1. Profile
    1. Basic legislation
    2. Legal definition
    3. Guidelines and codes of conduct
    4. International arrangements
  2. Planning
    1. Authorization system
    2. Access to land and water
    3. EIA
  3. Operation
    1. Water and wastewater
    2. Fish movement
    3. Disease control
    4. Drugs
    5. Feed
  4. Food safety
    1. Miscellaneous
      1. References
        1. Legislation
        2. Related resources
      2. Related links
        Basic legislation
        Aquaculture in the United States of America (U.S.A.) is regulated at the federal and state level. The Food and Drug Administration (FDA) of the Department of Health and Human Service (DHHS), the Department of Agriculture (USDA), and the Environmental Protection Agency, are the leading federal agencies that regulate aquaculture within the United States of America. There are other agencies and programs at the federal level involved in aquaculture activities such as the National Oceanic and Atmospheric Administration (NOAA) in the Department of Commerce, the Joint Subcommittee on Aquaculture, the Center for Veterinary Medicine (FDA), the Animal and Plant Health Inspection Service (USDA), and the U.S. Fish and Wildlife Service (FWS) of the Department of the Interior. The federal government regulates those aquaculture and food-related activities that involve the trade of goods and services between the states, or with foreign countries.

        Because many of the federal regulations and statutes also apply to the states, this study focuses on the application of federal and state legislation, as applied within the state. The relevant federal statutes rarely address aquaculture directly, and more detailed legislation exists at the state level. For example, the Federal Water Pollution Control Act, the Food, Drug & Cosmetic Act, the Animal Drug Availability Act, and the Magnuson-Stevens Fisheries Conservation Act do not significantly address aquaculture, but provide the statutory framework for regulating food safety, veterinary medicines, HACCP programs, coastal zone management, and other activities related to aquaculture. In many instances, it is the state that monitors and enforces both federal and state aquaculture regulations.

        Although the United States of America aquaculture industry is the most robust in the states bordering the Gulf of Mexico such as Florida, Louisiana, and Alabama, this study focuses on the application of aquaculture regulation in California and Florida, in part due these states's vast coastline, interstate river systems, and the variety of aquaculture activities ensuing from their diverse climate and terrain. The California Resource Agency is the lead agency within California, responsible for the statutory framework of state aquaculture activities in the state. The Agency is made up of several departments, including the California Department of Fish and Game (CDFG), and the Department of Water Resources. However, the Department of Fish and Game takes the lead role in regulating California's aquaculture. Other agencies that regulate certain aquaculture activities such as food safety and water discharge permits include the California Department of Food and Agriculture (CDFA), and the California Department of Health Services (CDHS). In Florida, the Florida Department of Agriculture and Consumer Services (DACS) is the lead aquaculture agency. The Aquaculture and Licensing division of the agency implements key state aquaculture policies. The Aquaculture Review Council, a stakeholder advisory group of commercial aquaculturists, also assists the agency in developing an annual Aquaculture Plan. As a general rule, federal regulations become applicable within the state when aquaculture activities involve interstate modes of transport, or interstate waters.
        Legal definition
        At the federal level, aquaculture is defined in the National Aquatic Act of 1980  as the “propagation and rearing of aquatic species in controlled or selected environments, including but not limited to, ocean ranching (except private ocean ranching of Pacific salmon for profit in those States where such ranching is prohibited by law)”. In California (CA), aquaculture is defined in the Fish and Game Code and the Public Resource Code.

        In Florida (FL), aquaculture is defined in the Aquaculture Policy Act, which is a part of the Florida Statutes on Agriculture, Horticulture, and Animal Industry (Chapter 597, Title XXXV). Aquaculture is also defined in the annual Florida Aquaculture Plan. The CA Fish and Game Code defines aquaculture as a form of agriculture, “devoted to the propagation, cultivation, maintenance, and harvesting of aquatic plants and animals in marine, brackish, and freshwater,” and the CA Public Resource Code, defines aquaculture as “the culture and husbandry of aquatic organisms, including, but not limited to, fish, shellfish, mollusks, crustaceans, kelp, and algae.”

        The FL Aquaculture Policy Act and the 2013-2014 FL Aquaculture Plan define aquaculture as “the cultivation of aquatic organisms.”
        Guidelines and codes of conduct
        International arrangements
        International Organizations with aquaculture activities to which the United States of America is a party:
        • African Development Bank Group.
        • Asia-Pacific Economic Council.
        • ASEAN Regional Forum.
        • Asian Development Bank.
        • Food and Agriculture Organization.
        • Inter-American Development Bank.
        • International Fund for Agricultural Development.
        • International Maritime Organization.
        • Office International des Epizooties (OIE).
        • Organization for Economic Co-operation and Development.
        • United Nations.
        • World Bank Group (IBRD, IFC, IDA, MIGA).
        • World Health Organization.
        • World Trade Organization.
        International agreements with aquaculture activities to which the United States of America is a party:
        • International Plant Protection Convention (Ippc).
        • Agreement to Promote Compliance with International Conservation and Management Measures by Fishing Vessels on The High Seas.
        • Food Aid Convention, 1980.
        • Codex Alimentarious.
        • Convention on the Inter-American Institute for Cooperation on Agriculture.
        • Convention on Biological Diversity.
        • Convention for the Conservation of Anadromous Stocks in the North Pacific Ocean.
        • Fisheries Treaty with Certain Pacific Island States.
        • Amendment to the 1978 Convention on International Trade in Endangered Species of Wild Fauna and Flora.
        • North American Free Trade Agreement between the Government of Canada, the Government of the United Mexican States, and the Government of the United States of America (NFTA).
        Other United States of America International agreements, available at:
        Authorization system
        The CDFG regulates and licenses aquaculture activities within the State of California. All fish-farming activities, including activities in coastal waters within three miles of the state's coast line, are subject to state regulations. It is unlawful to conduct aquaculture operations or to culture approved species of aquatic plants and animals unless registered with state authorities. Furthermore, it is unlawful to spawn, incubate, or cultivate any species of finfish belonging to the family salmonidae, transgenic fish species, or any exotic species of finfish, in coastal waters managed by the state.

        Aquatic plants and animals, including fish, may only be collected by a registered aquaculturist, with written approval of CDFG. The owner of each aquaculture facility must register with the department, specifying the identity of the owner, the species grown, and the location of each aquaculture operation. The department specifies the time, place, and manner of collection, and allocates a fee sufficient to cover the cost of processing the approval. In California, broodstock can only be received from a licensed commercial fisher, a registered aquaculturist, CDFG, or an authorized importer. CDFG may assess a fee on aquaculture products grown on public land or water, and may prohibit an aquaculture operation where it is determined to be detrimental to adjacent native wildlife.

        In Florida, the Division of Aquaculture regulates and certifies aquaculture activities within the state. Any person engaging in aquaculture must be certified by the Division. Applications must include. inter alia, a legal property description, an actual physical street address, and description of production facilities at each aquaculture facility. It is unlawful for an aquaculture registrant to commingle any shellfish aquaculture product with a wild product in the same container. It is also unlawful to transport by vessel over water wild and aquaculture products of the same species at the same time.

        Special regulations apply to the cultivation and processing of shellfish. A lease must be granted by the state to any qualified person that seeks to lease a part of the bottom, water column, or bed of any state waters for the purpose of growing oysters or clams. Special activity licenses can also be authorized to permit the harvest or cultivation of oysters, clams, mussels, and crabs. It is unlawful to use a dredge or any means other than hand tongs to remove oysters from natural or artificial state reefs or beds.
        Access to land and water
        Granting access to land and water for aquaculture is primarily the responsibility of the state. The California Fish and Game Commission may lease state water bottoms to any person for aquaculture activities, and adopt regulations governing the terms of the leases. State water bottoms can only be leased if the commission determines that the lease is in the public interest. Designated areas used for public clam digging are not eligible for lease. An application to lease water bottoms must contain, inter alia, a map of the area to be leased, ownership and boundary lines, a description of the organisms to be grown, and the culture techniques to be used. The CA State Legislature retains the authority to increase or decrease the rents, fees, taxes, and other charges relating to the lease, however increases in rent do not take effect until renewal of registration. No initial term of a state water bottom lease can exceed 25 years.

        At the state level, the CDFG may assess a fee on persons growing aquaculture products on public lands and in public waters based on the price per pound of the products sold. The fees are allocated at an amount necessary to defray the costs of the commission and the department.

        California coastal waters extend three miles seaward from the coastline. CDFG drafts a master plan for coastal zone management with a team from the Department of Parks and Recreation, and the State Water Resources Control Board. The master plan is prepared in consultation with participants in the various fisheries, marine conservationists and scientists, etc. California also designates marine protected areas (MPAs) and marine managed areas (MMA), which are primarily intended to protect or conserve marine life and habitat. The Fish and Game Commission may authorize commercial and recreational fishing activities in the MPAs. In general however, it is unlawful to take marine fish in a reserve, except through authorization of the Commission for scientific purposes.

        In Florida, qualified persons may file a lease application form to use a part of the bottom, water column, or bed of any state waters. The lands leased should be as compact as possible. DACS will use official surveys or can make its own survey before granting the lease. The FL State Legislature may set fees, surcharges, and conditions associated with the lease. Lessees are subject to cultivation requirements regarding the density, type, shape, depth, size, and height of cultch materials. Leases are inheritable and transferable, and also subject to mortgage, pledge, hypothecation, seizure and sale for debts. Leases to natural reefs or beds can be cancelled after an investigation has been conducted to confirm that the leased area constitutes a large enough area with sufficient natural or maternal oysters or clams to constitute a stratum sufficient for public use. Natural reefs or beds may be included in leases if it is in the best interest of the state. A special protection exists for Franklin County, where only certain leases are allowed, and DACS may include restrictions it deems necessary to protect the environment, existing leaseholders, and public fishery.
        In California, an environmental impact assessment is not required before an aquaculture facility is registered. The CDFG may however, prohibit the culturing of any species at a location determined to be detrimental to native wildlife. In general however, the use of any vacuum or suction dredge equipment is prohibited in any river, stream, or lake, except by permit. Before a permit is issued, an application must be submitted to the department, specifying the type and size of equipment to be used and other information as the department may require. A permit to vacuum or dredge will be issued where the department determines that the operation will not be deleterious to fish. The permit also designates waters or areas wherein vacuum or suction dredges may be used, the maximum size of dredges, and the time of year the dredges may be used. Where discharge of pollutants is into inter-state waters, a state-level permit system must receive approval from the Environmental Protection Agency (EPA) before issuing such a permit.

        Similar restrictions exist in Florida, where an environmental impact assessment is also not required to certify an aquaculture facility.
        Water and wastewater
        Wastewater discharge and water quality are controlled at both the federal and the state level. The Environmental Protection Agency (EPA) is the lead federal agency that regulates water quality, and the Department of Water Resources is the lead agency in California, and the Department of Environmental Protection handles water management in Florida. In Florida, the Department is further divided into five water management districts, each of which issues a separate consumptive use permit. Under the Federal Water Pollution Control Act (“Clean Water Act”), any activity that may result in a discharge of pollutants into navigable waters, including construction or operation of a facility, must provide a state-issued permit, certifying the discharge is in compliance with specified federal standards. According to the Clean Water Act, the State must provide public notice when the state receives applications for discharge permits, and provide hearings as necessary. The Clean Water Act's National Pollutant Discharge Elimination System (NPDES) authorizes the EPA to permit the discharge of pollutants into “navigable waters” of the United States of America (i.e. rivers, lakes, and streams that cross state boundaries). The NPDES permit can be issued by the CA State Water Resources Control Board or the FL Department of Environmental Protection, which both monitors and enforces EPA regulations.

        A state's governor wishing to administer a state-wide program for discharge of pollutants into United States of America navigable waters can apply to the EPA, ensuring, inter alia, that the laws of the state provide adequate authority to carry out the proposed program. The program must meet federal effluent standards, water quality effluent limitations, water quality standards, and limits for toxic effluents. The permits are not to last more than five years.

        At the federal level, the EPA's involvement also includes a Coastal Water Quality Monitoring Program that measures the quality of the nation's coastal ecosystems through collection and assimilation of scientific data. Among other things, the program identifies and analyzes sources of environmental degradation, accumulation of floatables, and analyzes short- and long-term trends in environmental quality. The program also coordinates monitoring activities of other federal agencies with similar reporting requirements under the Clean Water Act. States that offer discharge permit systems to coastal aquaculture facilities must do so in compliance with the program.

        The EPA may issue a dumping permit where the agency determines that such dumping will not unreasonably degrade or endanger human health, welfare, amenities, the marine environment, ecological systems, or economic potentialities. The EPA takes into consideration the effect of dumping on human health and welfare, the effect, or potential effect of dumping on fisheries resources, plankton, fish, shellfish, wildlife, shore lines and beaches, and marine ecosystems. No permit is required for the dumping of fish waste, except when waste would be deposited into harbors or other protected coastal waters, or where the EPA finds a potential danger to human health, the environment, or ecological systems.

        The Clean Water Act also directs the EPA to review effluent guidelines and set schedules for effluent guidelines within federal waters. In 2004, the EPA finalized the Effluent Limitations Guidelines and New Source Performance Standards for the Concentrated Aquatic Animal Production Point Source Category. The rule establishes effluent limitations guidelines (ELGs) for facilities that directly discharge wastewater, produce at least 100 000 pounds of fish a year, and use flow-through, recirculating, or net pen systems. The guidelines aim to help reduce discharges of conventional pollutants (primarily total suspended solids), and reduce non-conventional pollutants such as nutrients, and to a lesser extent, reduce the discharge of drugs and chemicals that are used to manage fish health.
        Fish movement
        A Prior Notice of Imported Food Shipments must be filed with the FDA before the arrival of fish into the United States of America. Meat, poultry, and egg products are under the exclusive jurisdiction of the USDA. An importer must provide written verification that the fish or fish products were processed in accordance with FDA regulations. FDA routinely conducts inspections of seafood importers to assure compliance. FDA also regulates the importation, interstate movement, and field testing of genetically modified organisms (GMOs), including fish, pursuant to its regulatory authority under the Plant Protection Act of 2000.

        Exporters of fish or fish products must keep records demonstrating that the products meet the requirements the Federal Food Drug & Cosmetic Act (FFDCA). Records related to food should be kept for a minimum of three (3) years, and all other records should be kept for a time period required by good manufacturing practice or quality systems regulations. These records should demonstrate, inter alia, that the exported product meets the foreign purchaser's specifications, that the product does not conflict with the laws of the importing country, that the product is labeled as an export, and the exporter should maintain records indicating the product is not for sale within the United States of America. Depending on the foreign nation, an export health certificate endorsed by USDA's Animal and Plant Health Inspection Service (AHIPS) may be required to verify the health status of the fish.

        In November of 2005, a joint Health Certificate for the Export of Live Crustaceans, Finfish, Mollusks, and Related Products, was proposed by APHIS, NOAA, the National Marine Fisheries Service (NMFS), United States of America Department of Commerce, and the Fish and Wildlife Service (FWS). The proposed health certificate will bear the logo of all three agencies when an export health certificate is issued. The certificate will require the names of the species exported from the United States of America, their age and weights, their place of origin, country of destination, date and method of transport, and designate whether they are cultured stock or wild stock. This certificate is based upon the international veterinary health certificates in the Aquatic Animal Health Code (2005) designed by the Office International des Epizooties (OIE, i.e. the World Organization of Animal Health).

        At the state level, the CA Fish and Game Commission may regulate the transportation, purchase, possession, and sale of specific aquaculture products when necessary for the protection of native wildlife. Written approval from the CDFG is required before the importation of live aquatic plant or animal into the state of California. In addition, a certificate of veterinary inspection (CVI) may be required by an importing state. Issued by a licensed veterinarian, a CVI is an official document certifying that an animal appears healthy and shows no sign of contagious or communicable diseases.

        A permit issued by the State of California must enumerate the approximate number of imports, the scientific name of each species, the carrier, probable point of first entry into the state, the purpose of importation or transportation, and the identity of the consignee and consignor. The permit must also contain a statement describing the manner and conditions of entry, and a statement certifying the conditions under which the species will be kept after importation. Fees for permits, applications, and facility inspections are adjusted to cover the costs of administering, implementing, and enforcing the department's regulations.

        It is unlawful to import live fish, fresh or saltwater animals, or aquatic plants into California without submitting the stock for inspection. The CDFG can inspect the aquaculture facilities, of each person holding a permit. Any person who transports, receives, or imports any live wild animal into California, must hold the animal in confinement for inspection. If there are any species presented upon inspection that are not named in the permit, or are present in greater number than the permit provides, the animals are not admitted into the state. If an inspection of an aquaculture facility or shipment reveals a disease, or there is reason to suspect the presence of a disease, the diseased animal, or the entire shipment can be destroyed. The shipment will not be destroyed if its quarantine and subsequent disinfection does not cause harm, or the shipment can be returned to its point of origin without detriment.

        In Florida, the FL Fish and Wildlife Conservation Commission protects and manages commercial freshwater and saltwater fishing. Fishers must obtain a Saltwater Fishing License before harvesting or selling any marine fish or other saltwater products in the state. A commercial fishing license is also available for freshwater fish or frogs. Licensees may sell to anyone but cannot buy fish for the purpose of sale. Licenses requirements and fees differ based on whether the applicant is a resident of the state of Florida or not. Licenses and restriction also vary by dealer type. For example, the registration fees for wholesale dealers are significantly higher than those for retail dealers. Lastly, any Floridian that processes or sells food products must possess a Food Permit issued by the DACS.
        Disease control
        Collectively, the FDA, APHIS, and the FWS are involved in the regulation, research, and control of fish-related diseases and pests that may affect man or animal. In addition, APHIS and the National Animal Health Monitoring System (NAHMS) also ensure disease prevention, health, and quality of animal products by collecting, analyzing and disseminating data relating to animal health, management and productivity. The FWS is involved in research, conservation, protection, and health of fish habitats and production. At the federal level, the FWS’s California – Nevada Fish Health Center, deals with detection and prevention of diseases and parasites that threaten aquatic species. The Center supports federally funded fish hatcheries within California by providing health diagnostic and inspection services. In addition, the Center works with other federal and local agencies in surveying, sampling, and analyzing hatchery and wild fish populations.

        Also at the federal level, the Joint Subcommittee on Aquaculture (JSA) has commissioned a National Aquatic Animal Health Task Force on Aquaculture to develop a national strategy for the management and protection of wild and cultured aquatic species. The plan, to be completed in 2007, is to provide for the safe and effective international and domestic commerce of aquatic animals; protection of aquatic animals from foreign pests and diseases; diagnostic and certification services; and the plan assists the United States of America government in meeting its trade obligations.

        Within California, both the CDFG and the California Department of Health Services (CDHS) are responsible for disease control. CDHS is responsible for those diseases that potentially affect humans, while CDFG is responsible for aquaculture disease detection, control, and eradication that do not affect human health. The Fish and Game Commission, in consultation with the CA Aquaculture Disease Committee (CADC) and the CDFG compiles a list of diseases and parasites and the aquatic plants and animals they are known to infect or parasitize. The CADC may recommend such regulations as monitoring and diagnostic procedures, criteria for ordering quarantine, methods for the destruction of quarantined animals, and compensation.

        The CDFG is authorized at all times, to enter any car, warehouse, depot, ship, or growing area where any fish are held or stored, in order to examine and to ascertain whether such fish are infected, diseased, or parasitized. If any of the diseases or parasites is found, CDFG and CADC may establish a quarantine area and list the aquatic plants and animals affected by the quarantine. The department may post weekly notices describing the boundaries of an area within which specific disease or parasite infestations are found. The department may hold and impound diseased or parasitized plants and animals, or restrict the movement of all fish and other plants and animals, subject to the disease or parasite. The department may also order the destruction and disposal of diseased or parasitized plants and animals.

        In general, it is unlawful to move any aquatic plants or animals subject to quarantine, across the quarantine line unless a permit is obtained from the CDFG. The Director of the Fish and Game Department may issue a permit after inspection of the quarantined facility, if the quarantined shipment, premises, transportation vehicles, and equipment are properly cleaned and disinfected. The owner of an aquaculture facility is responsible for cleansing the quarantined area. If the owner does not pay for disinfecting the quarantined area, then the owner must reimburse the CDFG for its eradication expenses. Where aquatic animals or plants are destroyed, the owner of the product is compensated seventy-five (75) percent of the replacement value. Where there is a dispute over the value of the fish destroyed, the statue allows the parties to arbitrate.

        The Florida DACS Division of Food Safety and the Florida Department of Health promote and conduct food safety, sanitation, and inspection programs. The Division of Food Safety conducts food establishment inspections, certifies food managers, runs food grading programs, and a HACCP program. To satisfy the Interstate Shellfish Sanitation Conference (ISSC) guidelines, DACS staff collects water and shellfish samples for testing, to ensure that red tide cell counts and brevetoxin toxicity levels are permissible.
        At the federal level pesticide regulations are derived from two primary sources, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)  , the FFDCA, and the Food Quality Protection Act of 1996 (FQPA)  , amending both FIFRA and FFDCA. EPA uses FIFRA to prescribe labeling and prevent adverse effects upon human health and the environment, while the FFDCA is used to set tolerances for pesticide residue levels in food. The FQPA resolves inconsistencies between the two pieces of legislation and among other things requires periodic re-evaluation of tolerances, and applies a new safety standard to ensure with reasonable certainty that no harm will ensue from use of new and existing pesticides. Enforcement of pesticide regulations is split between the Food and Drug Administration and USDA's Food Safety Inspection Service (FSIS).

        The United States of America Environmental Protection Agency (EPA) sets federal standards for pesticide residues (i.e. tolerances) in food, which are specified in the United States of America Code of Federal Regulations. The FDA and FSIS monitor food within the chain of commerce to ensure that pesticide levels do not exceed permitted tolerances. In addition, the FDA regulates the manufacturing, registration, distribution and testing of chemicals and veterinary drugs in fish and other foods, under authority of the FFDCA. The quality, safety, and efficacy of any marketed drug must be approved by the FDA before it is sold.

        According to the FFDCA, animal feed containing drugs can only be administered by a licensed veterinarian or upon a feed directive issued by a veterinarian. The feed directive is subject to regulations promulgated by the Secretary of Health and Human Services. The Secretary assigns a registration number to all new manufactures and processors of animal drugs, who must register their name, place of business, and the type of establishment. Establishments are subject to inspection once every two years, but pharmacists, wholesalers, certain exempt practitioners, and suppliers of research or teaching related drugs are generally exempted from registration and inspection. Registrants are also required to furnish a bi-annual list of new drugs sold, discontinued drug sales, or the resumed sale or manufacture of discontinued drugs.

        FDA has multiple roles in the regulation of animal drugs used in aquaculture. Under the Animal Drug Availability Act of 1996  , the Secretary of Health and Human Services establishes tolerances for animal drugs that may be used in animals grown that are imported into the United States of America. Under the National Environmental Policy Act   the FDA (Center for Veterinary Medicine) reviews new aquaculture-related animal drugs to determine their environmental safety. EPA classifies pesticides into two categories: general- and restricted-use pesticides. A pesticide applicators license is required where a fish farmer wants to apply restricted pesticides to a culture system. Restricted use pesticides, which make up about a quarter of total pesticides used, may be applied only by or under the direct supervision of a trained and certified applicator. The USDA also has a role in the regulation of pesticides. Where the Secretary of Agriculture has established feed tolerances, new animal drugs can be imported into the United States of America where the new drugs tolerances do not exceed the established limits.

        All federal pesticide regulations are applicable in California and Florida. The California Department of Food and Agriculture (CDFA) also regulates the manufacturing, sale, and labeling of animal drugs. Anyone who manufactures livestock drugs must register with the department. The CDFA director establishes good manufacturing practices, which regulate additives including medicated feed premixes and medicated feeds, and are based upon federal food and drug statutes and regulations. The director also chairs a pest management advisory committee that assists the department in identifying, facilitating, and promoting environmentally sound pest management practices and pest management systems.

        A person cannot sell livestock drugs in California without a certificate of registration. It is also unlawful to use or administer any registered livestock drug except in accordance with the label instructions, which include all warnings, withdrawal periods, and time-frames for the disposal of livestock products. The purchaser of a restricted drug must sign and provide an address to be kept in the sellers records when such a restricted sale is made. Among other things, proper labeling of livestock drugs must include the name, brand, and trademark of the drug; the name and address of the applicant; the minimum net contents of the container; active ingredients, instructions; and a statement of the disease which it is claimed to alleviate.

        The CDFA may revise numerical values for pesticide residues when it is necessary to protect the groundwater of the state, but the values must at minimum be as stringent as the values of the EPA. In California, CDFA establishes specific numerical values for water solubility, soil adsorption coefficient (Koc), hydrolysis, aerobic and anaerobic soil metabolism, and field dissipation. The values established by the department shall be at least equal to those established by the EPA.

        CDFA conducts a pesticide residue monitoring program for produce, including fish and shellfish, to determine which pesticides are most likely to leave a residue and to establish the degree of monitoring required. A monitoring program considers pesticides of greatest health concern, and monitors various subpopulations, particularly infants and children which may be uniquely sensitive to pesticide residues. Agriculture inspectors take samples of produce at wholesale and retail levels, including points of entry such as commercial ports. If there are illegal levels of pesticides in a sample prior to harvest, the California Department of Pesticide Regulation (CDPR) may order the harvest destroyed, but also has the authority to quarantine food where it has entered the channels of trade. The EPA also monitors pesticides registered and identified as carcinogens, pesticides listed as a high priority for risks in the Birth Defect Prevention Act of 1984, and pesticides known to cause cancer or reproductive toxicity.

        A Californian manufacturer, importer, or dealer of any pesticide, must obtain a certificate of registration from the department before the pesticide is offered for sale. A registrant must submit to the director, information related to each active ingredient in each pesticide registered. The registrant must also submit information relating to water solubility, vapor pressure, the octanol-water partition coefficient, soil adsorption coefficient, and to Henry's Law constant. Anyone desiring to register a pesticide must also submit dissipation studies to the director, that include hydrolysis, photolysis, aerobic and anaerobic soil metabolism, and field dissipation.

        Similarly, in Florida pesticide use must be registered with the state and DACS may require evidence that the pesticide will not cause an unreasonable adverse effect on public health or the environment before approving the use. Registration also entails verification that the pesticide is correctly labeled, that the equipment used to distribute the pesticide does not contaminate the water supply, and that the method of use conforms to federal and state standards. A license must also be obtained for pesticide applicators. Licenses are categorized based on the kind of applicator used and various conditions apply.
        The FDA regulates the use of feed additives, used in aquaculture activities. The FDA's Center for Veterinary Medicine and the CDFA's Feed, Fertilizer, and Livestock Drugs Program enforces regulations governing the safety of animal feed, and food derived from medicated animal products.

        Animal feed having a higher potential of causing significant residues in food (Category II, Type A medicated articles) may only be mixed and sold by a licensed feed mill. Among other things, the licensee must certify that animal feed containing any new animal drug, is manufactured and labeled in accordance with the Food, Drug, & Cosmetic Act  , and that the methods used in manufacturing, packaging and processing conform to the Acts current good manufacturing practices (cGMPs). All federal drug regulations adopted pursuant to the FFDCA are applicable in California.

        The CDFA is responsible for regulating the manufacture and distribution of commercial feed within California. In California, it is unlawful to manufacture or distribute any commercial feed without complying with the department's regulations on commercial feed. Commercial feed also includes all material used as feed or feed mix, except preparations used for domestic pets. It is also unlawful to use any commercial feed containing drugs or food additives without compliance with all directions accompanying the commercial feed. Animal feed includes, “commercial feed, grain, forage, feed ingredients, mineral feed, drugs, poultry or fish health products, customer-formula feed, any mixture or preparation for feeding poultry or fish, any of the constituent nutrients of a poultry or fish ration, or any other food which is used for the feeding of poultry or fish.”

        The Department may establish tolerances for any pesticide chemical if the level is found to be useful for production and marketing, or the pesticide residue chemicals are not dangerous to human or animal health. CDFA may inspect and take samples of any produce sold, grown, processed, packed, stored, shipped, transported, or delivered for shipment. When fish produce destined for processing is not compliant with pesticide regulations, the director must notify the CA Director of Health Services.

        In Florida, all commercial feed and feedstuff distributed within the state is subject to inspection by DACS or its authorized agents. Samples are collected and analyzed by the department or an approved certified laboratory. The state legislature has specified sampling requirements, frequency, and analysis requirements. The legislature also sets tolerance levels for nutrients, medicaments, aflatoxins, pesticide residues, and weight. Ingredient statements must comply with the names and definitions set by the Association of American Feed Control Officials. Rejected feed shipments must be reported to the Feed Inspection Section of DACS and must include a description of the feed, the name of the feed distributor, the amount of feed rejected, the destination of the rejected feed, if known, and the reason for the rejection. Each package or bulk lot of feed must be correctly labeled according to standards set by the legislature, and conflict labels cannot appear on tags, containers, delivery tickets, or invoices. Distributors of commercial feed are required to report the number of tons of feed distributed in Florida on a quarterly basis to the DACS Bureau of Compliance Monitoring, Feed, Seed and Fertilizer Section. Failure to comply with any of these requirements results in financial penalties.
        Food safety
        With the exception of meat and poultry and egg products which are regulated by USDA, the FDA regulates the safety of food and drugs in fish and fish products. However, veterinary biologics are regulated by APHIS's Center for Veterinary Biologics according to statutory guidelines in the Virus-Serum-Toxin Act  . Anyone involved in manufacturing, processing, packing, or holding fish for consumption in the United States of America must register their facility with the FDA. A voluntary fee-for-service Seafood Inspection Program, managed by NOAA, ensures food safety by offering inspection services to the seafood industry, and providing assurances for products in compliance with food safety regulations. NOAA authorizes the use of official federal seals (such as U.S. Grade A) to production facilities that are compliant with applicable food standards. The Seafood Inspection Program does not replace FDA inspections, or exempt a seafood processor from regular FDA inspections. The seal is used only to demonstrate that quality of the product meets applicable food standards.

        Hazard Analysis Critical Control Point (HACCP)

        All seafood processors must comply with FDA Fish and Fishery Products HACCP regulation (21 C.F.R. § 123)  . The FDA HACCP program focuses on food safety hazards associated with fish species and processes. FDA has enforcement authority and may take regulatory action in the event of non-compliance with HACCP regulations. The federal HACCP plan must list the food safety hazards associated with fish species and processes that are likely to occur, and identify the conditions that must be controlled for each type of fish. In formulating the program, producers should give consideration to whether hazards are likely to occur as a result of, inter alia, natural toxins, microbiological contamination, chemical contamination, pesticides, and drug residues.

        Generally, a processing facility must have a separate HACCP plan for each kind of fish produced, where there are different food safety hazards, critical limits, and critical control points for each species of fish, for as long as the facility processes each type of fish. For refrigerated products, all records must be retained at the processing facility or importer's place of business for at least one (1) year after the date they were prepared and for at least two (2) years in the case of frozen, preserved or shelf-stable products. HACCP plans must be administered by individuals whose training or job experience in HACCP application is comparable or equivalent to the training recognized by the FDA. Developing, reassessing or modifying a HACCP plan must be performed by an individual who has completed training in the application of HACCP principles under a standardized curriculum recognized by the FDA. However, job experience will qualify a person to perform these functions if it has provided a level of knowledge at least equivalent to a training curriculum.

        At the state level, the California Department of Food and Agriculture (CDFA) has primary responsibility for food safety, but the California Department of Health Services (CDHS) operates a parallel food safety program. The Department of Health Services Food Safety Branch (FSB) manages the food safety programs in California. The FSB's mission ensures that foods are safe, un-adulterated, appropriately labeled, and not falsely advertised. FSB investigators will examine a fish facilities complete production and quality assurance system, personnel qualifications, use of food additives, and other chemicals; control of critical production parameters; and methods of storage, labeling, and advertising.

        In addition, the CDHS may establish definitions and standards of identity and food quality. The department will require permits for manufacturing, processing, and handling of foods, such as fish products, that are classified as potentially injurious to human or animal health. The Department is required to inspect all new firms and to ensure compliance with applicable regulations before issuing a new registration. Among other things, the Department may also prescribe tolerances, for poisonous or deleterious substances, food additives, and pesticide chemicals.

        Manufacturing, packing, or holding of any processed food requires a valid registration from the CDHS. The registration is non-transferable, and must be renewed annually. Temporary holders of foods, such as processors of fresh seafood, frozen seafood held in bulk, or shellfish, are exempt from this requirement, and must register under a different program. Fees for processed food facilities are based on a sliding scale that depends upon the size of the facility, number of employees, etc. The Department regulates the processing of shellfish in accordance with standards and procedures adopted by the National Shellfish Sanitation Program  , a voluntary program to ensure shellfish safety conducted in cooperation with federal, state, and private sector participants. The Department conducts sanitary surveys of shellfish growing in water to assure safety and compliance with state and federal bacteriological, chemical, and toxicologic standards.

        The CA Health Safety Code  sets critical limits for the handling of potentially hazardous food, the transfer of food to or from retail facilities, and sets statutory requirements for inspection of food upon arrival at the food facility. Where a food facility develops an HACCP plan in accordance with the statutory framework, prior approval by the Department of Health Services is not required. However, a facility that uses critical control points outside of the statutory framework, must receive prior approval and inspection.

        Under the state's HACCP program the person operating a food facility must develop the plan, verify the plans effectiveness, and train employees. The person designated to administer the program must be knowledgeable in the causes of food borne illness, and knowledgeable of HACCP principles and their application. Training of employees in HACCP principles must be documented, and training records must be retained for the duration of employment or a minimum of two years, whichever is greater. The CA Department of Health Services may suspend or revoke its approval of a HACCP plan if the plan is determined to pose a public health risk (due to changes in scientific knowledge or the presence of hazards); or the department finds that the food facility is unable, or does not consistently follow an HACCP plan.

        Florida has three food regulatory agencies. The Department of Business and Professional Regulation licenses lodgings, free standing restaurants, fast food services, mobile units that serve hot dogs and/or full food service, and bars that serve food. The Food Safety Division of DACS licenses bakeries, grocery stores, and convenience stores. The Florida Department of Health (DOH) licenses bars that do not serve food and institutions such as schools and hospitals. All three agencies administer and enforce sections of the Florida Administrative Code that regulate food safety and hygiene. In addition to licensing DACS also conducts inspections, and evaluates consumer complaints related to food. The DOH also runs a risk-based food hygiene inspection program, evaluating facilities that may pose a greater risk to the public more frequently. The FL Administrative Code sets food and nutrition standards, license and food permit requirements, as well as any federal standards and regulations that have been adopted by the state of Florida. Shellfish processing plants are required to obtain special certification from DACS to ensure that adequate operation and sanitary conditions are maintained, and that the HACCP plan is being followed and reassessed annually.


        For produce to be sold or labeled as “organic,” products must meet federal regulations prohibiting the production or handling of fish products with specified synthetic and non-synthetic substances, sewage sludge, radiation, non-organic substances, and un-approved vaccines. Within California, CDFA and the CA Organic Food Advisory Board adopts regulations listing specific prohibited materials of substances that are not allowed in organic foods. This list must comply with the national materials list (i.e. the National List) of the U.S. Department of Agriculture (USDA), pursuant to the Organic Foods Production Act of 1990. The Florida Certified Organic Growers is a USDA accredited organization that implements the Florida Organic Farming and Food Law of 1990, and ensures compliance with USDA regulations.
        Aquaculture investment 
        The National Aquatic Act of 1980 authorizes the Secretary of Agriculture, Commerce, and the Department of the Interior to develop a National Aquaculture Development Plan (NADP), to identify aquatic species, make recommendations to public and private sector on issues including research and development, technical assistance, extension and education services, and training. The NADP includes, inter alia, facility design, water quality management, use of waste products, nutrition and development of economic foods, life history, disease control, processing and marketing, production management and quality control.

        At the federal level, the USDA develops a continual aquaculture assessment that identifies private and public institutions involved in credit, extension, research and development, and marketing for the aquaculture industry. The NADP also identifies species being cultured and the status of commercial development, and identifies aquaculture production regions, as well as new markets, and identifies a catalogue of federal support programs. It also identifies legal and institutional barriers that prohibit development.

        Within the state of California, all money collected under the provisions of the Fish and Game Code and any law relating to the protection and preservation of birds, mammals, fish, reptiles, or amphibia are set aside for the Fish and Game Preservation Fund. All fines and forfeitures imposed or collected in any court for violations of the Fish and Game Code or regulation made pursuant to the code, or any other law for the protection or preservation of the above animals, shall be paid monthly: one-half (1/2) for deposit in the Fish and Game Preservation Fund in the State Treasury, and one-half (1/2) to the county in which the offence was committed.
        Federal Agencies

        Federal legislation, as amended:
        available at http://thomas.loc.gov/
        Animal Health Protection Act (now part of the Farm Security and Rural Investment Act of 2002)
        Animal Drug Availability Act of 1996
        Federal Insecticide, Fungicide, and Rodenticide Act of 1996
        Federal Water Pollution Control Act of 1972 (“Clean Water Act”)
        Farm Security and Rural Investment Act of 2002
        Food Quality Protection Act of 1996
        Food Drug & Cosmetic Act of 1938
        Magnuson-Stevens Fishery Conservation and Management Act of 1976
        National Aquatic Act of 1980
        National Environmental Policy Act of 1969
        Public Health Security and Bioterrorism Preparedness and Response Act of 2002
        Virus-Serum-Toxin Act of 1913

        Federal regulations:
        available at http://www.gpoaccess.gov/cfr/index.html
        Exportation and Importation of Animals (including Poultry) and Animal Products (9 Code of Federal Regulation part 91, subchapter D)
        Fish and Fishery Products regulation (21 Code of Federal Regulations part 123)
        Interim Rule - Prior Notice of Imported Food Shipments (68 Federal Register 58975)

        California regulations, as amended:
        available at http://www.leginfo.ca.gov/calaw.html
        California Fish and Game Code
        California Food and Agriculture Code
        California Health and Safety Code
        California Public Resources Code
        California Water Code

        Florida Administrative Code:
        available at https://www.flrules.org/
        5L-1 The Comprehensive Shellfish Control Code
        5L-3 Aquaculture Best Management Practices
        18-21 Sovereignty Submerged Lands Management
        12B-5.400 Producers and Importers of Pollutants
        5E-9.021 Categories of Licensure for Pesticide Applicators
        62-660.820 General Permit for Fish Farms
        5E-3.003 Inspection; Sampling; Analysis; Reporting Rejected Feed and Feedstuff; Reduced Sampling Requirements; Laboratory Certification/Exemption Requirements and Fees
        5E-3.005 Labels
        5E-3.016 Tolerances for Nutrients, Minerals, Medicaments, Aflatoxin, Pesticide Residues and Weight
        5E-3.018 Penalties
        64E-11 Food Hygiene
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