Topic 18

42. In undertaking risk analysis, risks should be addressed through a suitable scientific method of assessing the likelihood of events and the magnitude of impacts, and take into account relevant uncertainties. Appropriate reference points should be determined and (19)remedial actions taken if reference points are approached or exceeded.

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.

From the United States Department of Agriculture Animal and Plant Health Inspection Service website “Aquaculture Information”: CAHPS Concept Paper (USDA-APHIS-VS 2017):

The CAHPS (Commercial Aquaculture Health Program Standards) recognize that there are regional differences in aquatic animal pathogen prevalence and encourage scientifically valid risk analysis when setting any aquatic animal pathogen control standards and regulations. 

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

The Weed Program Mission Statement: APHIS will use science-based methods to prevent the introduction of parasitic-plant pests and Federal noxious weeds (including those already regulated and candidates for regulation) into the United States.

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

Goal 1. Develop Economic Growth through Aquaculture

Objective 1.2: Enable science-based regulation and management of domestic aquaculture

A key impediment to the growth of the aquaculture industry is the complex and often unpredictable regulatory framework that can be costly for small farms to document compliance. Aquaculture businesses are regulated under an array of Federal, State, and local laws that govern a range of issues, including but not limited to animal health, water quality, impacts to navigation, and property rights. Many of these issues and Federal actions to improve regulatory efficiency for aquaculture are outlined in a report from the Subcommittee on Aquacultures Regulatory Efficiency Task Force.

Science has a key role to play in developing, analyzing, and interpreting datasets that inform Federal and State regulatory and management decision-making processes. Regulatory processes require objective, efficient, and timely decisions that are based on the best available science and appropriate risk management. Developing science-based approaches to siting and managing aquaculture facilities includes minimizing negative impacts to protected species and habitats, reducing risk of invasive species introductions, minimizing use conflicts, evaluating risks associated with disease and genetic risks of breeding between escaped farmed and wild populations, improving our understanding of existing uses to minimize conflict with other user groups, minimizing risks to water quality, and other tools. Such advancements will continually employ state-of-the-art scientific tools and approaches to advance the quality, consistency, and efficacy of regulatory decision-making for the benefit of industry, society, and the environment. Continual improvement of science-based management tools will be key to realizing the goals of economic performance, legal compliance, and environmental compatibility.

R&D projects can produce methods and technologies that minimize environmental impacts and increase efficiency of growing aquatic proteins. Science-based regulatory tools will lead to continuous improvement in economic, environmental, and social performance in all types of aquaculture industries.

The following actions will balance regulatory decision-making and environmental compliance with the need to expand domestic aquaculture production. 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 1.2.1 DOC NOAA (NOS, SG, NMFS), EPA, and DOE (ARPA-E, BETO) will develop tools for both regulators and producers who will assess potential production sites for their capacity to minimize negative impacts to protected species and habitats, reduce risk of invasive species introductions, minimizing use conflicts, evaluate risks associated with disease and genetic risks of breeding between escaped farmed and wild populations, improve our understanding of existing uses to minimize conflict with other user groups, and minimize risks to water quality.

• Action 1.2.2 DOC NOAA (NOS, SG, NMFS) will support the development of models that account for the potential effects from environmental change on aquaculture production in the United States.

• Action 1.2.3 DOC NOAA (NOS, NMFS), DOI (USGS), and EPA will support research on permitting processes and provide tools that inform State and local regulators developing guidance on potential new locations aquaculture facilities can expand to improve environmental quality in the Great Lakes and marine waters.

• Action 1.2.4 DOI (USFWS, USGS), and DOC NOAA (NMFS) will develop methods and best practices to use for recreational opportunities, and/or increase commercial fisheries harvests.

§ 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.

§ 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).

(n) Judicial review

Any person, as defined by section 1532(13) of this title, may obtain judicial review, under chapter 7 of title 5, of any decision of the Endangered Species Committee under subsection (h) in the United States Court of Appeals for (1) any circuit wherein the agency action concerned will be, or is being, carried out, or (2) in any case in which the agency action will be, or is being, carried out outside of any circuit, the District of Columbia, by filing in such court within 90 days after the date of issuance of the decision, a written petition for review. A copy of such petition shall be transmitted by the clerk of the court to the Committee and the Committee shall file in the court the record in the proceeding, as provided in section 2112 of title 28. Attorneys designated by the Endangered Species Committee may appear for, and represent the Committee in any action for review under this subsection.

Subchapter III Prevention and control of aquatic nuisance species dispersal

§ 4722  Aquatic nuisance species program

(e) Control

(1) In general

The Task Force may develop cooperative efforts, within the program established under subsection (a), to control established aquatic nuisance species to minimize the risk of harm to the environment and the public health and welfare. For purposes of this chapter, control efforts include eradication of infestations, reductions of populations, development of means of adapting human activities and public facilities to accommodate infestations, and prevention of the spread of aquatic nuisance species from infested areas. Such control efforts shall be developed in consultation with affected Federal agencies, States, Indian Tribes, local governments, interjurisdictional organizations, and other appropriate entities. Control actions authorized by this section shall be based on the best available scientific information and shall be conducted in an environmentally sound manner.

Subchapter III Standards and enforcement

§ 1314 Information and guidelines

(a) Criteria development and publication

(1) The Administrator, after consultation with appropriate Federal and State agencies and other interested persons, shall develop and publish, within one year after October 18, 1972 (and from time to time thereafter revise) criteria for water quality accurately reflecting the latest scientific knowledge (A) on the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish, shellfish, wildlife, plant life, shorelines, beaches, esthetics, and recreation which may be expected from the presence of pollutants in any body of water, including ground water; (B) on the concentration and dispersal of pollutants, or their byproducts, through biological, physical, and chemical processes; and (C) on the effects of pollutants on biological community diversity, productivity, and stability, including information on the factors affecting rates of eutrophication and rates of organic and inorganic sedimentation for varying types of receiving waters.

(3) Such criteria and information and revisions thereof shall be issued to the States and shall be published in the Federal Register and otherwise made available to the public.

(9) Revised criteria for coastal recreation waters.-

(A) In general.-Not later than 5 years after October 10, 2000, after consultation and in cooperation with appropriate Federal, State, tribal, and local officials (including local health officials), the Administrator shall publish new or revised water quality criteria for pathogens and pathogen indicators (including a revised list of testing methods, as appropriate), based on the results of the studies conducted under section 1254(v) of this title, for the purpose of protecting human health in coastal recreation waters.

(B) Reviews.-Not later than the date that is 5 years after the date of publication of water quality criteria under this paragraph, and at least once every 5 years thereafter, the Administrator shall review and, as necessary, revise the water quality criteria.

§ 360.501 Petitions to remove a taxon from the noxious weed lists.

A person may petition the Administrator to remove a taxon from the noxious weeds lists in § 360.200. Details of the petitioning process for removing a taxon from the lists are available at http://www.aphis.usda.gov/plant_health/plant_pest_info/weeds/downloads/delistingguide.pdf. Persons who submit a petition to remove a taxon from the noxious weed lists would be required to provide their name, address, telephone number, and (if available) e-mail address. Persons who submit a petition to remove a taxon from the noxious weed lists are encouraged to provide the following information, which can help speed up the review process and help APHIS determine whether the specified plant taxon should not be listed as a noxious weed:

(c) For cultivars of a listed noxious weed, scientific evidence that the cultivar has a combination of risk elements that result in a low pest risk. For example, the cultivar may have a narrow habitat suitability, low dispersal potential, evidence of sterility, inability to cross-pollinate with introduced wild types, or few if any potential negative impacts on the economy or environment of the United States.

§ 360.600 Preemption of State and local laws.

(a) Under section 436 of the Plant Protection Act (7 U.S.C. 7756), a State or political subdivision of a State may not regulate in foreign commerce any noxious weed in order to control it, eradicate it, or prevent its dissemination. A State or political subdivision of a State also may not impose prohibitions or restrictions upon the movement in interstate commerce of noxious weeds if the Secretary has issued a regulation or order to prevent the dissemination of the noxious weed within the United States. The only exceptions to this are: 

(2) If the State or political subdivision of a State demonstrates to the Secretary and the Secretary finds that there is a special need for additional prohibitions or restrictions based on sound scientific data or a thorough risk assessment.

Part 216 Regulations governing the taking and importing of marine mammals

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

§ 216.102 Scope.

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

(a) Finds, based on the best scientific evidence available, that the total taking by the specified activity during the specified time period will have a negligible impact on species or stock of marine mammal(s) and will not have an unmitigable adverse impact on the availability of those species or stocks of marine mammals intended for subsistence uses;

Part 1502 Environmental Impact Statement

§ 1502.21 Incomplete or unavailable information.

(a) When an agency is evaluating reasonably foreseeable significant adverse effects on the human environment in an environmental impact statement, and there is incomplete or unavailable information, the agency shall make clear that such information is lacking. 

(b) If the incomplete but available information relevant to reasonably foreseeable significant adverse impacts is essential to a reasoned choice among alternatives, and the overall costs of obtaining it are not unreasonable, the agency shall include the information in the environmental impact statement. 

(c) If the information relevant to reasonably foreseeable significant adverse impacts cannot be obtained because the overall costs of obtaining it are unreasonable or the means to obtain it are not known, the agency shall include within the environmental impact statement: 

(1) A statement that such information is incomplete or unavailable; 

(2) A statement of the relevance of the incomplete or unavailable information to evaluating reasonably foreseeable significant adverse impacts on the human environment; 

(3) A summary of existing credible scientific evidence that is relevant to evaluating the reasonably foreseeable significant adverse impacts on the human environment; and 

(4) The agency's evaluation of such impacts based upon theoretical approaches or research methods generally accepted in the scientific community. 

(d) For the purposes of this section, “reasonably foreseeable” includes impacts that have catastrophic consequences, even if their probability of occurrence is low, provided that the analysis of the impacts is supported by credible scientific evidence, is not based on pure conjecture, and is within the rule of reason.

§ 1502.23 Methodology and scientific accuracy.

Agencies shall ensure the professional integrity, including scientific integrity, of the discussions and analyses in environmental documents. Agencies shall make use of reliable existing data and resources. Agencies may make use of any reliable data sources, such as remotely gathered information or statistical models. They shall identify any methodologies used and shall make explicit reference to the scientific and other sources relied upon for conclusions in the statement. Agencies may place discussion of methodology in an appendix. Agencies are not required to undertake new scientific and technical research to inform their analyses. Nothing in this section is intended to prohibit agencies from compliance with the requirements of other statutes pertaining to scientific and technical research.

Agreement

The FDA and AAFCO agree to the following:

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

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

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/ 

USDA-APHIS-VS. 2017. United States Commercial Aquaculture Health Program Standards (CAHPS) Concept Paper. Animal and Plant Health Inspection Service. United States Department of Agriculture. Riverdale, Maryland, USA. https://www.aphis.usda.gov/animal_health/animal_dis_spec/aquaculture/downloads/cahps_concept_paper.pdf