Topic 10

29. Where feed is used, aquaculture operations should include procedures for avoiding feed contamination in compliance with national regulations or as determined by internationally agreed standards. Aquaculture operations should use feeds and feed ingredients which do not contain unsafe levels of pesticides, biological, chemical and physical contaminants and/or other adulterated substances. Feed which is manufactured or prepared on the farm should contain only substances permitted by the national competent authorities.

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.

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.

36. Workers should be trained in good hygienic practices to ensure they are aware of their roles and responsibilities for protecting aquaculture products from contamination and deterioration.

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.

From the United States Food and Drug Administration website “FSMA Final Rule on Sanitary Transportation of Human and Animal Food” (FDA-FSMA 2018):

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food ... advanc(es) FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation...

This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

The rule builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Because of illness outbreaks resulting from human and animal food contaminated during transportation, and incidents and reports of unsanitary transportation practices, there have long been concerns about the need for regulations to ensure that foods are being transported in a safe manner.

The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.

Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.

An Aquaculture Depredation Order was created in 1998 under the authority granted by the Migratory Bird Treaty Act to the U.S. Fish and Wildlife Service that allows the USDA Wildlife Service to work with fish farmers in 13 states to implement non-lethal and lethal techniques to deter double-crested cormorants from eating fish grown in ponds (i.e., catfish, hybrid striped bass, redfish, baitfish and ornamental fish). An Individual Permit program was established to prevent fish death, injury and disease and to manage double-crested cormorants across 37 central and eastern States and the District of Columbia under a Population Take Limit (PTL) model. Permits are not required to harass or haze birds (except eagles) provided farmers do not cause nest abandonment or destroy an active nest with a viable egg or chick or take birds protected under the Migratory Bird Treaty Act.

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 2.3: Advance fish nutrition and feed production technologies to produce healthy fish, reduce environmental impacts and provide nutritious seafood

The growth and sustainability of the fish farming industry depends on the availability of adequate sources of feed. Therefore, it is important to identify feed ingredients, feeding practices, and feed production technologies that meet fish nutrient requirements, are palatable, and that do not have deleterious effects on the growth and health of the fish, on wild fish stocks harvested for feed, or on the broader ecosystem. Some finfish and shrimp aquaculture production systems have traditionally relied on the use of fish meal and fish oil as feed ingredients to provide a source of essential amino acids, minerals and vitamins, and essential fatty acids. However, due in part to Federal research, that is changing, and these industries are pioneering the development of numerous alternative feed ingredients.

Many of the human health benefits of seafood consumption stem from the long-chain, highly unsaturated omega-3 fatty omega-3 and omega-6 fatty acids that enrich many aquaculture seafood products, which is achieved using fish oil in aquaculture feeds. However, demands for fish meal and fish oil are high with concomitant high costs, and are somewhat limited by natural flux in wild harvests. To address these issues, new sources of fish feed ingredients must be identified that ensure quality and food safety of aquaculture products.

Achieving the desired partitioning of nutrients into the competing systems of muscle development, digestive metabolism, health maintenance, and reproduction is critical for improving productivity and reducing cost and waste. Stressors caused by nutritional and environmental factors and their interactions must be understood to limit poor animal health, disease, and product quality; suboptimal growth and production efficiency; and excess waste.

The following actions will improve the feeds used in aquaculture systems. 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 2.3.1 DOC NOAA (SG), DOE (BETO, ARPA-E), USDA (ARS, NIFA), DOI (USGS), and HHS (FDA) will collaborate to support or conduct research that determines the nutrient requirements to feed new and existing cultured species of finfish, mollusks, and microalgae and seaweeds at all stages of life to increase nutritional efficiency and provide maximal nutritional value for human consumption while minimizing potential impacts on wild fish stocks and the broader ecosystem.

• Action 2.3.2 USDA (ARS, NIFA), DOC NOAA (NMFS, SG), DOI (USGS), and HHS (FDA) will support or conduct research to provide feed manufacturers with cost-effective choices in feed ingredients suitable for marine and freshwater aquaculture production.

• Action 2.3.3 USDA (ARS, NIFA) and DOC NOAA (SG, NMFS) will conduct or support research to develop feeds and feed production methods (including live feeds) for all life stages of target organisms that result in high performance.

• Action 2.3.4 DOC NOAA (NMFS, SG), DOI (USGS), USDA (NIFA), and HHS (FDA) will collaborate to provide Extension Service and production assistance for new aquafeeds and aquaculture products to standardize growth conditions, identify factors affecting expansion to commercial scales, reduce risk for new farm and production systems, and inform feed regulatory approval.

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.

§ 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;

Subchapter I Generally

§ 1801 Findings, purposes and policy

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

(1) to take immediate action to conserve and manage the fishery resources found off the coasts of the United States, and the anadromous species and Continental Shelf fishery resources of the United States, by exercising (A) sovereign rights for the purposes of exploring, exploiting, conserving, and managing all fish, within the exclusive economic zone established by Presidential Proclamation 5030, dated March 10, 1983, and (B) exclusive fishery management authority beyond the exclusive economic zone over such anadromous species and Continental Shelf fishery resources;

Subchapter V Drugs and Devices

Part A Drugs and Devices

§ 354  Veterinary feed directive drugs

(a) Lawful veterinary feed directive requirement

(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.

§ 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

(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed be deemed unsafe for purposes of section 351(a)(6) of this title unless-

(A) there is in effect-

(i) an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such approved application;

(ii) a conditional approval of an application filed pursuant to section 360ccc of this title with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such conditionally approved application; or

(iii) an index listing pursuant to section 360ccc–1 of this title with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such index listing; and

(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(1) to manufacture such animal feed.

(3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for the purposes of section 351(a)(5) or (6) of this title if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under subsection (j).

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...

(b) Congressional recognition, preservation, and protection of primary responsibilities and rights of States

It is the policy of the Congress to recognize, preserve, and protect the primary responsibilities and rights of States to prevent, reduce, and eliminate pollution, to plan the development and use (including restoration, preservation, and enhancement) of land and water resources, and to consult with the Administrator in the exercise of his authority under this chapter...

Vehicles and Transportation Equipment

§ 1.906 What requirements apply to vehicles and transportation equipment?

(d) Vehicles and transportation equipment must be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in food for which it will be used becoming unsafe during transportation operations.

Transportation Operations

§ 1.908 What requirements apply to transportation operations?

(a) General requirements.

(4) The type of food, e.g., animal feed, pet food, human food, and its production stage, e.g., raw material, ingredient or finished food, must be considered in determining the necessary conditions and controls for the transportation operation.

(c) Requirements applicable to loaders engaged in transportation operations. 

(1) Before loading food not completely enclosed by a container onto a vehicle or into transportation equipment the loader must determine, considering, as appropriate, specifications provided by the shipper in accordance with paragraph (b)(1) of this section, that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, e.g., it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. This may be accomplished by any appropriate means.

Subpart A General Provisions

§ 123.11  Sanitation control procedures.

(b) Sanitation monitoring.  Each processor shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 of this chapter and in subpart B of part 117 of this chapter that are both appropriate to the plant and the food being processed and relate to the following: 

(8) Exclusion of pests from the food plant.

Subpart A - General Provisions

§ 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.

(a) 

(1) The management of an establishment must ensure that all individuals who manufacture, process, pack, or hold animal food subject to subparts B and F of this part are qualified to perform their assigned duties; and 

(2) The owner, operator, or agent in charge of a facility must ensure that all individuals who manufacture, process, pack, or hold animal food subject to subparts C, D, E, or F of this part are qualified to perform their assigned duties. 

(b) Each individual engaged in manufacturing, processing, packing, or holding animal food (including temporary and seasonal personnel) or in the supervision thereof must: 

(1) Be a qualified individual as that term is defined in § 507.3, i.e., have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual's assigned duties; and 

(2) Receive training in the principles of animal food hygiene and animal food safety, including the importance of employee health and personal hygiene, as appropriate to the animal food, the facility and the individual's assigned duties. 

(c) Responsibility for ensuring compliance by individuals with the requirements of this part must be clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of safe animal food. 

(d) Records that document training required by paragraph (b)(2) of this section must be established and maintained and are subject to the recordkeeping requirements in subpart F of this part.

§ 507.7 Requirements that apply to a qualified facility.

(a) A qualified facility must submit the following attestations to FDA:

(2)

(i) An attestation that you have identified the potential hazards associated with the animal food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; 

(ii) An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight.

Subpart B - Current Good Manufacturing Practice

§ 507.19 Sanitation.

(a) Buildings, structures, fixtures, and other physical facilities of the plant must be kept clean and in good repair to prevent animal food from becoming adulterated.

(b) Animal food-contact and non-contact surfaces of utensils and equipment must be cleaned and maintained and utensils and equipment stored as necessary to protect against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials. When necessary, equipment must be disassembled for thorough cleaning. In addition: 

(1) When animal food-contact surfaces used for manufacturing, processing, packing, or holding animal food are wet-cleaned, the surfaces must, when necessary, be thoroughly dried before subsequent use; and 

(2) In wet processing of animal food, when cleaning and sanitizing are necessary to protect against the introduction of undesirable microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have become contaminated. 

(c) Cleaning compounds and sanitizing agents must be safe and adequate under the conditions of use. 

(d) The following applies to toxic materials: 

(1) Only the following toxic materials may be used or stored in the plant area where animal food is manufactured, processed, or exposed: 

(i) Those required to maintain clean and sanitary conditions; 

(ii) Those necessary for use in laboratory testing procedures; 

(iii) Those necessary for plant and equipment maintenance and operation; and 

(iv) Those necessary for use in the plant's operations. 

(2) Toxic materials described in paragraph (d)(1) of this section (e.g., cleaning compounds, sanitizing agents, and pesticide chemicals) must be identified, used, and stored in a manner that protects against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials; and 

(3) Other toxic materials (such as fertilizers and pesticides not included in paragraph (d)(1) of this section) must be stored in an area of the plant where animal food is not manufactured, processed, or exposed. 

(e) Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of animal food by pests. The use of pesticides in the plant is permitted only under precautions and restrictions that will protect against the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials. 

(f) Trash must be conveyed, stored, and disposed of in a way that protects against the contamination of animal food, animal food-contact surfaces, animal food-packaging materials, water supplies, and ground surfaces, and minimizes the potential for the trash to become an attractant and harborage or breeding place for pests.

Subpart C - Hazard Analysis and Risk-Based Preventive Controls

§ 507.31 Food safety plan.

(a) You must prepare, or have prepared, and implement a written food safety plan. 

(b) One or more preventive controls qualified individuals must prepare, or oversee the preparation of, the food safety plan. 

(c) The written food safety plan must include: 

(1) The written hazard analysis as required by § 507.33(a)(2); 

(2) The written preventive controls as required by § 507.34(b); 

(3) The written supply-chain program as required by subpart E of this part; 

(4) The written recall plan as required by § 507.38(a)(1); 

(5) The written procedures for monitoring the implementation of the preventive controls as required by § 507.40(a); 

(6) The written corrective action procedures as required by § 507.42(a)(1); and 

(7) The written verification procedures as required by § 507.49(b). 

(d) The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part.

Subpart E - Supply-Chain Program

§ 507.105 Requirement to establish and implement a supply-chain program.

(a) 

(1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control. 

(2) A receiving facility that is an importer, is in compliance with the foreign supplier verification requirements under part 1, subpart L of this chapter, and has documentation of verification activities conducted under § 1.506(e) of this chapter (which provides assurance that the hazards requiring a supply-chain-applied control for the raw material or other ingredient have been significantly minimized or prevented) need not conduct supplier verification activities for that raw material or other ingredient. 

(3) The requirements in this subpart do not apply to animal food that is supplied for research or evaluation use, provided that such animal food: 

(i) Is not intended for retail sale and is not sold or distributed to the public; 

(ii) Is labeled with the statement “Animal food for research or evaluation use”; 

(iii) Is supplied in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the animal food is used only for this purpose, and any unused quantity is properly disposed of; and 

(iv) Is accompanied with documents, in accordance with the practice of the trade, stating that the animal food will be used for research or evaluation purposes and cannot be sold or distributed to the public. 

(b) The supply-chain program must be written. 

(c) When a supply-chain-applied control is applied by an entity other than the receiving facility's supplier (e.g., when a non-supplier applies controls to certain produce (i.e., produce covered by part 112 of this chapter), because growing, harvesting, and packing activities are under different management), the receiving facility must: 

(1) Verify the supply-chain-applied control; or 

(2) Obtain documentation of an appropriate verification activity from another entity, review and assess the entity's applicable documentation, and document that review and assessment.

§ 507.110 General requirements applicable to a supply-chain program.

(a) The supply-chain program must include: 

(1) Using approved suppliers as required by § 507.120; 

(2) Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) as required by § 507.125; 

(3) Conducting supplier verification activities as required by §§ 507.130 and 507.135; 

(4) Documenting supplier verification activities as required by § 507.175; and 

(5) When applicable, verifying a supply-chain-applied control applied by an entity other than the receiving facility's supplier and documenting that verification as required by § 507.175, or obtaining documentation of an appropriate verification activity from another entity, reviewing and assessing that documentation, and documenting the review and assessment as required by § 507.175. 

(b) The following are appropriate supplier verification activities for raw materials and other ingredients: 

(1) Onsite audits; 

(2) Sampling and testing of the raw material or other ingredient; 

(3) Review of the supplier's relevant food safety records; and 

(4) Other appropriate supplier verification activities based on supplier performance and the risk associated with the raw material or other ingredient. 

(c) The supply-chain program must provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.

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: 

(a) Solids control.  The permittee must: 

(1) Employ efficient feed management and feeding strategies that limit feed input to the minimum amount reasonably necessary to achieve production goals and sustain targeted rates of aquatic animal growth in order to minimize potential discharges of uneaten feed and waste products to waters of the U.S.

(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. 

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

Subpart F Offshore Marine Aquaculture in the Gulf of Mexico

§ 622.102 Recordkeeping and reporting. 

(a) Participants in Gulf aquaculture activities addressed in this subpart must keep records and report as specified in this section. Unless otherwise specified, required reporting must be accomplished electronically via the Web site. See § 622.100(a)(3) regarding provisions for paper-based reporting in lieu of electronic reporting during catastrophic conditions as determined by the RA. Recordkeeping (i.e., maintaining records versus submitting reports) may, to the extent feasible, be maintained electronically; however, paper-based recordkeeping also is acceptable. 

(1) Aquaculture facility owners or operators.  An aquaculture facility owner or operator must comply with the following requirements:

(i) Reporting requirements  - 

(H) Feed invoices.  The permittee must keep the original purchase invoices for feed or copies of purchase invoices for feed, make them available to NMFS or an authorized officer upon request, and be maintained for a period of 3 years. 

§ 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.

(7) Feed practices and monitoring.  The permittee must conduct feed monitoring and management practices in compliance with EPA regulations at 40 CFR 451.21, if applicable to the facility.

Background

The United States Food and Drug Administration (FDA) is the primary federal agency responsible for enforcing the Federal Food, Drug, and Cosmetic Act (the Act).  Included within the FDA’s responsibilities under the Act is the responsibility for regulation of animal foods/feeds.  The Act provides the authority for FDA to regulate essentially all ingredients and additives used in animal feed. Depending on its intended purpose or use, an ingredient or additive could be classified as a food additive, a generally recognized as safe substance, a new animal drug, or a color additive. 

The Association of American Feed Control Officials (AAFCO) is a voluntary membership organization of the states in the United States (US) and Federal government agencies, as well as government agencies from other countries, responsible for the execution of laws and regulations pertaining to the production, labeling, distribution, use, or sale of animal feed and feed ingredients.  The purpose of AAFCO is to provide a mechanism for developing and implementing uniform and equitable laws, regulations, standards, definitions, and enforcement policies for the manufacturing, labeling, and sale of animal feeds and ingredients.  AAFCO provides “model laws” and regulations that nearly all states have adopted as the basis for their feed-control program.  It is governed by officers and a board of directors (known collectively as the Board) elected by the membership at the annual meeting of AAFCO.  The FDA is a member of AAFCO and serves in a non-voting advisory role on the AAFCO Board.

AAFCO provides a process (herein called the AAFCO Ingredient Definition Request Process) to identify the safety, utility, and identity of ingredients used in animal feed.  This process helps to ensure ingredients used in animal feed are suitable for that use and also establishes a common or usual name for the ingredients.  This common or usual identity is required on feed labels by both federal law and state regulations.  The AAFCO Ingredient Definition Request Process is operated by AAFCO, with the FDA providing scientific and technical assistance.  The result of this collaboration has been the establishment of an effective program of benefit to feed regulatory officials, the industry, and the public.

Purpose

The purpose of this memorandum is to facilitate the FDA’s collaboration with AAFCO in the AAFCO Ingredient Definition Request Process by clarifying the responsibilities of the FDA and AAFCO during the feed ingredient definition request process and providing mechanisms for resolving disputes that arise and for modifying the definitions when required.

Agreement

The FDA and AAFCO agree to the following:

A. AAFCO maintains definitions of various feed ingredients, which includes the common ingredient name, description, and any appropriate limitations for its use, and publishes the currently accepted feed ingredient definitions in the AAFCO Official Publication (OP).

C. AAFCO will seek advice and a letter of concurrence regarding the suitability of the feed ingredient for its proposed use from the FDA prior to adopting new feed ingredient definitions or amending existing ones.

F. If the FDA determines it will publish a food additive regulation of a requested ingredient definition under section 409 of the Act and FDA’s implementing regulations in 21 CFR 571.1 for a feed ingredient, AAFCO will not include that ingredient in the AAFCO OP until the FDA completes the regulation.

H. AAFCO will consider all requests from the FDA to remove an ingredient definition from the AAFCO OP upon the FDA presenting scientific evidence substantiating their conclusion the ingredient is no longer suitable for its stated intended use.  The Ingredient Definitions Committee will vote on the FDA request to remove the ingredient from the Feed Ingredient Definitions section in the AAFCO OP at their next scheduled meeting. Disagreements between AAFCO and the FDA would be handled as stated in G.

I. AAFCO is allowed, on its own initiative and with FDA concurrence, to request that an AAFCO Feed Ingredient Definition be removed upon AAFCO providing scientific evidence substantiating their conclusion that the ingredient is no longer suitable for its stated use.  The Ingredient Definitions Committee will vote to remove the ingredient from the Feed Ingredient Definitions section in the AAFCO OP at their next scheduled meeting. Disagreements between AAFCO and FDA would be handled as stated in section G.

SEC. II Model Ordinance

Chapter XI. Shucking and Packing

.02 Sanitation

H. Exclusion of Pests. The dealer shall operate his facility to assure that pests are excluded from the facility and processing activities. Animals shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored. 

Chapter XII. Repacking of Shucked Shellfish

.02 Sanitation

H. Exclusion of Pests.  The dealer shall operate his facility to assure that pests are excluded from the facility and processing activities. Animals shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored. 

Chapter XIII. Shellstock Shipping

.02 Sanitation

H. Exclusion of Pests.  The dealer shall operate his facility to assure that pests are excluded from the facility and processing activities. Animals shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored.

Chapter XIV. Reshipping

.02 Sanitation

H. Exclusion of Pests.  The dealer shall operate his facility to assure that pests are excluded from the facility and processing activities. Animals shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored. 

Chapter XV. Depuration

.02 Sanitation

H. Exclusion of Pests. The dealer shall operate his facility to assure that pests are excluded from the facility and processing activities. Animals shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored. 

SEC. III Public Health Reasons and Explanations

Chapters XI., XII., XIII., and XIV. Shellfish Processing and Handling

.02 Sanitation Requirements

Exclusion of Pests.

Controlling flies, cockroaches, and other insects may prevent shellfish and food-contact surfaces from being contaminated with disease organisms. Controls should be directed at preventing the entrance of insects, rodents, and other vermin into the building, and at depriving them of food, water, and shelter.

Chapter XV. Depuration

.02 Sanitation 

Exclusion of Pests.

Controlling flies, cockroaches, and other insects may prevent shellfish and food-contact surfaces from being contaminated with disease organisms. Controls should be directed at preventing the entrance of insects, rodents, and other vermin into the building, and at depriving them of food, water, and shelter.

.03 Other Model Ordinance Requirements

A. Plants and Grounds.

The grounds about a depuration plant must be free from conditions that may result in contamination of shellfish at any time during processing and storage. The plant building or structure shall be suitable in size, construction, and design to prevent contamination of shellfish by animals and other pests; to keep untreated and treated shellfish separate; and to facilitate adequate cleaning, sanitizing, operation, and maintenance of the depuration facilities. Processing tanks, containers, piping and conveyances must be enclosed within a protective structure.

FDA-FSMA. 2018. United States Food and Drug Administration website "FSMA Final Rule on Sanitary Transportation of Human and Animal Food": Home » Food  » Guidance & Regulation (Food and Dietary Supplements) » Food Safety Modernization Act (FSMA) » FSMA Final Rule on Sanitary Transportation of Human and Animal Food. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food ; Content current as of: 09/12/2018.

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/