Topic 6

21. Movement of aquatic animals, animal genetic material and animal products should take place in accordance with the relevant provisions in the OIE Aquatic Animal Health Code to prevent introduction or transfer of diseases and infectious agents pathogenic to aquatic animals while avoiding unwarranted sanitary measures.

23. Veterinary medicines should be used in a responsible manner and in accordance with applicable national legislation or relevant international agreements that ensure effectiveness, safety of public and animal health, and protection of the environment.

30. All veterinary drugs and chemicals for use in aquaculture shall comply with national regulations, as well as international guidelines. Wherever applicable, veterinary drugs and chemicals should be registered with the competent national authority. Veterinary drugs should be scheduled (classified). Control of diseases with veterinary drugs and antimicrobials should be carried out only on the basis of an accurate diagnosis and knowledge that the drug is effective for control or treatment of a specific disease. In some classifications, veterinary drugs may only be prescribed and distributed by personnel authorized under national regulations. All veterinary drugs and chemicals or medicated feeds should be used according to the instructions of the manufacturer or other competent authority, with particular attention to withdrawal periods. Banned non-registered and/or non-permitted antimicrobial agents, veterinary drugs and/or chemicals must not be used in aquaculture production, transportation or product processing. Prophylactic use of veterinary medicinal products, particularly antimicrobial agents{Antimicrobial agents do not include vaccines.}, should not take place.

33. Traceability and record-keeping of farming activities and inputs which impact food safety should be ensured by documenting, inter alia:

·   the source of inputs such as feed, seed, veterinary drugs and antibacterials, additives, chemicals; and

·   type, concentration, dosage, method of administration and withdrawal times of chemicals, veterinary drugs and antibacterials and the rationale for their use.

52. Feeds, feed additives, chemicals, veterinary drugs, including antimicrobials, manure and fertilizer, should be used responsibly to minimize their adverse impacts on the environment and to promote economic viability.

The United States Food and Drug Administration (FDA) “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply…” (FDA 2018). Any drug administered to a food animal must be approved by FDA for such use. The Federal Food, Drug, and Cosmetic Act defines a drug as “articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”. Essentially, anything administered to the aquatic food organism is considered a drug, i.e., anything other than the water it is living in and unadulterated feed. This includes substances administered to treat sickness, sedate or anesthetize, mark skeletal tissue, or induce spawning (Bowker 2018a). 

The FDA's “Center for Veterinary Medicine is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. This authority is derived from the Federal Food, Drug, and Cosmetic Act (which) was amended in 1968 to include sections which specifically address animal drugs. These amendments were designed to ensure that animal drugs are safe and effective for their intended uses and that they do not result in unsafe residues in foods” (FDA-CVM 2018).

The FDA’s medicine chest contains 22 unique drugs in six different categories (Bowker 2018b):

1. FDA Approved drugs, which have gone through the New Animal Drug Applications process

Nine products; four antibiotics [three in-feed antibiotics that require a Veterinary Feed Directive, i.e., a prescription (the FDA has also issued a compliance policy guideline permitting veterinarians to prescribe these Veterinary Feed Directive drugs for extra-label use when necessary) and one immersion antibiotic for marking skeletal tissue, which requires veterinary oversight]; three water immersion antimicrobials, which are broad-spectrum, nonselective oxidizing agents (i.e.,  hydrogen peroxide, chloramine-T, formalin); one sedative to temporarily immobilize fish; and one spawning aid that can be used via veterinary prescription only

2. Investigational New Animal Drugs (INADS), which are in the approval pipeline and can be used under certain conditions

Fifteen products; six antibiotics [four in-feed antibiotics (two of which have already been approved for other uses/species; one new in-feed antibiotic to control sea/lice/copepod infestations); one immersion antibiotic (which has already been approved for other uses); and one injectable antibiotic]; three antimicrobials (two of which have already been approved for other uses; one new EPA-registered herbicide); one sex manipulation drug; one sedative; four spawning aids (injection or implant); and one marking agent. The INAD exemption allows use of the drug for research purposes, including use on a production scale while high-quality data are being generated. The INAD exemption involves very specific use guidelines, and results, problems, and other information must be reported to the drug sponsor. 

3. Deferred regulatory status drugs, which are in the approval pipeline for broader use

Two antimicrobial products that are EPA-registered products (e.g., copper sulfate, potassium permanganate)

4. Conditionally approved drugs, which have gone through the New Animal Drug Application Process with the exception of effectiveness

One product (drug was approved to treat a specific disease; the sponsors suggest it can treat another disease as well, although the evidence to support effectiveness for the other disease has not yet been fully provided)

5. Indexed Drugs, which are not approved but can be legally marketed for use with ornamental aquarium fish only: 

Two products (one is a spawning aid and the other is a sedative)

6. Low Regulatory Priority Drugs, which are not approved but are “low risk” products (e.g., ice, salt)

For using Veterinary Feed Directive drugs, a veterinarian must be involved, and thus, a valid veterinary/patient/client relationship must be established. Every State has a definition for that veterinary/patient/client relationship and if it does not the default is the federal relationship (Bowker 2018c). Antibiotics are no longer available over the counter. Since January 1, 2017, all approved antibiotics for use in aquaculture are Veterinary Feed Directive drugs only. Therefore, there is no option to legally purchase unless a veterinarian fills out the veterinary/patient/client relationship paperwork for an approved drug or the user enrolls in an Investigational New Animal Drug program (if they want to use a drug that is not yet approved for that specific use). 

Licensing programs have been established for domestic manufacturers of veterinary biologics to ensure that these products are pure, safe, potent, and effective. Testing fish biologics is conducted at APHIS' Center for Veterinary Biologics.  Import permits are required for veterinary biologics produced in other countries.  Veterinary biologics production facilities, methods, and records are also inspected. The APHIS Center for Veterinary Biologics also develops test methods, as well as references and reagents, oversees prelicensing field trials, establishes and enforces regulations for interstate movement of veterinary biologics and issues documents to meet foreign countries' requirements for accepting export shipments of veterinary biologics produced by U.S. manufacturers.  Procedures are in place for issuing permits for the importation of organisms and vectors used for master seed and biologics research as well as for licensing veterinary biologics for the prevention, diagnosis, and/or treatment of diseases of aquatic animals and investigating consumer complaints regarding biologics used in aquaculture.  

From the U.S. Fish & Wildlife Service website “Aquatic Animal Drug Approval Partnership Program” (USFWS-AADAP 2019):

The Aquatic Animal Drug Approval Partnership (AADAP) program is part of the USFWS Fish and Aquatic Conservation fish health work. It is the only program in the United States singularly dedicated to obtaining U.S. Food and Drug Administration (FDA) approval of new medications needed for use in fish culture and fisheries management. Since the late 1990’s, AADAP has contributed to virtually every new fish medication approved by the FDA. Ultimately, the AADAP program allows fisheries professionals to more effectively and efficiently rear and manage a variety of fish species to meet production goals, stock healthy fish, and maintain a healthy environment.

With respect to the food safety provisions, seafood processors are required to and do have Hazard Analysis and Critical Control Point (HACCP) plans to ensure food products are not adulterated and safe for human consumption.  The regulations for the Safe and Sanitary Processing and Importing of Fish and Fishery Products have been established (21 C.F.R. part 123) and require that all seafood products in interstate commerce in the United States to be processed in accordance with both the HACCP principles and the sanitation prerequisite requirements that are specified in those regulations. These requirements apply to imported as well as domestic products.  The Final Rule establishing procedures for the safe and sanitary processing and importing of fish and fishery products (60 F.R. 65096) was published on December 18, 1995. The FDA Food Safety Modernization Act (Pub. L. 111-353) passed in 2017 updated the FDA seafood safety program (FDA 2022).

From the U.S. Food and Drug Administration website “HACCP Principles & Application Guidelines” (FDA-HACCP 1997) as relates to independent evidence:

(An) important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled… 

Subsequent validations are performed and documented by a HACCP team or an independent expert as needed… 

In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.

Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function…

In February 2001, the General Accounting Office (GAO) released an independent evaluation FDA’s seafood HACCP program. GAO concluded that while FDA has made progress in ensuring the safety of seafood through HACCP, the program needed to be strengthened in order to reach its full objective. The report confirmed the findings of an internal evaluation by FDA’s own Office of Seafood, released in December 2000.  FDA took corrective action as a result of the evaluation to further strengthen its Seafood HACCP program, including increasing the frequency of government inspections, providing more extensive laboratory testing for pathogens and histamines, improving guidance and training to the industry and regulators, and  implementing enforcement action where appropriate (GAO 2001). 

Progress was confirmed by two independent surveys of the seafood industry, one by the New York Sea Grant Extension Program and one by the Seafood HACCP Alliance, which reported that, “as a result of FDA’s HACCP program, the seafood industry is acquiring a better understanding of food safety hazards and how to control them. As a result, the industry is engaging in significant upgrades in facilities, equipment, and daily plan operations to ensure safety. Implementation of these state-of-the-art preventive controls by the seafood processing industry contributes to a significant increase in the margin of safety for consumers of these products” (FDA-HACCP 2001).

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

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.

Although the FDA’s medicine chest currently contains 22 unique drugs, there are a number of areas where additional approvals are warranted. Drug labels specify both species and production systems, and their potential use can only occur under veterinarian supervision. Most of these drugs are designated for use in freshwater food fish only. The FDA’s list does not currently include vaccines, which are part of an integrated health management plan. Vaccines are given to aquatic organisms before a sickness outbreak, and thus are implemented proactively. Drugs for manipulating sex determination and parasite treatment (e.g., sea lice) are also much needed. Virtually all of the drugs in FDA’s medicine chest are designated for very specific uses and species, and the establishment of drugs for broad use would be helpful. In addition, although three antibiotics are currently approved by the FDA, additional antibiotics can help address concerns regarding antimicrobial resistance (Bowker 2018a;b).

§ 152  Importation regulated and prohibited

The importation into the United States of any virus, serum, toxin, or analogous product for use in the treatment of domestic animals, and the importation of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, is prohibited without (1) a permit from the Secretary of Agriculture, or (2) in the case of an article originating in Canada, such permit or, in lieu of such permit, such certification by Canada as may be prescribed by the Secretary of Agriculture.

Subchapter II Definitions

§ 321  Definitions; generally

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

Subchapter V Drugs and Devices

Part A Drugs and Devices

§ 354  Veterinary feed directive drugs

(a) Lawful veterinary feed directive requirement

(1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title to use under the professional supervision of a licensed veterinarian is a veterinary feed directive drug. Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice. When labeled, distributed, held, and used in accordance with this section, a veterinary feed directive drug and any animal feed bearing or containing a veterinary feed directive drug shall be exempt from section 352(f) of this title.

(3)(A) Any persons involved in the distribution or use of animal feed bearing or containing a veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed directive shall maintain a copy of the veterinary feed directive applicable to each such feed, except in the case of a person distributing such feed to another person for further distribution. Such person distributing the feed shall maintain a written acknowledgment from the person to whom the feed is shipped stating that that person shall not ship or move such feed to an animal production facility without a veterinary feed directive or ship such feed to another person for further distribution unless that person has provided the same written acknowledgment to its immediate supplier.

(B) Every person required under subparagraph (A) to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(C) Any person who distributes animal feed bearing or containing a veterinary feed directive drug shall upon first engaging in such distribution notify the Secretary of that person's name and place of business. The failure to provide such notification shall be deemed to be an act which results in the drug being misbranded.

§ 360b New animal drugs

(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances

(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of section 351(a)(5) of this title and section 342(a)(2)(C)(ii) of this title unless-

(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application;

(B) there is in effect a conditional approval of an application filed pursuant to section 360ccc of this title with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application;

(C) there is in effect an index listing pursuant to section 360ccc–1 of this title with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or

(D) there is in effect an authorization pursuant to section 360bbb–3 of this title with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to any conditions of such authorization.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m).

(4)

(B) If the Secretary finds that there is a reasonable probability that a use of an animal drug authorized under subparagraph (A) may present a risk to the public health, the Secretary may-

(i) establish a safe level for a residue of an animal drug when it is used for such different use authorized by subparagraph (A); and

(ii) require the development of a practical, analytical method for the detection of residues of such drug above the safe level established under clause (i).

The use of an animal drug that results in residues exceeding a safe level established under clause (i) shall be considered an unsafe use of such drug under paragraph (1). Safe levels may be established under clause (i) either by regulation or order.

(D) If the Secretary finds, after affording an opportunity for public comment, that a use of an animal drug authorized under subparagraph (A) presents a risk to the public health or that an analytical method required under subparagraph (B) has not been developed and submitted to the Secretary, the Secretary may, by order, prohibit any such use.

Part F New Animal Drugs for Minor Use and Minor Species (Minor Use and Minor Species Animal Health Act)

§ 360ccc-1  Index of legally marketed unapproved new animal drugs for minor species

(a) Establishment and content

(1) The Secretary shall establish an index limited to-

(A) new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals; and

(B) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-food life stage of a food-producing minor species, where safety for humans is demonstrated in accordance with the standard of section 360b(d) of this title (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance).

§ 608  Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products

The Secretary shall cause to be made, by experts in sanitation or by other competent inspectors, such inspection of all slaughtering, meat canning, salting, packing, rendering, or similar establishments in which amenable species are slaughtered and the meat and meat food products thereof are prepared for commerce as may be necessary to inform himself concerning the sanitary conditions of the same, and to prescribe the rules and regulations of sanitation under which such establishments shall be maintained; and where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, he shall refuse to allow said meat or meat food products to be labeled, marked, stamped or tagged as "inspected and passed."

§ 161.1  Statement of purpose; requirements and application procedures for accreditation.

(a) This subchapter concerns a program administered by APHIS to accredit veterinarians and thereby authorize them to perform, on behalf of APHIS, certain activities specified in this chapter. This program is intended to ensure that an adequate number of qualified veterinarians are available in the United States to perform such activities.

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;

Subpart A General Provisions

§ 123.5  Current good manufacturing practice. 

(a) Except as provided by § 117.5(b), parts 110 and 117 of this chapter apply in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether these products have been processed under sanitary conditions. 

(b) The purpose of this part is to set forth requirements specific to the processing of fish and fishery products.

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

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

(1) List the food safety hazards that are reasonably likely to occur, as identified in accordance with paragraph (a) of this section, and that thus must be controlled for each fish and fishery product. Consideration should be given to whether any food safety hazards are 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 product 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; 

(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. 

§ 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.

Part 122 General Provisions: EPA Administered Permit Programs - The National Pollutant Discharge Elimination System

Subpart B - Permit Application and Special NPDES Program Requirements

§ 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.

§ 451.3  General Reporting Requirements

(a) Drugs.  Except as noted below, a permittee subject to this part must notify the permitting authority of the use in a concentrated aquatic animal production facility subject to this part of any investigational new animal drug (INAD) or any extralabel drug use where such a use may lead to a discharge of the drug to waters of the U.S. Reporting is not required for an INAD or extralabel drug use that has been previously approved by FDA for a different species or disease if the INAD or extralabel use is at or below the approved dosage and involves similar conditions of use.

Subpart A Flow-Through and Recirculating Systems Subcategory

§ 451.11  Effluent limitations attainable by the application of the best practicable control technology currently available (BPT).

Except as provided in 40 CFR 125.30 through 125.32, any existing point source subject to this subpart must meet the following requirements, expressed as practices (or any modification to these requirements as determined by the permitting authority based on its exercise of its best professional judgment) representing the application of BPT:

(b) Materials storage.  The permittee must:

(1) Ensure proper storage of drugs, pesticides, and feed in a manner designed to prevent spills that may result in the discharge of drugs, pesticides or feed to waters of the U.S. 

(2) Implement procedures for properly containing, cleaning, and disposing of any spilled material.

Part 622 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic

Subpart F Offshore Marine Aquaculture in the Gulf of Mexico

§ 622.106 Aquaculture operations. 

(a) Operational requirements and restrictions.  An owner or operator of an aquaculture facility for which a Gulf aquaculture permit has been issued must comply with the following operational requirements and restrictions.

(6) Use of drugs and other chemicals or agents.  Use of drugs, pesticides, and biologics must comply with all applicable Food and Drug Administration (FDA), EPA, and USDA requirements (e.g., Federal, Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.; Clean Water Act, 40 CFR part 122; 9 CFR parts 101 through 124; 21 CFR parts 500 through 599; and 40 CFR parts 150 through 189).

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).

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 ... 

Bowker, J. 2018a. “Fish Health Medicine Chest Part 1”. ATOLL BONUS CONTENT  (Aquaculture America 2018). February 19, 2018. Available via https://www.udemy.com/atoll-introduction-to-aquaculture/  

Bowker, J. 2018b. “Fish Health Medicine Chest Part 2”. ATOLL BONUS CONTENT  (Aquaculture America 2018). February 19, 2018. Available via https://www.udemy.com/atoll-introduction-to-aquaculture/  

Bowker, J. 2018c. “Fish Health Medicine Chest Part 3”. ATOLL BONUS CONTENT  (Aquaculture America 2018). February 19, 2018. Available via https://www.udemy.com/atoll-introduction-to-aquaculture/   

FDA. 2018. United States Food and Drug Administration website "What We Do": Home » About FDA  » What We Do. https://www.fda.gov/about-fda/what-we-do; Content current as of: 03/28/2018.

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