Topic 4

20. Aquaculture operations should implement aquatic animal health management programmes set up in compliance with relevant national legislation and regulations, taking into account the FAO CCRF Technical Guidelines on Health Management for Responsible Movement of Live Aquatic Animals and relevant OIE standards.

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

27. Aquaculture activities should be conducted in a manner that ensures food safety by implementing appropriate national or international standards and regulations including those defined by FAO/WHO Codex Alimentarius. Although Codex Alimentarius covers both safety and quality issues concerning aquatic products, for the purpose of these guidelines, quality aspects are not currently addressed in detail.

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.

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

37. Aquaculture should be planned and practised in an environmentally responsible manner, in accordance with appropriate local, national and international laws and regulations.

39. Aquaculture can impact on the environment and aquaculture certification schemes should ensure these impacts are identified and adverse impacts are managed or mitigated to an acceptable level in accordance with local and national laws. Whenever possible, native species should be used for culture and measures should be taken to minimize unintentional release or escape of cultured species into natural environments.

44. Environmental impact assessments should be conducted, according to national legislation, prior to approval of establishment of aquaculture operations.

53. Aquaculture should be conducted in a socially responsible manner, within national rules and regulations, having regard to the ILO-convention on labour rights, not jeopardizing the livelihood of aquaculture workers and local communities. Aquaculture contributes to rural development, enhances benefits and equity in local communities, alleviates poverty and promotes food security. As a result, socio-economic issues should be considered at all stages of aquaculture planning, development and operation.

55. Workers should be treated responsibly and in accordance with national labour rules and regulations and, where appropriate, relevant ILO conventions.

56. Workers should be paid wages and provided benefits and working conditions according to national laws and regulations.

57. Child labour should not be used in a manner inconsistent with ILO conventions and international standards.

The U.S. federal regulatory framework for aquaculture includes a number of government agencies that have a role in managing the industry (See "Federal Management Overview" tab). In addition, there are state, tribal, territory, and local laws, regulations, and policies that producers must comply with as well. Additionally, regulations must comply with the Endangered Species Act, the Marine Mammal Protection Act, the Migratory Bird Treaty Act, the National Environmental Policy Act, the Paperwork Reduction Act, the Regulatory Flexibility Act and other laws. If compliance is in question, litigation ensues (often initiated by non-governmental organizations or stakeholder groups) and any identified noncompliance is rectified through settlement via the U.S. judiciary system.

The major agencies and their roles are summarized below:

•  The U.S. Environmental Protection Agency (EPA) oversees the National Pollutant Discharge Elimination System (NPDES), which was created in 1972 by the Clean Water Act (CWA). The NPDES permit program is authorized to State governments by EPA to perform many permitting, administrative, and enforcement aspects of the program. EPA retains authorization for the program components for which a State is not authorized. The CWA authorizes EPA to classify aquaculture as a point source and subject to industrial wastewater regulations that include permitting. 

•  The U.S. Food and Drug Administration (FDA; Department of Health and Human Services) has the authority to develop regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act (FDCA) and other laws. The FDA oversees the Hazard Analysis and Critical Control Points (HACCP) system, the cooperative federal/state National Shellfish Sanitation Program (NSSP), and other programs relevant to ensuring biosecurity.

•  The U.S. Department of Agriculture (Department of the Interior) oversees the Animal and Plant Health Inspection Service (APHIS) and animal production and protection through its Agricultural Research Service. 

•  The U.S. Fish and Wildlife Service (USFWS; Department of the Interior) enforces the wildlife aspects of the Lacey Act, the Endangered Species Act, and other laws and regulations relevant to invasive species and migratory birds. The Lacey Act addresses the protection of plants, fish, and wildlife by defining and enforcing illegal trade under provisions of U.S., tribal, and foreign law.

•  The National Oceanic and Atmospheric Administration (NOAA; Department of Commerce) administers laws including the Lacey Act, the Endangered Species Act, The Coastal Zone Management Act, and other laws and regulations relevant to marine fisheries and aquaculture through its National Marine Fisheries Service. NOAA also oversees the National Sea Grant College Program, a federal/university partnership between NOAA and 33 university-based programs in every coastal and Great Lakes state, Puerto Rico, and Guam. The Sea Grant network provides training tools, opportunities, and extension services to the aquaculture community.

•  The U.S. Army Corps of Engineers (ACOE; Department of Defense) regulates aquaculture permitting via the Rivers and Harbors Act of 1899. ACOE issues Nationwide Permits, which authorize the addition of structures and materials into navigable waters of the United States. Nationwide Permits are issued at the federal level under the Clean Water Act and the Rivers and Harbors Act to permit minimally impactful activities. In particular, Nationwide Permit 48 Commercial Shellfish Mariculture Activities “... authorizes the installation of buoys, floats, racks, trays, nets, lines, tubes, containers, and other structures...". However, even if applicants are granted a permit by ACOE, state agencies can implement additional requirements.

•  The U.S. Department of Homeland Security oversees the Chemical Facility Anti-Terrorism Standards (CFATS). “Certain aquaculture drugs may present security issues if they are released, stolen, or diverted or used for purposes of sabotage or intentional contamination... Facilities that manufacture, use, store, or distribute certain chemicals at or above a specified quantity may be regulated. Each facility is responsible for evaluating their own chemical use patterns and determining which are subject to CFATS.” (AFS 2014). 

•  The U.S. Department of Labor regulates the Fair Labor Standards Act and includes the Occupational Safety and Health Administration and the Equal Employment Opportunity Commission. “The Fair Labor Standards Act … establishes a federal minimum wage, overtime pay eligibility, recordkeeping, and child labor standards...” (WA-OFM 2021). 

•   States, tribes, and territories also enact their own laws, regulations, and policies to additionally regulate and guide aquaculture within their jurisdiction. These entities are authorized to perform many permitting, administrative, and enforcement aspects of the NPDES permit program through a process that is defined by CWA [Section 402 (b) and 40 CFR Part 123]. They also have authority to regulate the addition of structures and materials into their navigable waters (beyond ACOE permitting). These regional entities are an integral part of the Sea Grant network. States, tribes, and territories often take the lead in the implementation of laws and regulations regarding the operation and resources pertinent to aquaculture, 

From Aquaculture Facility Certification; BAP Farm Standard. Best Aquaculture Practices Certification Standards, Implementation Guidelines  (BAP-Farm 2021) under the section on Legal Rights and Regulatory Compliance:

Laws, regulations, licenses and permits regarding the operation and resource use of farms vary significantly from place to place. Among other requirements, they can call for:

• business licenses

• aquaculture licenses

• land deeds, leases or concession agreements

• land use taxes

• construction or habitat modification permits

• water use permits

• protection of mangroves or other sensitive habitats

• effluent or waste discharge permits

• adherence to veterinary and aquatic animal health regulations

• use of therapeutics and antimicrobial agents

• permits related to non-native species

• introductions or movements of seed (fingerlings, juveniles, post-larvae)

• use of genetically modified or bioengineered organisms

• predator control permits

• well operation permits

• landfill operation permits

• disposal of mortalities

• adherence to environmental regulations (e.g., water quality monitoring)

• environmental impact assessments

• bonds for potential environmental damage.

In Gulf Fishermens Association et al. v. National Marine Fisheries Service et al., No. 16-1271 (USDCED 2018), the Court ruled that existing fisheries management laws were never intended to regulate aquaculture, concluding that NMFS had acted outside of its statutory authority in promulgating rules under USC 16-38-1801 et seq.

From Center for American Progress (Carter & Goldstein 2019):

On September 25, 2018, the U.S. District Court of Louisiana issued an opinion denying the NMFS’ final rule and halting implementation of the management plan for the Gulf of Mexico. The judge wrote: “It is often said that ‘Congress does not hide elephants in mouseholes,’ and this Court cannot imagine a more fitting example. Had Congress intended to give the NMFS the authority to create an entirely new regulatory permitting scheme for aquaculture operations, it would have said more than ‘harvesting’”(USDCED 2018). The court’s decision stopped the NMFS from permitting aquaculture under the MSA, leaving congressional action as one of the only options for improving the aquaculture development process in U.S. federal waters.

The Department of Justice filed a brief in the appeal of this court's decision. On August 3, 2020, the U.S. Court of Appeals for the Fifth Circuit upheld the decision (USDCA 2020). Although the ruling blocks NOAA from regulating offshore aquaculture under the Magnuson-Stevens Act, other federal laws and permits do apply. 

Aquaculture Stewardship Council (ASC) and Global Aquaculture Alliance’s Best Aquaculture Practices (BAP) certification programs provide a mechanism for independent verification of compliance with U.S. federal and state statutes regarding health and welfare, food safety, environmental integrity, and socio-economic issues.  ASC Principle 1 addresses legal compliance with national and local laws and regulations (ASC 2022). BAP standards demand compliance with local regulations as the first step toward certification. For example, the BAP Mollusk Farm Standards (BAP-M 2021) state that for certified sites:

1.1: Current documents shall be available to prove legal land, seabed and/or water use, where applicable.

1.2: Current documents shall be available to prove all business and operating licenses have been acquired.

1.3 : Current documents shall be available to prove compliance with applicable environmental regulations for construction and operation.

1.4 : Where applicable, current documents shall be available to prove compliance with laws protecting the resources of indigenous peoples and/or independent agreements the applicant may have made with them.

1.5 : Where applicable, current documents shall be available to show compliance with the cultivation site’s own regional industry codes of practice, if they exist.

By the numbers (as of November 27, 2022) –

• ASC certifications: 6 U.S. aquaculture farms (21 sites) and 361 U.S. seafood supply companies

• BAP certifications: 15 U.S. aquaculture farms, 8 U.S. hatcheries, 20 U.S. seafood processors, and 26 U.S. seafood reprocessors

A priority is providing greater clarity in the management of aquaculture in federal waters of the United States. NOAA’s authority to issue permits for aquaculture in federal waters under authorities granted under the Magnuson-Stevens Act was challenged in the Eastern District Court of Louisiana.  The court ruling effectively blocked NOAA from implementing regulations for the Gulf of Mexico Fishery Management Council’s Fishery Management Plan for Aquaculture. Further, the FDA/ISSC system for reviewing safety of shellfish products was not designed to address shellfish operations in federal waters. 

Several pathways have been suggested to resolve this:

• High-level executive action (e.g., an executive order or directive) that clarifies federal permitting processes and establishes lead agencies under NEPA

• Increased federal resources to develop tools for management that help resolve permitting questions

• New legislation that clarifies the ability of federal agencies to issue permits for federal waters 

§ 8309 Veterinary accreditation program

(a) In general. The Secretary may establish a veterinary accreditation program that is consistent with this chapter, including the establishment of standards of conduct for accredited veterinarians.

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

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

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

§ 664 Administration; rules and regulations; availability of lands to State agencies. Such areas as are made available to the Secretary of the Interior for the purposes of this Act, pursuant to sections 661 and 663 of this title or pursuant to any other authorization, shall be administered by him directly or in accordance with cooperative agreements entered into pursuant to the provisions of section 661 of this title and in accordance with such rules and regulations for the conservation, maintenance, and management of wildlife, resources thereof, and its habitat thereon, as may be adopted by the Secretary in accordance with general plans approved jointly by the Secretary of the Interior and the head of the department or agency exercising primary administration of such areas: Provided, That such rules and regulations shall not be inconsistent with the laws for the protection of fish and game of the States in which such area is situated: Provided, further, That lands having value to the National Migratory Bird Management Program may, pursuant to general plans, be made available without cost directly to the State agency having control over wildlife resources, if it is jointly determined by the Secretary of the Interior and such State agency that this would be in the public interest: And provided further, That the Secretary of the Interior shall have the right to assume the management and administration of such lands in behalf of the National Migratory Bird Management Program if the Secretary finds that the State agency has withdrawn from or otherwise relinquished such management and administration.

§ 1456 Coordination and cooperation

(c) Consistency of Federal activities with State management programs; Presidential exemption; certification

(1)(A) Each Federal agency activity within or outside the coastal zone that affects any land or water use or natural resource of the coastal zone shall be carried out in a manner which is consistent to the maximum extent practicable with the enforceable policies of approved State management programs. A Federal agency activity shall be subject to this paragraph unless it is subject to paragraph (2) or (3).

(3)(A) After final approval by the Secretary of a state’s management program, any applicant for a required Federal license or permit to conduct an activity, in or outside of the coastal zone, affecting any land or water use or natural resource of the coastal zone of that state shall provide in the application to the licensing or permitting agency a certification that the proposed activity complies with the enforceable policies of the state’s approved program and that such activity will be conducted in a manner consistent with the program. At the same time, the applicant shall furnish to the state or its designated agency a copy of the certification, with all necessary information and data. Each coastal state shall establish procedures for public notice in the case of all such certifications and, to the extent it deems appropriate, procedures for public hearings in connection therewith. At the earliest practicable time, the state or its designated agency shall notify the Federal agency concerned that the state concurs with or objects to the applicant’s certification. If the state or its designated agency fails to furnish the required notification within six months after receipt of its copy of the applicant’s certification, the state’s concurrence with the certification shall be conclusively presumed. No license or permit shall be granted by the Federal agency until the state or its designated agency has concurred with the applicant’s certification or until, by the state’s failure to act, the concurrence is conclusively presumed, unless the Secretary, on his own initiative or upon appeal by the applicant, finds after providing a reasonable opportunity for detailed comments from the Federal agency involved and from the state, that the activity is consistent with the objectives of this chapter or is otherwise necessary in the interest of national security.

(f) Construction with existing requirements of water and air pollution programs. Notwithstanding any other provision of this chapter, nothing in this chapter shall in any way affect any requirement (1) established by the Federal Water Pollution Control Act, as amended [33 U.S.C. 1251 et seq.], or the Clean Air Act, as amended [42 U.S.C. 7401 et seq.], or (2) established by the Federal Government or by any state or local government pursuant to such Acts. Such requirements shall be incorporated in any program developed pursuant to this chapter and shall be the water pollution control and air pollution control requirements applicable to such program.

§ 1531 Congressional findings and declaration of purposes and policy

(a) Findings

The Congress finds and declares that-

(4) the United States has pledged itself as a sovereign state in the international community to conserve to the extent practicable the various species of fish or wildlife and plants facing extinction, pursuant to-

(A) migratory bird treaties with Canada and Mexico;

(B) the Migratory and Endangered Bird Treaty with Japan;

(C) the Convention on Nature Protection and Wildlife Preservation in the Western Hemisphere;

(D) the International Convention for the Northwest Atlantic Fisheries;

(E) the International Convention for the High Seas Fisheries of the North Pacific Ocean;

(F) the Convention on International Trade in Endangered Species of Wild Fauna and Flora; and

(G) other international agreements; and

(5) encouraging the States and other interested parties, through Federal financial assistance and a system of incentives, to develop and maintain conservation programs which meet national and international standards is a key to meeting the Nation's international commitments and to better safeguarding, for the benefit of all citizens, the Nation's heritage in fish, wildlife, and plants.

§ 1536 Interagency cooperation

(a) Federal agency actions and consultations

(2) Each Federal agency shall, in consultation with and with the assistance of the Secretary, insure that any action authorized, funded, or carried out by such agency (hereinafter in this section referred to as an "agency action") is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of habitat of such species which is determined by the Secretary, after consultation as appropriate with affected States, to be critical, unless such agency has been granted an exemption for such action by the Committee pursuant to subsection (h) of this section. In fulfilling the requirements of this paragraph each agency shall use the best scientific and commercial data available.

(c) Biological assessment. 

(1) To facilitate compliance with the requirements of subsection (a)(2), each Federal agency shall, with respect to any agency action of such agency for which no contract for construction has been entered into and for which no construction has begun on November 10, 1978, request of the Secretary information whether any species which is listed or proposed to be listed may be present in the area of such proposed action. If the Secretary advises, based on the best scientific and commercial data available, that such species may be present, such agency shall conduct a biological assessment for the purpose of identifying any endangered species or threatened species which is likely to be affected by such action. Such assessment shall be completed within 180 days after the date on which initiated (or within such other period as is mutually agreed to by the Secretary and such agency, except that if a permit or license applicant is involved, the 180-day period may not be extended unless such agency provides the applicant, before the close of such period, with a written statement setting forth the estimated length of the proposed extension and the reasons therefor) and, before any contract for construction is entered into and before construction is begun with respect to such action. Such assessment may be undertaken as part of a Federal agency's compliance with the requirements of section 102 of the National Environmental Policy Act of 1969 (42 U.S.C. 4332).

§ 1853 Contents of fishery management plans

(a) Required provisions

Any fishery management plan which is prepared by any Council, or by the Secretary, with respect to any fishery, shall-

(1) contain the conservation and management measures, applicable to foreign fishing and fishing by vessels of the United States, which are-

(C) consistent with the national standards, the other provisions of this chapter, regulations implementing recommendations by international organizations in which the United States participates (including but not limited to closed areas, quotas, and size limits), and any other applicable law;

§ 1855 Other requirements and authority

(f) Judicial review

(1) Regulations promulgated by the Secretary under this chapter and actions described in paragraph (2) shall be subject to judicial review to the extent authorized by, and in accordance with, chapter 7 of title 5, if a petition for such review is filed within 30 days after the date on which the regulations are promulgated or the action is published in the Federal Register, as applicable ...

(2) The actions referred to in paragraph (1) are actions that are taken by the Secretary under regulations which implement a fishery management plan, including but not limited to actions that establish the date of closure of a fishery to commercial or recreational fishing.

(4) Upon a motion by the person who files a petition under this subsection, the appropriate court shall assign the matter for hearing at the earliest possible date and shall expedite the matter in every possible way.

§ 3372 Prohibited acts

(a) Offenses other than marking offenses

It is unlawful for any person-

(1) to import, export, transport, sell, receive, acquire, or purchase any fish or wildlife or plant taken, possessed, transported, or sold in violation of any law, treaty, or regulation of the United States or in violation of any Indian tribal law;

(2) to import, export, transport, sell, receive, acquire, or purchase in interstate or foreign commerce-

(A) any fish or wildlife taken, possessed, transported, or sold in violation of any law or regulation of any State or in violation of any foreign law;

(B) any plant-

(i) taken, possessed, transported, or sold in violation of any law or regulation of any State, or any foreign law, that protects plants or that regulates-

(I) the theft of plants;

(II) the taking of plants from a park, forest reserve, or other officially protected area;

(III) the taking of plants from an officially designated area; or

(IV) the taking of plants without, or contrary to, required authorization;

(ii) taken, possessed, transported, or sold without the payment of appropriate royalties, taxes, or stumpage fees required for the plant by any law or regulation of any State or any foreign law; or

(iii) taken, possessed, transported, or sold in violation of any limitation under any law or regulation of any State, or under any foreign law, governing the export or transshipment of plants; or

(C) any prohibited wildlife species (subject to subsection (e));

(3) within the special maritime and territorial jurisdiction of the United States (as defined in section 7 of title 18)-

(A) to possess any fish or wildlife taken, possessed, transported, or sold in violation of any law or regulation of any State or in violation of any foreign law or Indian tribal law, or

(B) to possess any plant-

(i) taken, possessed, transported, or sold in violation of any law or regulation of any State, or any foreign law, that protects plants or that regulates-

(I) the theft of plants;

(II) the taking of plants from a park, forest reserve, or other officially protected area;

(III) the taking of plants from an officially designated area; or

(IV) the taking of plants without, or contrary to, required authorization;

(ii) taken, possessed, transported, or sold without the payment of appropriate royalties, taxes, or stumpage fees required for the plant by any law or regulation of any State or any foreign law; or

(iii) taken, possessed, transported, or sold in violation of any limitation under any law or regulation of any State, or under any foreign law, governing the export or transshipment of plants; or

(4) to attempt to commit any act described in paragraphs (1) through (3).

§ 4725 Relationship to other laws

(a) Consistency with environmental laws

All actions taken by Federal agencies in implementing the provisions of section 4722 of this title shall be consistent with all applicable Federal, State, and local environmental laws.

§ 354 Veterinary feed directive drugs

(a) Lawful veterinary feed directive requirement

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

§ 606  Inspection and labeling of meat food products

(a) In general. 

For the purposes hereinbefore set forth the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all meat food products prepared for commerce in any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and for the purposes of any examination and inspection and inspectors shall have access at all times, by day or night, whether the establishment be operated or not, to every part of said establishment; and said inspectors shall mark, stamp, tag, or label as "Inspected and passed" all such products found to be not adulterated; and said inspectors shall label, mark, stamp, or tag as "Inspected and condemned" all such products found adulterated, and all such condemned meat food products shall be destroyed for food purposes, as hereinbefore provided, and the Secretary may remove inspectors from any establishment which fails to so destroy such condemned meat food products: Provided, That subject to the rules and regulations of the Secretary the provisions of this section in regard to preservatives shall not apply to meat food products for export to any foreign country and which are prepared or packed according to the specifications or directions of the foreign purchaser, when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is to be exported; but if said article shall be in fact sold or offered for sale for domestic use or consumption then this proviso shall not exempt said article from the operation of all the other provisions of this chapter.

Subchapter III Standards and enforcement

§ 1321 Oil and Hazardous Substance Liability

(b) Congressional declaration of policy against discharges of oil or hazardous substances; designation of hazardous substances; study of higher standard of care incentives and report to Congress; liability; penalties; civil actions: penalty limitations, separate offenses, jurisdiction, mitigation of damages and costs, recovery of removal costs, alternative remedies, and withholding clearance of vessels

(3) The discharge of oil or hazardous substances (i) into or upon the navigable waters of the United States, adjoining shorelines, or into or upon the waters of the contiguous zone, or (ii) in connection with activities under the Outer Continental Shelf Lands Act [43 U.S.C. 1331 et seq.] or the Deepwater Port Act of 1974 [33 U.S.C. 1501 et seq.], or which may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States (including resources under the Magnuson-Stevens Fishery Conservation and Management Act [16 U.S.C. 1801 et seq.]), in such quantities as may be harmful as determined by the President under paragraph (4) of this subsection, is prohibited, except (A) in the case of such discharges into the waters of the contiguous zone or which may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States (including resources under the Magnuson-Stevens Fishery Conservation and Management Act), where permitted under the Protocol of 1978 Relating to the International Convention for the Prevention of Pollution from Ships, 1973, and (B) where permitted in quantities and at times and locations or under such circumstances or conditions as the President may, by regulation, determine not to be harmful. Any regulations issued under this subsection shall be consistent with maritime safety and with marine and navigation laws and regulations and applicable water quality standards.

(j) National Response System

(1) In general

Consistent with the National Contingency Plan required by subsection (c)(2) 2 of this section, as soon as practicable after October 18, 1972, and from time to time thereafter, the President shall issue regulations consistent with maritime safety and with marine and navigation laws (A) establishing methods and procedures for removal of discharged oil and hazardous substances, (B) establishing criteria for the development and implementation of local and regional oil and hazardous substance removal contingency plans, (C) establishing procedures, methods, and equipment and other requirements for equipment to prevent discharges of oil and hazardous substances from vessels and from onshore facilities and offshore facilities, and to contain such discharges, and (D) governing the inspection of vessels carrying cargoes of oil and hazardous substances and the inspection of such cargoes in order to reduce the likelihood of discharges of oil from vessels in violation of this section.

§ 1321 Working relations with the U.S. Environmental Protection Agency (EPA) and related State environmental agencies.

(a) Background.  The authorities and missions of NRCS, EPA, and state environmental agencies make it imperative that an effective cooperative and coordinative working relationship be developed and maintained in areas of mutual concern. These common areas include air quality, water quality, pesticides, waste recycling and disposal, environmental considerations in land use, Environmental Impact Statements (EIS's) and environmental considerations in the conservation and development of natural resources. 

(b) Policy.  NRCS will work closely with EPA in accordance with the provisions of the EPA-USDA Memorandum of Understanding July 31, 1974, at all administrative levels and with related state agencies to meet statutory requirements and to achieve harmonious implementation of all actions of mutual concern directed to improving or maintaining the quality of the environment.

§ 161.7  Activities performed by non-accredited veterinarians.

(b) Except as provided by paragraph (a) of this section, anyone who performs accredited veterinarian duties that he or she is not authorized to perform will be subject to such criminal and civil penalties as are provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or other applicable Federal statutes or regulations. Performing accredited duties without having been accredited will be considered grounds for the Administrator to deny an application for accreditation.

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

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

Subpart A - General Provisions

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

(a) § 507.7 Requirements that apply to a qualified facility.

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

(2)(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.

Chapter 4: Formal consultation

4.4  Formal consultation procedures

(B) Coordination with other environmental reviews.
Formal consultation and the Services' preparation of a biological opinion often involve coordination with the preparation of documents mandated by other environmental statutes and regulations, including the Fish and Wildlife Coordination Act (FWCA) and the National Environmental Policy Act (NEPA). Although other environmental reviews may be processed concurrently with a section 7 consultation package, they should be separate entities. The contents of the biological opinion and incidental take statement, including the discussion of effects to listed or proposed species and/or critical habitats, and appropriate measures to avoid or minimize those effects, may be addressed in the Service's comments and recommendations under the FWCA, section 404(m) of the Clean Water Act, NEPA, and other authorities. The section 7 consultation package may be prepared as a stand-alone document under separate signature, or one cover transmittal may be used as long as the consultation package is identified as a separate entity.

Chapter 1: Key Concepts

... The use of laboratory animals in research, teaching, testing, and production is also governed or affected by various federal and local laws, regulations, and standards; for example, in the United States the Animal Welfare Act (42 USC § 289d) and Regulations (9 CFR 1A) and/or Public Health Service Policy may apply. Compliance with these laws, regulations, policies, and standards (or subsequent revised versions) in the establishment and implementation of a program of animal care and use is discussed in Chapter 2.

Taken together, the practical effect of these laws, regulations, and policies is to establish a system of self-regulation and regulatory oversight that binds researchers and institutions using animals. Both researchers and institutions have affirmative duties of humane care and use that are supported by practical, ethical, and scientific principles. This system of self-regulation establishes a rigorous program of animal care and use and provides flexibility in fulfilling the responsibility to provide humane care.

Chapter 2: Animal Care and Use Program

REGULATIONS, POLICIES, AND PRINCIPLES

The use of laboratory animals is governed by an interrelated, dynamic system of regulations, policies, guidelines, and procedures. The Guide takes into consideration regulatory requirements relevant to many US-based activities, including the Animal Welfare Regulations (9 CFR 1A; 42 USC § 289d) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The use of the Guide by non-US entities also presumes adherence to all regulations relevant to the humane care and use of laboratory animals applicable in those locations. The Guide also takes into account the U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

PROGRAM MANAGEMENT

An effective Program requires clearly defined roles that align responsibility with regulatory and management authority. US federal law creates a statutory basis for the institutional official (IO), the attending veterinarian (AV), and the institutional animal care and use committee (IACUC). The Guide endorses these concepts as important operating principles for all US and non-US animal care and use programs.

PROGRAM OVERSIGHT

Postapproval Monitoring

Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. A variety of mechanisms can be used to facilitate ongoing protocol assessment and regulatory compliance. Postapproval monitoring (PAM) is considered here in the broadest sense, consisting of all types of protocol monitoring after the IACUC’s initial protocol approval.

Chapter 4: Veterinary Care

ANIMAL PROCUREMENT AND TRANSPORTATION

Animal Procurement

All animals must be acquired lawfully, and the receiving institution should ensure that all procedures involving animal procurement are conducted in a lawful manner. 

Transportation of Animals

 Institutions should contact appropriate authorities to ensure compliance with any relevant statutes and other animal transportation requirements that must be met for animals to cross international boundaries, including those not of the country of final destination. The (National Research Council) publication Guidelines for the Humane Transportation of Research Animals provides a comprehensive review of this topic ...; additional references on transportation of animals are available in Appendix A.

CLINICAL CARE AND MANAGEMENT

Recordkeeping

... All those involved in animal care and use must comply with federal laws and regulations regarding human and veterinary drugs and treatments...

SEC. III Public Health Reasons and Explanations

Chapter X. General Requirements for Dealers

.01 General HACCP Requirements

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

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

AFS. 2014. Guidelines for the Use of Fishes in Research. Use of Fishes in Research Committee (a joint committee of the American Fisheries Society, the American Institute of Fishery Research Biologists, and the American Society of Ichthyologists and Herpetologists). American Fisheries Society, Bethesda, Maryland. ISBN-13: 978-1-934874-39-4

ASC. 2022. Aquaculture Stewardship Council website "15 Facts about the ASC": Home » What We Do » About Us » 15 Facts about the ASC. https://www.asc-aqua.org/what-we-do/about-us/15-facts-about-the-asc/.  Last Accessed: Nov 27, 2022. 

BAP-Farm. 2021. Aquaculture Facility Certification; BAP Farm Standard. Best Aquaculture Practices Certification Standards, Implementation Guidelines. Document ID: PI1-0107. Document Name: Farm Standard. Issue 3.0 – 01-March-2021. 

BAP-M. 2021.  Aquaculture Facility Certification; Mollusk Farms; Best Aquaculture Practices Certification Standards, Guidelines. Document ID: PI1-0109. Document Name: Mollusk Farm Standard. Issue 1.1 – 15-March-2021. 

Carter, A. & Goldstein, M. 2019. American Aquaculture - An Overview of the Current Status, Environmental Impacts, and Legislative Opportunities. Energy and Environment. Center for American Progress. Posted on May 13, 2019, 9:00 am. https://www.americanprogress.org/issues/green/reports/2019/05/13/469730/american-aquaculture/   

USDCA. 2020. Gulf Fishermens Association et al. v. National Marine Fisheries Service et al., No. 19-30006. United States Court of Appeals for the Fifth Circuit. Case: 19-30006 Document: 00515512593. Filed 08/03/20. https://www.centerforfoodsafety.org/files/ca5-gulf-aquaculture-decision_8_3_2020_71933.pdf 

USDCED. 2018. Gulf Fishermens Association et al. v. National Marine Fisheries Service et al., No. 16-1271. Section “H”(1). United States District Court Eastern District of Louisiana. Case 2:16-cv-01271-JTM-KWR. Document 94. Filed 09/25/18. https://www.centerforfoodsafety.org/files/2018-09-25-dkt-94-order-re-x-msj-pl-granted-def-denied_05487.pdf   

WA-OFM. 2021. State of Washington Office of Financial Management website "Fair Labor Standards Act (FLSA)": Home » State Human Resources » Compensation & job classes » Compensation administration » Fair Labor Standards Act (FLSA) & Washington Minimum Wage Act (WMWA) » Fair Labor Standards Act (FLSA). https://ofm.wa.gov/state-human-resources/compensation-job-classes/compensation-administration/fair-labor-standards-act-flsa-washington-minimum-wage-act-wmwa/fair-labor-standards-act-flsa. Last Updated: Jul 23, 2021.