(2) Establishing test methods and criteria for product acceptance and serial release.

(3) Establishing license requirements ensuring compliance by each applicant before issuance of a license.

(4) Establishing production standards and procedures.

(5) Reviewing veterinary biologics labels and advertising claims for compli

ance.

(6) Establishing criteria for inspection of licensed establishments and the evaluation of such inspections.

(7) Developing policies and directives governing and pertaining to biologics activities and programs.

(8) Serving as consultant and advisor to government officials, professional and industry organizations, and the general public concerning scientific and administrative aspects of the biologics program.

(c) Biotechnology Permits. (1) Reviewing and processing permit applications under part 340 of this chapter.

(2) Issuing permits for the introduction of regulated articles.

(3) Maintaining liaison with state departments of agriculture, the academic community and scientific societies.

(4) Providing technical information for environmental analysis for permits allowing environmental release of regulated articles.

(5) Serving as a resource at the request of the Administrator for other APHIS and USDA units, and other government agencies.

(d) Environmental Documentation. (1) Planning, producing, and analyzing all environmental documentation relative to compliance with the NEPA and other environmental laws. This documentation includes but is not limited to environmental assessments, environmental impact statements, records of decisions.

and

(2) Ensuring agency compliance with NEPA.

(3) Conducting public hearings and analyzing comments on agency NEPA regulations and conducting agency scoping hearings relating to environmental impact statements.

(4) Serving as liaison with the Department's Office of the General Counsel on matters pertaining to NEPA-re

lated documents and other environmental laws.

§ 371.14 Delegations of authority.

(a) Associate Administrator. The Associate Administrator is delegated the authority to perform all the duties and to exercise all the functions and powers that are now, or that may become, vested in the Administrator, including the power of redelegation except where prohibited, and including authority reserved to the Administrator in §371.16 of this part. The Associate Administrator is also authorized to act for the Administrator in the absence of the Administrator.

(b) Deputy Administrators and Directors. The Deputy Administrators of PPQ, VS, ADC, M&B, REAC, and IS, and the Directors of PPD, R&D, LPA, S&T, and BBEP, and the officers they designate to act for them-with prior specific approval of the Administrator-are delegated the authority, severally, to perform all duties and to exercise all the functions and powers that are now, or that may become vested in the Administrator (including the power of redelegation, except where prohibited) except authority that is reserved to the Administrator. Each Deputy Administrator or Director shall be responsible for the programs and activities in APHIS assigned to that Deputy Administrator or Director.

(c) PPQ, VS, ADC, REAC, M&B, S&T, REAC, and IS. The Directors of Operational Support for PPQ, VS, ADC, and IS; the Regional Directors for PPQ, VS, ADC, and IS; the Directors of the National Veterinary Services Laboratories, the Denver Wildlife Research Center, the Plant Methods Development Centers, and the National Monitoring and Residue Analysis Laboratory; and the Assistant Deputy Administrator for REAC are delegated authority in connection with the respective functions assigned to each of them in this part. They are authorized to perform all the duties and exercise all the functions or powers that are now or that may become vested in the Administrator except the authorities reserved to the Administrator or a Deputy Administrator. The Directors of the Budget and Accounting, Human Resources,

Sys

Administrative Services, and Information Systems and Communications Divisions, Resource Management tems and Evaluation Staff, the Field Servicing Office, Equal Opportunity and Civil Rights, and Equal Opportunity Counseling are delegated authority in connection with the respective functions assigned to each of them in this part to perform all the duties and exercise all the functions and powers that are now or that may become vested in the Administrator except the authorities reserved to the Administrator or Deputy Administrator.

(d) Area Veterinarians in Charge, VS. Area Veterinarians in Charge of VS programs are delegated authority to:

(1) Issue exemptions to facilities or premises from the requirements of section 4 of the Swine Health protection Act pursuant to section 4(b) of the Act (7 U.S.C. 3803), and

(2) Issue permits to operate facilities to treat garbage pursuant to section (5)(a) of the Swine Health Protection Act (7 U.S.C. 3804).

§ 371.15 Concurrent authority and responsibility to the Administrator.

(a) No delegation or authorization in this part shall preclude the Administrator or each Deputy Administrator or Director from exercising any of the powers or functions or from performing any of the duties conferred upon each, respectively. Any delegation or authorization is subject at all times to withdrawal or amendment by the Administrator, and in their respective fields, by each Deputy Administrator or Director. The Officers to whom authority is delegated in this part shall:

(1) Maintain close working relationships with the officers to whom they report,

(2) Keep them advised with respect to major problems and developments, and

(3) Discuss with them proposed actions involving major policy questions or other important considerations or questions including matters involving relationships with other federal agencies, other agencies of the Department, other divisions and staffs or offices of the agency or other governmental or private organizations or groups.

(b) Prior authorizations and delegations. All prior delegations and redele

(b) The issuance of regulations pursuant to law.

(c) The transfer of functions between Deputy Administrators or Directors. (d) The transfer of funds between Deputy Administrators or Directors.

(e) The transfer of funds between work projects within each Deputy Administrator's or Director's area, except those not exceeding 10 percent of base funds or $50,000 in either work project, whichever is less.

(f) The approval of any change in the formal organization, including a section, its equivalent, or higher level.

(g) The making of recommendations to the Department concerning establishment, consolidation, change in location, or abolishment of any regional, state, area, and other field headquarters, and any region or other program area that involves two or more states, or that crosses state lines.

(h) Authority to establish, consolidate, or change a location or abolish any field office or change program area boundaries not included in paragraph (g) of this section.

(i) Approval of all appointments, promotions, and reassignments in GS-14 and GM-14 and above.

(j) Authorization for foreign travel and for attendance at foreign and international meetings, including those held in the United States.

(k) Approval of all appointments, promotions, and reassignments of employees to foreign countries.

(1) Approval of budget estimates.

The terminology set forth in the Council on Environmental Quality's (CEQ) implementing regulations at 40 CFR part 1508 is incorporated herein. In addition, the following terms, as used in these procedures, are defined as follows:

APHIS. The Animal and Plant Health Inspection Service (APHIS).

Decisionmaker. The agency official responsible for executing findings of no significant impact in the environmental assessment process and the record of decision in the environmental impact statement process.

Department. The United States Department of Agriculture (USDA).

Environmental unit. Environmental Analysis and Documentation, the analytical unit in Biotechnology, Biologics, and Environmental Protection responsible for coordinating APHIS' compliance with the National Environmental Policy Act and other environmental laws and regulations.

§ 372.5 Classification of actions.

(a) Actions normally requiring environmental impact statements. This class of policymakings and rulemakings seeks to establish programmatic approaches to animal and plant health issues. Actions in this class typically involve the agency, an entire program, or a substantial program component and are characterized by their broad scope (often global or nationwide) and potential effect (impacting a wide range of environmental quality values or indicators, whether or not affected individuals or systems may be completely identified at the time). Ordinarily, new or untried methodologies, strategies, or techniques to deal with pervasive threats to animal and plant health are the subjects of this class of actions. Alternative means of dealing with those threats usually have not been well developed. Actions in this class include:

(1) Formulation of contingent response strategies to combat future widespread outbreaks of animal and plant diseases; and

(2) Adoption of strategic or other long-range plans that purport to adopt for future program application a preferred course of action.

(b) Actions normally requiring environmental assessments but not necessarily environmental impact statements. This class of APHIS actions may involve the agency as a whole or an entire program, but generally is related to a more discrete program component and is characterized by its limited scope (particular sites, species, or activities) and potential effect (impacting relatively few environmental values or systems). Individuals and systems that may be affected 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

179-018 0—98——16

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. (1) 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:

(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 excluded 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