Topic 11

31. Water used for aquaculture should be of a quality suitable for the production of food which is safe for human consumption. Wastewater should not be used in aquaculture. If wastewater is used, the WHO guidelines for the safe use of wastewater and excreta in aquaculture should be followed.

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.

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

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

“One Health” concepts recognize that the health of people is connected to the health of farmed organisms and the environment. One Health approaches to developing healthy ecosystems are collaborative, multisectoral, and transdisciplinary—working at the local, regional, national, and global levels—with the goal of achieving optimal health outcomes. These approaches recognize the interconnection between people, animals, plants, and their shared environments. Optimal implementation of One Health principles requires the development and coordination of programs, policies, legislation, and research in which multiple sectors communicate and work together to achieve better public health outcomes. Specifically, the concept focuses on ways to improve food security, quality, and safety; control diseases; and manage environmental factors through harmonization and standardization. To apply the One Health concept to aquaculture, Federal research should be coordinated to:

• Improve aquatic animal and algal health management;

• Ensure the safety of all biologics and therapeutics being used in domestic aquaculture;

• Promote and ensure the safety and health benefits of consuming aquaculture products;

• Minimize the potential for impacts on the environment from aquaculture facilities;

• Restore endangered species and habitats;

• Increase the socioeconomic health of communities;

• Improve U.S. food and nutritional security; and

• Where appropriate, minimize negative secondary impacts to human, animal, and plant health.

Objective 3.1: Develop strategies to protect the health and well-being of aquaculture species

Disease causes economic and ecological losses across the aquaculture sector. In addition to direct losses to production, disease can have broader indirect impacts on the surrounding ecosystem, public perception, demand for cultured products, and policy decisions. Accordingly, significant investments should be directed toward understanding priority disease issues and developing tools and capabilities to proactively address them. Wherever possible, prevention of disease through good farm management (i.e., maintaining good water quality, not overfeeding, not overstocking) and sound on-farm biosecurity programs and vaccination is preferred to treatment with pharmaceuticals. This also includes the need to integrate oceanographic and epidemiological models to help site and manage marine aquaculture. Disease prevention is also improved by national and regional biosecurity efforts, including inspection and approval protocols for aquaculture inputs such as feed, eggs and juveniles.

Where preventive measures have not been developed or are not adequate, safe and effective treatment options must be developed to avoid unnecessary losses and protect animal and plant welfare. Research is needed to characterize important and emerging disease issues, identify effective prevention measures, including vaccines, and develop safe and effective treatment options using approved drugs and biologics.

Domesticating aquaculture species for commercial production often requires treatments with specific drugs to better predict spawning times and enhance reproductive success or develop monosex or sterile populations. These treatments can reduce the impacts of sexual dimorphism, reduce risks associated with escapes, and protect investments in selected stocks. Anesthetics are also needed for tagging, weighing, and nonlethal sampling wild and domesticated stocks.

Key actions listed below will protect aquatic animal health and the agencies listed will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• Action 3.1.1 USDA (APHIS, ARS, NIFA), DOC NOAA (SG, NMFS), and DOI (USGS, USFWS) will support or conduct research and industry outreach to improve farm-level biosecurity and management practices including non-lethal pathogen testing to maintain adequate water quality, minimize animal stress, and prevent diseases.

• Action 3.1.2 DOI (USFWS), USDA (APHIS), and DOC NOAA (SG, NMFS) will conduct outreach to improve regional and national biosecurity procedures including transfers of juveniles and other aquaculture inputs and products.

• Action 3.1.3 HHS (FDA), USDA (APHIS, ARS, NIFA), DOI (FWS, USGS), and DOC NOAA (SG, NMFS) will collaborate to support or conduct research that identifies and characterizes key unmet needs or provides information on the safety and effectiveness for drugs and biologics across the aquaculture sector, including vaccine and disease treatments, anesthetics, marking agents, and tools to aid in spawning and gender control.

• Action 3.1.4 HHS (FDA), and DOC NOAA (NSIL) will validate new chemical detection methods for residues of approved and unapproved drugs to support regulatory compliance and surveillance activities.

• Action 3.1.5 HHS (FDA), USDA (APHIS), and DOI (USFWS) will develop standardized criteria to interpret laboratory tests intended to provide surveillance for monitoring antimicrobial resistance and to inform judicious use of antimicrobials.

• Action 3.1.6 HHS (FDA), DOI (USFWS) and DOC NOAA (NMFS) will investigate alternative approaches to the standard drug development process to increase availability of approved therapies for U.S. aquaculture.

• Action 3.1.7 USDA (APHIS, ARS), DOI (USGS) and DOC (NMFS) will conduct research to detect and characterize important and emerging aquatic diseases to support early detection (biosurveillance) and develop effective responses.

§ 136a-1  Reregistration of registered pesticides

(c) Phase one

(1) Priority for reregistration

For purposes of the reregistration of the pesticides described in subsection (a), the Administrator shall list the active ingredients of pesticides and shall give priority to, among others, active ingredients (other than active ingredients for which registration standards have been issued before the effective date of this section) that-

(A) are in use on or in food or feed and may result in postharvest residues;

§ 601  Definitions. As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below:

(w) The term “amenable species” means—

(1) those species subject to the provisions of this chapter on the day before November 10, 2005;

(2) all fish of the order Siluriformes; and

(3) any additional species of livestock that the Secretary considers appropriate.

Subchapter E Regulatory Requirements Under the Federal Meat Inspection Act and the Poultry Products Inspection Act : Part 417. Hazard Analysis And Critical Control Point (HACCP) Systems 

§ 417.2 Hazard Analysis and HACCP Plan.

(a) Hazard analysis.

(1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

(2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.

(3) Food safety hazards might be expected to arise from the following:

(i) Natural toxins;

(ii) Microbiological contamination;

(iii) Chemical contamination;

(iv) Pesticides;

(v) Drug residues;

(vi) Zoonotic diseases;

(vii) Decomposition;

(viii) Parasites;

(ix) Unapproved use of direct or indirect food or color additives; and

(x) Physical hazards.

(b) The HACCP plan.

(1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section…

(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

(1) List the food safety hazards identified in accordance with paragraph (a) of this section, which must be controlled for each process.

(2) List the critical control points for each of the identified food safety hazards, including, as appropriate:

(i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and

(ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment;

(3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met;

(4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point;

Subchapter F Mandatory Inspection of Fish of the Order Siluriformes and Products of Such Fish: Part 534 Pre-Harvest Standards and Transportation to Processing Establishment

§ 534.2  Water Quality For Food Fish

Farmers of fish should monitor the water in which the fish are raised for the presence of suspended solids, organic matter, nutrients, heavy metals, pesticides, fertilizers, and industrial chemicals that may contaminate fish. FSIS will collect samples of feed, fish, and water from producers, at intervals to be determined by the Administrator, for the purpose of verifying that fish are being raised under conditions that will yield safe, wholesome products.

Part 109 Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material

§ 109.4 Establishment of tolerances, regulatory limits, and action levels.

(a) When appropriate under the criteria of § 109.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount of the substance in food. 

(b) When appropriate under the criteria of § 109.6, and under section 402(a)(1) of the act, a regulatory limit for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart C of this part under the provisions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit any detectable amount of the substance in food. The regulatory limit established represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act. 

(c) 

(1) When appropriate under the criteria of § 109.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established to define a level of contamination at which a food may be regarded as adulterated. 

(2) Whenever an action level is established or changed, a notice shall be published in the Federal Register as soon as practicable thereafter. The notice shall call attention to the material supporting the action level which shall be on file with the Division of Dockets Management before the notice is published. The notice shall invite public comment on the action level. 

(d) A regulation may be established in subpart D of this part to identify a food containing a naturally occurring poisonous or deleterious substance which will be deemed to be adulterated under section 402(a)(1) of the act. These regulations do not constitute a complete list of such foods.

§ 109.7 Unavoidability.

(a) Tolerances and action levels in this part are established at levels based on the unavoidability of the poisonous or deleterious substance concerned and do not establish a permissible level of contamination where it is avoidable. 

(b) Compliance with tolerances, regulatory limits, and action levels does not excuse failure to observe either the requirement in section 402(a)(4) of the act that food may not be prepared, packed, or held under insanitary conditions or the other requirements in this chapter that food manufacturers must observe current good manufacturing practices. Evidence obtained through factory inspection or otherwise indicating such a violation renders the food unlawful, even though the amounts of poisonous or deleterious substances are lower than the currently established tolerances, regulatory limits, or action levels. The manufacturer of food must at all times utilize quality control procedures which will reduce contamination to the lowest level currently feasible.

Part 123 Fish and Fishery Products

§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.

(g) Legal basis.  Failure of a processor to have and implement a HACCP plan that complies with this section whenever a HACCP plan is necessary, otherwise operate in accordance with the requirements of this part, shall render the fish or fishery products of that processor adulterated under section 402(a)(4) of the act. Whether a processor's actions are consistent with ensuring the safety of food will be determined through an evaluation of the processors overall implementation of its HACCP plan, if one is required.

I. PURPOSE

This agreement will establish a basis upon which to foster and improve the sanitation and quality of shellfish in this country by stating the responsibilities of the Food and Drug Administration (FDA) and the Interstate Shellfish Sanitation Conference (ISSC) and the establishment of the Interstate Shellfish Sanitation Program (ISSP) and the ISSC Procedures (Procedures).

III. BACKGROUND

The purpose of the ISSC is to provide a formal structure wherein State regulatory authorities can establish updated guidelines, and procedures for the uniform application of those guidelines, for sanitary control of the shellfish industry. The ISSC is a voluntary organization and is open to all persons interested in fostering controls that will assure sources of safe and sanitary shellfish.

SEC I. Purposes & Definitions

Purpose

In 1984, the FDA entered into a Memorandum of Understanding (MOU) with the Interstate Shellfish Sanitation Conference recognizing the ISSC as the primary voluntary national organization of State shellfish regulatory officials that provide guidance and counsel on matters for the sanitary control of shellfish. The purpose of the ISSC is to provide a formal structure for State regulatory authorities to participate in establishing updated regulatory guidelines and procedures for uniform State application of the Program. The ISSC has adopted formal procedures for State representatives to review shellfish sanitation issues and develop regulatory guidelines. Following FDA concurrence, these guidelines are published in revisions of the NSSP Model Ordinance.

The NSSP Guide for the Control of Molluscan Shellfish consists of a Model Ordinance, supporting guidance documents, recommended forms, and other related materials associated with the Program. The Model Ordinance includes guidelines to ensure that the shellfish produced in States in compliance with the guidelines are safe and sanitary. The Model Ordinance provides readily adoptable standards and administrative practices necessary for the sanitary control of molluscan shellfish...