FDA to be generally recognized as safe (GRAS) or effective (GRAE) for their proposed uses. For a compound to be classified as GRAS or GRAE, general recognition by experts must be supported by published scientific studies that meet strict FDA standards.

There are several options for legally obtaining and using drugs and chemicals:

1. FDA-approved new animal drugs. Only five new animal drugs are currently approved by FDA for use in food- producing aquatic species. Each drug is approved for specific species, for specific disease conditions, and at specific dosages. Refer to Appendix A (Table 1) for a listing of these approved drugs.

2. Investigational new animal drugs. These drugs are used under an investigational new animal drug exemption. INAD exemptions are granted by FDA CVM to permit the purchase, shipment, and use of an unapproved new animal drug for investigational purposes. INAD exemptions are granted with the expectation that meaningful data will be generated to support a new animal drug approval.

Numerous requirements must be met for the establishment and maintenance of aquaculture INADs. There are two types of INADs: standard and compassionate. Aquaculture INADs, most of which are compassionate, consist of two types: routine and emergency (see Appendix D). A compassionate INAD exemption is used in cases in which the aquatic animal's health is of primary concern.

In certain situations, producers can use unapproved drugs as clinical investigators (under a compassionate INAD exemption) subject to FDA approval. In these cases, producer facilities are used to conduct closely monitored clinical field trials. Producers are thus enabled not only to supply important information to contribute toward the approval of a new animal drug, but also to use unapproved drugs for emergency situations and for special needs in cases in which approved new animal drugs are not available.

FDA reviews protocols, authorizes specific conditions of use, and monitors closely any drug use under an INAD exemption. An application to renew this type of exemption is required each year. Data recording and reporting are required under the INAD exemption in order to support the approval of a new animal drug or an extension of approval for new uses of the drug.

3. Unapproved new animal drugs of low regulatory priority. Neither an approved new animal drug application (NADA) nor an INAD exemption is required for drugs in this category. Although FDA is not aware of safety problems associated with the specific uses of these substances, their uses have not been shown to be safe and effective in well-controlled scientific studies. Regulatory action is unlikely if an appropriate grade is used, good management practices are followed, and local environmental requirements are met. (See Appendix A, Table 2.)

4. Extra-label use of an approved new animal drug. Extra-label drug use refers to the actual or intended use of an approved new animal drug in a manner that is not in accordance with the approved label directions. This includes, but is not limited to, use in species or for indications not listed on the label. Extra-label drugs can be prescribed by a licensed veterinarian under FDA CVM's extra-label drug use policy.

FDA CVM recognizes that there are some diseases for which no drugs are approved. A strict enforcement policy would not allow for the proper treatment of these conditions. CVM's extra-label drug use policy (COMPLIANCE POLICY GUIDE 7125.06) states that licensed veterinarians may consider extra-label drug use in treating food-producing animals if the health of animals is immediately threatened and if suffering or death would result from failure to treat the affected animals. The extra-label policy does not allow the use of drugs to prevent diseases (prophylactic use), improve growth rates, or enhance reproduction or fertility. Spawning hormones cannot be used under the extra-label policy. The veterinarian assumes responsibility for drug safety and efficacy and for potential drug residues in the animal. For further information regarding extra-label drug use, producers should contact their veterinarian.

USE OF DRUGS IN A MANNER OTHER THAN THE OPTIONS DISCUSSED IS SUBJECT TO REGULATORY ACTION BY FDA.

Drugs in Aquaculture Feed

New animal drugs that are added to aquaculture feed are subject to FDA approval and must be specifically approved for use in aquaculture feed. Drugs approved for use in feed, like the drugs approved for administration in other forms, must be safe and effective.

Approved new animal drugs may be mixed in feed only for uses and at levels that are specified in FDA medicated-feed regulations. It is unlawful to add drugs to feed unless the drugs are approved for feed use. For example, producers may not top-dress feed with a water-soluble, over-the-counter antibiotic product.

Some medicated feeds, such as Romet 30, may be manufactured only after FDA has approved a medicated-feed application (Form FDA 1900) submitted by the feed manufacturer. This requirement applies whether the producer or a commercial company makes the medicated feed. Neither an approved 1900 Form nor FDA registration is required for the manufacture of certain other medicated feeds, such as those containing Terramycin. However, those who manufacture such feeds are subject to the regulations covering current good manufacturing practices and drug usage.

Water Treatments

Many of the chemicals used in aquaculture are applied directly to water. The federal agency (either FDA or EPA) with jurisdiction over chemicals applied to the water is determined by the intended use of the product.

Fish and other aquatic species are exposed to any compound present in the water. An off-flavor is an example of a condition that can develop when fish are exposed to certain compounds--even those found naturally in water.

Although some products may be beneficial when applied to aquaculture systems at low concentrations, they may also act as irritants or even become toxic at higher concentrations. The improper use or application of water treatments can cause severe stress, which can lead to an animal disease outbreak or even death. Some compounds can accumulate in the animal and may cause illegal chemical residues in tissues intended for human consumption. Illegal residues can also result from the improper use of products to control weeds or unwanted fish or to alter water quality. To prevent possible fish losses and illegal chemical residues from excessive treatment levels, always read and strictly follow product label directions.

Record keeping

Record keeping is essential for any aquaculture business and is a critical element of quality assurance programs. A good record keeping system helps producers keep track of specific treatments and their results with identifiable, known populations or stocks of aquatic animals, as well as the specific water and land areas involved.

Good records provide a basis for sound, cost-effective management decisions. The treatment status of animals, ponds, and other areas is known at all times. Records are needed to determine dosage rates and certify withdrawal times. Processors may require records to demonstrate that all drugs and chemicals have been used properly. Federal seafood processing inspection regulations may also require such record keeping. Records provide valuable evidence and protection in liability case.

Accurate record keeping is required for any producer using an INAD exemption in clinical field trials. In case of crop loss resulting from a natural disaster, proper records are necessary for eligibility and possible compensation under federal programs. Lenders may require that production input and output records be kept for at least 2 years.

New pesticide record keeping regulations for farmers went into effect in 1993. The regulations require that private as well as commercial users of restricted use pesticides keep records of the use of these compounds. No record keeping is required for general use pesticides, which do not have the restricted use pesticide designation. The records must indicate the date of use, the product name, the EPA product registration number, the size of the area treated, and the amount of the product used on the site as well as the name and license number of the applicator. Records must be kept for 2 years from the date of application.

Check with your county agricultural Extension office for record keeping help and record keeping requirements, such as those for restricted use pesticides. Assistance is also available for other farm record keeping systems.

Calculating Withdrawal Times

Product withdrawal times must be observed to ensure that any product used in an aquatic site or on animals does not exceed legal tolerance levels in the animal tissue. Using proper withdrawal times helps to ensure that products reaching consumers are safe and wholesome.

All federally approved products list any specific required withdrawal times. Withdrawal information is found on the product label, package insert, or feed tag. An exception to withdrawal requirements is made for products used in an extra-label manner. Extra-label use may require the same or a different withdrawal time from that listed on the label, depending on the species, treatment, and other conditions. Withdrawal times for the extra-label use of an approved product are not listed on the label and must be determined by the prescribing licensed veterinarian.

Withdrawal times are usually reported as a specific number of days. Each withdrawal day is a full 24 hours, starting from the last time an animal receives or is exposed to a drug, pesticide, or vaccine. For example, a treatment with a product that has a 5-day withdrawal time is completed at 9:00 a.m. on Friday. At 9:00 a.m. on Saturday, the treated animals have completed their first withdrawal day. The fifth withdrawal day will end at 9:00 a.m. on Wednesday. Waiting restrictions may apply not only to the slaughter time for treated aquaculture stocks but also to treated water used for swimming, livestock watering, crop or turf irrigation, a potable drinking supply, or other purposes.

Storage, Handling, Mixing, and Disposal

Always follow label directions for storing, handling, mixing, diluting, reconstituting, and disposing of regulated products and their containers. This preserves the activity and quality of the product and helps prevent misuse, damaging effects on plants and animals, human injury, and environmental contamination.

Disinfectants, pesticides, and most drugs should be stored in a locked cabinet in a dry, well-ventilated utility area away from children, animals, food, feed, and living areas. Some drugs and veterinary biologics require refrigerated storage; other products require storage in a freezer or at room temperature. All disinfectants, pesticides, drugs, and veterinary biologics should be stored away from bright light, because light can cause inactivation or deterioration of the product. Most of these compounds should be stored in the dark, or at least in closed carton.

Regulated products should be stored in their original containers with the original label attached. Dampness in storage areas can cause paper packages to deteriorate, metal containers to rust, and metal and glass containers to lose their labels. Disinfectants, pesticides, and drugs should not be stored where flooding is possible or in sites where they might spill or leak into the environment. High-temperature storage (above 80 or 90 degrees Fahrenheit) can cause excessive pressure in and bursting of sealed containers. Exposure to high temperatures can also result in product deterioration, shortened shelf-life, premature inactivity, and inactivation.

Proper mixing, diluting, and reconstituting are essential for the effectiveness of products requiring such steps as well as for reasons of safety. Powders may be harmful or toxic if they are inhaled as dusts; fumes and evaporating ingredients may also be harmful or toxic. Improper dilution may cause the concentration or dosage administered to be too great or too small. Incomplete mixing can cause variations in the concentration or dosage applied or administered, with uneven effects ranging from ineffectiveness to overdose and toxicity. Some veterinary biologics are supplied with accompanying diluents that are necessary for reconstitution and the proper concentration of materials.

The use of any pesticide (and some other regulated products) requires adequate protection from exposure. Users should always read the product label for information on recommended personal protective equipment. Common-sense precautions should be followed, such as wearing gloves, long-sleeved shirts and long pants, socks, shoes or boots, a hat and goggles, protective glasses, and/or a face shield. Some pesticides may require use of a respirator. Persons mixing and/or applying pesticide, or working in an area where pesticides are being applied or have recently been applied, should shower and wash their clothes after actual or possible exposure.

As emphasized earlier, USERS SHOULD NOT MIX DIFFERENT REGULATED PRODUCTS UNLESS THIS IS SPECIFICALLY RECOMMENDED ON THE LABEL. The combining of products can have many--mostly undesirable--effects. One or both products can be inactivated, and chemical reactions can produce harmful gases or other reaction products and by-products, some of them toxic. Following appropriate precautions can prevent accidental poisoning from pesticide contact with bare skin or from the inhalation of fumes or dust.

The pesticide label provides important product-specific information on mixing, diluting, storage, and disposal, as well as on first aid in the event of accidental poisoning. Material Safety Data Sheets, provided by product manufacturers upon request, are a source of additional information on safety precautions.

It is important that unused portions of a regulated product and empty containers be disposed of properly. The best approach is to purchase only the amount of material that will be used within a reasonable time period and to use all of the product for its intended purpose. Empty containers must be disposed of, however, and often a quantity of the product is left over. Product labels provide instructions for safe disposal; these instructions should be followed. Improper disposal can result in toxicity, environmental contamination, and liability problems.

Contact the county agricultural Extension office in your area for further information on product storage and handling and on local regulations for the disposal of pesticide containers.

Pesticide Applicator Certification

Restricted use pesticides can be purchased and applied only by a Certified Pesticide Applicator or under a Certified Applicator's direct supervision. Certification includes both "private" (mostly farmers) and "commercial" applicators. Pesticide certification programs are offered through state Departments of Agriculture and state Cooperative Extension Services and through EPA regional offices.

Fish toxicants listed in Appendix B (Table 2) provide examples of restricted use pesticides. For information on pesticide use, training programs, and certification requirements in any state, contact your local county agricultural Extension office.

Importation of Regulated Products

To be imported, a new animal drug must either be approved by FDA or be intended for investigational use under an INAD exemption. Without approval or proper identification as an investigational new animal drug, a compound can be refused entry into the United States. If the drug is imported under false pretenses, the responsible person(s) involved are subject to enforcement action by FDA as well as the U.S. Customs Service.

Veterinary biologics may be imported only under a permit, and veterinary biologics for sale must meet U.S. requirements. To ensure compliance, manufacturing specifications are monitored, and manufacturing facilities are inspected. Manufacturers of veterinary biologics for experimental use or field testing must meet strict permit requirements and must have provided extensive information to APHIS prior to the issuance of a permit. Permits are not issued for preventive products if the organism in question does not exist in this country.

Regulations also require that before any person in a state or foreign country can sell or distribute any pesticide in the United States, he or she must obtain a registration from EPA. Pesticides produced by foreign manufacturers and imported into the United States must comply with all requirements applicable to domestic manufacturers. In addition, the regulations require an importer to submit to EPA a Notice of Arrival of Pesticides and Devices for review and for a determination as to whether the shipment should be sampled and/or permitted entry into the United States.

Tips for Use of Regulated Products

1. Obtain a diagnosis of the problem(s) before applying any treatment.
2. Seek professional advice if ever in doubt as to when or how to use regulated products.
3. Use regulated products only for those species and indications listed on the label, unless extra-label use is specifically prescribed by a licensed veterinarian.
4. Read the product label carefully.
5. Use the proper dosage, amount, or concentration for the species, area, and/or specific condition.
6. Use the correct method and route of application or administration, whether by spraying vegetation, water treatment (ponds, tanks, or immersion), injection, or oral administration (with medicated feed and some biologics).
7. Calculate withdrawal times accurately.
8. Identify treated populations or stocks with clear markings of production and holding units.
9. Do not use antibiotic drugs or medicated feed for disease prevention unless they are specifically approved for that use.
10. Do not substitute unlabeled or generic products for trade-name products that are labeled and approved for aquaculture or aquatic site uses.
11. Keep accurate records.
12. Consider the environmental impact of discharging treated water, including possible effects on non target organisms.
13. Adopt a producer quality assurance program or a Hazard Analysis Critical Control Points (HACCP) program that provides guidelines for preventing tissue residue violations and for producing high-quality, wholesome products for consumers.
14. Be aware of personal safety measures and proper procedures for farm workers and pesticide applicators who handle or apply regulated products.
15. Consider the economic consequences, both short- and long-term, of treatment before using a regulated product.

APPENDIXES: FEDERALLY REGULATED PRODUCTS AND DIAGNOSTIC TEST KITS

The legal status of regulated products approved, registered, or licensed for aquaculture or for aquatic site uses can change for a variety of reasons, such as new or terminated approvals, reregistrations, or new data. For updated information on the status of a regulated product, contact any FARAD Regional Access Center or other organizations and agencies listed in Appendix E. It is especially important to avoid introducing potentially harmful chemicals into the food chain through improper product use. This can occur not only through direct exposure of food fish to such chemicals, but also through indirect means (for example, livestock contact with contaminated water).

Some products may be approved only for use with non-food fish or for certain life stages of aquatic species. The use of products may also be restricted to specified aquatic sites (for example, drainage ditches) rather than sites containing aquatic food species.

IT IS THE USER'S RESPONSIBILITY TO KNOW WHETHER A PARTICULAR PRODUCT IS APPROVED FOR AN INTENDED USE IN AQUACULTURE. Refer to the product label for information on dosages, conditions of use, withdrawal times, and other instructions for product use. Be sure to read the entire label.

APPENDIX A: FDA-REGULATED DRUGS FOR AQUACULTURE

The drugs listed in this section include FDA-approved new animal drugs as well as unapproved drugs of low regulatory priority (LRP) for FDA. Federal approval of new animal drugs applies only to specific products that are the subject of approved new animal drug applications.

Active ingredients from sources other than the listed sponsors are not considered approved new animal drugs. Such products cannot legally be marketed or used. States may impose additional regulatory requirements and restrictions on FDA-regulated drugs for aquaculture.

Table 1. FDA-Approved New Animal Drugs

Table 2. Unapproved Drugs of Low Regulatory Priority for FDA(See NOTE at bottom of table.)

NOTE: FDA is unlikely to object at present to the use of these low regulatory priority substances if the following conditions are met:

1. The drugs are used for the prescribed indications, including species and life stage where specified.
2. The drugs are used at the prescribed dosages.
3. The drugs are used according to good management practices.
4. The product is of an appropriate grade for use in food animals.
5. An adverse effect on the environment is unlikely.

FDA's enforcement position on the use of these substances should be considered neither an approval nor an affirmation of their safety and effectiveness. Based on information available in the future, FDA may take a different position on their use.

Classification of substances as new animal drugs of low regulatory priority does not exempt facilities from complying with other federal, state, and local environmental requirements. For example, facilities using these substances would still be required to comply with the National Pollutant Discharge Elimination System (NPDES) requirements.

APPENDIX B: EPA-REGISTERED PESTICIDES FOR AQUACULTURE/AQUATIC SITES

The trade names and common names listed in this section are registered by EPA for application and use in aquatic sites. Before purchasing or using any commercial product, read the label carefully to make certain that the product is approved for its intended use. IT IS THE RESPONSIBILITY OF THE APPLICATOR TO USE THE PROPER COMPOUND(S) AND TO READ AND FOLLOW LABEL DIRECTIONS.

The following tables include general information rather than detailed instructions on the specific conditions of use for each product. Restrictions may apply to the use of some compounds. For example, a pesticide or fish toxicant MAY BE APPROVED ONLY FOR USE WITH NON-FOOD FISH SPECIES or for certain sites, such as drainage ditches. In some cases, a specified waiting time must elapse before treated water can be used for crop irrigation, livestock watering, or other purposes.

Restricted use products such as rotenone fish toxicants can be purchased only by a Certified Pesticide Applicator and can be applied only by a Certified Pesticide Applicator or under a certified applicator's direct supervision. To identify such products, look for the "restricted use pesticide" designation on the label.

The following explanations are necessary to understand the product listings in this section. The products are subject to manufacturers' name changes as well as inevitable lag time between EPA registration and updates of the EPA PEST-BANK database from which the listings are derived. Some products are not currently being distributed despite the fact that their EPA registrations are still active. EPA is currently re-registering all pesticides registered prior to 1984. In many cases, this process requires new data. Consequently, some product registrations are not being maintained.

Disinfectants are not included in this listing. Refer to FARAD for current information on EPA-registered disinfectants used to sanitize or disinfect facilities and equipment. ALWAYS REFER TO THE PRODUCT LABEL FOR DETAILS ON RECOMMENDED OR APPROVED TREATMENT RATES AND USAGE AS WELL AS FOR ANY RESTRICTIONS ON USE. Updated information on the status of regulated products may be obtained by contacting the Food Animal Residue avoidance Databank and the other sources of information and assistance listed in Appendix E.

Table 1. EPA-Registered Algicides

Table 2. EPA-Registered Fish Toxicants

Table 3. EPA-Registered Herbicides