Topic 17

41. Certification schemes may consider application of the “precautionary approach” in accordance with the relevant provisions of the Code of Conduct for Responsible Fisheries.

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 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 National Research Council's Science and Decisions: Advancing Risk Assessment (NRC 2009):

The term risk assessment does not appear often in the statutes, and it is important to note that these statues were enacted prior to the emergence of risk analysis as an integrative discipline in the late 1970s and early 1980s. Rather, EPA risk-assessment principles and

practices stem from statutory provisions calling for information on “adverse effects”..., “relative risk”...,, “unreasonable risk”...,, and “the current scientific knowledge” ... and for regulatory decisions on protecting human health and the environment. The statutes provide various standards and procedures related to the scientific analyses used to evaluate the risk potential of pollutants subject to the statutes.

From the National Oceanic and Atmospheric Administration General Counsel  International Section website “Precautionary Approach” (USFWS-AADAP 2019):

A precautionary approach to addressing threats to the environment can be traced back to domestic German law in the 1970s.  It was first used in an international agreement in 1980.  However, it was at the1992 United Nations Conference on Environment and Development that it received broad  international recognition in the  Rio Declaration on Environment and Development of 1992. “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall be not used as a reason for postponing cost-effective measures to prevent environmental degradation.” Principle 15, Rio Declaration.  The precautionary approach has been incorporated into several international treaties to which the United States is party ...

Congress and the federal agencies have invested considerable resources into risk analysis. The EPA perhaps has the longest history of utilizing environmental risk approaches into its regulatory decision making.  EPA maintains online resources on risk assessment at www.epa.gov/risk. EPA's Guidelines for Ecological Risk Assessment (1998) provides a framework for undertaking ecological risk assessments.  U. S. Fish and Wildlife provides Ecological Risk Screening Summaries, which provide a rapid evaluation of a species’ potential invasiveness. 

Neither NEPA, nor the implementing regulations under C. F. R. Title 40 Chapter V Part 1502, specifically require a “risk assessment” or the use of a “precautionary approach.” Note that in C. F. R. 40-1502.21, agencies are required to evaluate “reasonably foreseeable adverse effects,” including those that have “catastrophic consequences, even if their probability of occurrence is low” and must indicate if there is incomplete or unavailable information.

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.

§ 1536 Interagency cooperation

(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).

(2) Any person who may wish to apply for an exemption under subsection (g) of this section for that action may conduct a biological assessment to identify any endangered species or threatened species which is likely to be affected by such action. Any such biological assessment must, however, be conducted in cooperation with the Secretary and under the supervision of the appropriate Federal agency.

(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

(c) Prevention

(1) In general

The Task Force shall establish and implement measures, within the program developed under subsection (a), to minimize the risk of introduction of aquatic nuisance species to waters of the United States, including-

(A) identification of pathways by which aquatic organisms are introduced to waters of the United States;

(B) assessment of the risk that an aquatic organism carried by an identified pathway may become an aquatic nuisance species; and

(C) evaluation of whether measures to prevent introductions of aquatic nuisance species are effective and environmentally sound.

(2) Implementation

Whenever the Task Force determines that there is a substantial risk of unintentional introduction of an aquatic nuisance species by an identified pathway and that the adverse consequences of such an introduction are likely to be substantial, the Task Force shall, acting through the appropriate Federal agency, and after an opportunity for public comment, carry out cooperative, environmentally sound efforts with regional, State and local entities to minimize the risk of such an introduction.

§ 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.

§ 350g Hazard analysis and risk-based preventive controls

(j) Exemption for seafood, juice, and low-acid canned food facilities subject to HACCP

(1) In general

This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:

(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(o) Definitions

For purposes of this section:

(3) Preventive controls

The term "preventive controls" means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis...

Subchapter III Standards and Enforcement

§ 1313 Water quality standards and implementation plans

(c) Review; revised standards; publication

(2)(B) Whenever a State reviews water quality standards pursuant to paragraph (1) of this subsection, or revises or adopts new standards pursuant to this paragraph, such State shall adopt criteria for all toxic pollutants listed pursuant to section 1317(a)(1) of this title for which criteria have been published under section 1314(a) of this title, the discharge or presence of which in the affected waters could reasonably be expected to interfere with those designated uses adopted by the State, as necessary to support such designated uses. Such criteria shall be specific numerical criteria for such toxic pollutants. Where such numerical criteria are not available, whenever a State reviews water quality standards pursuant to paragraph (1), or revises or adopts new standards pursuant to this paragraph, such State shall adopt criteria based on biological monitoring or assessment methods consistent with information published pursuant to section 1314(a)(8) of this title. Nothing in this section shall be construed to limit or delay the use of effluent limitations or other permit conditions based on or involving biological monitoring or assessment methods or previously adopted numerical criteria.

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

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

Subpart B - Current Good Manufacturing Practice

§ 507.19 Sanitation.

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

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

Subpart E - Supply-Chain Program

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

(a) 

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

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.

NRC. 2009. Science and Decisions: Advancing Risk Assessment. National Research Council. Washington, DC: The National Academies Press. https://doi.org/10.17226/12209

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/