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1 <?xml version="1.0" encoding="UTF-8"?>
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2 <results>
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3 <summaries>
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4
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5 <summary><p type="2">SUMMARY:</p>
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6 <p type="1">This policy, published jointly by the Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS), jointly referred to as the Services, addresses the role of controlled propagation in the conservation and recovery of species listed as endangered or threatened under the Endangered Species Act of 1973 (as amended) (Act). The policy provides guidance and establishes consistency for use of controlled propagation as a component of a listed species recovery strategy. This policy will help to ensure smooth transitions between various phases of conservation efforts such as propagation, reintroduction and monitoring, and foster efficient use of available funds. The policy supports the controlled propagation of listed species when recommended in an approved recovery plan or when necessary to prevent extinction of a species. Appropriate uses of controlled propagation include supporting recovery related research, maintaining refugia populations, providing plants or animals for reintroduction or augmentation of existing populations, and conserving species or populations at risk of imminent extinction or extirpation.</p>
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7 </summary><summary><p type="2">SUMMARY:</p>
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8 <p type="1">This policy, published jointly by the Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS), jointly referred to as the Services, addresses the role of controlled propagation in the conservation and recovery of species listed as endangered or threatened under the Endangered Species Act of 1973 (as amended) (Act). The policy provides guidance and establishes consistency for use of controlled propagation as a component of a listed species recovery strategy. This policy will help to ensure smooth transitions between various phases of conservation efforts such as propagation, reintroduction and monitoring, and foster efficient use of available funds. The policy supports the controlled propagation of listed species when recommended in an approved recovery plan or when necessary to prevent extinction of a species. Appropriate uses of controlled propagation include supporting recovery related research, maintaining refugia populations, providing plants or animals for reintroduction or augmentation of existing populations, and conserving species or populations at risk of imminent extinction or extirpation.</p>
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9 </summary></summaries>
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10 <supplementary_information>
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11
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12 <supplInfo><p type="2">SUPPLEMENTARY INFORMATION:</p>
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13 <p type="1">The Endangered Species Act specifically charges us with the responsibility for identification, protection, management, and recovery of species of plants and animals in danger of extinction. Fulfilling this responsibility requires the protection and conservation of not only individual organisms and populations, but also the genetic and ecological resources that listed species represent. Long-term viability depends on maintaining genetic adaptability within each species. Species, as defined in section 3(15) of the Act, includes “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” Though the Act emphasizes the restoration of listed species in their natural habitats, section 3(3) of the Act recognizes propagation as a tool available to us to achieve this end. The controlled propagation of animals and plants in certain situations is an essential tool for the conservation and recovery of listed species. In the past, we have used controlled propagation to reverse population declines and to successfully return listed species to suitable habitat in the wild. To support the goal of restoring endangered and threatened animals and plants, we are obligated to develop sound policies based on the best available scientific and commercial information.</p>
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14 <p type="2">Summary of Comments and Recommendations</p>
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15 <p type="1">A draft policy on this subject was published on February 7, 1996 (61 FR 4716), and invited public comment. We received 47 comments. Twenty-four were from zoos, aquariums, botanical gardens, and conservation organizations, 3 from academic institutions, 6 from private individuals and business organizations, 2 from government organizations, and 12 from State natural resource agencies. Nearly all comments received were supportive of the policy and its goals. Comments that expressed concerns or criticisms were limited, though quite specific. We reviewed all comments received, and suggestions or clarifications have been incorporated into the final policy text. The following describes the major issues identified and our responses.</p>
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16 <p type="1">Issue: The draft policy, as published, would have a significant impact in terms of increased workload on the Services, zoological parks and aquariums, private organizations, and individual citizens.</p>
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17 <p type="1">Response: We acknowledge this concern and have modified the policy to reduce impacts to the zoo and aquarium community, botanical facilities, Federal fish hatcheries, and others who may be involved in propagation of listed species. As amended, this final policy is not expected to have a significant impact on organizations or individuals involved in propagation of listed species. The majority of zoological parks and aquaria that are involved in programs assisting the recovery of endangered and threatened animal species native to the United States are members of the American Zoo and Aquarium Association (AZA). The AZA has developed numerous strategies, protocols, and standards that address concerns associated with captive animal populations involved in conservation-based breeding programs. This final policy encourages the Services, and others, to follow as may be practical, the protocols and standards of the AZA, and other appropriate organizations, for the controlled propagation of animal species. The Center for Plant Conservation (CPC) is similar to the AZA in that this organization consists of member botanical gardens and arboreta that are involved in preventing the extinction of native plants, including those federally listed as endangered or threatened. When practical, the Services and others are encouraged to use the protocols and standards of the CPC, and other appropriate organizations, when propagating listed plant species.</p>
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18 <p type="1">Those individuals or organizations that currently have permits to keep listed species are exempt from this policy for the duration of the permit unless the RegionalDirector (FWS) or Assistant Administrator (NMFS) determines otherwise. For example, a permit holder implementing activities recommended in an approved recovery plan is exempt and would not need to reapply for a new permit. We have made substantial efforts to avoid adverse impacts, economic or otherwise, in order that cooperative recovery partnership opportunities may be maintained or increased with qualified organizations and individuals.</p>
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19 <p type="1">Issue: The policy would apply to research activities identified in recovery plans in which controlled propagation or unintentional propagation may occur.</p>
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20 <p type="1">Response: Research identified in recovery plans, including research that may lead to development of a controlled propagation capacity, is not covered by this policy because the intent of such research is not the production of individuals for introduction into the wild. Should offspring that are the product of research efforts be proposed for introduction into the wild, such offspring and any proposed reintroductions will be subject to this policy.</p>
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21 <p type="1">Should circumstances arise in the course of implementing recovery activities, including research, in which application of this policy is deemed necessary for the benefit of the listed species, the decision to apply the policy will rest with the Regional Director or Assistant Administrator.</p>
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22 <p type="1">Research on species with short lifespans ( e.g. , 1 to 2 years) that requires maintenance of a captive population not intended for release to the wild is exempt from this policy. However, all activities involving reproduction of a listed U.S. species must meet the requirements of the Act, as well as any other legal and administrative obligations. All persons or institutions conducting approved activities involving controlled propagation of listed species for purposes other than release in the wild will still be required to develop appropriate measures to address concerns identified under section E. 5. of this policy.</p>
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23 <p type="1">Issue: The policy would apply to foreign species being maintained and propagated in U.S. zoological and aquarium facilities or by private individuals.</p>
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24 <p type="1">Response: This policy only applies to species indigenous to the United States and its territories for which we have, or intend to prepare, recovery plans. We have exempted foreign species that are listed under the Act and being propagated or maintained in the United States for conservation purposes.</p>
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25 <p type="1">Issue: Requirements to develop genetics and reintroduction guidance documents for species being propagated for augmentation of existing populations or for the establishment of new populations in the wild are not practical.</p>
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26 <p type="1">Response: We recognize this concern and have modified the policy accordingly. In many instances there is insufficient biological knowledge of the listed species to develop detailed genetic management documents, and the requirement for these documents may unnecessarily burden conservation and recovery efforts. However, we strongly recommend development of these documents if adequate information is available. Furthermore, we reemphasize the recommendation in the draft policy that controlled propagation activities follow accepted standards, which include appropriate genetics management.</p>
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27 <p type="1">Issue: There are too many reporting requirements.</p>
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28 <p type="1">Response: We have reduced reporting requirements. However, we need to identify those listed species involved in controlled propagation programs, the level of production in these programs, and efforts to secure appropriate habitat for population augmentation, reintroduction, and recovery.</p>
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29 <p type="1">Issue: The requirement that controlled propagation be permitted only if indicated in an approved final recovery plan would place an unnecessary burden on Federal programs to revise existing recovery plans to meet this requirement.</p>
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30 <p type="1">Response: We do not agree. The recovery plans for most species for which controlled propagation is occurring have identified this action as a specific recovery task. Where controlled propagation is not identified as a task in the recovery plan, but has been subsequently determined to be necessary to the recovery of the species, the plan would need to be amended or revised.</p>
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31 <p type="2">Required Determinations</p>
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32 <p type="2">1. Regulatory Planning and Review</p>
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33 <p type="1">In accordance with Executive Order 12866, this policy was submitted for review by the Office of Management and Budget. In accordance with the criteria set forth in Executive Order 12866, this policy is not a significant regulatory action. Under current and anticipated levels of activity, this policy will not result in an annual economic effect of $100 million or more. Moreover, this policy will not adversely affect an economic sector, productivity, jobs, the environment, or other units of government. The controlled propagation policy does not pertain to commercial products or activities or anything traded in the marketplace.</p>
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34 <p type="1">2. Regulatory Flexibility Act (5 U.S.C. 601 et seq. )</p>
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35 <p type="1">We certify that this policy will not have a significant economic effect on a substantial number of small entities. This policy does not apply to all species listed under the Act but only to those species native to the United States and its territories for which recovery plans exist or are expected to be developed. Furthermore, controlled propagation is restricted to those species for which such propagation is specifically recommended in an approved final recovery plan. Programs involving the controlled propagation of federally listed species are typically restricted to institutions such as the FWS's National Fish Hatcheries and Fish Technology Centers. Nongovernmental entities that may be involved in the controlled propagation of listed species are typically organizations with a high level of technical skill in the captive maintenance and breeding of plants and animals, such as zoos, aquaria, and botanical gardens. Rarely are academic institutions and even more infrequently, private individuals, involved in the controlled propagation of listed species for conservation and recovery purposes.</p>
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36 <p type="2">3. Small Business Regulatory Fairness Act (5 U.S.C. 804(2))</p>
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37 <p type="1">This is not a major rule under 5 U.S.C. 804(2). This policy will not have an annual effect on the economy of $100 million or more, produce increases in costs or prices for consumers, individual industries or Federal, State or local government agencies, affect economic competitiveness, or economically impact geographic regions in the United States or its territories.</p>
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38 <p type="2">4. Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. )</p>
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39 <p type="1">This policy does not impose an unfunded mandate on any State, Tribal, or local government or the private sector of $100 million or more per year.</p>
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40 <p type="2">5. Takings</p>
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41 <p type="1">In accordance with Executive Order 12630, this policy does not pose significant takings implications, and a takings implication assessment is not required. Implementation of this policy will not result in “take” of private property and will not alter the value of private property. Many reintroductions of propagated species occur exclusively on FWS, other Federal, or State lands, but reintroductions on private lands are not unknown. In such cases, the private entities work with the Services as willing partners to ensure the success of the reintroduction effort.</p>
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42 <p type="2">6. Federalism</p>
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43 <p type="1">In accordance with Executive Order 13132, this policy does not have sufficient federalism implications to warrant the preparation of a federalism assessment. It does not affect the structure or role of States, and will not have direct, substantial, or significant effects on States. Releases of propagated species typically occur on Federal or State lands. The States work with the Services as willing partners to ensure the success of reintroduction efforts.</p>
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44 <p type="2">7. Civil Justice Reform</p>
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45 <p type="1">In accordance with Executive Order 12988, the Department of the Interior's Office of the Solicitor has determined that this policy does not unduly burden the judicial system. The final policy provides clear standards, simplifies procedures, reduces burden, and is clearly written such that litigation risk is minimized.</p>
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46 <p type="2">8. Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )</p>
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47 <p type="1">This policy does not contain any new information collection requirements for which Office of Management and Budget approval under the Paperwork Reduction Act is required. The OMB control number for the FWS is 1018-0094 and for NMFS is 0648-0230 and 0648-0402.</p>
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48 <p type="2">9. National Environmental Policy Act</p>
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49 <p type="1">We have analyzed this policy under the criteria of the National Environmental Policy Act of 1969 as amended, and have determined that the issuance of this policy is categorically excluded by the Department of the Interior in 516 DM 2, Appendix 1.10. The NMFS concurs with the Department of the Interior's determination that the issuance of this policy qualifies for a categorical exclusion and satisfies the categorical exclusion criteria in the National Oceanic and Atmospheric Administration 216-6 Administrative Order, Environmental Review Procedure. No further NEPA documentation is required.</p>
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50 <p type="2">10. Government-to-Government Relationship With Tribes</p>
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51 <p type="1">Though no reintroductions of captively propagated federally endangered or threatened species have been undertaken, in accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we recognize the potential for such actions in the future and the obligation to relate to federally recognized Tribes on a government-to-government basis.</p>
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52 <p type="2">References Cited</p>
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53 <p type="1">A complete list of all references cited in this final policy is available on request from the Washington Office of the Division of Endangered Species (see ADDRESSES section).</p>
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54 <p type="1">Authors. The primary authors of this policy are David Harrelson of the Fish and Wildlife Service's Division of Endangered Species, Mail Stop 420 ARLSQ, 1849 C Street, NW, Washington, DC 20240 (703/358-2171), and Marta Nammack of the National Marine Fisheries Service's Protected Species Management Division, 1335 East-West Highway, Silver Spring, Maryland 20910 (301/713-1401).</p>
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55 <p type="2">Policy Statement</p>
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56 <p type="1">A. What is the purpose of this policy? This policy provides guidance and establishes consistency with respect to Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS), jointly called the Services, activities in which the controlled propagation of a listed species, as the term “species” is defined in section 3(15) of the Act, is implemented as a component of the recovery strategy for a listed species. It supports and promotes coordination between various phases of controlled propagation efforts such as propagation technology development, propagation for release, population augmentation, reintroduction, and monitoring. This policy will also contribute to the efficient use of funding resources.</p>
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57 <p type="1">Guidance is provided regarding the use of controlled propagation for:</p>
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58 <p type="1">• Preventing the extinction of listed species, subspecies, or populations;</p>
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59 <p type="1">• Recovery-oriented scientific research, including, but not restricted to, developing propagation methods and technology, and other actions that are expected to result in a net benefit to the listed taxon. Use of surrogates, while applicable to the recovery of listed species, is exempt from the requirements of this policy;</p>
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60 <p type="1">• Maintaining genetic vigor and demographic diversity of listed species, subspecies, or populations;</p>
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61 <p type="1">• Maintaining refugia populations for nearly extinct animals or plants on a temporary basis until threats to a listed species' habitat are alleviated, or necessary habitat modifications are completed, or when potentially catastrophic events occur ( e.g. , chemical spills, severe storms, fires, flooding);</p>
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62 <p type="1">• Providing individuals for establishing new, self-sustaining populations necessary for recovery of the listed species; and</p>
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63 <p type="1">• Supplementing or enhancing extant populations to facilitate recovery of the listed species.</p>
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64 <p type="1">B. What is the scope of this policy? This policy applies to all pertinent organizational elements of both Services, notwithstanding those differences in administrative procedures and policies as noted. Exceptions to this policy appear in section F. This policy pertains to all efforts requiring permits under 50 CFR 17 subparts C and D, funded, authorized, or carried out by us that are conducted to propagate threatened or endangered species by:</p>
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65 <p type="1">• Establishing or maintaining refugia populations;</p>
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66 <p type="1">• Producing individuals for research and technology development needs;</p>
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67 <p type="1">• Producing individuals for supplementing extant populations; and</p>
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68 <p type="1">• Producing individuals for reintroduction to suitable habitat within the species' historic range.</p>
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69 <p type="1">C. Why is this policy necessary? The controlled propagation of animals and plants in certain situations is an essential tool for the conservation and recovery of listed species. In the past, we have used controlled propagation to reverse population declines and to successfully return listed species to suitable habitat in the wild.</p>
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70 <p type="1">Though controlled propagation has a supportive role in the recovery of some listed species, the intent of the Act is “to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved.” Controlled propagation is not a substitute for addressing factors responsible for an endangered or threatened species' decline. Therefore, our first priority is to recover wild populations in their natural habitat wherever possible, without resorting to the use of controlled propagation. This position is fully consistent with the Act.</p>
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71 <p type="1">We recognize that genetic and ecological risks may be associated with introducing to the wild, animals and plants bred and reared in a controlled environment. When considering controlled propagation as a recovery option, the potential benefits and risks must be assessed and alternatives requiring less intervention objectively evaluated. If controlled propagation is identified as an appropriate strategy for the recovery of a listed species, it must be conducted in a manner that will, to the maximum extent possible, preserve the genetic and ecological distinctiveness of the listed species and minimize risks to existing wild populations.</p>
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72 <p type="1">We recognize that for many species, information available for detailed genetics conservation management or assessment of risks associated with reintroduction may be insufficient. Therefore, this policy does not specifically require written genetic management plans and ecological risk assessments to initiate or support controlled propagation programs. Additionally, acute conservation needs may legitimately outweigh delays that would be incurred by such a requirement. However, where sufficient biological and environmental information exists, and where conservation activities would not be unduly constrained, a formal assessment of ecological and genetic risks is strongly encouraged. Risks that must be evaluated in the planning of controlled propagation programs include the following specific examples:</p>
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73 <p type="1">• Removal of natural parental stock that may result in an increased risk of extinction by reducing the abundance of wild individuals and reducing genetic variability within naturally occurring populations;</p>
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74 <p type="1">• Equipment failures, human error, disease, and other potential catastrophic events that may cause the loss of some or all of the population being held or maintained in captivity or cultivation;</p>
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75 <p type="1">• The potential for an increased level of inbreeding or other adverse genetic effects within populations that may result from the enhancement of only a portion of the gene pool;</p>
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76 <p type="1">• Potential erosion of genetic differences between populations as a result of mixed stock transfers or supplementation;</p>
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77 <p type="1">• Exposure to novel selection regimes in controlled environments that may diminish a listed species' natural capacity to survive and reproduce in the wild;</p>
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78 <p type="1">• Genetic introgression, which may diminish local adaptations of the naturally occurring population;</p>
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79 <p type="1">• Increased predation, competition for food, space, mates, or other factors that may displace naturally occurring individuals, or interfere with foraging, migratory, reproductive, or other essential behaviors; and</p>
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80 <p type="1">• Disease transmission.</p>
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81 <p type="1">Controlled propagation programs must be undertaken in a manner that minimizes potentially adverse impacts to existing wild populations of listed species, and we must conduct controlled propagation programs in a manner that avoids additional listing actions.</p>
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82 <p type="1">D. What are the definitions for terms used in this policy? The following definitions apply:</p>
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83 <p type="1">Controlled environment —A controlled environment is one manipulated for the purpose of producing or rearing progeny of the species in question, and of a design intended to prevent unplanned escape or entry of plants, animals, or gametes, embryos, seeds, propagules, or other potential reproductive products.</p>
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84 <p type="1">Controlled propagation —Among animals, it includes natural or artificial matings, fertilization of sex cells, transfer of embryos, development of offspring, and grow-out of individuals of a species when the species is intentionally confined or the mating is directly intended by human intervention.</p>
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85 <p type="1">The term also includes the human-induced propagation of plants from seeds, spores, callus tissue, divisions, cuttings, or other plant tissue, or through pollination in a controlled environment.</p>
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86 <p type="1">• Defined in the context of this policy, controlled propagation refers to the production of individuals, generally within a managed environment, for the purpose of supplementing or augmenting a wild population(s), or reintroduction to the wild to establish new populations.</p>
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87 <p type="1">Intercross —Any instance of interbreeding or genetic exchange between individuals of different species, subspecies, or distinct population segments of a vertebrate species.</p>
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88 <p type="1">Phenotype —The expression of the genetic makeup of an organism through physical characteristics that make up its appearance.</p>
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89 <p type="1">Recovery priority system —The system used for assigning recovery priorities to listed species and to recovery tasks. Recovery priority is based on the degree of threat, recovery potential, taxonomic distinctness, and presence of an actual or imminent conflict between the species' conservation, adverse human activities, and other threats.</p>
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90 <p type="1">Rescue and salvage —These terms refer to extreme conditions wherein a species or population segment at risk of extinction is brought into a controlled environment (i.e., refugia) on a temporary or permanent basis.</p>
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91 <p type="1">Taxon —A formal group of organisms of any rank or formal scientific classification.</p>
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92 <p type="1">E. What is our Policy? This policy is intended to address candidate, proposed, and listed species indigenous to the United States and its territories for which the Services, have, or intend to prepare, recovery plans. This policy focuses primarily on those activities involving gamete transfer and subsequent development and grow-out of offspring in a laboratory, botanical facility, zoo, hatchery, aquarium, or similarly controlled environment. This policy also addresses activities related to or preceding controlled propagation activities such as:</p>
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93 <p type="1">• Obtaining and rearing offspring for research;</p>
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94 <p type="1">• Procuring broodstock for future controlled propagation and augmentation efforts; or</p>
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95 <p type="1">• Holding offspring for a substantial portion of their development or through a life-stage that experiences poor survival in the wild.</p>
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96 <p type="1">The goals of this policy include coordinating recovery actions specific to controlled propagation activities; maximizing benefits to the listed species from controlled propagation efforts; assuring that appropriate recovery measures other than controlled propagation and that other existing recovery priorities are considered in making controlled propagation decisions; and ensuring prudent use of funds.</p>
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97 <p type="1">Our policy is that the controlled propagation of threatened and endangered species will be:</p>
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98 <p type="1">1. Used as a recovery strategy only when other measures employed to maintain or improve a listed species' status in the wild have failed, are determined to be likely to fail, are shown to be ineffective in overcoming extant factors limiting recovery, or would be insufficient to achieve full recovery. All reasonable effort should be made to accomplish conservation measures that enable a listed species to recover in the wild, with or without intervention ( e.g. , artificial cavity provisioning), prior to implementing controlled propagation for reintroduction or supplementation.</p>
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99 <p type="1">2. Coordinated with conservation actions and other recovery measures, as appropriate or specified in recovery plans, that will contribute to, or otherwise support, the provision of secure and suitable habitat. Controlled propagation programs intended for reintroduction or augmentation must be coordinated with habitat management, restoration, and other species' recovery efforts.</p>
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100 <p type="1">3. Based on the specific recommendations of recovery strategies identified in approved recovery plans or supplements to approved recovery plans whenever practical. The recovery plan, in addressing controlled propagation, should clearly identify the necessity and role of this activity as a recovery strategy.</p>
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101 <p type="1">4. Based on specific consideration of the potential ecological and genetic effects of the removal of individuals for controlled propagation purposes on wild populations and the potential effects of introductions of artificially bred animals or plants on the receiving population and other resident species. Assessments of potential risks and benefits will be addressed, as required, through sections 7 and 10 of the Act and the National Environmental Policy Act (NEPA, 42 U.S.C. 4332) for proposed controlled propagation actions.</p>
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102 <p type="1">5. Based on sound scientific principles to conserve genetic variation and species integrity. Intercrossing will not be considered for use in controlled propagation programs unless recommended in an approved recovery plan; supported in an approved genetic management plan (if information is available to develop such a plan, and which may or may not be part of an approved recovery plan); implemented in a scientifically controlled and approved manner; and undertaken to compensate for a loss of genetic viability in listed taxa that have been genetically isolated in the wild as a result of human activity. Use of intercross individuals for species conservation will require the approval of the FWS Director or that of the NMFS Assistant Administrator, in accordance with all applicable policies.</p>
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103 <p type="1">6. Preceded, when practical, by the development of a genetics management plan based on accepted scientific principles and procedures. Controlled propagation protocols will follow accepted standards such as those employed by the American Zoo and Aquarium Association (AZA), the Center for Plant Conservation (CPC), and Federal agency protocols such as fish management guidelines to the extent practical. All efforts will be made by us and our cooperators to ensure that the genetic makeup of propagated individuals is representative of that in free-ranging populations and that propagated individuals are behaviorally and physiologically suitable for introduction. Determination of biological “suitability” may include, but should not necessarily be limited to, analysis of geomorphological similarities of habitat, genetic similarity, phenotypic characteristics, stock histories, habitat use, and other ecological, biological, and behavioral indicators. All controlled propagation programs will address the issue of disposition of individuals found to be:</p>
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104 <p type="1">(a) Unfit for introduction to the wild;</p>
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105 <p type="1">(b) Unfit to serve as broodstock;</p>
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106 <p type="1">(c) Surplus to program needs; or</p>
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107 <p type="1">(d) Surplus to the recovery needs for the species ( e.g., to preclude genetic and ecological swamping).</p>
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108 <p type="1">Controlled propagation activities should not be initiated without including consideration of these issues and obtaining required permits and other authorizations as necessary. Disposition of individuals surplus to program needs may include use for research or other appropriate purposes.</p>
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109 <p type="1">Programs involving the controlled propagation of listed species for research purposes identified in final recovery plans and in which progeny will not be reintroduced to the wild are exempt from this policy. Examples of exempt actions include research involving the determination of germination rates in plants and spawning success rates in fish. This exemption does not extend to the need for these activities to comply with any other applicable Federal or State permitting or regulatory requirements.</p>
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110 <p type="1">7. Conducted in a manner that takes all known precautions to prohibit the potential introduction or spread of diseases and parasites into controlled environments or suitable habitat.</p>
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111 <p type="1">8. Conducted in a manner that will prevent the escape or accidental introduction of individuals outside their historic range.</p>
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112 <p type="1">9. Conducted, when feasible, at more than one location in order to reduce the potential for catastrophic loss at a single facility when a substantial fraction of a species or important population segment is brought into captivity.</p>
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113 <p type="1">10. Coordinated, as appropriate, with organizations and qualified individuals both within and outside our agencies. We will cooperate with other Federal agencies and State, Tribal, and local governments.</p>
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114 <p type="1">11. Conducted in a manner that will meet our information needs and that will be in accordance with accepted protocols and standards. In the case of listed species for which traditional studbooks or registrations are not practical, records of eggs, larvae, or other life-stages will be maintained.</p>
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115 <p type="1">12. With limited exceptions, implemented only after a commitment to funding is secured.</p>
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116 <p type="1">13. Prior to releases of propagated individuals, tied to development of a reintroduction plan, unless this information is already contained in an approved recovery plan, species survival plan, or equivalent document that has received the approval of the appropriate Service. Controlled propagation and reintroduction plans will identify measurable objectives and milestones for the proposed propagation and reintroduction effort. The controlled propagation and reintroduction plan should be based on strategies identified in the approved recovery plan. It should include protocols for health management, disease screening and disease-free certification, monitoring and evaluation of genetic, demographic, life-history, phenotypic, and behavioral characteristics, data collection, recordkeeping, and reporting as appropriate. On implementation, periodic evaluations must be made to assess project progress and consider new scientific information and the status of habitat conservation efforts.</p>
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117 <p type="1">14. Conducted in accordance with the regulations implementing the Endangered Species Act, Marine Mammal Protection Act, Animal Welfare Act, Lacey Act, Fish and Wildlife Act of 1956, and the Services' procedures relative to NEPA.</p>
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118 <p type="1">F. Does this policy allow any exceptions? Except as identified in this section, any exceptions to the above policy guidelines will require specific approval from the FWS Director or the NMFS Assistant Administrator on a case by case basis. The following circumstances have been anticipated and are exempted from this policy.</p>
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119 <p type="1">1. Pacific salmon are exempted from this policy. NMFS, as the lead Service for the recovery of listed Pacific salmon, has developed and will continue to use the interim policy (April 5, 1993, 58 FR 17573) addressing controlled propagation of these species. The NMFS interim artificial propagation policy more specifically addresses the biological needs of these species.</p>
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120 <p type="1">2. Cases where a listed species has an ephemeral reproductive stage or short (1-2 year) lifespan that necessitates controlled propagation to sustain the listed species in refugia, or to maintain a research population where there is no intent to release captive-bred individuals from that population into the wild, are exempt.</p>
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121 <p type="1">3. In the absence of an approved recovery plan, recommendations contained in recovery outlines, draft recovery plans, or made in writing by a recovery team may be used to justify controlled propagation as a necessary recovery measure for listed species in danger of imminent extinction or extirpation of critical populations. However, under such circumstances initiation of controlled propagation activities will require the Regional Director's or Assistant Administrator's approval.</p>
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122 <p type="1">4. Candidate and proposed species held in refugia, used in research, or used for the development of propagation technology that are subsequently listed as endangered or threatened are exempted from this policy. Any propagation program initiated with candidate or proposed species with the intent to produce individuals for release to the wild are not exempted and must comply with this policy.</p>
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123 <p type="1">5. Captive breeding of listed species that are not native to the United States or its territories or possessions, and producing individuals not addressed in an approved recovery plan and not intended for release within the United States or its territories or possessions, is exempt from this policy. However, such activities must comply with any other Federal and State laws, permit needs, or other requirements.</p>
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124 <p type="1">6. The temporary removal and holding of listed individuals, unless such actions intentionally involve reproduction other than for purposes of recovery-related research or as needed to maintain a refugia population is exempted.</p>
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125 <p type="1">7. The short-term holding or captive-rearing of wild-bred individuals obtained for later reintroduction, augmentation, or translocation efforts when controlled propagation does not take place or is not intended during the period of captive maintenance.</p>
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126 <p type="1">8. Actions involving cryopreservation or other methods of conserving biological materials, if not intended for near-term use in controlled propagation or the reintroduction into the wild of listed species, are exempt from this policy. When and if reintroduction to the wild requires the use of these materials, such activities would come under the scope of this policy.</p>
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127 <p type="1">9. Additional exceptions to this policy may be made on a case-by-case basis with the approval of the FWS Director or NMFS Assistant Administrator, as warranted.</p>
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128 <p type="1">Where conflicts may arise between this policy and programs carried out in furtherance of restoration goals or required by treaty, trust resources obligations, or other legal mandate, we will, to the extent practical, make every effort to achieve solutions that are consistent with the requirements of the Act and this policy.</p>
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129 <p type="1">G. Who are our potential partners? We recognize the need for partnerships with other Federal agencies, States, Tribes, local governments, and private entities in the recovery of listed species. We will seek to develop partnerships with qualified cooperators for the purpose of propagating listed, proposed, and candidate species (as authorized under sections 6 and 2(a)(5) of the Act). Guidance for this activity is as follows:</p>
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130 <p type="1">1. The FWS Regional Directors or the NMFS Regional Administrators may explore opportunities for accomplishing controlled propagation and any associated research tasks with other Federal cooperators, FWS/NMFS facilities, State agencies, Tribes, zoological parks, aquaria, botanical gardens, academia, and other qualified parties at their discretion. We will select cooperators on the basis of scientific merits; technical capability; willingness to adhere to our policies, guidance, and protocols; and cost-effectiveness.</p>
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131 <p type="1">2. Regional Directors or Regional Administrators, depending on which agency has lead for the species, will be responsible for ensuring appropriate staff oversight of programs conducted by all cooperators to ensure adherence to necessary protocols, guidance, and permit conditions, and to coordinate reporting requirements.</p>
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132 <p type="1">H. What are the Federal agency responsibilities under this policy? This policy shall be implemented in accordance with the following guidelines:</p>
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133 <p type="1">1. The Regional Directors and Regional Administrators will ensure compliance with this policy for those species for which they have responsibility.</p>
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134 <p type="1">2. Regional Directors and Regional Administrators are responsible for recovery of listed species under their jurisdiction. Recovery actions for which Regional Directors and Regional Administrators have authority include establishment of refugia, initiation of necessary research or technology development, implementation of controlled propagation programs, and propagation research for listed species. When determining species' priority for inclusion in controlled propagation programs, we will consider the following:</p>
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135 <p type="1">(a) Whether or not a listed species' recovery plan outline, draft recovery plan, or final recovery plan identifies controlled propagation as an appropriate recovery strategy and what priority this task is assigned within the overall recovery strategy.</p>
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136 <p type="1">(b) The availability and willingness of cooperators to contribute to recovery activities, including cost sharing.</p>
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137 <p type="1">3. In the event that the current recovery plan fails to identify the establishment of refugia, initiation of propagation research, or controlled propagation as recovery tasks as necessary to the recovery of the species, the recovery plan will be updated, amended, or revised as appropriate. Recovery plans not yet finalized will be amended to reflect the changed recovery requirements of the listed species and provide justifications as necessary.</p>
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138 <p type="1">4. Within 6 months of the effective date of this policy, FWS Regional Directors will identify all listed species for which they have the lead recovery responsibility that are (1) being held in refugia; (2) involved in pre-propagation research; and (3) are involved in controlled propagation programs. For species involved in controlled propagation programs, the level of production and the recovery purpose ( e.g. , augmentation of extant populations, establishment of new populations) will be identified. This information will be reported to the Assistant Director, Endangered Species, in the FWS Washington D.C. Office.</p>
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139 <p type="1">5. Continuation of those programs not in conformity with this policy 12 months following implementation of this policy will require the FWS Director's or NMFS Assistant Administrator's concurrence. The Regional Director and Regional Administrator will provide his or her recommendation to the Director or Assistant Administrator.</p>
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140 <p type="1">I. Does the policy include annual reporting requirements? For the FWS, annual reports based on fiscal years will be prepared by the responsible regional authority and submitted to the Director, through the Assistant Director, Endangered Species, not later than October 31st of each year. Reports will contain the following information for each species being maintained in refugia, in pre-propagation research, or under propagation:</p>
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141 <p type="1">• Recovery priority number;</p>
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142 <p type="1">• Policy criteria that are not met (if any);</p>
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143 <p type="1">• A brief description of the controlled propagation program, including objectives and status;</p>
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144 <p type="1">• List of cooperators, if any;</p>
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145 <p type="1">• Expenditures for the past fiscal year;</p>
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146 <p type="1">• Prospects for, or obstacles to, achieving research, controlled propagation, or reintroduction objectives, and,</p>
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147 <p type="1">• A brief description of the status of wild populations, if any.</p>
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148 <p type="1">J. What authorities support this policy? The Endangered Species Act of 1973, as amended; Marine Mammal Protection Act of 1972, as amended; Animal Welfare Act; Lacey Act; Fish and Wildlife Act of 1956; and National Environmental Policy Act.</p>
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149 <p type="1">K. What are the information collection requirements? The permit application required for participation in the controlled propagation of species listed under the Act is FWS form #3-200-55 Interstate Commerce and Recovery and form #3-200-56 for incidental take. Applicants for NMFS research/enhancement permits or incidental take permits must meet certain criteria in their applications but there are no specific forms. We use these forms or applications to permit recovery actions that may be undertaken for scientific purposes, enhancement of propagation or survival, or for incidental taking. Whenever we ask the public to submit information, we must have authorization from the Office of Management and Budget. As part of the permitting process, we often ask the public to provide information such as filling out permit applications or submitting reports.</p>
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150 <p type="1">Information collection requirements under this policy are included under the Office of Management and Budget collection approval number 1018-0094 (FWS) and 0648-0230 (NMFS), which includes information collection for permits granted for interstate commerce and recovery and incidental take. The expiration date of this approval is February 28, 2001(FWS), and October 31, 2001 (NMFS). The purpose of information collection is to identify performance of permitted tasks and make decisions, according to criteria established in various Federal wildlife and plant conservation statutes and described in 50 CFR 17.22(a)(1) and (3) and 17.32(a)(1) and (3) (FWS) and 50 CFR 222 (NMFS).</p>
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151 <p type="1">We have estimated that the time required by an applicant to complete FWS form 3-200-55 is 2 hours. Applications to NMFS for these permits are estimated to require 80 hours for completion. The information required is already known to the applicant and need only be entered on the application form. Summary information for endangered species permit applications will be published in the Federal Register as required by regulation. This notice is provided pursuant to section 10(c) of the Act and NEPA regulations (40 CFR 1506.6). The total burden hours for completing reporting requirements is also estimated at 2 hours for the FWS and 80 hours for NMFS. No costs to applicants beyond the cost of hour burden described above are anticipated. Annual reports are generally required for permits for scientific research.</p>
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152 <p type="1">For organizations, businesses, or individuals operating as a business ( i.e. , permittee not covered by the Privacy Act), we request that such entities identify any information that should be considered privileged and confidential business information to allow us to meet our responsibilities under the Freedom of Information Act. Confidential business information must be clearly marked “Business Confidential” at the top of the first page and each succeeding page, and must be accompanied by a nonconfidential summary of the confidential information. Documents may be made available to the public under Department of the Interior Freedom of Information Act (FOIA) regulations in 43 CFR 2.13(c)(4), 43 CFR 2.15(d)(1)(I) and Department of Commerce 15 CFR 4. Documents and other information submitted with these applications are made available for public review, subject to the requirements of the Privacy Act and FOIA, by any party who submits a written request for a copy of such documents to the appropriate Service within 30 days of the date of publication of the notice.</p>
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153 </supplInfo><supplInfo><p type="2">SUPPLEMENTARY INFORMATION:</p>
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154 <p type="1">The Endangered Species Act specifically charges us with the responsibility for identification, protection, management, and recovery of species of plants and animals in danger of extinction. Fulfilling this responsibility requires the protection and conservation of not only individual organisms and populations, but also the genetic and ecological resources that listed species represent. Long-term viability depends on maintaining genetic adaptability within each species. Species, as defined in section 3(15) of the Act, includes “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” Though the Act emphasizes the restoration of listed species in their natural habitats, section 3(3) of the Act recognizes propagation as a tool available to us to achieve this end. The controlled propagation of animals and plants in certain situations is an essential tool for the conservation and recovery of listed species. In the past, we have used controlled propagation to reverse population declines and to successfully return listed species to suitable habitat in the wild. To support the goal of restoring endangered and threatened animals and plants, we are obligated to develop sound policies based on the best available scientific and commercial information.</p>
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155 <p type="2">Summary of Comments and Recommendations</p>
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156 <p type="1">A draft policy on this subject was published on February 7, 1996 (61 FR 4716), and invited public comment. We received 47 comments. Twenty-four were from zoos, aquariums, botanical gardens, and conservation organizations, 3 from academic institutions, 6 from private individuals and business organizations, 2 from government organizations, and 12 from State natural resource agencies. Nearly all comments received were supportive of the policy and its goals. Comments that expressed concerns or criticisms were limited, though quite specific. We reviewed all comments received, and suggestions or clarifications have been incorporated into the final policy text. The following describes the major issues identified and our responses.</p>
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157 <p type="1">Issue: The draft policy, as published, would have a significant impact in terms of increased workload on the Services, zoological parks and aquariums, private organizations, and individual citizens.</p>
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158 <p type="1">Response: We acknowledge this concern and have modified the policy to reduce impacts to the zoo and aquarium community, botanical facilities, Federal fish hatcheries, and others who may be involved in propagation of listed species. As amended, this final policy is not expected to have a significant impact on organizations or individuals involved in propagation of listed species. The majority of zoological parks and aquaria that are involved in programs assisting the recovery of endangered and threatened animal species native to the United States are members of the American Zoo and Aquarium Association (AZA). The AZA has developed numerous strategies, protocols, and standards that address concerns associated with captive animal populations involved in conservation-based breeding programs. This final policy encourages the Services, and others, to follow as may be practical, the protocols and standards of the AZA, and other appropriate organizations, for the controlled propagation of animal species. The Center for Plant Conservation (CPC) is similar to the AZA in that this organization consists of member botanical gardens and arboreta that are involved in preventing the extinction of native plants, including those federally listed as endangered or threatened. When practical, the Services and others are encouraged to use the protocols and standards of the CPC, and other appropriate organizations, when propagating listed plant species.</p>
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159 <p type="1">Those individuals or organizations that currently have permits to keep listed species are exempt from this policy for the duration of the permit unless the RegionalDirector (FWS) or Assistant Administrator (NMFS) determines otherwise. For example, a permit holder implementing activities recommended in an approved recovery plan is exempt and would not need to reapply for a new permit. We have made substantial efforts to avoid adverse impacts, economic or otherwise, in order that cooperative recovery partnership opportunities may be maintained or increased with qualified organizations and individuals.</p>
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160 <p type="1">Issue: The policy would apply to research activities identified in recovery plans in which controlled propagation or unintentional propagation may occur.</p>
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161 <p type="1">Response: Research identified in recovery plans, including research that may lead to development of a controlled propagation capacity, is not covered by this policy because the intent of such research is not the production of individuals for introduction into the wild. Should offspring that are the product of research efforts be proposed for introduction into the wild, such offspring and any proposed reintroductions will be subject to this policy.</p>
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162 <p type="1">Should circumstances arise in the course of implementing recovery activities, including research, in which application of this policy is deemed necessary for the benefit of the listed species, the decision to apply the policy will rest with the Regional Director or Assistant Administrator.</p>
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163 <p type="1">Research on species with short lifespans ( e.g. , 1 to 2 years) that requires maintenance of a captive population not intended for release to the wild is exempt from this policy. However, all activities involving reproduction of a listed U.S. species must meet the requirements of the Act, as well as any other legal and administrative obligations. All persons or institutions conducting approved activities involving controlled propagation of listed species for purposes other than release in the wild will still be required to develop appropriate measures to address concerns identified under section E. 5. of this policy.</p>
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164 <p type="1">Issue: The policy would apply to foreign species being maintained and propagated in U.S. zoological and aquarium facilities or by private individuals.</p>
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165 <p type="1">Response: This policy only applies to species indigenous to the United States and its territories for which we have, or intend to prepare, recovery plans. We have exempted foreign species that are listed under the Act and being propagated or maintained in the United States for conservation purposes.</p>
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166 <p type="1">Issue: Requirements to develop genetics and reintroduction guidance documents for species being propagated for augmentation of existing populations or for the establishment of new populations in the wild are not practical.</p>
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167 <p type="1">Response: We recognize this concern and have modified the policy accordingly. In many instances there is insufficient biological knowledge of the listed species to develop detailed genetic management documents, and the requirement for these documents may unnecessarily burden conservation and recovery efforts. However, we strongly recommend development of these documents if adequate information is available. Furthermore, we reemphasize the recommendation in the draft policy that controlled propagation activities follow accepted standards, which include appropriate genetics management.</p>
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168 <p type="1">Issue: There are too many reporting requirements.</p>
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169 <p type="1">Response: We have reduced reporting requirements. However, we need to identify those listed species involved in controlled propagation programs, the level of production in these programs, and efforts to secure appropriate habitat for population augmentation, reintroduction, and recovery.</p>
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170 <p type="1">Issue: The requirement that controlled propagation be permitted only if indicated in an approved final recovery plan would place an unnecessary burden on Federal programs to revise existing recovery plans to meet this requirement.</p>
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171 <p type="1">Response: We do not agree. The recovery plans for most species for which controlled propagation is occurring have identified this action as a specific recovery task. Where controlled propagation is not identified as a task in the recovery plan, but has been subsequently determined to be necessary to the recovery of the species, the plan would need to be amended or revised.</p>
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172 <p type="2">Required Determinations</p>
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173 <p type="2">1. Regulatory Planning and Review</p>
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174 <p type="1">In accordance with Executive Order 12866, this policy was submitted for review by the Office of Management and Budget. In accordance with the criteria set forth in Executive Order 12866, this policy is not a significant regulatory action. Under current and anticipated levels of activity, this policy will not result in an annual economic effect of $100 million or more. Moreover, this policy will not adversely affect an economic sector, productivity, jobs, the environment, or other units of government. The controlled propagation policy does not pertain to commercial products or activities or anything traded in the marketplace.</p>
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175 <p type="1">2. Regulatory Flexibility Act (5 U.S.C. 601 et seq. )</p>
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176 <p type="1">We certify that this policy will not have a significant economic effect on a substantial number of small entities. This policy does not apply to all species listed under the Act but only to those species native to the United States and its territories for which recovery plans exist or are expected to be developed. Furthermore, controlled propagation is restricted to those species for which such propagation is specifically recommended in an approved final recovery plan. Programs involving the controlled propagation of federally listed species are typically restricted to institutions such as the FWS's National Fish Hatcheries and Fish Technology Centers. Nongovernmental entities that may be involved in the controlled propagation of listed species are typically organizations with a high level of technical skill in the captive maintenance and breeding of plants and animals, such as zoos, aquaria, and botanical gardens. Rarely are academic institutions and even more infrequently, private individuals, involved in the controlled propagation of listed species for conservation and recovery purposes.</p>
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177 <p type="2">3. Small Business Regulatory Fairness Act (5 U.S.C. 804(2))</p>
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178 <p type="1">This is not a major rule under 5 U.S.C. 804(2). This policy will not have an annual effect on the economy of $100 million or more, produce increases in costs or prices for consumers, individual industries or Federal, State or local government agencies, affect economic competitiveness, or economically impact geographic regions in the United States or its territories.</p>
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179 <p type="2">4. Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. )</p>
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180 <p type="1">This policy does not impose an unfunded mandate on any State, Tribal, or local government or the private sector of $100 million or more per year.</p>
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181 <p type="2">5. Takings</p>
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182 <p type="1">In accordance with Executive Order 12630, this policy does not pose significant takings implications, and a takings implication assessment is not required. Implementation of this policy will not result in “take” of private property and will not alter the value of private property. Many reintroductions of propagated species occur exclusively on FWS, other Federal, or State lands, but reintroductions on private lands are not unknown. In such cases, the private entities work with the Services as willing partners to ensure the success of the reintroduction effort.</p>
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183 <p type="2">6. Federalism</p>
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184 <p type="1">In accordance with Executive Order 13132, this policy does not have sufficient federalism implications to warrant the preparation of a federalism assessment. It does not affect the structure or role of States, and will not have direct, substantial, or significant effects on States. Releases of propagated species typically occur on Federal or State lands. The States work with the Services as willing partners to ensure the success of reintroduction efforts.</p>
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185 <p type="2">7. Civil Justice Reform</p>
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186 <p type="1">In accordance with Executive Order 12988, the Department of the Interior's Office of the Solicitor has determined that this policy does not unduly burden the judicial system. The final policy provides clear standards, simplifies procedures, reduces burden, and is clearly written such that litigation risk is minimized.</p>
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187 <p type="2">8. Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )</p>
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188 <p type="1">This policy does not contain any new information collection requirements for which Office of Management and Budget approval under the Paperwork Reduction Act is required. The OMB control number for the FWS is 1018-0094 and for NMFS is 0648-0230 and 0648-0402.</p>
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189 <p type="2">9. National Environmental Policy Act</p>
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190 <p type="1">We have analyzed this policy under the criteria of the National Environmental Policy Act of 1969 as amended, and have determined that the issuance of this policy is categorically excluded by the Department of the Interior in 516 DM 2, Appendix 1.10. The NMFS concurs with the Department of the Interior's determination that the issuance of this policy qualifies for a categorical exclusion and satisfies the categorical exclusion criteria in the National Oceanic and Atmospheric Administration 216-6 Administrative Order, Environmental Review Procedure. No further NEPA documentation is required.</p>
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191 <p type="2">10. Government-to-Government Relationship With Tribes</p>
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192 <p type="1">Though no reintroductions of captively propagated federally endangered or threatened species have been undertaken, in accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we recognize the potential for such actions in the future and the obligation to relate to federally recognized Tribes on a government-to-government basis.</p>
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193 <p type="2">References Cited</p>
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194 <p type="1">A complete list of all references cited in this final policy is available on request from the Washington Office of the Division of Endangered Species (see ADDRESSES section).</p>
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195 <p type="1">Authors. The primary authors of this policy are David Harrelson of the Fish and Wildlife Service's Division of Endangered Species, Mail Stop 420 ARLSQ, 1849 C Street, NW, Washington, DC 20240 (703/358-2171), and Marta Nammack of the National Marine Fisheries Service's Protected Species Management Division, 1335 East-West Highway, Silver Spring, Maryland 20910 (301/713-1401).</p>
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196 <p type="2">Policy Statement</p>
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197 <p type="1">A. What is the purpose of this policy? This policy provides guidance and establishes consistency with respect to Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS), jointly called the Services, activities in which the controlled propagation of a listed species, as the term “species” is defined in section 3(15) of the Act, is implemented as a component of the recovery strategy for a listed species. It supports and promotes coordination between various phases of controlled propagation efforts such as propagation technology development, propagation for release, population augmentation, reintroduction, and monitoring. This policy will also contribute to the efficient use of funding resources.</p>
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198 <p type="1">Guidance is provided regarding the use of controlled propagation for:</p>
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199 <p type="1">• Preventing the extinction of listed species, subspecies, or populations;</p>
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200 <p type="1">• Recovery-oriented scientific research, including, but not restricted to, developing propagation methods and technology, and other actions that are expected to result in a net benefit to the listed taxon. Use of surrogates, while applicable to the recovery of listed species, is exempt from the requirements of this policy;</p>
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201 <p type="1">• Maintaining genetic vigor and demographic diversity of listed species, subspecies, or populations;</p>
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202 <p type="1">• Maintaining refugia populations for nearly extinct animals or plants on a temporary basis until threats to a listed species' habitat are alleviated, or necessary habitat modifications are completed, or when potentially catastrophic events occur ( e.g. , chemical spills, severe storms, fires, flooding);</p>
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203 <p type="1">• Providing individuals for establishing new, self-sustaining populations necessary for recovery of the listed species; and</p>
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204 <p type="1">• Supplementing or enhancing extant populations to facilitate recovery of the listed species.</p>
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205 <p type="1">B. What is the scope of this policy? This policy applies to all pertinent organizational elements of both Services, notwithstanding those differences in administrative procedures and policies as noted. Exceptions to this policy appear in section F. This policy pertains to all efforts requiring permits under 50 CFR 17 subparts C and D, funded, authorized, or carried out by us that are conducted to propagate threatened or endangered species by:</p>
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206 <p type="1">• Establishing or maintaining refugia populations;</p>
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207 <p type="1">• Producing individuals for research and technology development needs;</p>
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208 <p type="1">• Producing individuals for supplementing extant populations; and</p>
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209 <p type="1">• Producing individuals for reintroduction to suitable habitat within the species' historic range.</p>
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210 <p type="1">C. Why is this policy necessary? The controlled propagation of animals and plants in certain situations is an essential tool for the conservation and recovery of listed species. In the past, we have used controlled propagation to reverse population declines and to successfully return listed species to suitable habitat in the wild.</p>
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211 <p type="1">Though controlled propagation has a supportive role in the recovery of some listed species, the intent of the Act is “to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved.” Controlled propagation is not a substitute for addressing factors responsible for an endangered or threatened species' decline. Therefore, our first priority is to recover wild populations in their natural habitat wherever possible, without resorting to the use of controlled propagation. This position is fully consistent with the Act.</p>
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212 <p type="1">We recognize that genetic and ecological risks may be associated with introducing to the wild, animals and plants bred and reared in a controlled environment. When considering controlled propagation as a recovery option, the potential benefits and risks must be assessed and alternatives requiring less intervention objectively evaluated. If controlled propagation is identified as an appropriate strategy for the recovery of a listed species, it must be conducted in a manner that will, to the maximum extent possible, preserve the genetic and ecological distinctiveness of the listed species and minimize risks to existing wild populations.</p>
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213 <p type="1">We recognize that for many species, information available for detailed genetics conservation management or assessment of risks associated with reintroduction may be insufficient. Therefore, this policy does not specifically require written genetic management plans and ecological risk assessments to initiate or support controlled propagation programs. Additionally, acute conservation needs may legitimately outweigh delays that would be incurred by such a requirement. However, where sufficient biological and environmental information exists, and where conservation activities would not be unduly constrained, a formal assessment of ecological and genetic risks is strongly encouraged. Risks that must be evaluated in the planning of controlled propagation programs include the following specific examples:</p>
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214 <p type="1">• Removal of natural parental stock that may result in an increased risk of extinction by reducing the abundance of wild individuals and reducing genetic variability within naturally occurring populations;</p>
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215 <p type="1">• Equipment failures, human error, disease, and other potential catastrophic events that may cause the loss of some or all of the population being held or maintained in captivity or cultivation;</p>
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216 <p type="1">• The potential for an increased level of inbreeding or other adverse genetic effects within populations that may result from the enhancement of only a portion of the gene pool;</p>
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217 <p type="1">• Potential erosion of genetic differences between populations as a result of mixed stock transfers or supplementation;</p>
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218 <p type="1">• Exposure to novel selection regimes in controlled environments that may diminish a listed species' natural capacity to survive and reproduce in the wild;</p>
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219 <p type="1">• Genetic introgression, which may diminish local adaptations of the naturally occurring population;</p>
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220 <p type="1">• Increased predation, competition for food, space, mates, or other factors that may displace naturally occurring individuals, or interfere with foraging, migratory, reproductive, or other essential behaviors; and</p>
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221 <p type="1">• Disease transmission.</p>
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222 <p type="1">Controlled propagation programs must be undertaken in a manner that minimizes potentially adverse impacts to existing wild populations of listed species, and we must conduct controlled propagation programs in a manner that avoids additional listing actions.</p>
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223 <p type="1">D. What are the definitions for terms used in this policy? The following definitions apply:</p>
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224 <p type="1">Controlled environment —A controlled environment is one manipulated for the purpose of producing or rearing progeny of the species in question, and of a design intended to prevent unplanned escape or entry of plants, animals, or gametes, embryos, seeds, propagules, or other potential reproductive products.</p>
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225 <p type="1">Controlled propagation —Among animals, it includes natural or artificial matings, fertilization of sex cells, transfer of embryos, development of offspring, and grow-out of individuals of a species when the species is intentionally confined or the mating is directly intended by human intervention.</p>
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226 <p type="1">The term also includes the human-induced propagation of plants from seeds, spores, callus tissue, divisions, cuttings, or other plant tissue, or through pollination in a controlled environment.</p>
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227 <p type="1">• Defined in the context of this policy, controlled propagation refers to the production of individuals, generally within a managed environment, for the purpose of supplementing or augmenting a wild population(s), or reintroduction to the wild to establish new populations.</p>
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228 <p type="1">Intercross —Any instance of interbreeding or genetic exchange between individuals of different species, subspecies, or distinct population segments of a vertebrate species.</p>
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229 <p type="1">Phenotype —The expression of the genetic makeup of an organism through physical characteristics that make up its appearance.</p>
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230 <p type="1">Recovery priority system —The system used for assigning recovery priorities to listed species and to recovery tasks. Recovery priority is based on the degree of threat, recovery potential, taxonomic distinctness, and presence of an actual or imminent conflict between the species' conservation, adverse human activities, and other threats.</p>
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231 <p type="1">Rescue and salvage —These terms refer to extreme conditions wherein a species or population segment at risk of extinction is brought into a controlled environment (i.e., refugia) on a temporary or permanent basis.</p>
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232 <p type="1">Taxon —A formal group of organisms of any rank or formal scientific classification.</p>
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233 <p type="1">E. What is our Policy? This policy is intended to address candidate, proposed, and listed species indigenous to the United States and its territories for which the Services, have, or intend to prepare, recovery plans. This policy focuses primarily on those activities involving gamete transfer and subsequent development and grow-out of offspring in a laboratory, botanical facility, zoo, hatchery, aquarium, or similarly controlled environment. This policy also addresses activities related to or preceding controlled propagation activities such as:</p>
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234 <p type="1">• Obtaining and rearing offspring for research;</p>
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235 <p type="1">• Procuring broodstock for future controlled propagation and augmentation efforts; or</p>
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236 <p type="1">• Holding offspring for a substantial portion of their development or through a life-stage that experiences poor survival in the wild.</p>
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237 <p type="1">The goals of this policy include coordinating recovery actions specific to controlled propagation activities; maximizing benefits to the listed species from controlled propagation efforts; assuring that appropriate recovery measures other than controlled propagation and that other existing recovery priorities are considered in making controlled propagation decisions; and ensuring prudent use of funds.</p>
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238 <p type="1">Our policy is that the controlled propagation of threatened and endangered species will be:</p>
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239 <p type="1">1. Used as a recovery strategy only when other measures employed to maintain or improve a listed species' status in the wild have failed, are determined to be likely to fail, are shown to be ineffective in overcoming extant factors limiting recovery, or would be insufficient to achieve full recovery. All reasonable effort should be made to accomplish conservation measures that enable a listed species to recover in the wild, with or without intervention ( e.g. , artificial cavity provisioning), prior to implementing controlled propagation for reintroduction or supplementation.</p>
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240 <p type="1">2. Coordinated with conservation actions and other recovery measures, as appropriate or specified in recovery plans, that will contribute to, or otherwise support, the provision of secure and suitable habitat. Controlled propagation programs intended for reintroduction or augmentation must be coordinated with habitat management, restoration, and other species' recovery efforts.</p>
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241 <p type="1">3. Based on the specific recommendations of recovery strategies identified in approved recovery plans or supplements to approved recovery plans whenever practical. The recovery plan, in addressing controlled propagation, should clearly identify the necessity and role of this activity as a recovery strategy.</p>
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242 <p type="1">4. Based on specific consideration of the potential ecological and genetic effects of the removal of individuals for controlled propagation purposes on wild populations and the potential effects of introductions of artificially bred animals or plants on the receiving population and other resident species. Assessments of potential risks and benefits will be addressed, as required, through sections 7 and 10 of the Act and the National Environmental Policy Act (NEPA, 42 U.S.C. 4332) for proposed controlled propagation actions.</p>
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243 <p type="1">5. Based on sound scientific principles to conserve genetic variation and species integrity. Intercrossing will not be considered for use in controlled propagation programs unless recommended in an approved recovery plan; supported in an approved genetic management plan (if information is available to develop such a plan, and which may or may not be part of an approved recovery plan); implemented in a scientifically controlled and approved manner; and undertaken to compensate for a loss of genetic viability in listed taxa that have been genetically isolated in the wild as a result of human activity. Use of intercross individuals for species conservation will require the approval of the FWS Director or that of the NMFS Assistant Administrator, in accordance with all applicable policies.</p>
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244 <p type="1">6. Preceded, when practical, by the development of a genetics management plan based on accepted scientific principles and procedures. Controlled propagation protocols will follow accepted standards such as those employed by the American Zoo and Aquarium Association (AZA), the Center for Plant Conservation (CPC), and Federal agency protocols such as fish management guidelines to the extent practical. All efforts will be made by us and our cooperators to ensure that the genetic makeup of propagated individuals is representative of that in free-ranging populations and that propagated individuals are behaviorally and physiologically suitable for introduction. Determination of biological “suitability” may include, but should not necessarily be limited to, analysis of geomorphological similarities of habitat, genetic similarity, phenotypic characteristics, stock histories, habitat use, and other ecological, biological, and behavioral indicators. All controlled propagation programs will address the issue of disposition of individuals found to be:</p>
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245 <p type="1">(a) Unfit for introduction to the wild;</p>
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246 <p type="1">(b) Unfit to serve as broodstock;</p>
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247 <p type="1">(c) Surplus to program needs; or</p>
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248 <p type="1">(d) Surplus to the recovery needs for the species ( e.g., to preclude genetic and ecological swamping).</p>
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249 <p type="1">Controlled propagation activities should not be initiated without including consideration of these issues and obtaining required permits and other authorizations as necessary. Disposition of individuals surplus to program needs may include use for research or other appropriate purposes.</p>
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250 <p type="1">Programs involving the controlled propagation of listed species for research purposes identified in final recovery plans and in which progeny will not be reintroduced to the wild are exempt from this policy. Examples of exempt actions include research involving the determination of germination rates in plants and spawning success rates in fish. This exemption does not extend to the need for these activities to comply with any other applicable Federal or State permitting or regulatory requirements.</p>
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251 <p type="1">7. Conducted in a manner that takes all known precautions to prohibit the potential introduction or spread of diseases and parasites into controlled environments or suitable habitat.</p>
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252 <p type="1">8. Conducted in a manner that will prevent the escape or accidental introduction of individuals outside their historic range.</p>
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253 <p type="1">9. Conducted, when feasible, at more than one location in order to reduce the potential for catastrophic loss at a single facility when a substantial fraction of a species or important population segment is brought into captivity.</p>
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254 <p type="1">10. Coordinated, as appropriate, with organizations and qualified individuals both within and outside our agencies. We will cooperate with other Federal agencies and State, Tribal, and local governments.</p>
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255 <p type="1">11. Conducted in a manner that will meet our information needs and that will be in accordance with accepted protocols and standards. In the case of listed species for which traditional studbooks or registrations are not practical, records of eggs, larvae, or other life-stages will be maintained.</p>
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256 <p type="1">12. With limited exceptions, implemented only after a commitment to funding is secured.</p>
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257 <p type="1">13. Prior to releases of propagated individuals, tied to development of a reintroduction plan, unless this information is already contained in an approved recovery plan, species survival plan, or equivalent document that has received the approval of the appropriate Service. Controlled propagation and reintroduction plans will identify measurable objectives and milestones for the proposed propagation and reintroduction effort. The controlled propagation and reintroduction plan should be based on strategies identified in the approved recovery plan. It should include protocols for health management, disease screening and disease-free certification, monitoring and evaluation of genetic, demographic, life-history, phenotypic, and behavioral characteristics, data collection, recordkeeping, and reporting as appropriate. On implementation, periodic evaluations must be made to assess project progress and consider new scientific information and the status of habitat conservation efforts.</p>
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258 <p type="1">14. Conducted in accordance with the regulations implementing the Endangered Species Act, Marine Mammal Protection Act, Animal Welfare Act, Lacey Act, Fish and Wildlife Act of 1956, and the Services' procedures relative to NEPA.</p>
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259 <p type="1">F. Does this policy allow any exceptions? Except as identified in this section, any exceptions to the above policy guidelines will require specific approval from the FWS Director or the NMFS Assistant Administrator on a case by case basis. The following circumstances have been anticipated and are exempted from this policy.</p>
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260 <p type="1">1. Pacific salmon are exempted from this policy. NMFS, as the lead Service for the recovery of listed Pacific salmon, has developed and will continue to use the interim policy (April 5, 1993, 58 FR 17573) addressing controlled propagation of these species. The NMFS interim artificial propagation policy more specifically addresses the biological needs of these species.</p>
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261 <p type="1">2. Cases where a listed species has an ephemeral reproductive stage or short (1-2 year) lifespan that necessitates controlled propagation to sustain the listed species in refugia, or to maintain a research population where there is no intent to release captive-bred individuals from that population into the wild, are exempt.</p>
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262 <p type="1">3. In the absence of an approved recovery plan, recommendations contained in recovery outlines, draft recovery plans, or made in writing by a recovery team may be used to justify controlled propagation as a necessary recovery measure for listed species in danger of imminent extinction or extirpation of critical populations. However, under such circumstances initiation of controlled propagation activities will require the Regional Director's or Assistant Administrator's approval.</p>
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263 <p type="1">4. Candidate and proposed species held in refugia, used in research, or used for the development of propagation technology that are subsequently listed as endangered or threatened are exempted from this policy. Any propagation program initiated with candidate or proposed species with the intent to produce individuals for release to the wild are not exempted and must comply with this policy.</p>
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264 <p type="1">5. Captive breeding of listed species that are not native to the United States or its territories or possessions, and producing individuals not addressed in an approved recovery plan and not intended for release within the United States or its territories or possessions, is exempt from this policy. However, such activities must comply with any other Federal and State laws, permit needs, or other requirements.</p>
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265 <p type="1">6. The temporary removal and holding of listed individuals, unless such actions intentionally involve reproduction other than for purposes of recovery-related research or as needed to maintain a refugia population is exempted.</p>
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266 <p type="1">7. The short-term holding or captive-rearing of wild-bred individuals obtained for later reintroduction, augmentation, or translocation efforts when controlled propagation does not take place or is not intended during the period of captive maintenance.</p>
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267 <p type="1">8. Actions involving cryopreservation or other methods of conserving biological materials, if not intended for near-term use in controlled propagation or the reintroduction into the wild of listed species, are exempt from this policy. When and if reintroduction to the wild requires the use of these materials, such activities would come under the scope of this policy.</p>
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268 <p type="1">9. Additional exceptions to this policy may be made on a case-by-case basis with the approval of the FWS Director or NMFS Assistant Administrator, as warranted.</p>
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269 <p type="1">Where conflicts may arise between this policy and programs carried out in furtherance of restoration goals or required by treaty, trust resources obligations, or other legal mandate, we will, to the extent practical, make every effort to achieve solutions that are consistent with the requirements of the Act and this policy.</p>
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270 <p type="1">G. Who are our potential partners? We recognize the need for partnerships with other Federal agencies, States, Tribes, local governments, and private entities in the recovery of listed species. We will seek to develop partnerships with qualified cooperators for the purpose of propagating listed, proposed, and candidate species (as authorized under sections 6 and 2(a)(5) of the Act). Guidance for this activity is as follows:</p>
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271 <p type="1">1. The FWS Regional Directors or the NMFS Regional Administrators may explore opportunities for accomplishing controlled propagation and any associated research tasks with other Federal cooperators, FWS/NMFS facilities, State agencies, Tribes, zoological parks, aquaria, botanical gardens, academia, and other qualified parties at their discretion. We will select cooperators on the basis of scientific merits; technical capability; willingness to adhere to our policies, guidance, and protocols; and cost-effectiveness.</p>
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272 <p type="1">2. Regional Directors or Regional Administrators, depending on which agency has lead for the species, will be responsible for ensuring appropriate staff oversight of programs conducted by all cooperators to ensure adherence to necessary protocols, guidance, and permit conditions, and to coordinate reporting requirements.</p>
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273 <p type="1">H. What are the Federal agency responsibilities under this policy? This policy shall be implemented in accordance with the following guidelines:</p>
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274 <p type="1">1. The Regional Directors and Regional Administrators will ensure compliance with this policy for those species for which they have responsibility.</p>
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275 <p type="1">2. Regional Directors and Regional Administrators are responsible for recovery of listed species under their jurisdiction. Recovery actions for which Regional Directors and Regional Administrators have authority include establishment of refugia, initiation of necessary research or technology development, implementation of controlled propagation programs, and propagation research for listed species. When determining species' priority for inclusion in controlled propagation programs, we will consider the following:</p>
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276 <p type="1">(a) Whether or not a listed species' recovery plan outline, draft recovery plan, or final recovery plan identifies controlled propagation as an appropriate recovery strategy and what priority this task is assigned within the overall recovery strategy.</p>
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277 <p type="1">(b) The availability and willingness of cooperators to contribute to recovery activities, including cost sharing.</p>
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278 <p type="1">3. In the event that the current recovery plan fails to identify the establishment of refugia, initiation of propagation research, or controlled propagation as recovery tasks as necessary to the recovery of the species, the recovery plan will be updated, amended, or revised as appropriate. Recovery plans not yet finalized will be amended to reflect the changed recovery requirements of the listed species and provide justifications as necessary.</p>
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279 <p type="1">4. Within 6 months of the effective date of this policy, FWS Regional Directors will identify all listed species for which they have the lead recovery responsibility that are (1) being held in refugia; (2) involved in pre-propagation research; and (3) are involved in controlled propagation programs. For species involved in controlled propagation programs, the level of production and the recovery purpose ( e.g. , augmentation of extant populations, establishment of new populations) will be identified. This information will be reported to the Assistant Director, Endangered Species, in the FWS Washington D.C. Office.</p>
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280 <p type="1">5. Continuation of those programs not in conformity with this policy 12 months following implementation of this policy will require the FWS Director's or NMFS Assistant Administrator's concurrence. The Regional Director and Regional Administrator will provide his or her recommendation to the Director or Assistant Administrator.</p>
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281 <p type="1">I. Does the policy include annual reporting requirements? For the FWS, annual reports based on fiscal years will be prepared by the responsible regional authority and submitted to the Director, through the Assistant Director, Endangered Species, not later than October 31st of each year. Reports will contain the following information for each species being maintained in refugia, in pre-propagation research, or under propagation:</p>
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282 <p type="1">• Recovery priority number;</p>
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283 <p type="1">• Policy criteria that are not met (if any);</p>
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284 <p type="1">• A brief description of the controlled propagation program, including objectives and status;</p>
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285 <p type="1">• List of cooperators, if any;</p>
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286 <p type="1">• Expenditures for the past fiscal year;</p>
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287 <p type="1">• Prospects for, or obstacles to, achieving research, controlled propagation, or reintroduction objectives, and,</p>
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288 <p type="1">• A brief description of the status of wild populations, if any.</p>
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289 <p type="1">J. What authorities support this policy? The Endangered Species Act of 1973, as amended; Marine Mammal Protection Act of 1972, as amended; Animal Welfare Act; Lacey Act; Fish and Wildlife Act of 1956; and National Environmental Policy Act.</p>
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290 <p type="1">K. What are the information collection requirements? The permit application required for participation in the controlled propagation of species listed under the Act is FWS form #3-200-55 Interstate Commerce and Recovery and form #3-200-56 for incidental take. Applicants for NMFS research/enhancement permits or incidental take permits must meet certain criteria in their applications but there are no specific forms. We use these forms or applications to permit recovery actions that may be undertaken for scientific purposes, enhancement of propagation or survival, or for incidental taking. Whenever we ask the public to submit information, we must have authorization from the Office of Management and Budget. As part of the permitting process, we often ask the public to provide information such as filling out permit applications or submitting reports.</p>
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291 <p type="1">Information collection requirements under this policy are included under the Office of Management and Budget collection approval number 1018-0094 (FWS) and 0648-0230 (NMFS), which includes information collection for permits granted for interstate commerce and recovery and incidental take. The expiration date of this approval is February 28, 2001(FWS), and October 31, 2001 (NMFS). The purpose of information collection is to identify performance of permitted tasks and make decisions, according to criteria established in various Federal wildlife and plant conservation statutes and described in 50 CFR 17.22(a)(1) and (3) and 17.32(a)(1) and (3) (FWS) and 50 CFR 222 (NMFS).</p>
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292 <p type="1">We have estimated that the time required by an applicant to complete FWS form 3-200-55 is 2 hours. Applications to NMFS for these permits are estimated to require 80 hours for completion. The information required is already known to the applicant and need only be entered on the application form. Summary information for endangered species permit applications will be published in the Federal Register as required by regulation. This notice is provided pursuant to section 10(c) of the Act and NEPA regulations (40 CFR 1506.6). The total burden hours for completing reporting requirements is also estimated at 2 hours for the FWS and 80 hours for NMFS. No costs to applicants beyond the cost of hour burden described above are anticipated. Annual reports are generally required for permits for scientific research.</p>
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293 <p type="1">For organizations, businesses, or individuals operating as a business ( i.e. , permittee not covered by the Privacy Act), we request that such entities identify any information that should be considered privileged and confidential business information to allow us to meet our responsibilities under the Freedom of Information Act. Confidential business information must be clearly marked “Business Confidential” at the top of the first page and each succeeding page, and must be accompanied by a nonconfidential summary of the confidential information. Documents may be made available to the public under Department of the Interior Freedom of Information Act (FOIA) regulations in 43 CFR 2.13(c)(4), 43 CFR 2.15(d)(1)(I) and Department of Commerce 15 CFR 4. Documents and other information submitted with these applications are made available for public review, subject to the requirements of the Privacy Act and FOIA, by any party who submits a written request for a copy of such documents to the appropriate Service within 30 days of the date of publication of the notice.</p>
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294 </supplInfo></supplementary_information>
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295 </results>
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