systems). Individuals and systems that may be affected can be identified. Methodologies, strategies, and techniques employed to deal with the issues at hand are seldom new or untested. Alternative means of dealing with those issues are well established. Mitigation measures are generally available and have been successfully employed. Actions in this class include: (1) Policymakings and rulemakings that seek to remedy specific animal and plant health risks or that may affect opportunities on the part of the public to influence agency environmental planning and decisionmaking. Examples of this category of actions include: (i) Development of program plans that seek to adopt strategies, methods, and techniques as the means of dealing with particular animal and plant health risks that may arise in the future; (ii) Implementation of program plans at the site-specific, action level, except for actions that are categorically excluded, as provided in paragraph (c) of this section. (2) Planning, design, construction, or acquisition of new facilities, or proposals for modifications to existing facilities. (3) Disposition of waste and other hazardous or toxic materials at laboratories and other APHIS facilities, except for actions that are categorically excluded, as provided in paragraph (c) of this section. (4) Approvals and issuance of permits for proposals involving genetically engineered or nonindigenous species, except for actions that are categorically excluded, as provided in paragraph (c) of this section. (5) Research or testing that: (i) Will be conducted outside of a laboratory or other containment area (field trials, for example); or (ii) Reaches a stage of development (e.g., formulation of premarketing strategies) that forecasts an irretrievable commitment to the resulting products or technology. (c) Categorically excluded actions. This class of APHIS actions shares many of the same characteristics—particularly in terms of the extent of program involvement, as well as the scope, effect of, and the availability of alternatives to proposed actions as the class of actions that normally requires environmental assessments but not necessarily environmental impact statements. The major difference is that the means through which adverse environmental impacts may be avoided or minimized have actually been built right into the actions themselves. The efficacy of this approach generally has been established through testing and/or monitoring. The Department of Agriculture has also promulgated a listing of categorical exclusions that are applicable to all agencies within the department unless their procedures provide otherwise. Those categorical exclusions, codified at 7 CFR 1b.3(a), are entirely appropriate for APHIS. Other actions in this class include: (1) Routine measures. (i) Routine measures, such as identifications, inspections, surveys, sampling that does not cause physical alteration of the environment, testing, seizures, quarantines, removals, sanitizing, inoculations, control, and monitoring employed by agency programs to pursue their missions and functions. Such measures may include the use-according to any label instructions or other lawful requirements and consistent with standard, published program practices and precautions—of chemicals, pesticides, or other potentially hazardous or harmful substances, materials, and target-specific devices or remedies, provided that such use meets all of the following criteria (insofar as they may pertain to a particular action): (A) The use is localized or contained in areas where humans are not likely to be exposed, and is limited in terms of quantity, i.e., individualized dosages and remedies; (B) The use will not cause contaminants to enter water bodies, including wetlands; (C) The use does not adversely affect any federally protected species or critical habitat; and (D) The use does not cause bioaccumulation. (ii) Examples of routine measures include: 1 1 1 (A) Inoculation or treatment of discrete herds of livestock or wildlife undertaken in contained areas (such as a barn or corral, a zoo, an exhibition, or an aviary); (B) Pesticide treatments applied to infested plants at a nursery; and (C) Isolated (for example, along a highway) weed control efforts. (2) Research and development activities. (i) Activities that are carried out in laboratories, facilities, or other areas designed to eliminate the potential for harmful environmental effects-internal or external-and to provide for lawful waste disposal. (ii) Examples of this category of actions include: (A) The development and/or production (including formulation, repackaging, movement, and distribution) of previously approved and/or licensed program materials, devices, reagents, and biologics; (B) Research, testing, and development of animal repellents; and (C) Development and production of sterile insects. (3) Licensing and permitting. (i) Issuance of a license, permit, or authorization to ship for field testing previously unlicensed veterinary biological products; (ii) Permitting, or acknowledgment of notifications for, confined field releases of genetically engineered organisms and products; and (iii) Permitting of: (A) Importation of nonindigenous species into containment facilities, (B) Interstate movement of nonindigenous species between containment facilities, or (C) Releases into a State's environment of pure cultures of organisms that are either native or are established introductions. (4) Rehabilitation of facilities. Rehabilitation of existing laboratories and other APHIS facilities, functional replacement of parts and equipment, and minor additions to such existing APHIS facilities. (d) Exceptions for categorically exIcluded actions. Whenever the decisionmaker determines that a categorically excluded action may have the potential to affect "significantly" the quality of the "human environment," as those terms are defined at 40 CFR 1508.27 and 1508.14, respectively, an environmental assessment or an environmental impact statement will be prepared. For example: (1) When any routine measure, the incremental impact of which, when added to other past, present, and reasonably foreseeable future actions (regardless of what agency or person undertakes such actions), has the potential for significant environmental impact; (2) When a previously licensed or approved biologic has been subsequently shown to be unsafe, or will be used at substantially higher dosage levels or for substantially different applications or circumstances than in the use for which the product was previously approved; (3) When a previously unlicensed veterinary biological product to be shipped for field testing contains live microorganisms or will not be used exclusively for in vitro diagnostic testing; extent possible, surveys and studies required by other environmental statutes, such as the Endangered Species Act. [60 FR 6002, Feb. 1, 1995; 60 FR 13212, Mar. 10, 1995] § 372.8 Major planning and decision points and public involvement. (a) Major planning and decisions points. The NEPA process will be fully coordinated with APHIS planning in cooperation with program personnel. Specific decision points or milestones will be identified and communicated to the public and others in a notice of intent and in the context of the public scoping process. (b) Public involvement. There will be an early and open process for determining the scope of issues to be addressed in the environmental impact statement process. (1) A notice of intent to prepare an environmental impact statement will be published in the FEDERAL REGISTER as soon as it is determined that a proposed major Federal action has the potential to affect significantly the quality of the human environment. The notice may include a preliminary scope of environmental study. All public and other involvement in APHIS' environmental impact statement process, including the scoping process, commenting on draft documents, and participation in the preparation of any supplemental documents, will be pursuant to CEQ's implementing regulations. (2) Opportunities for public involvement in the environmental assessment process will be announced in the same fashion as the availability of environmental assessments and findings of no significant impact. (3) Notification of the availability of environmental assessments and findings of no significant impact for proposed activities will be published in the FEDERAL REGISTER, unless it is determined that the effects of the action are primarily of regional or local concern. Where the effects of the action are primarily of regional or local concern, notice will normally be provided through publication in a local or area newspaper of general circulation and/or the procedures implementing Executive Order 12372, "Intergovernmental Review of Federal Programs." (4) All environmental documents, comments received, and any underlying documents, including interagency correspondence where such correspondence transmits comments of Federal agencies on the environmental impact of proposals for which documents were prepared (except for privileged or confidential information (50 FR 38561)), will be made available to the public upon request. Materials to be made available will be provided without charge, to the extent practicable, or at a fee not more than the actual cost of reproducing copies required to be sent to other Federal agencies, including CEQ. $372.9 Processing and use of environmental documents. (a) Environmental assessments will be forwarded immediately upon completion to the decisionmaker for a determination of whether the proposed action may have significant effects on the quality of the human environment, and for the execution, as appropriate, of a finding of no significant impact or a notice of intent to prepare an environmental impact statement. (1) The availability of environmental assessments will be announced by publishing a notice consistent with the notification provisions of § 372.8. (2) Comments, if any, will be transmitted, together with any analyses and recommendations, to the APHIS decisionmaker who may then take appropriate action. (3) Changes to environmental assessments and findings of no significant impact that are prompted by comments, new information, or any other source, will normally be announced in the same manner as the notice of availability (except that all commenters will be mailed copies of changes directly) prior to implementing the proposed action or any alternative. (b) Environmental impact statements will be processed from inception (publication of the notice of intent) to completion (publication of a final environmental impact statement or a supplement) according to the Council on Environmental Quality implementing regulations. (c) For rulemaking or adjudicatory proceedings, relevant environmental documents, comments, and responses will be a part of the administrative record. (d) For all APHIS activity that is subject to the NEPA process, relevant environmental documents, comments, and responses will accompany proposals through the review process. (e) The APHIS decisionmaker will consider the alternatives discussed in environmental documents in reaching a determination on the merits of proposed actions. (f) APHIS will implement mitigation and other conditions established in environmental documentation and committed to as part of the decisionmaking process. $372.10 Supplementing environmental impact statements. Once a decision to supplement an environmental impact statement is made, a notice of intent will be published. The administrative record will thereafter be open. The supplemental document will then be processed in the same fashion (exclusive of scoping) as a draft and a final statement (unless alternative procedures are approved by CEQ) and will become part of the administrative record. AUTHORITY: Sec. 1, 37 Stat. 315, as amended; sec. 5, 37 Stat. 316, as amended; sec. 7, 37 Stat. 317, as amended; secs. 8 and 10, 37 Stat. 318, as amended; sec. 9, 37 Stat. 318; sec. 10, 45 Stat. 468; sec. 15, 45 Stat. 565; 56 Stat. 40, as amended; secs. 103 and 105, 71 Stat. 32, as amended; sec. 106, 71 Stat. 33; sec. 108, 71 Stat. 34, as amended; sec. 11(a), 87 Stat. 897; sec. 4, 95 Stat. 1074; 7 U.S.C. 149, 150bb 150dd, 150ee, 150gg, 154, 159-164a, 167, 16 U.S.C. 1540(a), 3373 (a) and (b), 7 CFR 2.22, 2.80, 371.2(c). Subpart A-General § 380.1 Scope and applicability of rules of practice. The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7 CFR are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions: Act of August 20, 1912, commonly known as the Plant Quarantine Act, section 10, as amended (7 U.S.C. 163, 164), Act of January 31, 1942, as amended (7 U.S C. 149), Federal Plant Pest Act, section 108, as amended (7 U.S.C. 150gg), Endangered Species Act Amendments of 1973, as amended, section 11(a) (16 U.S.C. 1540 (a)), and Lacey Act Amendments of 1981, section 4 (a) and (b) (16 U.S.C. 3373 (a) and (b)). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings. [49 FR 22247, May 29, 1984] Subpart B-Supplemental Rules of Practice § 380.10 Stipulations. (a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 380.1, the Administrator, in his discretion, may enter into a stipulation with any person in which: (1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act; (2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and (3) The Administrator agrees to accept the specified penalty in settlement of the particular matter involved if the penalty is paid within the designated time. (b) If the specified penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in |