DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 372 [Docket No. 93-165-3] RIN 0579-AA33
National Environmental Policy Act Implementing Procedures
AGENCY: Animal and Plant Health Inspection Service,
USDA.
AGENCY: Final rule.
SUMMARY: These final procedures set forth the principles
and practices the Animal and Plant Health Inspection Service will follow
to comply with the National Environmental Policy Act of 1969, the Council
on Environmental Quality regulations, and the U.S. Department of Agriculture
regulations implementing the National Environmental Policy Act. These
procedures replace APHIS Guidelines Concerning Implementation of NEPA
Procedures.
EFFECTIVE DATE: March 3, 1995.
FOR FURTHER INFORMATION CONTACT: Mr. Robert E. Pizel,
Branch Chief, Biotechnology, Biologics, and Environmental Protection,
APHIS, USDA, P.O. Drawer 810, Riverdale MD 20738. The telephone number
for the agency contact will change when agency offices in Hyattsville,
MD, move to Riverdale, MD, during January 1995. Telephone: (301) 436-8565
(Hyattsville); (301) 734-8565 (Riverdale).
SUPPLEMENTARY INFORMATION:
Background
The regulations of the President's Council on Environmental Quality
(CEQ) implementing section 102(2) of the National Environmental Policy
Act (hereinafter referred to as NEPA) are applicable to and binding on
all agencies of the Federal Government. Pursuant to the CEQ implementing
regulations, the Animal and Plant Health Inspection Service (APHIS) is
implementing procedures to ensure that its planning and decisionmaking
are in accordance with the policies and purposes of NEPA. The CEQ implementing
regulations direct that agencies shall include, at a minimum, procedures
required by 40 CFR 1501.2(d), 1502.9(c)(3), 1505.1, 1506.6(e), 1507.3(b)(2),
and 1508.4 (1992). APHIS' procedures supplant the APHIS Guidelines Concerning
Implementation of NEPA Procedures originally published in the Federal
Register
on August 28, 1979 (44 FR 50381-50384) and corrections as published in
the Federal Register on August 31, 1979 (44 FR 51272-51274).
On June 3, 1994, we published in the Federal Register (59 FR 28814-28821,
Docket No. 93-165-1) proposed procedures implementing CEQ's NEPA regulations.
Comments on the proposed procedures were required to be received on
or before July 18, 1994. During the comment period, we received a request
from the Association of Natural Bio-control Producers that we extend
the comment period. The comment stated that additional time was necessary
to allow interested parties to evaluate fully and respond to the proposed
procedures. In response to this comment, we published a notice in the
Federal Register on July 22, 1994 (59 FR 37442, Docket No. 93-165-2),
reopening and extending the comment period until August 2, 1994.
We received seven comments by August 2, 1994, from the following commenters:
American Veterinary Medical Association; Asgrow Seed Company; Association
of Natural Bio-control Producers; Environmental Defense Fund; State of
California, Department of Food and Agriculture; The Humane Society of
the United States; and the Office of the Secretary of the U.S. Department
of the Interior. We carefully considered all of the comments we received.
Noteworthy issues that were raised in comments--whether or not they prompted
changes to the proposed procedures--are developed below either under
the appropriate section headings or, if they do not fit within a section
heading, under the "miscellaneous" heading that follows. Sections 372.1
through 372.3and 372.7 through 372.10 were not addressed in comments
and, except where
language was modified to improve clarity or eliminate, insofar as possible," jargon," remain
as originally proposed.
DISCUSSION OF ISSUES
Definitions (Section 372.4)
One commenter, concerned that some language in the procedures is too
species-specific, has suggested that APHIS broaden significantly its
definition of "environment." The term "environment" is not defined in
theseprocedures. CEQ's regulations provide that the term "`human environment'shall
be interpreted comprehensively to include the natural and physicalenvironment
and the relationship of people with that environment." Inevaluating
impacts of agency proposals and exploring alternatives under NEPA,we
are guided by CEQ's interpretation of the term "human environment." Incertain
cases, limiting language is used in these procedures, not tocircumscribe
the scope of required NEPA analysis, but in recognition ofprogram jurisdictional
constraints. In no case is language employed to limitAPHIS' environmental
responsibilities.
Classification of Actions (Section 372.5)
One commenter has criticized the failure of this section to distinguish
consistently between specific criteria for and identification of classes
of
action. He has also urged that examples and classes of action be presented
with much greater specificity. We agree and have rewritten this section
(the substance of which has not been changed) in an attempt to accommodate
those concerns and for general clarification.
Categorically excluded actions. One commenter has asked who will make
the decisions regarding what is or is not categorically excluded. The
decision in the first instance belongs to program personnel who should
be greatly assisted in that effort through the rewrite of this section.
Another commenter is "concerned about the possibility that APHIS may,
under the language now proposed, consider the seizure or removal of wild
animals from a population for such purposes as disease testing as actions
which are categorically excluded." The fact is that such seizures or
removals, which are generally very limited in scope and humanely pursued,
would seldom have the potential to affect significantly the quality of
the human environment.
One commenter has inquired whether small-scale field tests of genetically
engineered plants is included as a categorically excluded action under
paragraph (c)(2), which provides an exclusion for "[a]ctivities that
are carried out in laboratories, facilities, or other areas designed
to eliminate the potential for harmful environmental effects." In fact,
the environmental assessment process has been undertaken for hundreds
of permits that have been issued to conduct small-scale (or "confined," as
expressed in current biotechnology literature) field tests of genetically
engineered plants. In every case a finding of no significant impact was
reached, reason enough to conclude that such tests ought to be categorically
excluded. To eliminate any confusion, this action (including "notifications," which
are little more thanlogical extensions) will be described separately
as an example of categorical exclusions under a retitled paragraph (c)(3).
We emphasize, in response to concerns raised by another commenter on
this subject, that this categoricalexclusion applies only to confined
field tests; unconfined testing would not
qualify for categorical exclusion.
Two other commenters maintain that the movement and release of at least
some nonindigenous species also would qualify for categorical exclusion
under the same exclusion theory as small-scale field tests of genetically
engineered plants. We agree that categorical exclusion of some nonindigenous
species activities--movement to and from "containment," as well as the
release into a State's environment of pure cultures of organisms that
are either native or are established introductions--is appropriate. These
actions also will bedescribed separately as examples of categorical exclusions
under paragraph (c)(3).
Finally, the substance of paragraph (c)(3) of the proposed procedures
is provided as an example under paragraph (c)(1) of these final procedures.
The substance of paragraph (c)(5) of the proposed procedures appears
in these final procedures as paragraph (c)(3), which has been retitled "Licensing
and permitting" and expanded to include activities described in the preceding
two paragraphs.
Early Planning for Applicants and Non-APHIS Entities (Section 372.6)
One commenter has complained that the failure to develop "the necessary
environmental data needs" leaves potential applicants in the dark. This
situation, according to the commenter, could lead to imposition of inconsistent
and burdensome requirements. Data requirements have indeed been developed
for some agency programs. Other programs are in the process of incorporating
such requirements into their guidance.
Miscellaneous
Appeals. One commenter has expressed concern about "the absence of proposed
procedures to provide the public with an opportunity to appeal APHIS
decisions with which it disagrees." The appeal procedures, according
to thatcommenter, should be made a part of the agency's NEPA procedures
so that the public will not be forced "to seek judicial review as the
first and only response to inadequate NEPA documents."
We do not believe that the agency's NEPA procedures should be the vehicle
through which APHIS decisions may be appealed. These procedures are designed
to complement the CEQ regulations and to ensure that the NEPA process
aids this agency's decisionmaking and contributes to public understanding
of APHIS' duties and functions at all levels of administrative action.
It is through NEPA's public process that the best possible documentation
will be prepared; turning that process into a form of adjudication will
do nothing to enhance document quality.
Emergencies. The agency has been urged by one commenter to address" emergencies" in
its NEPA procedures. It has been recommended that (1) theterm "emergency" be
defined as "a situation or occurrence of an extremelyserious nature that
has developed suddenly and unexpectedly and requiresimmediate action
to address a serious threat to life or property," and (2) aprovision
be added to the procedures that would require the agency to consultwith
CEQ in emergency circumstances "as soon as possible about alternativearrangements
for compliance with NEPA."
The CEQ regulations, which deal expressly with "emergency circumstances," have
been (and will continue to be) complied with by APHIS as necessary. Duplicating
the CEQ "emergency" regulations here would serve no useful purpose; indeed,
we are discouraged from doing so.
Compliance issues. One commenter has expressed concern that Executive
Order 12778 "moves all decision making and document preparation to the
highest possible level--USDA national staff in Hyattsville" and that
the executive order is at "odds with CEQA [California Environmental Quality
Act], and leaves[California citizens and officials] open to litigation
under CEQA despitehaving met NEPA standards."
The notice of proposed rulemaking merely recited how these procedures
are affected by Executive Order 12778, which we cannot disavow. But the
fact is that APHIS has not centralized environmental decisionmaking;
on the contrary, environmental decisionmaking at this agency is in the
process of being decentralized. Furthermore, it is doubtful that California's
CEQA would be found to be in "conflict" with this agency's procedures.
Nevertheless, principles of federalism permit suits to be brought in
State court under State law whether or not there is compliance with a
counterpart Federal statute. Executive Order 12866 and Regulatory Flexibility
Act This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for purposes of Executive Order
12866 and, therefore, has not been reviewed by the Office of Management
and Budget. These procedures satisfy the requirement to implement CEQ's
NEPA regulations and have been designed to reduce to a minimum the regulatory
burden on small entities and all other individuals and organizations,
public and private.
Under these circumstances, the Administrator of the Animal and Plant
Health Inspection Service has determined that these procedures will not
have asignificant economic impact on a substantial number of small entities.Executive
Order 12372This program/activity is listed in the catalog of Federal
DomesticAssistance under No. 10.025 and is subject to Executive Order
12372, whichrequires intergovernmental consultation with State and local
officials. (See7 CFR part 3015, subpart V.)Executive Order 12778
This rule has been reviewed under Executive Order 12778, Civil Justice
Reform. This rule (1) Preempts all State and local laws and regulations
that are in conflict with these procedures; (2) has no retroactive effect;
and (3) does not require administrative proceedings before parties may
file suit in court challenging this rule.
The National Environmental Policy Act Implementation of these procedures
will not significantly impact the quality of the human environment.
Paperwork Reduction Act These procedures contain no information collection
or recordkeeping requirements under the Paperwork Reduction Act of 1980
(44 U.S.C. 3501 et seq.).
List of Subjects in 7 CFR Part 372
Administrative practice and procedure, Environmental assessment, Environmental
impact statement, and National Environmental Policy Act.
Accordingly, title 7, chapter III, of the Code of Federal Regulations
is amended by adding a new part 372 to read as follows:
PART 372
NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES
Sec.
372.1 Purpose.
372.2 Designation of responsible APHIS official.
372.3 Information and assistance.
372.4 Definitions.
372.5 Classification of actions.
372.6 Early planning for applicants and non-APHIS entities.
372.7 Consultation.
372.8 Major planning and decision points and public involvement.
372.9 Processing and use of environmental documents.
372.10 Supplementing environmental impact statements.
AUTHORITY: 42 U.S.C. 4321 et seq.; 40 CFR parts 1500-1508; 7 CFR parts
1b, 2.17, 2.51, 371.2, 371.2(m), 371.13(d), and 371.14(b).
These procedures implement section 102(2) of the National Environmental
Policy Act by assuring early and adequate consideration of environmental
factors in Animal and Plant Health Inspection Service planning and decisionmaking
and by promoting the effective, efficient integration of all relevant
environmental requirements under the National Environmental Policy Act.
The goal of timely, relevant environmental analysis will be secured principally
by adhering to the National Environmental Policy Act implementing regulations
(40 CFR parts 1500-1508), especially provisions pertaining to timing
(• 1502.5), integration (• 1502.25), and scope of analysis
(• 1508.25).
- 372.2 Designation of responsible APHIS official. The Administrator
of APHIS, or an agency official to whom the Administrator may formally
delegate the task, is responsible for overall review of APHIS' NEPA
compliance.
- 372.3 Information and assistance. Information, including the status
of studies, and the availability of reference materials, as well
as the informal interpretations of APHIS' NEPA procedures and other
forms of assistance, will be made available upon request to Environmental
Analysis and Documentation, Biotechnology, Biologics, and Environmental
Protection, APHIS, USDA, P.O. Drawer 810, Riverdale MD 20738, (301)
436-8565 (Hyattsville) or (301) 734-8565 (Riverdale).
- 372.4 Definitions.
The terminology set forth in the Council on Environmental Quality's
(CEQ) implementing regulations at 40 CFR 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
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:
(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 acknowledgement 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
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;
or (4) When a confined field release of genetically engineered
organisms or products involves new species or organisms or
novel modifications that raise
new issues.
- 372.6 Early planning for applicants and non-APHIS entities. Each
prospective applicant who anticipates the need for approval of
proposed activities classified as normally requiring environmental
documentation is encouraged to contact, at the earliest opportunity,
APHIS' program staff.
- 372.7 Consultation. Prospective applicants are encouraged to contact
APHIS program officials to determine what types of environmental
analyses or documentation, if any, need to be prepared. NEPA documents
will incorporate, to the fullest extent possible, surveys and studies
required by other environmental statutes, such as the Endangered
Species Act.
- 372.8 Major planning and decision points and public involvement.
(a) Major planning and decision 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.
Done in Washington, DC, this _____ day of .
Acting Administrator, Animal and Plant Health Inspection Service
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