Topic 5

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

22. A culture environment should be maintained at all phases of the production cycle adapted to the species raised, to benefit aquatic animal health and welfare, and reduce the risks of introduction and spread of aquatic animal diseases. In particular, by

·   allowing for quarantining of stock where appropriate;

·   routine monitoring of stock and environmental conditions for early detection of aquatic animal health problems; and

·   implementation of management practices that (3)reduce the likelihood of disease transmission (5)within and between aquaculture facilities and natural aquatic fauna, and reduce stress on animals for the purpose of optimizing health.

32. The source of broodstock and seed for culture (larvae, post-larvae, fry and fingerling, etc.) should be such to reduce the risk of carryover of potential human health hazards (e.g. antibiotics, parasites, etc.) into the growing stocks.

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

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

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

34. Aquaculture facilities and operations should maintain good culture and hygienic conditions, including:

·   Good hygiene practices in the farm surroundings should be applied aiming at minimizing contamination of growing water, particularly from waste materials or faecal matter from animals or humans.

·   Good Aquaculture Practices should be applied during culture to ensure good hygienic culture conditions and safety and quality of aquaculture produce.

·   Farms should institute a pest control programme, so that rodents, birds and other wild and domesticated animals are controlled, especially around feed storage areas.

·   Farm grounds should be well maintained to reduce or eliminate food and feed safety hazards.

·   Appropriate techniques for harvesting, storing and transportation of aquaculture products should be applied to minimize contamination and physical damage.

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.

48. Where possible, hatchery produced seed should be used for culture. When wild seeds are used, they should be collected using responsible practices.

49. Exotic species are to be used only when they pose an acceptable level of risk to the natural environment, biodiversity and ecosystem health.

50. With reference to paragraph 9.3.1 of the Code of Conduct for Responsible Fisheries, where genetic material of an aquatic organism has been altered in a way that does not occur naturally, science-based risk assessment should be used to address possible risks on a case-by-case basis. Induction of polyploidy is not included.

Hatchery production dominates the shellfish industry; however, a few States still collect wild spat by placing shell in appropriate sites. No States allow exotic or genetically modified (GMO) shellfish. Note that “genetic modification” is distinguished from “genetic improvement”. From Tucker and Hargreaves (2008):

Genetically modified organisms are defined here as those whose genetic material has been altered with genetic material from a different species by genetic engineering techniques. Therefore, organisms resulting from the conventional breeding techniques of selective breeding, hybridization, and polyploid induction are not considered genetically modified organisms. The basic breeding techniques used in genetic improvement programs exploit natural heritable variation to improve performance characteristics such as growth rate, survival, disease resistance, and product quality.

From the U.S. Fish & Wildlife Service International Affairs website “Lacey Act” (USFWS-LA. 2022):

Under the Lacey Act, it is unlawful to import, export, sell, acquire, or purchase fish, wildlife or plants that are taken, possessed, transported, or sold: 1) in violation of U.S. or Indian law, or 2) in interstate or foreign commerce involving any fish, wildlife, or plants taken possessed or sold in violation of State or foreign law. 

The law covers all fish and wildlife and their parts or products, plants protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and those protected by State law. Commercial guiding and outfitting are considered to be a sale under the provisions of the Act… 

When the Lacey Act was passed in 1900, it became the first federal law protecting wildlife. It enforces civil and criminal penalties for the illegal trade of animals and plants. Today it regulates the import of any species protected by international or domestic law and prevents the spread of invasive, or non-native, species.

However, from Hill et al. (2019):

Recent court rulings (USCADC 2017) have determined that the U.S Fish and Wildlife Service (USFWS) lacks the authority to prohibit interstate transport of injurious wildlife under the Lacey Act. The District Court ruling also recognized that non-native species may be considered injurious to some states or regions and not to others… We further remind state agencies that the USFWS can still federally prosecute interstate violations of state non-native species regulations under Title 16 of the Lacey Act (wildlife trafficking provisions) if enforcement assistance is needed.

The Aquatic Nuisance Species Task Force (authorized by the Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990 and reauthorized with the passage of the National Invasive Species Act of 1996) developed a generic methodology related to exotic species and risk analysis. The USFWS developed a quick screen process to efficiently characterize and prioritize the potential risk of invasiveness from species of wild animals and plants, which resulted in a series of reports known as the Ecological Risk Screening Summaries. As an outcome of their effort, States are adopting quick screens to perform their own analysis and have included other quick screens (e.g., Fish Invasiveness Screening Kit) to, hopefully, improve the analysis.  The overall approach of the Aquatic Nuisance Species Task Force is to coordinate federal activities relative to invasive aquatic species through writing national species management plans and then extending that expertise to the states by encouraging, supporting, and providing limited funding to regional panels and state management plans. The development of these methodologies and programs provides outcome evidence that U.S. laws are being implemented and used to reduce the risk of impacts to the local environment.

From the United States Department of Agriculture Animal and Plant Health Inspection Service website “Noxious Weeds Program Home Page” (USDA-APHIS-NW. 2022):

The APHIS Federal noxious weed program is designed to prevent the introduction into the United States of nonindigenous invasive plants. APHIS noxious weed activities include exclusion and permitting and (in cooperation with other agencies and state agencies) integrated management of introduced weeds, including biological control.

The USDA APHIS Noxious Weed Program is authorized by the The Noxious Weed Control and Eradication Act, which is part of the Plant Protection Act (7 U.S.C. § 7701 et seq.) as amended. The program maintains the Federal Noxious Weed List.

From the Guide for the Care and Use of Laboratory Animals: Eighth Edition (2011):

Transportation of animals is governed by a number of US regulatory agencies and international bodies. The Animal Welfare Regulations (9 CFR 1A) set standards for interstate and export/import transportation of regulated species; the International Air Transport Association (IATA) updates the Live Animals Regulations annually and IATA member airlines and many countries agree to comply with these regulations to ensure the safe and humane transport of animals by air... The Centers for Disease Control and Prevention and USDA enforce regulations to prevent the introduction, transmission, or spread of communicable diseases and regulate the importation of any animal or animal product capable of carrying a zoonotic disease. The US Fish and Wildlife Service regulates importation/exportation of wild vertebrate and invertebrate animals and their tissues. As the national authority arm of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), the US Fish and Wildlife Service also regulates movement of CITES-listed species that are captive bred, including nonhuman primates (50 CFR Parts 10, 13, 17, and 23). 

Fines and actions taken by Washington State after a January 2018 Atlantic salmon escape from Cooke Aquaculture’s Cypress Island fish farm provide outcome evidence that state permitting laws governing environmental impacts linked to fish farming are being used and enforced.  This was the second pen collapse at the Cooke Aquaculture farm. A pen failure in August 2017 led to a state investigation and report on the incident, as well as a civil lawsuit filed in U.S. District Court in Seattle by a local wild-salmon advocacy group.  The advocacy group argues that the discharges (escapees) represent violations of the National Pollutant Discharge Elimination System (NPDES) permits under which Cooke Aquaculture’s Atlantic salmon net pens operated (USDCWD 2019). Under section 1365 of the Clean Water Act, “... any citizen may commence a civil action ... against any person … who is alleged to be in violation of ... an effluent standard…” The Clean Water Act gives states authority to interpret non-native species as biological pollutants under the Act, and at least one court has already concluded that a non-native species release constituted biological pollution (USCA2 2014). The State published its report in January 2018 that also outlined state agency roles in aquaculture management. Cooke Aquaculture was fined $332,000 for violating its water-quality permit before and during the net-pen collapse. By March 2018, Atlantic salmon farming was banned from Washington state waters after Gov. Jay Inslee signed the restrictions on nonnative fish farms into law.  Cooke Aquaculture’s permit phased out in 2022. 

USARK v. Zinke (USCADC 2017) determined that the USFWS lacks the authority to prohibit interstate transport of injurious wildlife under the Lacey Act. Hill et al. (2019) provide the following recommendations for future consideration:

Although many states have done considerable work in non-native species management, states are now incentivized to evaluate their current regulatory framework in light of the recent rulings. We specifically recommend that states (1) adopt risk analysis methods to support non-native species decision making, (2) evaluate risks of current federal injurious wildlife species and add them to state prohibited lists if warranted, (3) evaluate risks of future federal injurious wildlife species listings in the same manner, (4) strengthen and create partnerships to improve non-native species management, especially across political boundaries, and (5) work closely with professional society scientists to draw on their expertise for input, review, and training.

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 2.1: Provide farmers with access to improved genetics

Currently, fewer than 10 percent of all animals produced in aquaculture have been improved for aquaculture production through selective breeding, and many juveniles or seed stocks are directly harvested from wild populations or are the offspring of wild parents. For microalgae and macroalgae, selective breeding programs to improve traits such as biomass yield, chemical composition, and disease resistance have only recently been implemented, including approaches that employ genome-enabled selection technologies. Unlike much of terrestrial agriculture, wild populations still exist for a wide variety of newly cultured aquatic organisms. In those few aquatic species that have been domesticated, genetic selection programs have yet to be implemented, do not use state-of-the-art technologies, or have advanced only a few generations. There is a significant opportunity to apply genetic and genomic advances to agronomic improvement. Desirable production traits include disease resistance and fast, efficient growth, which results in increased product yield with lower inputs and lower waste production.

Aquaculture faces the challenge of domesticating and enhancing the economically important traits of aquatic species for commercial production while applying best science-based practices to successfully integrate commercial interests with protective measures for natural populations. For example, many aquaculture production systems are connected to aquatic natural resources such that farmed escapees could interact and mate with wild counterparts. Selectively bred salmon in net pens could escape and interact with natural salmon populations, potentially reducing genetic diversity and capacity for adapting to environmental stressors. Existing technologies such as those that produce sterile offspring to eliminate or minimize interactions with their wild counterparts must be implemented so genetic improvements made in cultured populations do not impact their wild counterparts.

Federal efforts for stock restoration for imperiled species recovery and for recreation programs currently strive to minimize genetic impact on wild stocks by ensuring that only animals with closely related genetics are released into native waters. Tools and technologies for managing populations’ genetics are species-specific and must be developed for each population.

The following actions will support genetic improvement and minimize risks to natural populations. The agencies listed below will support or conduct R&D activities, including technology transfer, or consult with science programs to identify research priorities and form science-based policy.

• Action 2.1.1 USDA (ARS), DOC NOAA (NMFS), and DOI (USGS and USFWS) will develop and operationalize a framework for genetic risk assessment and management that includes realistic science-based expectations for implementing genetic improvement programs, particularly selective breeding, while minimizing risk to wild populations from escapes.

• Action 2.1.2 USDA (ARS, NIFA), DOE (BETO), DOI (USGS, USFWS), and DOC NOAA (NMFS, SG) will develop and implement state-of-the-art genetic and genomic tools for breeding program(s) for fish, shellfish, microalgae, and seaweeds to improve production efficiency, product quality, animal well-being, and overall health.

• Action 2.1.3 DOC NOAA (NMFS, SG), USDA (ARS, NIFA), and DOI (USGS, USFWS) will develop technologies to prevent or reduce interactions and competition with native populations.

• Action 2.1.4 USDA (ARS), DOI (USFWS), and NOAA (NMFS) will ensure preservation of population diversity including wild-type and selectively bred populations.

Objective 2.4: Improve engineering systems for aquaculture 

Production systems for aquaculture in the United States include pond-based systems (e.g., catfish and crawfish production); raceway systems (e.g., rainbow trout and microalgae); near-shore and offshore net-pens and cages (e.g., Atlantic salmon and marine fish); hatcheries (e.g., Pacific salmon and marine fish); intertidal, off-bottom, and long-line coastal shellfish production; freshwater and marine algae (including seaweed) production systems; and recirculation systems (e.g., aquaponics, salmon, yellow perch, tilapia, ornamental species, and oyster spat). The hatcheries and nurseries for all these types of aquaculture represent unique engineering challenges, but all production systems would benefit from advanced monitoring and control systems, labor-saving process engineering, and other specialized devices. For example, renewable energy for the operation of offshore systems could be supplied by integrated marine wind and water power technologies. 

Aquaponics, the cultivation of plants in water downstream of aquatic animal production, demonstrates the potential of integrating hydroponics with modern aquaculture systems. Further R&D in combining complementary systems may enable large-scale production of both fish and vegetables in one system. This has the potential to help revitalize rural economies and provide for local production in food deserts where access to affordable, healthy food options is limited.

Significant opportunities exist to improve the performance and productivity of aquaculture production systems through innovative engineering and new devices and technologies. There is significant potential to adapt current commercial technologies and engineering solutions from other sectors, such as municipal wastewater treatment, manufacturing, medicine, information technology, artificial intelligence, sensors, and energy, that can be integrated into aquaculture systems to improve productivity and efficiency.

The following actions will improve the efficiency and sustainability of aquaculture production systems. The agencies listed below will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• • • Action 2.4.1 USDA (ARS, NIFA), DOC NOAA (SG, NMFS), and DOI (USFWS) will support research that ensures robust aquaculture system performance at reasonable costs that maximize production potential, safety, and economic performance and reduce risk to native populations (including endangered and threatened species), while minimizing labor needs and impacts on wild organisms.

    • Action 2.4.2 USDA (ARS), DOE (BETO), and DOC NOAA (NMFS, SG) will support or conduct research that develops highly effective hatcheries and harvest and processing equipment.

    • Action 2.4.3 USDA (NIFA), DOI (USGS), and DOC NOAA (SG) will support or conduct research to develop or improve various types of specialized aquaculture systems that may be appropriate for U.S. aquaculture.

    • Action 2.4.4 DOC NOAA (SG, NMFS) and USDA (NIFA) will provide Extension Service support, test beds, and demonstration and production assistance through public-private partnerships to increase the rate of knowledge transfer from research to implementation and provide effective communication to researchers on behalf of farmers.

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

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

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

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

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

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

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

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

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

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

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

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

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

§ 7782  Establishment of program

(a) In general.

The Secretary shall establish a program to provide financial and technical assistance to control or eradicate noxious weeds.

§ 8301  Findings. Congress finds that —

(3) the health of animals is affected by the methods by which animals and articles are transported in interstate commerce and foreign commerce;

§ 8303  Restriction on importation or entry

(a) In general
With notice to the Secretary of the Treasury and public notice as soon as practicable, the Secretary may prohibit or restrict—

(1) the importation or entry of any animal, article, or means of conveyance, or use of any means of conveyance or facility, if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock;

(2) the further movement of any animal that has strayed into the United States if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock; and

(3) the use of any means of conveyance in connection with the importation or entry of livestock if the Secretary determines that the prohibition or restriction is necessary because the means of conveyance has not been maintained in a clean and sanitary condition or does not have accommodations for the safe and proper movement of livestock.

(b) Regulations

(1) Restrictions on import and entry
The Secretary may issue such orders and promulgate such regulations as are necessary to carry out subsection (a).

§ 8305 Interstate movement. The Secretary may prohibit or restrict—

(1) the movement in interstate commerce of any animal, article, or means of conveyance if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock; and

(2) the use of any means of conveyance or facility in connection with the movement in interstate commerce of any animal or article if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock.

§ 8309 Findings. 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.

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

(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).

Subchapter I General Provisions

§ 4701  Findings and purposes

(b) Purposes

The purposes of this chapter are-

(3) to develop and carry out environmentally sound control methods to prevent, monitor and control unintentional introductions of nonindigenous species from pathways other than ballast water exchange;

Subchapter III Prevention and control of aquatic nuisance species dispersal

§ 4722  Aquatic nuisance species program

(a) In general

The Task Force shall develop and implement a program for waters of the United States to prevent introduction and dispersal of aquatic nuisance species; to monitor, control and study such species; and to disseminate related information.

§ 4727  Intentional introductions policy review

Within one year of November 29, 1990, the Task Force shall, in consultation with State fish and wildlife agencies, other regional, State and local entities, potentially affected industries and other interested parties, identify and evaluate approaches for reducing the risk of adverse consequences associated with intentional introduction of aquatic organisms and submit a report of their findings, conclusions and recommendations to the Congress.

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

(a)

(1) The importation into the United States, any territory of the United States, the District of Columbia, the Commonwealth of Puerto Rico, or any possession of the United States, or any shipment between the continental United States, the District of Columbia, Hawaii, the Commonwealth of Puerto Rico, or any possession of the United States, of the mongoose of the species Herpestes auropunctatus; of the species of so-called "flying foxes" or fruit bats of the genus Pteropus; of the zebra mussel of the species Dreissena polymorpha; of the quagga mussel of the species Dreissena rostriformis or Dreissena bugensis; of the bighead carp of the species Hypophthalmichthys nobilis; and such other species of wild mammals, wild birds, fish (including mollusks and crustacea), amphibians, reptiles, brown tree snakes, or the offspring or eggs of any of the foregoing which the Secretary of the Interior may prescribe by regulation to be injurious to human beings, to the interests of agriculture, horticulture, forestry, or to wildlife or the wildlife resources of the United States, is hereby prohibited. All such prohibited mammals, birds, fish (including mollusks and crustacea), amphibians, and reptiles, and the eggs or offspring therefrom, shall be promptly exported or destroyed at the expense of the importer or consignee. Nothing in this section shall be construed to repeal or modify any provision of the Public Health Service Act or Federal Food, Drug, and Cosmetic Act. Also, this section shall not authorize any action with respect to the importation of any plant pest as defined in the Federal Plant Pest Act,1 insofar as such importation is subject to regulation under that Act.

(2) As used in this subsection, the term “wild” relates to any creatures that, whether or not raised in captivity, normally are found in a wild state; and the terms “wildlife” and “wildlife resources” include those resources that comprise wild mammals, wild birds, fish (including mollusks and crustacea), and all other classes of wild creatures whatsoever, and all types of aquatic and land vegetation upon which such wildlife resources are dependent.

(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.

(3) Notwithstanding the foregoing, the Secretary of the Interior, when he finds that there has been a proper showing of responsibility and continued protection of the public interest and health, shall permit the importation for zoological, educational, medical, and scientific purposes of any mammals, birds, fish (including mollusks and crustacea), amphibia, and reptiles, or the offspring or eggs thereof, where such importation would be prohibited otherwise by or pursuant to this Act, and this Act shall not restrict importations by Federal agencies for their own use.

(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—

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

(w) The term “amenable species” means—

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

(2) all fish of the order Siluriformes; and

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

§ 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.

(b) Certain fish. In the case of an examination and inspection under subsection (a) of a meat food product derived from any fish described in section 601(w)(2) of this title, the Secretary shall take into account the conditions under which the fish is raised and transported to a processing establishment.

Subchapter I Research and Related Programs

§ 1251 Congressional declaration of goals and policy

(a) Restoration and maintenance of chemical, physical and biological integrity of Nation's waters; national goals for achievement of objective

The objective of this chapter is to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters...

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

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

Subchapter V General Provisions

§ 1362 Definitions. 

Except as otherwise specifically provided, when used in this chapter:

(6) The term "pollutant" means dredged spoil, solid waste, incinerator residue, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, radioactive materials, heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal, and agricultural waste discharged into water. This term does not mean (A) "sewage from vessels or a discharge incidental to the normal operation of a vessel of the Armed Forces" within the meaning of section 1322 of this title; or (B) water, gas, or other material which is injected into a well to facilitate production of oil or gas, or water derived in association with oil or gas production and disposed of in a well, if the well used either to facilitate production or for disposal purposes is approved by authority of the State in which the well is located, and if such State determines that such injection or disposal will not result in the degradation of ground or surface water resources.

(12) The term "discharge of a pollutant" and the term "discharge of pollutants" each means (A) any addition of any pollutant to navigable waters from any point source, (B) any addition of any pollutant to the waters of the contiguous zone or the ocean from any point source other than a vessel or other floating craft.

§ 1365 Citizen suits

(a) Authorization; jurisdiction

Except as provided in subsection (b) of this section and section 1319(g)(6) of this title, any citizen may commence a civil action on his own behalf-

(1) against any person (including (i) the United States, and (ii) any other governmental instrumentality or agency to the extent permitted by the eleventh amendment to the Constitution) who is alleged to be in violation of (A) an effluent standard or limitation under this chapter or (B) an order issued by the Administrator or a State with respect to such a standard or limitation, or

(2) against the Administrator where there is alleged a failure of the Administrator to perform any act or duty under this chapter which is not discretionary with the Administrator.

The district courts shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce such an effluent standard or limitation, or such an order, or to order the Administrator to perform such act or duty, as the case may be, and to apply any appropriate civil penalties under section 1319(d) of this title.

§ 3 Invasive Species Council.

(a) An Invasive Species Council (Council) is hereby established whose members shall include the Secretary of State, the Secretary of the Treasury, the Secretary of Defense, the Secretary of the Interior, the Secretary of Agriculture, the Secretary of Commerce, the Secretary of Transportation, and the Administrator of the Environmental Protection Agency. The Council shall be Co-Chaired by the Secretary of the Interior, the Secretary of Agriculture, and the Secretary of Commerce. The Council may invite additional Federal agency representatives to be members, including representatives from subcabinet bureaus or offices with significant responsibilities concerning invasive species, and may prescribe special procedures for their participation. The Secretary of the Interior shall, with concurrence of the Co-Chairs, appoint an Executive Director of the Council and shall provide the staff and administrative support for the Council. 

(b) The Secretary of the Interior shall establish an advisory committee under the Federal Advisory Committee Act, 5 U.S.C. App., to provide information and advice for consideration by the Council, and shall, after consultation with other members of the Council, appoint members of the advisory committee representing stakeholders. Among other things, the advisory committee shall recommend plans and actions at local, tribal, State, regional, and ecosystem-based levels to achieve the goals and objectives of the Management Plan in section 5 of this order. The advisory committee shall act in cooperation with stakeholders and existing organizations addressing invasive species. The Department of the Interior shall provide the administrative and financial support for the advisory committee. 

§ 360.200  Designation of noxious weeds.

The Administrator has determined that it is necessary to designate the following plants[1]   as noxious weeds to prevent their introduction into the United States or their dissemination within the United States: ...

§ 360.300  Notice of restrictions on movement of noxious weeds.

No person may move a Federal noxious weed into or through the United States, or interstate, unless: 

(a) He or she applies for a permit to move a noxious weed in accordance with § 360.301; 

(b) The permit application is approved; and 

(c) The movement is consistent with the specific conditions contained in the permit.

Part 16 Injurious Wildlife

Subpart A Introduction 

§ 16.1 Purpose of regulations.

The regulations contained in this part implement the Lacey Act (18 U.S.C. 42).

§ 16.3 General Restrictions.  

Any importation or transportation of live wildlife or eggs thereof, or dead fish or eggs or salmonids of the fish family Salmonidae into the United States or its territories or possessions is deemed to be injurious or potentially injurious to the health and welfare of human beings, to the interest of forestry, agriculture, and horticulture, and to the welfare and survival of the wildlife or wildlife resources of the United States; and any such importation into or the transportation of live wildlife or eggs thereof between the continental United States, the District of Columbia, Hawaii, the Commonwealth of Puerto Rico, or any territory or possession of the United States by any means whatsoever, is prohibited except for certain purposes and under certain conditions as hereinafter provided in this part: Provided, That the provisions of this section shall not apply to psittacine birds (see also §§ 16.32 and 16.33 for other exemptions).

Subpart B Importation or Shipment of Injurious Wildlife (§§ 16.11 - 16.15)

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

(a) Upon an exporter filing a written declaration with the District Director of Customs at the port of entry as required under § 14.61 of this chapter, live or dead fish, mollusks, and crustaceans, or parts thereof, or their gametes or fertilized eggs, may be imported, transported, and possessed in captivity without a permit except as follows:

(1) No such live fish, mollusks, crustacean, or any progency or eggs thereof may be released into the wild except by the State wildlife conservation agency having jurisdiction over the area of release or by persons having prior written permission from such agency.

(2) The importation, transportation, or acquisition of any of the species listed in this paragraph is prohibited except as provided under the terms and conditions set forth in § 16.22: ...

(3) Notwithstanding § 16.32, all Federal agencies shall be subject to the requirements stated within this section ... 

(d) Any fish caught in the wild in North America under a valid sport or commercial fishing license shall be exempt from sampling and certification requirements and from filing the Declaration for Importation of Wildlife. The Director may enter into formal agreements allowing the importation of gametes, fertilized eggs, live fish, or dead, uneviscerated fish without inspection and certification of pathogen status, if the exporting Nation has an acceptable program of inspection and pathogen control in operation, can document the occurrence and distribution of fish pathogens within its boundaries, and can demonstrate that importation of salmonid fishes into the United States from that National will not pose a substantial risk to the public and private fish stocks of the United States.

§ 16.14 Importation of live or dead amphibians or their eggs.

(a) The importation, transportation, or acquisition of any live or dead specimen, including parts, but not eggs or gametes, of the genera Chioglossa, Cynops, Euproctus, Hydromantes, Hynobius, Ichthyosaura, Lissotriton, Neurergus, Notophthalmus, Onychodactylus, Paramesotriton, Plethodon, Pleurodeles, Salamandra, Salamandrella, Salamandrina, Siren, Taricha, Triturus, and Tylototriton, including but not limited to, the species listed in this paragraph, is prohibited except as provided under the terms and conditions set forth at § 16.22 of this part: ...

§ 16.15 Importation of live reptiles or their eggs.

(a) The importation, transportation, or acquisition of any live specimen, gamete, viable egg, or hybrid of the species listed in this paragraph is prohibited except as provided under the terms and conditions set forth at § 16.22:

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

Subpart F Offshore Marine Aquaculture in the Gulf of Mexico

§ 622.105 Allowable aquaculture systems and species.

(b) Allowable aquaculture species.  Only the following federally managed species that are native to the Gulf and are not genetically engineered or transgenic, may be cultured in an aquaculture facility in the Gulf EEZ: 

(1) Species of coastal migratory pelagic fish, as defined in § 622.2. 

(2) Species of Gulf reef fish, as listed in appendix A to this part. 

(3) Red drum, Sciaenops ocellatus. 

(4) Spiny lobster, Panulirus argus.

§ 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.

Chapter 4: Veterinary Care

An adequate veterinary care program consists of assessment of animal well-being and effective management of

• animal procurement and transportation

• preventive medicine (including quarantine, animal biosecurity, and surveillance)

• clinical disease, disability, or related health issues

• protocol-associated disease, disability, and other sequelae

• surgery and perioperative care

• pain and distress

• anesthesia and analgesia

• euthanasia.

ANIMAL PROCUREMENT AND TRANSPORTATION

Animal Procurement

... Attention should also be given to the population status of the species under consideration; the threatened or endangered status of species is updated annually by the Fish and Wildlife Service...

Potential vendors should be evaluated for the quality of animals they supply. As a rule, vendors of purpose-bred animals (e.g., USDA Class A dealers) regularly provide information that describes the genetic and pathogen status of their colonies or individual animals and relevant clinical history (e.g., vaccination status and anthelminthic administration). The use of purpose-bred and preconditioned animals is therefore preferable when consistent with the research, teaching, and testing objectives. In general, animals used for scientific purposes should not be obtained from pet stores or pet distributors due to the unknown or uncontrolled background of animals from these sources and the potential for introducing health risks to personnel and other facility animals...

Transportation of Animals

... Careful planning for all types of transportation should occur to ensure animal safety and well-being...

For aquatic species and amphibians, special considerations are required for transportation in an aqueous or sufficiently moist environment, and special attention should be given to avoiding temperature extremes for poikilotherms.

PREVENTIVE MEDICINE

Animal Biosecurity

A successful animal biosecurity program incorporates a number of elements: procedures that ensure that only animals of a desired defined health status enter the facility; personnel and materials, especially consumables, that do not serve as fomites; practices that reduce the likelihood of cross contamination if an infectious agent is inadvertently introduced; a comprehensive ongoing system for evaluating animals’ health status, including access to all animals; and containment and eradication, if desired, of introduced infectious agents. Related components include procedures for evaluating and selecting appropriate animal suppliers (these may include quarantine and determination of animal health status if unknown); treatment of animals or their products at entry to minimize disease risks (e.g., surface disinfection of fish eggs); a comprehensive pest control program that may include evaluation of the health status of feral animals; procedures to ensure that all biologics administered to animals are free of contamination; and procedures for intra- and interfacility animal transport (e.g., transport of animals to laboratory and other facilities outside the animal facility can present challenges to animal biosecurity) (Balaban and Hampshire 2001). Additional details pertaining to these topics are available in the sections of Chapter 2 that deal with occupational health and safety.

Quarantine and Stabilization

... When quarantine is indicated, animals from one shipment should be handled separately or be physically separated from animals from other shipments to preclude transfer of infectious agents between groups.

Chapter 5: Physical Plant

GENERAL CONSIDERATIONS

Centralization Versus Decentralization

In a physically centralized animal facility, support, care, and use areas are adjacent to the animal housing space. Decentralized animal housing and use occur in space that is not solely dedicated to animal care or support or is physically separated from the support areas and animal care personnel. Centralization often reduces operating costs, providing a more efficient flow of animal care supplies, equipment, and personnel; more efficient use of environmental controls; and less duplication of support services. Centralization reduces the needs for transporting animals between housing and study sites, thereby minimizing the risks of transport stress and exposure to disease agents; affords greater security by providing the opportunity to control facility access; and increases the ease of monitoring staff and animals.

Goal 1. Ecosystem compatibility – Aquaculture development in federal waters is compatible with the functioning of healthy, productive, and resilient marine ecosystems.

NOAA will achieve this goal by:

- developing, implementing, and enforcing conservation and management measures for aquaculture designed to maintain the health, genetics, habitats, and populations of wild species; maintain water quality; prevent escapes and accidental discharges into the environment; and avoid harmful interactions with wild fish stock, marine mammals, birds, and protected species

- supporting the use of only native or naturalized species in federal waters unless best available science demonstrates use of non-native or other species in federal waters would not cause undue harm to wild species, habitats, or ecosystems in the event of an escape

Balaban, R. S. &  V. A. Hampshire. 2001. Challenges in small animal noninvasive imaging. ILAR Journal, 42(3): 248–262. https://doi.org/10.1093/ilar.42.3.248 

Hill, J. E., Q. M. Tuckett, & C. A. Watson. 2019. “The Courts Rule on the Lacey Act: What Does This Mean for Non-native Species Management?” Aquaculture 2019 - Meeting Abstract. New Orleans, LA. March 7-11, 2019. The World Aquaculture Society.  Conference Abstract Book. pp. 468. https://wasblobstorage.blob.core.windows.net/meeting-abstracts/AQ2019AbstractBook.pdf

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/ 

Tucker, C. S. & J. A. Hargreaves, eds. 2008. Environmental Best Management Practices for Aquaculture. Blackwell Publishing Ltd., Ames, IA, USA. 592 pages.

USCA2. 2014. Natural Resources Defense Council, Northwest Environmental Advocates, Center for Biological Diversity, and National Wildlife Federation, Petitioners, v. United States Environmental Protection Agency, Respondent, Lake Carriersʹ Association And Canadian Shipowners Association, Intervenors. United States Court of Appeals for the Second Circuit. August Term 2014. (Argued: January 30, 2015 Decided: October 5, 2015) Docket Nos. 13‐1745(L), 13‐2393(CON), 13‐2757(CON). https://cases.justia.com/federal/appellate-courts/ca2/13-1745/13-1745-2015-10-05.pdf?ts=1444057207  

USDA-APHIS-NW. 2022. United States Department of Agriculture Animal and Plant Health Inspection Service website "Noxious Weeds Program Home Page": Plant Health » Pests and Diseases » Programs » Weeds » Noxious Weeds Program. https://www.aphis.usda.gov/aphis/ourfocus/planthealth/plant-pest-and-disease-programs/pests-and-diseases/SA_Weeds/SA_Noxious_Weeds_Program; Last Modified: Aug 17, 2022.

USCADC. 2017. United States Association of Reptile Keeps, Inc. et al. v. Ryan Zinke, The Honorable, in his official capacity as the Secretary of the Interior and United States Fish and Wildlife Service et al., No. 15-5199. United States Court of Appeals for the District of Columbia (No. 1:13-cv-02007). Argued April 1, 2016. Decided April 7, 2017. https://www.cadc.uscourts.gov/internet/opinions.nsf/9E95E7C071BFF167852580FB004D3B14/$file/15-5199-1670024.pdf 

USDCWD. 2019. Wild Fish Conservancy v. Cooke Aquaculture Pac. LLC, No. C17-1708-JCC. United States  District Court Western District of Washington at Seattle. (W.D. Wash. Apr. 26, 2019). https://casetext.com/case/wild-fish-conservancy-v-cooke-aquaculture-pac-llc 

USFWS-LA. 2022. United States Fish & Wildlife Service International Affairs website "Lacey Act": https://www.fws.gov/international/laws-treaties-agreements/us-conservation-laws/lacey-act.html; Last Accessed: Oct 28, 2019.