U.S. Federal Management Overview

The Environmental Protection Agency (EPA) aquaculture programs are authorized under four laws:  Clean Water Act of 1972; Safe Drinking Water Act; Federal Insecticide, Fungicide, and Rodenticide Act; and Toxic Substances Control Act. 

The Clean Water Act (CWA) established the basic structure for regulating pollutant discharges into the waters of the United States and gave EPA the authority to implement pollution control programs such as setting wastewater standards for industry.  Two CWA programs that directly relate to aquaculture are: The National Pollutant Discharge Elimination System (NPDES) permit program and the CWA Section 404 program.

The National Pollutant Discharge Elimination System (NPDES) program was created under the federal Clean Water Act to protect and improve water quality by regulating operations with point source discharges of pollutants into waters of the United States. These operations are required to obtain coverage under NPDES permits (40 C.F.R. 122.2). A NPDES permit, issued by either EPA or an authorized state/territory, contains industry-specific technology-based and/or water-quality-based limits and establishes pollutant monitoring and reporting requirements to protect the quality of surface waters. An Effluent Limitation Guideline (ELG) has been developed for Concentrated Aquatic Animal Production (CAAP) facilities that produce 100,000 pounds of fish annually (40 C.F.R. 451). Facilities that are required to seek permit coverage but are not covered by the ELG (i.e., operations that do not produce 100,000 pounds of fish annually), are subject to technology-based limits based on Best Professional Judgement (BPJ) of the permitting authority. 

Section 404 of the CWA, administered by the U.S. Army Corps of Engineers (Corps) and the EPA, establishes a permitting program to regulate the discharge of dredged and fill material into waters of the U.S. Proposed discharges are evaluated for compliance with environmental criteria, i.e., the Section 404(b)(1) Guidelines, developed by the EPA in conjunction with the Corps. Examples of activities related to aquaculture that may be subject to Section 404 permitting requirements include the discharge of dredged or fill material into open waters, wetlands or vegetated shallows to prepare the bottom substrate for larval shellfish attachment and growth, or to construct fishery impoundments. 

EPA's Underground Injection Control Program allows aquaculture waste disposal wells if they do not endanger underground sources of drinking water and they comply with federal program requirements. While some aquaculture facilities use holding structures in natural, open water bodies and rely on natural water circulation for water replenishment, many facilities use closed systems (e.g., tanks or ponds) and accumulate wastewater and sludge that must be removed. At dozens of such facilities in Hawaii and several other states, this wastewater and sludge is disposed via underground injection. All injected aquaculture wastewater includes fecal and other excretory wastes and uneaten aquaculture food. The primary chemical and physical constituents of these wastewaters are nitrogen- and phosphorus-based nutrients and suspended and dissolved solids (https://www.epa.gov/sites/production/files/2015-08/documents/aquaculture.pdf). 

This Act requires all pesticides sold or distributed in the United States (including imported pesticides) to be registered by EPA. Chemicals and other materials to be used in aquaculture, such as products intended for use to control pests (including, but not limited to, any insect, other arthropod, nematode, any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher order, and any plant part such as a root) may be subject to Pesticide Registration by EPA prior to marketing to aquaculture producers. Depending on the proposed use of a pesticide, registrants are typically required to submit a range of studies on chemical/physical properties, environmental fate, and the toxicity of the pure chemical (active ingredient). These tests evaluate whether a pesticide has the potential to contaminate surface or ground water from leaching, runoff, and spray drift and cause short-term and/or long-term adverse effects on humans, wildlife, fish, and plants, including endangered species and non-target organisms. EPA evaluates the potential for human health risks which range from short-term toxicity to long-term effects, such as cancer and reproductive system disorders.

The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. 

The U.S. Food and Drug Administration's (FDA) aquaculture programs fall under two separate programs: The Center for Food Safety and Applied Nutrition and The Center for Veterinary Medicine. The Center for Food Safety and Applied Nutrition operates a mandatory safety program under the provisions of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301) and the Food Safety Modernization Act of 2011, which address research, inspection, compliance, enforcement, and the development of regulations and guidance for all domestic and imported fish and fishery products. The Center for Veterinary Medicine regulates the manufacture and distribution of food additives and drugs given to animals including cultured fish and shellfish. The Center for Veterinary Medicine also has the authority to regulate genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act, including genetically engineered fish and shellfish (e.g., Atlantic salmon). Several offices within the Center for Veterinary Medicine play a role with regard to aquaculture. 

A key component of FDA’s seafood safety program is the Hazard Analysis and Critical Control Point (HACCP) program developed as a preventive control system to address food safety through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement, and handling, to manufacturing, distribution, and consumption of the finished product (21 C.F.R. Part 123). Under this program, seafood processors must prepare HACCP plans to address identified hazards reasonably likely to occur as a result of the following: (i) Natural toxins; (ii) Microbiological contamination; (iii) Chemical contamination; (iv) Pesticides; (v) Drug residues; (vi) Decomposition in scombroid toxin-forming species or in any other species where a food safety hazard has been associated with decomposition; (vii) Parasites, where the processor has knowledge or has reason to know that the parasite-containing fish or fishery products will be consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so consumed; (viii) Unapproved use of direct or indirect food or color additives; and (ix) Physical hazards. HACCP plans must list critical control points for each hazard to control food safety hazards that could be introduced in the processing plant environment and outside the processing plant including hazards that occur before, during or after harvest. Procedures must be listed to monitor each critical control point to ensure compliance with critical limits and include corrective action plans in response to deviations from critical limits established within HACCP plans. Plans are reassessed and inspected annually by FDA or States under contract to FDA (21 C.F.R. 123.8).

The FDA Center for Food Safety and Applied Nutrition also manages surveillance monitoring programs to provide coverage of domestic and imported fish and fishery products and ensure a safe and wholesome seafood supply for the US market. The FDA programs routinely test for microbiological contamination, parasites, decomposition, chemical contaminants, marine toxins, food and color additives, filth, veterinary drug residues, and labeling. The programs also provide direction to the field for developing priorities and instructions specific to the inspection of seafood processing facilities and products. FDA also manages a program for the testing of food by accredited laboratories and developing a laboratory accreditation program as part of its Food Safety Modernization Act implementation efforts.

The Office of New Animal Drug Evaluation (ONADE) works with various government agencies and aquaculture associations to increase the number of safe and effective drugs that can be used by the aquaculture industry. As mandated by the Federal Food, Drug and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of an Approved New Animal Drug Application (NADA or ANADA), or there is a conditional approval (CNADA). All three types of NADAs are reviewed by ONADE. During the investigational stages of drug development, ONADE may also authorize Investigational New Animal Drug (INAD) exemptions to allow for the use of the drug to generate data to support an approval. 

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS), established under the Minor Use and Minor Species Animal Health Act of 2004, plays a critical role in making more drugs legally available to veterinarians and animal owners to treat minor animal species such as fish. OMUMS administers the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index is a list of new animal drugs intended for use in non-food producing minor species (e.g., ornamental fish) that have had their safety and effectiveness affirmed through an alternate review process involving expert panels external to FDA. OMUMS also manages the MUMS (Minor Use Minor Species) designation program which provides incentives for sponsors to seek approval of new animal drugs for MUMS indications. 

The Office of Research (OR) conducts aquaculture research in a state-of-the-art facility and assists in assuring that fish derived from aquaculture production environments are safe for human consumption.

The Office of Surveillance and Compliance (OSC) is responsible for compliance-related actions, post-approval monitoring (e.g., adverse drug event reporting), and animal feed safety. OSC reviews notices that a substance (including an aquaculture feed substance) is Generally Recognized as Safe (GRAS) for a specific use within an animal food, approves Food Additive Petitions (FAP), and regulates medicated animal feeds (i.e., feeds that contain a new animal drug). A Medicated Feed Mill License is required to manufacture some medicated feeds. These licenses are also approved by OSC. 

The National Oceanic and Atmospheric Administration has regulatory and stewardship authority for fisheries, marine sanctuaries, marine mammals, threatened and endangered species, and essential fish habitat conservation in the U.S. Exclusive Economic Zone (EEZ). NOAA engages in consultations with other agencies that issue permits for aquaculture activities in state and federal waters. NOAA also may issue permits authorizing an aquaculture operation’s interactions with, or the incidental take by an aquaculture operation of species protected under the Endangered Species Act (ESA) and the Marine Mammal Protection Act (MMPA).

In 2016, NOAA finalized regulations for a Gulf Aquaculture Plan developed under the Magnuson-Stevens Fishery Conservation and Management Act (MSA) by the Gulf of Mexico Fishery Management Council that established a regional permitting process to manage the development of an environmentally sound and economically sustainable aquaculture industry in federal waters of the Gulf of Mexico. The Gulf Aquaculture Plan allows up to 20 offshore aquaculture operations to be permitted in federal waters of the Gulf of Mexico over a 10-year period. In 2018, these regulations were challenged in the U.S. Eastern District Court of Louisiana, which ruled that NOAA does not have regulatory authority to regulate aquaculture under the MSA. As a result of the court ruling, NOAA is not issuing permits for aquaculture in federal waters of the Gulf of Mexico, however, other federal permits do apply. The Department of Justice has filed a brief in the appeal of this court's decision (status as of August 2019). Given conflicting court decisions and the desire for regulatory certainty, NOAA supports congressional efforts to clarify the agency’s statutory authority to regulate aquaculture in the EEZ.

Other NOAA aquaculture plans are intact. The culture of “live rock” in federal waters off the coast of Florida in the Gulf of Mexico and South Atlantic is authorized under Amendment 2 to the Fishery Management Plan for Coral and Coral Reefs of the Gulf of Mexico and South Atlantic (1994). NOAA Fisheries’ Southeast Regional Office issues these permits in conjunction with the U.S. Army Corps of Engineers via the Programmatic General Permit SAJ-71 (http://sero.nmfs.noaa.gov/operations_management_information_services/constituency_services_branch/permits/permit_apps/index.html).

Aquaculture may or may not be allowed, with a permit, in a national marine sanctuary. The management plan for each sanctuary provides information on authorized and unauthorized uses. 

NOAA Fisheries may issue a scientific research or enhancement permit for certain types of aquaculture activities involving Endangered Species Act (ESA)-listed species or require an incidental take permit for activities that interact with ESA-listed species.

NOAA also issues Authorizations or Letters of Authorization for aquaculture activities that interact with marine mammals. Incidental Harassment Authorizations are for activities with no potential for mortality or serious injury of marine mammals while utilizing required mitigation measures. Letters of Authorization are for activities that may result in injury or mortality of marine mammals despite utilizing required mitigation measures. NOAA Fisheries also issues an ‘Annual List of Fisheries’ specifying requirements for certain aquaculture activities.

If NOAA is the lead permitting agency for an aquaculture activity, NOAA may prepare an environmental assessment or an environmental impact statement where required under the National Environmental Policy Act (NEPA). NOAA may also participate as a “cooperating agency” with other federal regulatory agencies that issue permits for aquaculture (http://www.nepa.noaa.gov/).

The Coastal Zone Management Act is administered by NOAA's Office for Coastal Management and implemented through state coastal zone management programs. The Act requires an applicant for a federal license or permit for an activity affecting the coastal zone to provide a certification to the authorizing agency that the proposed activity complies with the enforceable policies of approved state coastal zone management programs and that such activity will be conducted in a manner consistent with the program (https://www.coast.noaa.gov/czm/consistency/).

The most frequent types of consultations in which NOAA engages are with the U.S. Army Corps of Engineers (ACOE) because most finfish and shellfish aquaculture facilities in state or federal waters require a federal permit from the ACOE. Consultations focus on impacts of aquaculture on ESA-listed species, critical habitat for ESA-listed species, essential fish habitat for MSA-managed species, and national marine sanctuaries (http://www.nmfs.noaa.gov/pr/consultation/).

Under Section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 403), ACOE permits are required for structures or work in navigable waters of the United States which include waters subject to the ebb and flow of the tide and waters that are presently used, or have been used in the past, or may be susceptible for use to transport interstate or foreign commerce. Activities that require section 10 permits include structures or work that would affect the course, location, condition, or capacity of navigable waters, such as constructing or placing structures in or over navigable waters or excavating materials from, or depositing materials into those waters. Examples of section 10 activities related to aquaculture include the placement of structures and equipment in navigable waters, such as piles, cages, trays, racks, ropes/lines, buoys, and floats. 

Section 404 of the Clean Water Act (33 U.S.C. 1344) is administered by the ACOE with EPA. Under section 404, permits are required for discharges of dredged or fill material into waters of the United States at specified disposal sites. Selection of such disposal sites must comply with the environmental criteria provided in the 404(b)(1) Guidelines. Section 404 permits are required for discharges of fill material that raise the bottom elevation of a waterbody or converts it to dry land. Examples of section 404 activities related to aquaculture include placement of dredged or fill material to prepare the substrate of a waterbody so that it is suitable for larval attachment and growth and placing fill in waters to construct impoundments. 

The U.S. Army Corps of Engineers (ACOE) issues four types of permits: standard individual permits, letters of permission, nationwide permits, and regional general permits. Standard individual permits involve a public notice and comment period prior to making a permit decision. Letters of permission are an abbreviated individual permit process for minor, non-controversial activities. Nationwide permits provide a streamlined process for authorizing categories activities across the country (e.g., nationwide permit 48 for commercial shellfish aquaculture activities). Regional general permits are issued by Corps districts or divisions to authorize categories of activities within a state or other geographic region. Some Corps districts have issued regional general permits to authorize aquaculture activities. 

Before an ACOE permit can be issued, there may have to be consultation under Section 7 of the Endangered Species Act and/or the Essential Fish Habitat provisions of the Magnuson-Stevens Fishery Conservation and Management Act. Water quality certification from the state must be obtained or waived for permits authorizing discharges into waters regulated under the Clean Water Act. Permitted activities must also be consistent with the state’s coastal zone management program (http://usace.army.mil/CECW/Pages/cecwo_reg.aspx). 

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) provides agricultural producers with a broad range of cooperative programs for aquaculture under its Veterinary Services (VS) and Plant Protection and Quarantine (PPQ) program for the protection of aquatic animals and plant health. The PPQ program safeguards U.S. agriculture and natural resources against the entry, establishment, and spread of economically and environmentally significant pests, and facilitates the safe trade of agricultural products. Veterinary Services aquaculture programs include Surveillance, Preparedness, and Response Services; National Import Export Services; and Science, Technology, and Analysis Services (STAS). 

Pertinent USDA legislative authorities include the Federal Meat Inspection Act,  the Animal Health Protection Act , and the Virus Serum Toxin Act. Implementing regulations promulgated under these statutes related to aquatic animal health address domestic production (9 C.F.R. 53.10; 9C FR 71.2; 9 C.F.R. 71.3), exported aquaculture products including the endorsement of export health certificates (9 C.F.R. 91), permitting of imported APHIS-regulated live fish and aquaculture products (9 C.F.R. 93.900-906), veterinary biologics (9 C.F.R. 101-123) and the National Veterinary Accreditation Program (9 C.F.R. 161-162), which provides training in aquatic animal health for accredited veterinarians who assist APHIS and state officials in controlling disease and facilitating movement of farmed aquatic animals (http://www.aphis.usda.gov/animal_health/vet_accreditation/). USDA also has standing policies on aquaculture-related diseases like Viral Hemorrhagic Septicemia (VHS), Spring Viremia of Carp (SVC), and Infectious Salmon Anemia (ISA). 

Surveillance, Preparedness and Response Services focuses on the broad spectrum of animal health needs centered on each of the major animal commodity groups. For each commodity, Surveillance, Preparedness and Response Services carries out functions ranging from early awareness and surveillance to the development and field implementation of animal health programs and emergency response. 

National Import Export Services brings together VS’ import and export activities, from policy setting to inspection at ports of entry. National Import Export Services comprises Policy, Permitting, and Regulatory Services; District Field Services; Animal Import Center Services; Port Services; Agricultural Select Agent Services; and International Animal Health Standards Services.

Science, Technology and Analysis Services brings together VS science centers to provide the solid scientific, technical, and analytical foundation needed to support VS in meeting its mission responsibilities. Science, Technology and Analysis Services leverages and integrates the scientific expertise that is inherent throughout VS and allows VS to incorporate new science and technologies to provide the best analysis, expertise, and information for policy and decision makers. Science, Technology and Analysis Services comprises the Center for Veterinary Biologics, the National Veterinary Services Laboratories, the Center for Epidemiology and Animal Health, and Interagency Coordination. 

National Veterinary Services Lab (NVSL) is the APHIS Reference Laboratory for aquatic animal diseases.  It provides laboratory confirmation services and support of animal disease diagnostics and reviews and approves laboratories as “APHIS–Approved” to conduct aquatic animal pathogen detection assays for export purposes. All federal, state, university, and private aquatic laboratories are eligible to apply for approval to become an APHIS-approved laboratory (http://www.aphis.usda.gov/animal_health/lab_info_services/about_nvsl.shtml).

The Center for Veterinary Biologics reviews and licenses manufacturing and product licenses for biologics (vaccines) in the United States and provides permits to sell and distribute biologics manufactured in foreign countries (http://www.aphis.usda.gov/animal_health/vet_biologics/ .

The Federal Meat Inspection Act (FMIA) as amended by the Food, Conservation, and Energy Act of 2008, also known as the 2008 Farm Bill, provides the USDA Food Safety Inspection Service (FSIS) with authority over the mandatory inspection of Siluriformes fish and fish products (catfish). The inspection and regulations apply to all establishments that may process or prepare Siluriformes fish, fish parts, or fish products capable of use as human food, or sell, transport, or offer for sale or transportation in commerce, and are intended to prevent the sale or transportation of fish or fish products that are adulterated or misbranded at the time of the sale, transportation, offer for sale or transportation, or receipt for transportation (9 C.F.R. 530.1). FSIS inspections also extend to periodic review of records of all persons engaged in the business of hatching, feeding, growing, or transporting fish between premises where fish are bred, hatcheries, and premises where fish are grown, and from these premises to processing establishments (9 C.F.R. 532.1).

The Animal Health Protection Act (AHPA) was enacted to prevent, detect, control, or eradicate diseases of farmed animals including aquaculture species and promoting species specific best management practices (7 U.S.C. 8301 – 8322 et. seq.).

The Virus Serum Toxin Act (VSTA) was enacted to ensure that pure, safe, potent, and effective biologic products are available for sale and distribution in the United States for use in animals (21 U.S.C. 151-159 et. seq.).  

APHIS VS in collaboration with the National Aquaculture Association (NAA) developed voluntary Commercial Aquaculture Health Program Standards (CAHPS) to improve aquatic animal health management, protect and expand aquaculture business opportunities, promote and facilitate trade, as well as efforts to improve resource protection and environmental sustainability. Principles outlined in the CAHPS provide for early disease detection, surveillance, reporting and response for the control of aquatic animal pathogens especially those listed by the World Organization for Animal Health (OIE) and to prevent pathogen dissemination via movement and trade of aquatic animals. The five principles of CAHPS address Aquatic Animal Health Team; Risk Characterization and Management; Surveillance; Investigation and Reporting; and Response. 

The U.S. Fish and Wildlife Service (USFWS) is the lead agency responsible for the implementation of the Lacey Act, an umbrella statute for the protection of wildlife species and plants taken or possessed in violation of State, tribal, foreign, or U.S. law. It provides authority to detain and inspect aquaculture product. The Lacey Act is implemented as two titles, Title 16 (16 U.S.C. 3371-3378) and Title 18 (18 U.S.C. 42) and is jointly administered by the U.S. Fish and Wildlife Service (Department of the Interior), NOAA National Marine Fisheries Service (Department of Commerce), and the Animal and Plant Health Inspection Service (Department of Agriculture). Title 16 is broad and can cover wildlife or plants whether alive or dead, whole or part, and protected or prohibited. Title 18, however, more narrowly regulates the importation and interstate transport of animal species determined to be injurious by the Secretary of the Interior; permits for injurious wildlife may be issued for zoological, educational, medical, or scientific purposes. 

Prohibitions under 16 U.S.C. 3371 – 3378 include: import or export, transport, sell, receive, acquire, or purchase in wildlife, fish, and plants that have been taken, possessed, transported, or sold in violation of any Federal, State, tribal or foreign laws (interstate or foreign commerce); false labeling, falsification of records or identification of species; failure to properly mark wildlife shipments; and for 18 U.S.C. 42 include inhumane transport and injurious species. Injurious wildlife regulations (50 C.F.R. 16.13) prevent the movement of potentially harmful live or dead Salmonid fishes that may carry pathogens into our Nation’s waters. 

All live Salmonid fish and their eggs and dead whole, uneviscerated Salmonids imports into the United States must be inspected by a USFWS-certified fish pathologist, fish health inspector, or veterinarian, who then certifies the shipment as disease free. This health certificate must accompany any shipment. Only Salmonids deemed “healthy” are allowed into the United States by the Director of the USFWS or his or her agents, except by permit (http://C.F.R..vlex.com/vid/live-dead-mollusks-crustaceans-eggs-19893282).

The National Aquatic Animal Health Plan (NAAHP) was developed in response to the growing need for a coordinated government effort to ensure aquatic animal health and address diseases in order to benefit aquaculture and aquatic animal resources in the United States.  Two primary drivers were the need to protect domestic commerce and resources, and the advent of new health regulations from foreign governments that restrict the import of live and processed aquatic animals from the United States.

The federal agencies with primary responsibility for aquatic animal health are the U.S. Department of Agriculture (USDA) through its Animal and Plant Health Inspections Service, the U.S. Department of Commerce (DOC) through the NOAA Fisheries Service, and the U.S. Department of the Interior (DOI) through the U.S. Fish and Wildlife Service. These agencies lead the development and implementation of the NAAHP from the federal perspective under the auspices of the Subcommittee on Aquaculture.

NAAHP provides guidance for the efficient, safe, and effective national and international commerce of aquatic animals; the protection of cultured and wild aquatic animals from foreign pests and diseases; U.S. government legal trade obligations; and the availability of diagnostic and certification services for public, private, and tribal entities. It was developed to:

● Facilitate the legal movement of all aquatic animals, their eggs, and products in interstate and international commerce;

● Protect the health and thereby improve the quality and productivity of farmed and wild aquatic animals;

● Ensure the availability of diagnostic, inspection, and certification services; and

● Minimize the impacts of diseases when they occur in farmed or wild aquatic animals.

 Its goal is to provide recommendations to industry, States, tribes, Federal agencies, and other stakeholders in support of the mission. These recommendations are not part of an overarching regulatory program to be implemented by the Federal government. Rather, the recommendations are intended to be considered by all stakeholders, whose cooperation is essential if the mission of the NAAHP is to be met. Activities addressed in the NAAHP include the following:

● Defining pathogens of national concern;

● Preventing, controlling and managing pathogens and/or the diseases caused by those pathogens;

● Describing and implementing surveillance programs;

● Creating and implementing disease management zones;

● Identifying priority areas for research and development in aquatic animal health, including identification of existing funding structures and recommendations on leveraging resources;

● Describing strategies for continued outreach and awareness regarding national aquatic animal health strategies and the NAAHP;

● Outlining education and training needs for all stakeholders; and

● Implementing the NAAHP

In addition to federal agency programs, partnership like the Interstate Shellfish Sanitation Conference (ISSC) play an important role in the management of aquaculture in the U.S. The ISSC was formed in 1982 to foster and promote shellfish sanitation through the cooperation of state and federal control agencies, the shellfish industry, and the academic community. To achieve this purpose the ISSC:

● Adopts uniform procedures, incorporated into an Interstate Shellfish Sanitation Program, and implemented by all shellfish control agencies;

● Gives state shellfish programs current and comprehensive sanitation guidelines to regulate the harvesting, processing, and shipping of shellfish;

● Provides a forum for shellfish control agencies, the shellfish industry, and academic community to resolve major issues concerning shellfish sanitation;

● Informs all interested parties of recent developments in shellfish sanitation and other major issues of concern through the use of news media, publications, regional and national meetings, internet, and by working closely with academic institutions and trade associations.

The National Shellfish Sanitation Program (NSSP) is a key cooperative State-FDA-Industry ISSC initiative for the sanitary control of shellfish. It provides a Guide for the Control of Molluscan Shellfish under which each state shall have adequate laws and regulations to provide a legal basis for sanitary control of all interstate phases of the shellfish industry. It also requires that state shellfish growing area classification authority shall forward the classification of shellfish growing waters in the state to the appropriate FDA Regional Office. Additional state requirements address training, enforcement of growing area criteria, area closures, depuration, and sample analysis.  Similar requirements for the federal partnership under the FDA call for uniformity in training, certification of state shellfish shippers, classification of shellfish growing waters, shellfish sanitation control and certification, depuration and laboratory phases of the program.