Topic 12

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.

45. Regular monitoring of on-farm and off-farm environmental quality should be carried out, combined with good record-keeping and use of appropriate methodologies.

Country of origin labeling regulations do require some elements of traceability and recordkeeping, but do not require information to be provided beyond the country of origin and production method. There are no regulations against co-mingling product, and products may be described as coming from multiple countries of origin, even when a specific aquaculture product only originated from one of those countries. Traceability to an individual farm is not necessarily required for any individual product.  Suppliers are required to possess records that substantiate claims for a period of 1 year. Producer affidavits are considered acceptable records. 

Chain of custody certification templates and programs are available from several certification and traceability organizations, and are standard practice in the industry. ISSC provides a template that could be considered for other aquaculture products. The HACCP program also provides a model for record keeping that is required for food safety but could be integrated into programs for ensuring the sustainability of aquaculture products.

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

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

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

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

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

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

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

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

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

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

§1638a Notice of country of origin

(a) In general

(1) Requirement

Except as provided in subsection (b), a retailer of a covered commodity shall inform consumers, at the final point of sale of the covered commodity to consumers, of the country of origin of the covered commodity.

(3) Designation of country of origin for fish

(A) In general

A retailer of a covered commodity that is farm-raised fish or wild fish may designate the covered commodity as having a United States country of origin only if the covered commodity-

(i) in the case of farm-raised fish, is hatched, raised, harvested, and processed in the United States; and

(ii) in the case of wild fish, is-

(I) harvested in the United States, a territory of the United States, or a State, or by a vessel that is documented under chapter 121 of title 46 or registered in the United States; and

(II) processed in the United States, a territory of the United States, or a State, including the waters thereof, or aboard a vessel that is documented under chapter 121 of title 46 or registered in the United States.

(B) Designation of wild fish and farm-raised fish

The notice of country of origin for wild fish and farm-raised fish shall distinguish between wild fish and farm-raised fish.

§2204g Authority of Secretary of Agriculture to conduct census of agriculture

(a) Census of agriculture required

(1) In general

In 1998 and every fifth year thereafter, the Secretary of Agriculture shall take a census of agriculture.

Subchapter I Generally

§ 1362 Definitions
For the purposes of this chapter-

(2) The terms "conservation" and "management" mean the collection and application of biological information for the purposes of increasing and maintaining the number of animals within species and populations of marine mammals at their optimum sustainable population. Such terms include the entire scope of activities that constitute a modern scientific resource program, including, but not limited to, research, census, law enforcement, and habitat acquisition and improvement. Also included within these terms, when and where appropriate, is the periodic or total protection of species or populations as well as regulated taking.

Subchapter II Conservation and Protection of Marine Mammals

§1371 Moratorium on taking and importing marine mammals and marine mammal products

(a) Imposition; exceptions

There shall be a moratorium on the taking and importation of marine mammals and marine mammal products, commencing on the effective date of this chapter, during which time no permit may be issued for the taking of any marine mammal and no marine mammal or marine mammal product may be imported into the United States except in the following cases:

(5)(A)(i) Except as provided by clause (ii), upon request therefor by citizens of the United States who engage in a specified activity (other than commercial fishing) within a specified geographical region, the Secretary shall allow, during periods of not more than five consecutive years each, the incidental, but not intentional, taking by citizens while engaging in that activity within that region of small numbers of marine mammals of a species or population stock if the Secretary, after notice (in the Federal Register and in newspapers of general circulation, and through appropriate electronic media, in the coastal areas that may be affected by such activity) and opportunity for public comment—

(I) finds that the total of such taking during each five-year (or less) period concerned will have a negligible impact on such species or stock and will not have an unmitigable adverse impact on the availability of such species or stock for taking for subsistence uses pursuant to subsection (b) or section 1379(f) of this title or, in the case of a cooperative agreement under both this chapter and the Whaling Convention Act of 1949 (16 U.S.C. 916 et seq.), pursuant to section 1382(c) of this title; and

(II) prescribes regulations setting forth—

(aa) permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for subsistence uses; and

(bb) requirements pertaining to the monitoring and reporting of such taking.

(D)(i) Upon request therefor by citizens of the United States who engage in a specified activity (other than commercial fishing) within a specific geographic region, the Secretary shall authorize, for periods of not more than 1 year, subject to such conditions as the Secretary may specify, the incidental, but not intentional, taking by harassment of small numbers of marine mammals of a species or population stock by such citizens while engaging in that activity within that region if the Secretary finds that such harassment during each period concerned—

(I) will have a negligible impact on such species or stock, and

(II) will not have an unmitigable adverse impact on the availability of such species or stock for taking for subsistence uses pursuant to subsection (b), or section 1379(f) of this title or pursuant to a cooperative agreement under section 1388 of this title.

(ii) The authorization for such activity shall prescribe, where applicable—

(III) requirements pertaining to the monitoring and reporting of such taking by harassment, including requirements for the independent peer review of proposed monitoring plans or other research proposals where the proposed activity may affect the availability of a species or stock for taking for subsistence uses pursuant to subsection (b) or section 1379(f) of this title or pursuant to a cooperative agreement under section 1388 of this title.

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;

§ 1802 Definitions. As used in this chapter, unless the context otherwise requires—

(16) The term “fishing” means—

(A) the catching, taking, or harvesting of fish;

(B) the attempted catching, taking, or harvesting of fish;

(C) any other activity which can reasonably be expected to result in the catching, taking, or harvesting of fish; or

(D) any operations at sea in support of, or in preparation for, any activity described in subparagraphs (A) through (C).

Such term does not include any scientific research activity which is conducted by a scientific research vessel.

§ 3372 Prohibited acts

(b) Marking offenses

It is unlawful for any person to import, export, or transport in interstate commerce any container or package containing any fish or wildlife unless the container or package has previously been plainly marked, labeled, or tagged in accordance with the regulations issued pursuant to paragraph (2) of section 3376(a) of this title.

(d) False labeling offenses

It is unlawful for any person to make or submit any false record, account, or label for, or any false identification of, any fish, wildlife, or plant which has been, or is intended to be-

(1) imported, exported, transported, sold, purchased, or received from any foreign country; or

(2) transported in interstate or foreign commerce

§3376 Administration

(a) Regulations

(2) The Secretaries of the Interior and Commerce shall jointly promulgate specific regulations to implement the provisions of section 3372(b) of this title for the marking and labeling of containers or packages containing fish or wildlife. These regulations shall be in accordance with existing commercial practices.

§ 42  Importation or shipment of injurious mammals, birds, fish (including mollusks and crustacea), amphibia, and reptiles; permits, specimens for museums; regulations

(b) Whoever violates this section, or any regulation issued pursuant thereto, shall be fined under this title or imprisoned not more than six months, or both.

(c) The Secretary of the Interior within one hundred and eighty days of the enactment of the Lacey Act Amendments of 1981 shall prescribe such requirements and issue such permits as he may deem necessary for the transportation of wild animals and birds under humane and healthful conditions, and it shall be unlawful for any person, including any importer, knowingly to cause or permit any wild animal or bird to be transported to the United States, or any Territory or district thereof, under inhumane or unhealthful conditions or in violation of such requirements. In any criminal prosecution for violation of this subsection and in any administrative proceeding for the suspension of the issuance of further permits— ...

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.

(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.

§607 Labeling, marking, and container requirements

(a) Labeling receptacles or coverings of meat or meat food products inspected and passed; supervision by inspectors

When any meat or meat food product prepared for commerce which has been inspected as hereinbefore provided and marked "Inspected and passed" shall be placed or packed in any can, pot, tin, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained, the person, firm, or corporation preparing said product shall cause a label to be attached to said can, pot, tin, canvas, or other receptacle or covering, under the supervision of an inspector, which label shall state that the contents thereof have been "inspected and passed" under the provisions of this chapter; and no inspection and examination of meat or meat food products deposited or inclosed in cans, tins, pots, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained shall be deemed to be complete until such meat or meat food products have been sealed or inclosed in said can, tin, pot, canvas, or other receptacle or covering under the supervision of an inspector.

(b) Information on articles or containers; legible form

All carcasses, parts of carcasses, meat and meat food products inspected at any establishment under the authority of this subchapter and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, directly thereon or on their containers, as the Secretary may require, the information required under paragraph (n) of section 601 of this title.

Subchapter III Standards and enforcement

§ 1314 Information and guidelines

(i) Guidelines for monitoring, reporting, enforcement, funding, personnel, and manpower

The Administrator shall

 (1) within sixty days after October 18, 1972, promulgate guidelines for the purpose of establishing uniform application forms and other minimum requirements for the acquisition of information from owners and operators of point-sources of discharge subject to any State program under section 1342 of this title, and
(2) within sixty days from October 18, 1972, promulgate guidelines establishing the minimum procedural and other elements of any State program under section 1342 of this title, which shall include:

(B) reporting requirements (including procedures to make information available to the public);

§ 1318 Records and reports; inspections

(a) Maintenance; monitoring equipment; entry; access to information

Whenever required to carry out the objective of this chapter, including but not limited to (1) developing or assisting in the development of any effluent limitation, or other limitation, prohibition, or effluent standard, pretreatment standard, or standard of performance under this chapter; (2) determining whether any person is in violation of any such effluent limitation, or other limitation, prohibition or effluent standard, pretreatment standard, or standard of performance; (3) any requirement established under this section; or (4) carrying out sections 1315, 1321, 1342, 1344 (relating to State permit programs), 1345, and 1364 of this title-

(A) the Administrator shall require the owner or operator of any point source to (i) establish and maintain such records, (ii) make such reports, (iii) install, use, and maintain such monitoring equipment or methods (including where appropriate, biological monitoring methods), (iv) sample such effluents (in accordance with such methods, at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and (v) provide such other information as he may reasonably require;

(b) Availability to public; trade secrets exception; penalty for disclosure of confidential information

Any records, reports, or information obtained under this section (1) shall, in the case of effluent data, be related to any applicable effluent limitations, toxic, pretreatment, or new source performance standards, and (2) shall be available to the public, except that upon a showing satisfactory to the Administrator by any person that records, reports, or information, or particular part thereof (other than effluent data), to which the Administrator has access under this section, if made public would divulge methods or processes entitled to protection as trade secrets of such person, the Administrator shall consider such record, report, or information, or particular portion thereof confidential in accordance with the purposes of section 1905 of title 18. Any authorized representative of the Administrator (including an authorized contractor acting as a representative of the Administrator) who knowingly or willfully publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information which is required to be considered confidential under this subsection shall be fined not more than $1,000 or imprisoned not more than 1 year, or both. Nothing in this subsection shall prohibit the Administrator or an authorized representative of the Administrator (including any authorized contractor acting as a representative of the Administrator) from disclosing records, reports, or information to other officers, employees, or authorized representatives of the United States concerned with carrying out this chapter or when relevant in any proceeding under this chapter.

§ 1321 Oil and hazardous substance liability

(m) Administrative provisions

(2) For facilities

(A) Recordkeeping

Whenever required to carry out the purposes of this section, the Administrator, the Secretary of Transportation, or the Secretary of the Department in which the Coast Guard is operating shall require the owner or operator of a facility to which this section applies to establish and maintain such records, make such reports, install, use, and maintain such monitoring equipment and methods, and provide such other information as the Administrator or Secretary, as the case may be, may require to carry out the objectives of this section.

(D) Public access

Any records, reports, or information obtained under this paragraph shall be subject to the same public access and disclosure requirements which are applicable to records, reports, and information obtained pursuant to section 1318 of this title.

Subchapter IV Permits and licenses

§ 1342 National pollutant discharge elimination system

(a) Permits for discharge of pollutants

(1) Except as provided in sections 1328 and 1344 of this title, the Administrator may, after opportunity for public hearing issue a permit for the discharge of any pollutant, or combination of pollutants, notwithstanding section 1311(a) of this title, upon condition that such discharge will meet either (A) all applicable requirements under sections 1311, 1312, 1316, 1317, 1318, and 1343 of this title, or (B) prior to the taking of necessary implementing actions relating to all such requirements, such conditions as the Administrator determines are necessary to carry out the provisions of this chapter.

(2) The Administrator shall prescribe conditions for such permits to assure compliance with the requirements of paragraph (1) of this subsection, including conditions on data and information collection, reporting, and such other requirements as he deems appropriate.

(3) The permit program of the Administrator under paragraph (1) of this subsection, and permits issued thereunder, shall be subject to the same terms, conditions, and requirements as apply to a State permit program and permits issued thereunder under subsection (b) of this section.

(b) State permit programs

At any time after the promulgation of the guidelines required by subsection (i)(2) of section 1314 of this title, the Governor of each State desiring to administer its own permit program for discharges into navigable waters within its jurisdiction may submit to the Administrator a full and complete description of the program it proposes to establish and administer under State law or under an interstate compact. In addition, such State shall submit a statement from the attorney general (or the attorney for those State water pollution control agencies which have independent legal counsel), or from the chief legal officer in the case of an interstate agency, that the laws of such State, or the interstate compact, as the case may be, provide adequate authority to carry out the described program. The Administrator shall approve each submitted program unless he determines that adequate authority does not exist:

(2)(A) To issue permits which apply, and insure compliance with, all applicable requirements of section 1318 of this title; or

(B) To inspect, monitor, enter, and require reports to at least the same extent as required in section 1318 of this title;

DEFINITIONS

§ 60.106 Farm-raised fish.

Farm-raised fish   means fish or shellfish that have been harvested in controlled environments, including ocean-ranched (e.g., penned) fish and including shellfish harvested from leased beds that have been subjected to production enhancements such as providing protection from predators, the addition of artificial structures, or providing nutrients; and fillets, steaks, nuggets, and any other flesh from a farm-raised fish or shellfish.

COUNTRY OF ORIGIN NOTIFICATION

§ 60.200 Country of origin notification.

In providing notice of the country of origin as required by the Act, the following requirements shall be followed by retailers: 

(a) General.  Labeling of covered commodities offered for sale whether individually, in a bulk bin, display case, carton, crate, barrel, cluster, or consumer package must contain country of origin and method of production information (wild and/or farm-raised) as set forth in this regulation. 

(d) Designation of Method of Production (Wild and/or Farm-Raised).  Fish and shellfish covered commodities shall also be labeled to indicate whether they are wild and/or farm-raised as those terms are defined in this regulation. 

(e) Labeling Covered Commodities of United States Origin.  A covered commodity may only bear the declaration of “Product of the U.S.” at retail if it meets the definition of United States Country of Origin as defined in § 60.128. 

(f) Labeling Imported Products That Have Not Undergone Substantial Transformation in the United States.  An imported covered commodity shall retain its origin as declared to U.S. Customs and Border Protection at the time the product entered the United States, through retail sale, provided that it has not undergone a substantial transformation (as established by U.S. Customs and Border Protection) in the United States. 

(g) Labeling Imported Products That Have Subsequently Been Substantially Transformed in the United States. 

(2) Wild and Farm-Raised Fish and Shellfish: If a covered commodity was imported from country X and subsequently substantially transformed (as established by U.S. Customs and Border Protection) in the United States or aboard a U.S. flagged vessel, such product shall be labeled at retail as “From country X, processed in the United States.” Alternatively, the product may be labeled as “Product of country X and the United States”. 

(h) Labeling Commingled Covered Commodities. 

(1) For imported covered commodities that have not subsequently been substantially transformed in the United States that are commingled with other imported covered commodities that have not been substantially transformed in the United States, and/or covered commodities of U.S. origin and/or covered commodities as described in § 60.200(g), the declaration shall indicate the countries of origin for covered commodities in accordance with existing Federal legal requirements. 

(2) For imported covered commodities that have subsequently undergone substantial transformation in the United States that are commingled with other imported covered commodities that have subsequently undergone substantial transformation in the United States (either prior to or following substantial transformation in the United States) and/or U.S. origin covered commodities, the declaration shall indicate the countries of origin contained therein or that may be contained therein. 

(i) Remotely Purchased Products.  For sales of a covered commodity in which the customer purchases a covered commodity prior to having an opportunity to observe the final package (e.g., Internet sales, home delivery sales, etc.), the retailer may provide the country of origin notification and method of production (wild and/or farm-raised) designation either on the sales vehicle or at the time the product is delivered to the consumer.

RECORDKEEPING

§ 60.400 Recordkeeping requirements.

(a) General. 

(1) All records must be legible and may be maintained in either electronic or hard copy formats. Due to the variation in inventory and accounting documentary systems, various forms of documentation and records will be acceptable. 

(2) Upon request by USDA representatives, suppliers and retailers subject to this subpart shall make available to USDA representatives, records maintained in the normal course of business that verify an origin claim and method of production (wild and/or farm-raised). Such records shall be provided within 5 business days of the request and may be maintained in any location. 

(b) Responsibilities of suppliers. 

(1) Any person engaged in the business of supplying a covered commodity to a retailer, whether directly or indirectly, must make available information to the buyer about the country(ies) of origin and method(s) of production (wild and/or farm-raised), of the covered commodity. This information may be provided either on the product itself, on the master shipping container, or in a document that accompanies the product through retail sale provided that it identifies the product and its country(ies) of origin and method(s) of production. In addition, the supplier of a covered commodity that is responsible for initiating a country(ies) of origin and method(s) of production (wild and/or farm-raised) claim must possess records that are necessary to substantiate that claim for a period of 1 year from the date of the transaction. Producer affidavits shall also be considered acceptable records that suppliers may utilize to initiate origin claims, provided it is made by someone having first-hand knowledge of the origin of the covered commodity and identifies the covered commodity unique to the transaction. 

(2) Any intermediary supplier handling a covered commodity that is found to be designated incorrectly as to the country of origin and/or method of production (wild and/or farm-raised) shall not be held liable for a violation of the Act by reason of the conduct of another if the intermediary supplier relied on the designation provided by the initiating supplier or other intermediary supplier, unless the intermediary supplier willfully disregarded information establishing that the country of origin and/or method of production (wild and/or farm-raised) declaration was false. 

(3) Any person engaged in the business of supplying a covered commodity to a retailer, whether directly or indirectly (i.e., including but not limited to harvesters, producers, distributors, handlers, and processors), must maintain records to establish and identify the immediate previous source (if applicable) and immediate subsequent recipient of a covered commodity for a period of 1 year from the date of the transaction. 

(4) For an imported covered commodity (as defined in § 60.200(f)), the importer of record as determined by U.S. Customs and Border Protection, must ensure that records: provide clear product tracking from the port of entry into the United States to the immediate subsequent recipient and accurately reflect the country of origin and method of production (wild and/or farm-raised) of the item as identified in relevant CBP entry documents and information systems; and must maintain such records for a period of 1 year from the date of the transaction. 

(c) Responsibilities of retailers. 

(1) In providing the country of origin and method of production (wild and/or farm-raised) notification for a covered commodity, in general, retailers are to convey the origin and method of production information provided to them by their suppliers. Only if the retailer physically commingles a covered commodity of different origins and/or methods of production in preparation for retail sale, whether in a consumer-ready package or in a bulk display (and not discretely packaged) (i.e., full service fish case), can the retailer initiate a multiple country of origin and/or method of production designation that reflects the actual countries of origin and method of production for the resulting covered commodity. 

(2) Records and other documentary evidence relied upon at the point of sale to establish a covered commodity's country(ies) of origin and designation of wild and/or farm-raised must either be maintained at the retail facility or at another location for as long as the product is on hand and provided to any duly authorized representative of USDA in accordance with § 60.400(a)(2). For pre-labeled products, the label itself is sufficient information on which the retailer may rely to establish the product's origin and method(s) of production (wild and/or farm-raised) and no additional records documenting origin and method of production information are necessary. 

(3) Records that identify the covered commodity, the retail supplier, and for products that are not pre-labeled, the country of origin information and the method(s) of production (wild and/or farm-raised) must be maintained for a period of 1 year from the date the declaration is made at retail. 

(4) Any retailer handling a covered commodity that is found to be designated incorrectly as to the country of origin and/or the method of production (wild and/or farm-raised) shall not be held liable for a violation of the Act by reason of the conduct of another if the retailer relied on the designation provided by the supplier, unless the retailer willfully disregarded information establishing that the country of origin and/or method of production declaration was false.

Subpart A General Provisions

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

(a) Hazard analysis.  Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that the processor can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls. 

(b) The HACCP plan.  Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, as described in paragraph (a) of this section. A HACCP plan shall be specific to: 

(1) Each location where fish and fishery products are processed by that processor; and 

(2) Each kind of fish and fishery product processed by the processor. The plan may group kinds of fish and fishery products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in paragraph (c) of this section are identical for all fish and fishery products so grouped or for all production methods so grouped.

(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; 

(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 processing plant environment; and 

(ii) Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest; 

(3) List the critical limits that must be met at each of the critical control points; 

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

(5) Include any corrective action plans that have been developed in accordance with § 123.7(b), to be followed in response to deviations from critical limits at critical control points; 

(6) List the verification procedures, and frequency thereof, that the processor will use in accordance with § 123.8(a); 

(7) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring. 

(d) Signing and dating the HACCP plan. 

(1) The HACCP plan shall be signed and dated, either by the most responsible individual onsite at the processing facility or by a higher level official of the processor. This signature shall signify that the HACCP plan has been accepted for implementation by the firm. 

(2) The HACCP plan shall be dated and signed: 

(i) Upon initial acceptance;

(ii) Upon any modification; and 

(iii) Upon verification of the plan in accordance with § 123.8(a)(1). 

(e) Products subject to other regulations.  For fish and fishery products that are subject to the requirements of part 113 or 114 of this chapter, the HACCP plan need not list the food safety hazard associated with the formation of Clostridium botulinum toxin in the finished, hermetically sealed container, nor list the controls to prevent that food safety hazard. A HACCP plan for such fish and fishery products shall address any other food safety hazards that are reasonably likely to occur. 

(f) Sanitation.  Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with § 123.11(b) they need not be included in the HACCP plan, and vice versa.

(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. 

§ 123.7 Corrective actions.

(d) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with § 123.8(a)(3)(ii) and the recordkeeping requirements of § 123.9.

§ 123.11 Sanitation control procedures.

(c) Sanitation control records.  Each processor shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the requirements of § 123.9.

Subpart C - Raw Molluscan Shellfish

§ 123.28 Source controls.

(c) To meet the requirements of paragraph (b) of this section, processors who receive shellstock shall accept only shellstock from a harvester that is in compliance with such licensure requirements as may apply to the harvesting of molluscan shellfish or from a processor that is certified by a shellfish control authority, and that has a tag affixed to each container of shellstock. The tag shall bear, at a minimum, the information required in § 1240.60(b) of this chapter. In place of the tag, bulk shellstock shipments may be accompanied by a bill of lading or similar shipping document that contains the information required in 1240.60(b) of this chapter. Processors shall maintain records that document that all shellstock have met the requirements of this section. These records shall document: 

(1) The date of harvest; 

(2) The location of harvest by State and site; 

(3) The quantity and type of shellfish; 

(4) The date of receipt by the processor; and 

(5) The name of the harvester, the name or registration number of the harvester's vessel, or an identification number issued to the harvester by the shellfish control authority.

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.

§ 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.

(1) The permittee must provide a written report to the permitting authority of an INAD's impending use within 7 days of agreeing or signing up to participate in an INAD study. The written report must identify the INAD to be used, method of use, the dosage, and the disease or condition the INAD is intended to treat. 

(2) For INADs and extralabel drug uses, the permittee must provide an oral report to the permitting authority as soon as possible, preferably in advance of use, but no later than 7 days after initiating use of that drug. The oral report must identify the drugs used, method of application, and the reason for using that drug. 

(3) For INADs and extralabel drug uses, the permittee must provide a written report to the permitting authority within 30 days after initiating use of that drug. The written report must identify the drug used and include: the reason for treatment, date(s) and time(s) of the addition (including duration), method of application; and the amount added. 

(b) Failure in, or damage to, the structure of an aquatic animal containment system resulting in an unanticipated material discharge of pollutants to waters of the U.S. In accordance with the following procedures, any permittee subject to this part must notify the permitting authority when there is a reportable failure. 

(1) The permitting authority may specify in the permit what constitutes reportable damage and/or a material discharge of pollutants, based on a consideration of production system type, sensitivity of the receiving waters and other relevant factors. 

(2) The permittee must provide an oral report within 24 hours of discovery of any reportable failure or damage that results in a material discharge of pollutants, describing the cause of the failure or damage in the containment system and identifying materials that have been released to the environment as a result of this failure. 

(3) The permittee must provide a written report within 7 days of discovery of the failure or damage documenting the cause, the estimated time elapsed until the failure or damage was repaired, an estimate of the material released as a result of the failure or damage, and steps being taken to prevent a reccurrence. 

(c) In the event a spill of drugs, pesticides or feed occurs that results in a discharge to waters of the U.S., the permittee must provide an oral report of the spill to the permitting authority within 24 hours of its occurrence and a written report within 7 days. The report shall include the identity and quantity of the material spilled. 

(d) Best management practices (BMP) plan.  The permittee subject to this part must: 

(1) Develop and maintain a plan on site describing how the permittee will achieve the requirements of § 451.11(a) through (e) or § 451.21(a) through (h), as applicable. 

(2) Make the plan available to the permitting authority upon request. 

(3) The permittee subject to this part must certify in writing to the permitting authority that a BMP plan has been developed.

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:

(d) Recordkeeping.  The permittee must: 

(1) In order to calculate representative feed conversion ratios, maintain records for aquatic animal rearing units documenting the feed amounts and estimates of the numbers and weight of aquatic animals. 

(2) Keep records documenting the frequency of cleaning, inspections, maintenance and repairs.

Subpart B - Net Pen Subcategory

§ 451.21 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:

(g) Recordkeeping. 

(1) In order to calculate representative feed conversion ratios, maintain records for aquatic animal net pens documenting the feed amounts and estimates of the numbers and weight of aquatic animals. 

(2) Keep records of the net changes, inspections and repairs.

Part 14 Importation, Exportation, and Transportation  of Wildlife

Subpart F - Wildlife Declarations

§ 14.61 Import declaration requirements.

Except as otherwise provided by the regulations of this subpart, importers or their agents must file with the Service a completed Declaration for Importation or Exportation of Fish or Wildlife (Form 3-177), signed by the importer or the importer's agent, upon the importation of any wildlife at the place where Service clearance under § 14.52 is requested. However, wildlife may be transshipped under bond to a different port for release from custody by Customs Service officers under 19 U.S.C. 1499. For certain antique articles as specified in § 14.22, importers or their agents must file a Form 3-177 with the District Director of Customs at the port of entry prior to release from Customs custody. Importers or their agents must furnish all applicable information requested on the Form 3-177 and the importer, or the importer's agent, must certify that the information furnished is true and complete to the best of his/her knowledge and belief.

Part 16 Injurious Wildlife

Subpart B - Importation or Shipment of Injurious Wildlife

§ 16.13 Importation of live or dead fish, mollusks, and crustaceans, or their eggs.

(b)

(1) The certification to accompany importations as required by this section shall consist of a statement in the English language, printed or typewritten, stating that this shipment of dead uneviscerated salmonid fish, live salmonid fish, or live, disinfected fertilized eggs or gametes of salmonid fish has been tested, by the methods outlined in this section, and none of the listed viruses were detected. The certification shall be signed in the country of origin by a qualified fish pathologist designated as a certifying official by the Director.

(2) The certification must contain: 

(i) The date and port of export in the country of origin and the anticipated date of arrival in the United States and port of entry; 

(ii) Surface vessel name or number or air carrier and flight number; 

(iii) Bill of lading number or airway bill number; 

(iv) The date and location where fish, tissue, or fluid samples were collected; 

(v) The date and location where virus assays were completed; and 

(vi) The original handwritten signature, in ink, of the certifying official and his or her address and telephone number.

Part 216 Regulations governing the taking and importing of marine mammals

Subpart I - General Regulations Governing Small Takes of Marine Mammals Incidental to Specified Activities

§ 216.102 Scope.

The taking of small numbers of marine mammals under section 101(a)(5) (A) through (D) of the Marine Mammal Protection Act may be allowed only if the National Marine Fisheries Service: 

(c) Prescribes either regulations or requirements and conditions contained within an incidental harassment authorization, as appropriate, pertaining to the monitoring and reporting of such taking. The specific regulations governing certain specified activities are contained in subsequent subparts of this part.

§ 216.105 Specific regulations.

(b) For allowed activities that may result in incidental takings of small numbers of marine mammals by harassment, serious injury, death or a combination thereof, specific regulations shall be established for each allowed activity that set forth:

(3) Requirements for monitoring and reporting, including requirements for the independent peer-review of proposed monitoring plans where the proposed activity may affect the availability of a species or stock for taking for subsistence uses.

§ 300.160 Requirement for marking of containers or packages.

Except as otherwise provided in this subpart, all persons are prohibited from importing, exporting, or transporting in interstate commerce any container or package containing any fish or wildlife (including shellfish) unless each container or package is conspicuously marked on the outside with both the name and address of the shipper and consignee and an accurate list of its contents by species and number of each species. 

§ 300.161 Alternatives and exceptions.

(b) The requirements of § 300.160 of chapter III of this title do not apply to containers or packages containing - 

(2) Fish or shellfish contained in retail consumer packages labeled pursuant to the Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.;

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  - 

(A) Transport of fingerlings/juvenile fish to an aquaculture facility.  Report the time, date, species and number of cultured fingerlings or other juvenile animals that will be transported from a hatchery to an aquaculture facility at least 72 hours prior to transport. This information may be submitted electronically via the Web site or via phone. In addition, permittees are to maintain and make available to NMFS or an authorized officer upon request a written or electronic daily record of the number of cultured animals introduced into and the total pounds and average weight of fish removed from each approved aquaculture system, including mortalities, for the most recent 3 years. 

(B) Major escapement.  Report any major escapement or suspected major escapement within 24 hours of the event. Major escapement is defined as the escape, within a 24-hour period, of 10 percent of the fish from a single approved aquaculture system (e.g., one cage or one net pen) or 5 percent or more of the fish from all approved aquaculture systems combined, or the escape, within any 30-day period, of 10 percent or more of the fish from all approved aquaculture systems combined. The report must include the items in paragraphs (a)(1)(i)(B)(1) through (6) of this section and may be submitted electronically via the Web site. If no major escapement occurs during a given year, an annual report must be submitted via the Web site on or before January 31 each year indicating no major escapement occurred. 

(1) Gulf aquaculture permit number; 

(2) Name and phone number of a contact person; 

(3) Duration and specific location of escapement, including the number of cages or net pens involved; 

(4) Cause(s) of escapement; 

(5) Number, size, and percent of fish, by species, that escaped; and 

(6) Actions being taken to address the escapement. 

(C) Pathogens.  Report, within 24 hours of diagnosis, all findings or suspected findings of any OIE-reportable pathogen episodes or pathogens that are identified as reportable pathogens in the NAAHP, as implemented by the USDA and U.S. Departments of Commerce and Interior, that are known to infect the cultured species. The report must include the items in paragraphs (a)(1)(i)(C)(1) through (6) of this section and may be submitted electronically via the Web site. If no finding or suspected finding of an OIE-reportable pathogen episode occurs during a given year, an annual report must be submitted via the Web site on or before January 31 each year indicating no finding or suspected finding of an OIE-reportable pathogen episode occurred. See § 622.108(a)(1) regarding actions NMFS may take to address a pathogen episode. 

(1) OIE-reportable pathogen; 

(2) Percent of cultured animals infected; 

(3) Findings of the aquatic animal health expert; 

(4) Plans for submission of specimens for confirmatory testing (as required by the USDA); 

(5) Testing results (when available); and 

(6) Actions being taken to address the reportable pathogen episode. 

(D) Harvest notification.  Report the time, date, and weight of fish to be harvested from an aquaculture facility at least 72 hours prior to harvest. This information may be submitted electronically via the Web site or via phone. 

(E) Landing information.  Report the intended time, date, and port of landing for any vessel landing fish harvested from an aquaculture facility at least 72 hours prior to landing. This information may be submitted electronically via the Web site or via phone. The person landing the cultured animals must validate the dealer transaction report required in paragraph (a)(2)(i) of this section by entering the unique PIN number of the Gulf aquaculture permit holder from whom the fish were received when the transaction report is submitted. 

(F) Change of hatchery.  Report any change in hatcheries used for obtaining fingerlings or other juvenile animals and provide updated names and addresses or specific locations (if no address is available) for the applicable hatcheries no later than 30 days after any such change occurs. This information may be submitted electronically via the Web site. 

(G) Entanglements or interactions with marine mammals, endangered species, or migratory birds.  Report any entanglement or interaction with marine mammals, endangered species, or migratory birds within 24 hours of the event. The report must include the items included in paragraphs (a)(1)(i)(G)(1) through (5) of this section and may be submitted electronically via the Web site. If no entanglement or interaction with marine mammals, endangered species, or migratory birds occurs during a given year, an annual report must be submitted via the Web site on or before January 31 each year indicating no entanglement or interaction occurred. 

(1) Date, time, and location of entanglement or interaction. 

(2) Species entangled or involved in interactions and number of individuals affected; 

(3) Number of mortalities and acute injuries observed; 

(4) Cause of entanglement or interaction; and 

(5) Actions being taken to prevent future entanglements or interactions. 

(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. 

(I) Any other reporting requirements specified by the RA for evaluating and assessing the environmental impacts of an aquaculture operation. 

(ii) Other reporting requirements.  In addition to the reporting requirements in paragraph (a)(1)(i) of this section, an aquaculture facility owner or operator must comply with the following reporting requirements: 

(A) Provide NMFS with current copies of all valid state and Federal permits (e.g., ACOE Section 10 permit, EPA NPDES permit) required for conducting offshore aquaculture and report any changes applicable to those permits. 

(B) Provide NMFS with current copies of all valid state and Federal aquaculture permits for each hatchery from which fingerlings or other juvenile animals are obtained and report any changes applicable to those permits within 30 days. 

(iii) Recordkeeping requirements.  An aquaculture facility owner or operator must comply with the following recordkeeping requirements: 

(A) Maintain for the most recent 3 years and make available to NMFS or an authorized officer, upon request, monitoring reports related to aquaculture activities required by all other state and Federal permits (e.g., EPA NPDES permit) required for conducting offshore aquaculture. 

(B) Maintain records of all sales of fish for the most recent 3 years and make that information available to NMFS or an authorized officer upon request. Sale records must include the species and quantity of fish sold in pounds round weight; estimated average weight of fish sold to the nearest tenth of a pound by species; date sold; and the name of the entity to whom fish were sold. 

(2) Aquaculture dealer recordkeeping and reporting requirements.  A dealer who purchases fish from an aquaculture facility in the Gulf EEZ must: 

(i) Complete a landing transaction report for each landing and sale of cultured animals via the Web site at the time of the transaction in accordance with reporting form and instructions provided on the Web site. This report includes date, time, and location of transaction; information necessary to identify the Gulf aquaculture permit holder, vessel, and dealer involved in the transaction; quantity, in pounds round weight, and estimated average weight of each species landed to the nearest tenth of a pound; and average price paid for cultured animals landed and sold by market category. A dealer must maintain such record for at least 3 years after the receipt date and must make such record available for inspection upon request to NMFS or an authorized officer. 

(ii) After the dealer submits the report and the information has been verified, the Web site will send a transaction approval code to the dealer and the aquaculture permit holder.

§ 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.

(4) Hatchery certifications. 

(i) The permittee must obtain and submit to NMFS a signed certification from the owner(s) of the hatchery, from which fingerlings or other juvenile animals are obtained, indicating the broodstock have been individually marked or tagged (e.g., via a Passive Integrated Transponder (PIT), coded wire, dart, or internal anchor tag) to allow for identification of those individuals used in spawning. 

(ii) The permittee also must obtain and submit to NMFS signed certification from the owner(s) of the hatchery indicating that fin clips or other genetic materials were collected and submitted for each individual brood animal in accordance with procedures specified by NMFS. 

(iii) The certifications required in paragraphs (a)(4)(i) and (ii) of this section must be provided to NMFS by the permittee each time broodstock are acquired by the hatchery or used for spawning. 

(5) Health certification.  Prior to stocking fish in an approved aquaculture system at an aquaculture facility in the Gulf EEZ, the permittee must provide NMFS a copy of a health certificate (suggested form is USDA/Animal and Plant Health Inspection Service (APHIS) VS 17-141, OMB 0579-0278) signed by an aquatic animal health expert, as defined in § 622.101(a)(2)(xv), certifying that the fish have been inspected and are visibly healthy and the source population is test negative for OIE pathogens specific to the cultured species and pathogens identified as reportable pathogens in the NAAHP as implemented by the USDA and U.S. Departments of Commerce and Interior.

(8) Monitoring and reporting compliance.  The permittee must monitor and report the environmental survey parameters at the aquaculture facility consistent with NMFS' guidelines that will be available on the Web site and from the RA upon request. The permittee also must comply with all applicable monitoring and reporting requirements specified in their valid ACOE Section 10 permit and valid EPA NPDES permit. 

(9) Inspection for protected species.  The permittee must regularly inspect approved aquaculture systems, including mooring and anchor lines, for entanglements or interactions with marine mammals, protected species, and migratory birds. The frequency of inspections will be specified by NMFS as a condition of the permit. If entanglements or interactions are observed, they must be reported as specified in § 622.102(a)(1)(i)(G).

Chapter 3: Environment, Housing, and Management

AQUATIC ANIMALS

Aquatic Environment

Water Quality

Routine measurement of various water characteristics (water quality testing) is essential for stable husbandry. Standards for acceptable water quality, appropriate parameters to test, and testing frequency should be identified at the institutional level and/or in individual animal use protocols depending on the size of the aquatic program. Staff managing aquatic systems need to be trained in biologically relevant aspects of water chemistry,  how water quality parameters may affect animal health and well-being, how to monitor water quality results, and how water quality may affect life support system function (e.g., biologic filtration).

Chapter 4: Veterinary Care

ANIMAL PROCUREMENT AND TRANSPORTATION

Animal Procurement

... Appropriate records and other forms of documentation should be maintained for animals acquired by an institution for its investigators.

Transportation of Animals

All animals in transit within and between institutions or jurisdictions should be accompanied by appropriate documentation to minimize delays in shipping and receipt. Documentation may include health certificates, sending and receiving institutions’ addresses and contacts, emergency procedures and veterinary contact information, and agency permits as needed.

CLINICAL CARE AND MANAGEMENT

Medical Management

There should be a timely and accurate method for communication of any abnormalities in or concerns about animal health, behavior, and wellbeing to the veterinarian or the veterinarian’s designee. The responsibility for communicating these concerns rests with all those involved with animal care and use. Reports should be triaged to ensure that animals most in need receive priority attention, and the veterinarian or veterinarian’s designee should perform an objective assessment of the animal(s) to determine an appropriate course of action.

Recordkeeping

Medical records are a key element of the veterinary care program and are considered critical for documenting animal well-being as well as tracking animal care and use at a facility... Drug records and storage procedures should be reviewed during facility inspections.

SURGERY

Presurgical Planning

Presurgical planning should specify the requirements for postsurgical monitoring, care, and recordkeeping, including the personnel who will perform these duties.

Goal 5. Industry Accountability – To secure long-term access to operate aquaculture facilities in federal waters, operators are held accountable for protecting the environment, wild species, and human safety and for conducting and reporting ongoing monitoring.

NOAA will achieve this goal by working with federal agencies and other partners to develop an appropriate framework through which operators of aquaculture facilities will:

- prepare, obtain federal approval for, and comply with a monitoring plan to meet all monitoring and reporting requirements, including reports of escapes, disease outbreaks, drug or chemical applications, nutrient discharges, and other environmental monitoring as required by NOAA or other federal agencies

SEC. III Public Health Reasons and Explanations

Chapter X. General Requirements for Dealers

.01 General HACCP Requirements

Hazard Analysis Critical Control Point (HACCP) is a preventive system of hazard control. It consists first of an identification of the likely hazards that could be presented by a specific product, followed by the identification of the critical control points in a specific production process where a failure to control would likely result in a hazard being created or allowed to persist. These critical control points (CCP) are then systematically monitored, and records are kept of that monitoring. Corrective actions are also documented when problems occur.

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 ... 

The HACCP Plan must also list the records that are necessary to document the result of monitoring at CCPs. These records must contain the actual values and observations obtained during monitoring. This requirement ensures that preventive monitoring is occurring in a systematic way.

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/