Topic 9

28. Aquaculture facilities should be located in areas where the risk of contamination is minimized and where sources of pollution can be controlled or mitigated.

34. Aquaculture facilities and operations should maintain good culture and hygienic conditions, including:

·   Good hygiene practices in the farm surroundings should be applied aiming at minimizing contamination of growing water, particularly from waste materials or faecal matter from animals or humans.

·   Good Aquaculture Practices should be applied during culture to ensure good hygienic culture conditions and safety and quality of aquaculture produce.

·   Farms should institute a pest control programme, so that rodents, birds and other wild and domesticated animals are controlled, especially around feed storage areas.

·   Farm grounds should be well maintained to reduce or eliminate food and feed safety hazards.

·   Appropriate techniques for harvesting, storing and transportation of aquaculture products should be applied to minimize contamination and physical damage.

35. Identification, classification, integrated management and monitoring programmes should be implemented in bivalve molluscs growing areas to prevent microbiological, chemical and reduce biotoxin contamination. Relaying and depuration of bivalve molluscs to remove microbial contamination should be carried in accordance with the requirements of the Codex.

From the U.S.  Food and Drug Administration website "FDA National Shellfish Sanitation Program" (FDA-NSSP. 2019):

Through the National Shellfish Sanitation Program (NSSP), FDA and other federal agencies including state regulatory agencies, tribes, academia, and the shellfish industry work together in a cooperative program to keep molluscan shellfish safe for consumption by adhering to strict controls on their growing, harvesting, processing, packaging, and transport.

The cooperative program has four components to help keep contaminated molluscan shellfish out of the marketplace:

● Classifying and monitoring shellfish growing areas based on potential pollution sources, water quality, and other factors that indicate suitability for harvest including pre-harvest Vibrio control.

● Inspecting facilities that handle shellfish to ensure the use of proper sanitary measures and adequate post harvest Vibrio control.

● Patrolling closed or prohibited waters to deter illegal harvesting.

● Conducting laboratory testing and analysis of shellfish and water samples

The ISSC (Interstate Shellfish Sanitation Conference; established  via the Public Health Service Act - 42 U.S.C. 243)  was formed in 1982 to foster and promote shellfish sanitation through the cooperation of state and federal regulatory agencies, the shellfish industry, and the academic community. FDA has a formal Memorandum of Understanding (MOU) with the ISSC that outlines each other's responsibilities.  

The shipment of live shellfish for human consumption from one coastal state to another can only occur if the shipment is in compliance with FDA regulations and the four NSSP components. 

NOAA's Coastal Aquaculture Planning Portal (CAPP) is a toolbox of coastal planning and siting tools designed to assist managers and industry with sustainable aquaculture development.  The tools provide outcome evidence that demonstrates federal and state laws are actively being implemented and are in conformance to FAO Aquaculture Guidelines 19-22 relating to health and welfare of aquatic species and maintenance of the culture environment, reducing the risk of contamination, maintaining water quality, minimizing contamination of growing waters, regular monitoring of environmental quality, evaluation and mitigation of adverse impacts of natural ecosystems including fauna and flora, and monitoring of water and effluent impacts on surrounding water resources.  This toolbox was developed in partnership with Digital Coast, a product of the NOAA National Ocean Service Office for Coastal Management. The online toolbox directs users to state, federal and regional products.

In federal waters, the FDA is the authority for testing shellfish safety.  In June 2017, the 100-acre Catalina Sea Ranch mussel farm located about six miles off the coast of Huntington Beach, CA, was prevented from beginning operations by a lack of FDA certified biotoxin testing labs in California.  The resulting year long delay in permitting provides outcome evidence of conformance in that permits were delayed until an FDA approved lab could be certified (Mayer, 2019). 

In February 2019, the U. S. Government Accountability Office (GAO) published an audit report on the U. S. Army Corps of Engineers shellfish aquaculture permitting activities. GAO was asked to review the Corps’ process for authorizing shellfish aquaculture activity in U. S. coastal waters. The report describes the number and outcomes of the applications the Corps received for shellfish aquaculture activities, the types of permits the Corps used to authorize such activities, and the experiences of permit applicants in selected districts in seeking Corps’ authorization for their shellfish aquaculture activities. The U.S. Army Corps of Engineers authorized most (87 percent) of the 3,751 shellfish aquaculture applications it received from audit period of 2012 through 2017.  The majority of those districts (13 of 17) authorized applications using Nationwide Permit 48 intended to streamline the authorization process for shellfish aquaculture activities. Additionally, districts may add conditions to nationwide permits or develop region-specific permits to address state or regional environmental concerns. Of the four districts GAO reviewed in detail, two districts added regional conditions applicable to Nationwide Permit 48, such as prohibiting shellfish activity within submerged aquatic vegetation beds or saltmarshes.  The audit provides independent evidence on the implementation process used by the Corps’ for Nationwide Permits relating to taking a precautionary approach to aquaculture siting (GAO 2019). 

A case study authored by Ted Maney of Northeastern Massachusetts Aquaculture Center and Cat Cove Marine Laboratory, Department of Biology, Salem State University (Maney 2018) provides an independent assessment of aquaculture permitting in federal waters and serves as independent evidence of conformance to the FAO Aquaculture Guidelines.  The case study also illustrates the comprehensiveness of the permitting review process.  The project began in September 2012 and a final permit was not issued until January 2015.  

As a part of this case study, the NOAA Office of Aquaculture commissioned a white paper from the National Sea Grant Law Center in 2012 to investigate the permitting process for mussel culture in federal waters. The objective of the study was to explore and define the actual permitting process for an offshore mussel farm and to permit and establish a commercial scale (33 acre, 1.44 million sq ft.) submerged blue mussel (Mytilus edulis) farm in federal waters 8.5 miles off Cape Ann, MA.  In September 2012, an informal conference was held with various state and federal government agencies to evaluate two possible sites and conduct preliminary site surveys.  It was determined that one of the sites was not feasible due to the fact that is was within the Stellwagen Bank Marine Sanctuary and mariculture activities are prohibited.

In June 2018, an evaluation of U.S. shellfish aquaculture permitting systems was completed, which reviewed aquaculture permitting systems at the federal, state, and local level (O’Connell 2018). This report was based upon a review of 22 shellfish aquaculture permitting systems covering all coastal States in the continental United States. The report provides 15 recommendations to improve permitting processes and communication and to create tools and methods to assist applicants. 

From "A National Strategic Plan for Aquaculture Research" prepared by the National Science and Technology Council Subcommittee on Aquaculture (NSTC  2022):

Goal 2. Improve Aquaculture Production Technologies and Inform Decision-making

Objective 2.2: Develop and refine production technologies to increase environmentally responsible food production and contribute ecosystem services

The need for practices to increase food production in a way that avoids or minimizes harm to the environment resonates globally in all agricultural production sectors, including aquaculture. Successful aquaculture depends on healthy ecosystems that provide clean water and nutrient cycling that processes or reuses wastes and co-products. In the United States, aquaculture’s environmental performance has improved dramatically during the past 20 years, driven by the need for more efficient use of resources and inputs due to rising costs of fuel and feed, increased awareness of environmental issues associated with aquaculture, application of science-based best management practices, technological innovation, knowledge about proper siting of facilities, and evolving aquaculture-specific environmental regulations at the State and Federal levels. Commercial aquaculture production in the United States operates under some of the most stringent environmental requirements in the world. Similarly, Federal agencies adhere to sound science and best management practices when employing aquaculture to fulfill their recovery and restoration missions.

Efficient and effective aquaculture production systems reduce inputs, operating costs, and wastes and create optimal conditions for growth, adaptability, and reproduction. Production efficiency and animal or plant well-being start with properly matching species to appropriate production environments and market demands. Defining optimal conditions requires a comprehensive understanding of the physiology of early development, growth, nutrition, stress response, and reproduction.

Aquaculture must not only have minimal impacts on host environments, but wherever possible it must contribute services that regenerate ecosystems, contribute to climate change adaptation and mitigation.

The following actions will improve production efficiency and develop new aquaculture production strategies that minimize environmental impacts. The agencies listed below will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• Action 2.2.1 DOC NOAA (NMFS, NOS, SG), USDA (ARS, NIFA), DOI (USGS), and DOE (ARPA-E, BETO) will support or conduct research to document the ecosystem services provided by aquaculture and identify new opportunities to utilize them, including increasing the effectiveness of monitoring environmental conditions in remote offshore environments.

• Action 2.2.2 DOC NOAA (SG), USDA (NIFA), and HHS (FDA) will conduct or support research to support innovation in aquaculture, traceability, and identification.

• Action 2.2.3 DOC NOAA (NMFS, SG) and DOI (USFWS) in association with State agencies and others will develop aquaculture methods that cost-effectively enhance, preserve, and rebuild wild stocks and their ecosystems.

Goal 3. Uphold Animal Well-Being, Product Safety, and Nutritional Value

Objective 3.2: Promote the safety and nutritional value of U.S. aquaculture products

Domestic seafood produced in aquaculture systems is safe and nutritious. The consumption of seafood has been associated with a lower risk of heart disease-related death and, part of a healthy eating pattern, with a lower risk of obesity.32 Seafood has also been associated with better health outcomes for children when mothers consume seafood while pregnant or breastfeeding. For these reasons, the 2020-2025 Dietary Guidelines for Americans recommends that the general population should eat at least 8 ounces of seafood per week; the average American consumes less than half that amount. Research that further documents the safety and benefits of seafood consumption will help inform the public and support increased consumption.

The following actions will inform consumers that seafood is safe and demonstrate the health benefits of domestic farm-raised seafood products. The agencies listed below will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• Action 3.2.1 HHS and USDA (ARS) will determine the overall seafood consumption benefits and risks and communicate dietary recommendations at various life stages to the public.

• Action 3.2.2 USDA (ARS) and DOI (USGS) will determine the nutritional profile of aquaculture and wild-caught products

• Action 3.2.3 HHS (FDA) and USDA (APHIS) will develop an integrated food safety and disease prevention program for use by domestic aquaculture farms.

"Evaluation of U.S. Shellfish Aquaculture Permitting Systems - Recommendations to Improve Permitting Efficiencies and Industry Development. A Report to NOAA Fisheries" (O’Connell 2018) provides 15 recommendations to improve permitting processes:

• Recommendation 1 - Coordinate/consolidate: Improve coordination within and between state and federal shellfish aquaculture permitting agencies fostered by a state aquaculture coordinator and a commitment from agency leadership, and consolidate state agency responsibilities where feasible [NOAA and federal/state partners].

• Recommendation 2 - Delegate federal authority: Consider strategies to incorporate state verification authority into Corps general permits [Corps and state agencies].

• Recommendation 3 - Establish categories for review levels: Consider strategies to utilize a tiered project level activity approach in general permits with categories linked to impact thresholds that determine the level of review necessary from the Corps [Corps].

• Recommendation 4 - Provide adequate staffing: Conduct a human resource needs assessment of agencies responsible for shellfish aquaculture development, and identify and implement strategies to address limitations [NOAA and federal/state partners].

• Recommendation 5 - One-stop permitting website for each state: Develop a centralized shellfish aquaculture permitting website in each state [State agencies].

• Recommendation 6 - State guides: Develop a shellfish aquaculture leasing and permitting guide for each state [State agencies and federal partners].

• Recommendation 7 - Siting tools: Develop shellfish aquaculture siting tools [State agencies and NOAA/NCCOS].

• Recommendation 8 - Local government authority: Examine existing state aquaculture permitting programs which include some level of authorization by a local government to identify ways to improve permitting efficiencies [State agencies].

• Recommendation 9 - Address scientific uncertainties/unknowns: Develop and implement prioritized list of science needs to improve shellfish aquaculture permitting efficiencies [NOAA and federal/state partners].

• Recommendation 10 - One-stop national “dashboard”: Prepare and maintain a national state-by-state depository of shellfish aquaculture permitting systems and industry related information [NOAA coordinate with Corps and State agencies].

• Recommendation 11 - Support for aquaculture businesses: Provide shellfish aquaculture industry with business planning tools and expertise through new resources and partnerships [NOAA, Corps and State agencies].

• Recommendation 12 - Encourage innovation: Establish expedited permitting program for small-scale ‘experimental’ shellfish aquaculture operations [Corps and State agencies].

• Recommendation 13 - Transition from bottom fishery to aquaculture: Increase the availability of traditional shellfish fishery bottom to shellfish aquaculture [State agencies – may require legislation and/or regulation].

• Recommendation 14 - Address the opposition: Consider existing strategies being used to address opposition / appeals from shoreline property owners and other user groups (e.g., boaters, fishermen) [NOAA and State agencies].

• Recommendation 15 - Expand shellfish initiatives: Establish additional state / regional shellfish initiatives [NOAA and state/federal partners].

The Report also notes:

“This study also revealed the need for improved communication among federal and state shellfish aquaculture coordinators and regulators across the nation. The ‘stage’ of each state’s shellfish aquaculture development varies significantly. In many instances, problems which exist for one state have already been experienced and addressed by another. Establishing, sharing and maintaining a depository of shellfish aquaculture permitting information will enable coordinators to more quickly identify proven solutions…”

§590a Purpose

It is recognized that the wastage of soil and moisture resources on farm, grazing, and forest lands of the Nation, resulting from soil erosion, is a menace to the national welfare and that it is declared to be the policy of Congress to provide permanently for the control and prevention of soil erosion to preserve soil, water, and related resources, promote soil and water quality, control floods, prevent impairment of reservoirs, and maintain the navigability of rivers and harbors, protect public health, public lands and relieve unemployment, and the Secretary of Agriculture, from now on, shall coordinate and direct all activities with relation to soil erosion and in order to effectuate this policy is authorized, from time to time-

(2) To carry out preventive measures, including, but not limited to, engineering operations, methods of cultivation, the growing of vegetation, and changes in use of land;

§ 590c Conditions under which benefits of law extended to nongovernment controlled lands

As a condition to the extending of any benefits under this chapter to any lands not owned or controlled by the United States or any of its agencies, the Secretary of Agriculture may, insofar as he may deem necessary for the purposes of this chapter, require the following:

(1) The enactment and reasonable safeguards for the enforcement of State and local laws imposing suitable permanent restrictions on the use of such lands and otherwise providing for the prevention of soil erosion.

§590q Coverage; "State" defined; short title

(a) This chapter shall apply to the States, the Commonwealth of Puerto Rico, Guam, American Samoa, the Northern Mariana Islands, and the Virgin Islands, and, as used in this chapter, the term "State" includes Puerto Rico, Guam, American Samoa, the Northern Mariana Islands, and the Virgin Islands.

Subchapter I Generally

§ 1801 Findings, purposes and policy

(b) Purposes. It is therefore declared to be the purposes of the Congress in this chapter—

(7) A national program for the development of fisheries which are underutilized or not utilized by the United States fishing industry, including bottom fish off Alaska, is necessary to assure that our citizens benefit from the employment, food supply, and revenue which could be generated thereby.

Subchapter I Research and Related Programs

§ 1251 Congressional declaration of goals and policy

(a) Restoration and maintenance of chemical, physical and biological integrity of Nation’s waters; national goals for achievement of objective. The objective of this chapter is to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters. In order to achieve this objective it is hereby declared that, consistent with the provisions of this chapter—

(2) it is the national goal that wherever attainable, an interim goal of water quality which provides for the protection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water be achieved by July 1, 1983;

Subchapter III Standards and Enforcement

§ 1311 Effluent limitations

(g) Modifications for certain nonconventional pollutants

(1) General authority

The Administrator, with the concurrence of the State, may modify the requirements of subsection (b)(2)(A) of this section with respect to the discharge from any point source of ammonia, chlorine, color, iron, and total phenols (4AAP) (when determined by the Administrator to be a pollutant covered by subsection (b)(2)(F)) and any other pollutant which the Administrator lists under paragraph (4) of this subsection.

(2) Requirements for granting modifications

A modification under this subsection shall be granted only upon a showing by the owner or operator of a point source satisfactory to the Administrator that-

(C) such modification will not interfere with the attainment or maintenance of that water quality which shall assure protection of public water supplies, and the protection and propagation of a balanced population of shellfish, fish, and wildlife, and allow recreational activities, in and on the water and such modification will not result in the discharge of pollutants in quantities which may reasonably be anticipated to pose an unacceptable risk to human health or the environment because of bioaccumulation, persistency in the environment, acute toxicity, chronic toxicity (including carcinogenicity, mutagenicity or teratogenicity), or synergistic propensities.

 § 243 General grant of authority for cooperation

(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees

The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence.

§ 611.2 Cooperative relationships.

(a) Soil surveys on nonfederal lands are carried out cooperatively with State agricultural experiment stations and other State agencies. The cooperative effort is evidenced in a memorandum of understanding setting forth guidelines for actions to be taken by each cooperating party in the performance of soil surveys. Similar cooperative arrangements exist between NRCS and other Federal agencies for soil surveys on Federal lands.

Subpart A General Provisions

§ 123.11  Sanitation control procedures.

(a) Sanitation SOP.  Each processor should have and implement a written sanitation standard operating procedure (herein referred to as SSOP) or similar document that is specific to each location where fish and fishery products are produced. The SSOP should specify how the processor will meet those sanitation conditions and practices that are to be monitored in accordance with paragraph (b) of this section.

Subpart C Raw Molluscan Shellfish

§ 123.28  Source controls.

(a) In order to meet the requirements of subpart A of this part as they apply to microbiological contamination, chemical contamination, natural toxins, and related food safety hazards, processors shall include in their HACCP plans how they are controlling the origin of the molluscan shellfish they process to ensure that the conditions of paragraphs (b), (c), and (d) of this section are met. 

(b) Processors shall only process molluscan shellfish harvested from growing waters approved for harvesting by a shellfish control authority. In the case of molluscan shellfish harvested from U.S. Federal waters, the requirements of this paragraph will be met so long as the shellfish have not been harvested from waters that have been closed to harvesting by an agency of the Federal government.

§ 122.24   Concentrated aquatic animal production facilities (applicable to State NPDES programs, see §123.25).

(a) Permit requirement.  Concentrated aquatic animal production facilities, as defined in this section, are point sources subject to the NPDES permit program.

(b) Definition. Concentrated aquatic animal production facility  means a hatchery, fish farm, or other facility which meets the criteria in appendix C of this part, or which the Director designates under paragraph (c) of this section. 

(c) Case-by-case designation of concentrated aquatic animal production facilities. 

(1) The Director may designate any warm or cold water aquatic animal production facility as a concentrated aquatic animal production facility upon determining that it is a significant contributor of pollution to waters of the United States. In making this designation the Director shall consider the following factors: 

(i) The location and quality of the receiving waters of the United States; 

(ii) The holding, feeding, and production capacities of the facility; 

(iii) The quantity and nature of the pollutants reaching waters of the United States; and 

(iv) Other relevant factors.

§ 600.920 Federal agency consultation with the Secretary.

(a) Consultation generally  -

(1) Actions requiring consultation.  Pursuant to section 305(b)(2) of the Magnuson-Stevens Act, Federal agencies must consult with NMFS regarding any of their actions authorized, funded, or undertaken, or proposed to be authorized, funded, or undertaken that may adversely affect EFH. EFH consultation is not required for actions that were completed prior to the approval of EFH designations by the Secretary, e.g., issued permits. Consultation is required for renewals, reviews, or substantial revisions of actions if the renewal, review, or revision may adversely affect EFH. Consultation on Federal programs delegated to non-Federal entities is required at the time of delegation, review, and renewal of the delegation. EFH consultation is required for any Federal funding of actions that may adversely affect EFH. NMFS and Federal agencies responsible for funding actions that may adversely affect EFH should consult on a programmatic level under paragraph (j) of this section, if appropriate, with respect to these actions. Consultation is required for emergency Federal actions that may adversely affect EFH, such as hazardous material clean-up, response to natural disasters, or actions to protect public safety. Federal agencies should contact NMFS early in emergency response planning, but may consult after-the-fact if consultation on an expedited basis is not practicable before taking the action.

SEC. III Public Health Reasons and Explanations

Chapter X. General Requirements for Dealers

.01 General HACCP Requirements

All dealers must conduct a hazard analysis or have one conducted on their behalf...

The hazard analysis must identify the hazard of pathogen contamination at the receiving CCP as a significant hazard for all raw, molluscan shellfish products. For this reason, all dealers must have and implement a written HACCP Plan ... 

SEC. IV Guidance Documents

Chapter II. Growing Areas

.11 Systematic Random Sampling Monitoring Strategy

The first critical control point in preventing food-borne illness from shellfish consumption is identifying shellfish growing areas of acceptable sanitary quality. The completion of a sanitary survey is of paramount importance in making the distinction between acceptable and unacceptable growing areas, and is the key to accurate growing area classification as approved, conditionally approved, restricted, conditionally restricted, or prohibited. A sanitary survey is required under the NSSP Model Ordinance for each growing area prior to its approval by the State as a source of shellfish for human consumption or as a source for shellfish to be used in a depuration or relay operation. The principal components of a sanitary survey are: (1) identification and evaluation of the pollution sources that may affect the areas; (2) an evaluation of the meteorological factors; (3) an evaluation of hydrographic factors that may affect distribution of pollutants throughout the area; and (4) an assessment of water quality...

FDA-NSSP. 2019. United States Food and Drug Administration website "FDA National Shellfish Sanitation Program": Home » For Federal, State, Local, Tribal, and Territorial Officials » State Cooperative Programs » FDA National Shellfish Sanitation Program. https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/state-cooperative-programs/fda-national-shellfish-sanitation-program; Content current as of: 11/14/2019.

GAO. 2019. U.S. Army Corps Of Engineers: Information on Shellfish Aquaculture Permitting Activities. United States General Accounting Office. Report to Congressional Requesters. GAO-19-145: Published: Feb 21, 2019. https://www.gao.gov/assets/700/697024.pdf 

Maney, T. 2018. Case Study - Northeast Ocean Data Portal Facilitates Establishment of First Shellfish Farm in Atlantic Federal Waters.  https://northeastoceandata.org/case-studies/offshore-shellfish-aquaculture/; Revised: February 8, 2018. 

Mayer, L. 2019. Catalina Sea Ranch: A case study in persistence. News. Profiles. Aquaculture North America. July 10, 2019. https://www.aquaculturenorthamerica.com/catalina-sea-ranch-a-case-study-in-persistence-2351/  

NSTC.  2022. A National Strategic Plan for Aquaculture Research. Prepared by the National Science and Technology Council Subcommittee on Aquaculture. February 2022. Available at: https://www.ars.usda.gov/animal-production-and-protection/aquaculture/docs/national-strategic-plan-federal-aquaculture-research/ 

O’Connell, T. 2018. Evaluation of U.S. Shellfish Aquaculture Permitting Systems - Recommendations to Improve Permitting Efficiencies and Industry Development. A Report to NOAA Fisheries. Final Report Submission – June 2018. https://media.fisheries.noaa.gov/dam-migration/evaluation_of_us_shellfish_aquaculture_permnitting_systems.pdf