[Federal Register Volume 81, Number 139 (Wednesday, July 20, 2016)]
[Proposed Rules]
[Pages 47051-47071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17138]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 372

[Docket No. APHIS-2013-0049]
RIN 0579-AC60


National Environmental Policy Act Implementing Procedures

AGENCY: Animal and Plant Health Inspection Service, USDA

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations that set out our 
National Environmental Policy Act implementing procedures. The 
amendments include clarifying and amending the categories of action for 
which we would normally complete an environmental impact statement or 
an environmental assessment for an action, expanding the list of 
actions subject to categorical exclusion from further environmental 
documentation, and setting out an environmental documentation process 
that could be used in emergencies. The proposed changes are intended to 
update the regulations and improve their clarity and effectiveness.

DATES: We will consider all comments that we receive on or before 
September 19, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0049.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0049, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0049 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Elizabeth E. Nelson, APHIS Federal 
NEPA Contact, Environmental and Risk Analysis Services, PPD, APHIS, 
4700 River Road Unit 149, Riverdale, MD 20737-1238; (301) 851-3089.

SUPPLEMENTARY INFORMATION:

Background

    The National Environmental Policy Act of 1969 (NEPA), as amended 
(42 U.S.C. 4321 et seq.), is the United States' basic charter for 
protection of the environment. The President's Council on Environmental 
Quality (CEQ) Regulations for Implementing the Procedural Provisions of 
the NEPA, published in 40 CFR parts 1500 through 1508 (referred to 
below as the CEQ regulations) regulate the implementation of NEPA 
across Federal agencies.
    The Office of the Secretary of the U.S. Department of Agriculture 
(USDA) has set forth departmental policy on the implementation of NEPA 
in 7 CFR part 1b. Within USDA, the Animal and Plant Health Inspection 
Service (APHIS) has regulations that set out its procedures for 
implementing NEPA in 7 CFR part 372 (referred to below as the 
regulations). APHIS' regulations are designed to ensure early and 
appropriate consideration of potential environmental effects when APHIS 
programs formulate policy and make decisions. The regulations also 
promote effective and efficient compliance with NEPA requirements and 
integration of other environmental review requirements under NEPA 
(e.g., 40 CFR 1500.2(c) and 40 CFR 1500.4(k)). Consistent with the 
requirements of the CEQ NEPA implementing regulations, the APHIS 
regulations supplement the CEQ regulations and the USDA NEPA 
implementing regulations to take into account APHIS missions, 
authorities, and decision-making. The APHIS regulations include 
definitions, categories of actions, major planning and decision points, 
opportunities for public involvement, and methods of processing 
different types of environmental documents.
    The APHIS regulations were last amended in a final rule published 
in the Federal Register on February 1, 1995 (60 FR 6000-6005, Docket 
No. 93-165-3; corrected on March 10, 1995, at 60 FR 13212). The CEQ 
regulations at 40 CFR 1507.3(a) indicate that agencies ``shall continue 
to review their policies and procedures and in consultation with the 
Council to revise them as necessary to ensure full compliance with the 
purposes and provisions of the Act.'' Since 1995, APHIS has begun 
several new types of actions (e.g., the Plant Protection Act of 2000) 
that are not covered in the current regulations, and gathered further 
data on the environmental impacts of those actions that are covered in 
the regulations. Accordingly, we have evaluated our regulations and 
identified changes that would reflect those new authorities, 
activities, and data. The changes we are proposing would also clarify 
certain areas of the regulations. APHIS has been and is consulting with 
CEQ regarding these changes, as required. In addition to reflecting 
APHIS' current responsibilities, the changes we are proposing reflect 
CEQ NEPA guidance that has been issued since the APHIS regulations were 
last amended. This guidance describes how Federal agencies can 
establish, revise, substantiate, and apply categorical exclusions, and 
how agencies can periodically review categorical exclusions to assure 
that they remain useful.\1\
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    \1\ You may view the CEQ guidance document on the Internet at 
https://ceq.doe.gov/ceq_regulations/NEPA_CE_Guidance_Nov232010.pdf.
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    NEPA and the CEQ regulations require all agencies of the Federal 
Government to include a detailed statement by the responsible official 
with every recommendation or report on proposals for legislation and 
other major Federal actions significantly affecting

[[Page 47052]]

the quality of the human environment. This statement must cover:
     The environmental impact of the proposed action,
     Any adverse environmental effects which cannot be avoided 
should the proposal be implemented,
     Reasonable alternatives to the proposed action,
     The relationship between local short-term uses of man's 
environment and the maintenance and enhancement of long-term 
productivity, and
     Any irreversible and irretrievable commitments of 
resources which would be involved in the proposed action should it be 
implemented.
    Such a detailed environmental statement is defined in the CEQ 
regulations as an environmental impact statement (EIS). The EIS is 
distinguished from the environmental assessment (EA), which is a 
concise public document that briefly provides sufficient evidence and 
analysis for determining whether to prepare an EIS or a finding of no 
significant impact (FONSI). Actions taken by an agency that do not 
individually or cumulatively have a significant effect on the human 
environment, may be categorically excluded from the requirement to 
prepare either an EA or an EIS.

Proposed Reorganization

    The CEQ regulations at 40 CFR 1507.3(b)(2) require agencies to 
develop specific criteria for and identification of those typical 
classes of action that normally require an EIS or an EA, as well as 
those that normally do not require further analysis in either an EIS or 
an EA and are thus categorically excludable actions. APHIS' regulations 
accomplishing this are currently found in Sec.  372.5, ``Classification 
of actions.''
    Since the last time the regulations were updated in 1995, APHIS has 
determined that many additional categories of APHIS actions can and 
should be categorically excluded. In addition, we are proposing to 
provide examples for broad categories of actions that would be 
categorically excluded and to further explain the process for using 
those categorical exclusions. For ease of reading, therefore, we are 
proposing to differentiate the categorical exclusions currently found 
in Sec.  372.5 into new sections. These new sections would be numbered 
Sec. Sec.  372.8 through 372.10 with 372.5 addressing environmental 
impact statements, 372.6 addressing environmental assessments, 372.7 
addressing categorical exclusions in general, and 372.8 through 372.10 
describing categorical exclusions. Consequently, current sections 
Sec. Sec.  372.6 through 372.10 would be redesignated. The proposed 
sections are listed in Table 1, along with the paragraph in current 
Sec.  372.5 to which they correspond.\2\
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    \2\ A detailed accounting of the rationale for each of the 
proposed changes may be found in the document entitled ``Proposed 
Amendments to National Environmental Policy Act Implementing 
Procedures (7 CFR part 372), Substantiating Document for Proposed 
Amendments,'' which is available on the Internet at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0049.

 Table 1--Current and Proposed Organization of Categories of Actions in
                         APHIS' NEPA Regulations
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                                                             Current
       Proposed section                  Title          paragraph(s)  in
                                                          Sec.   372.5
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372.5.........................  Actions normally        (a).
                                 requiring
                                 environmental impact
                                 statements.
372.6.........................  Actions normally        (b).
                                 requiring
                                 environmental
                                 assessments but not
                                 necessarily
                                 environmental impact
                                 statements.
372.7.........................  Categorical             Introductory
                                 exclusions; general     text of (c) and
                                 provisions.             (d), (d)(1).
372.8.........................  Categorical             (c)(1).
                                 exclusions;
                                 conventional measures.
372.9.........................  Categorical             (c)(3).
                                 exclusions;
                                 licensing,
                                 permitting, and
                                 authorization or
                                 approval.
372.10........................  Categorical             (c)(2), (c)(4).
                                 exclusions; other
                                 categories of actions.
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Actions Normally Requiring Environmental Impact Statements

    The introductory text of paragraph (a) of current Sec.  372.5 sets 
out a description of actions APHIS takes that normally require 
environmental impact statements.
    We are proposing to make several changes to the introductory text. 
First, we are proposing to refer to a category of actions rather than a 
class of actions. This change would be consistent with the CEQ 
regulations that use the phrase ``category of actions.'' We would make 
this change in the rest of our regulations as well.
    Second, rather than referring to policymakings and rulemakings, we 
are proposing to simply refer to ``actions.'' APHIS takes actions that 
are not policymakings or rulemakings but which could nevertheless have 
a significant impact on the human environment and thus warrant an EIS. 
For example, APHIS' Wildlife Services (WS) program prepared an EIS for 
gull hazard management actions at John F. Kennedy International 
Airport. These actions were not part of a policymaking or a rulemaking.
    We also are proposing to modify the regulations to add several 
types of EIS eligible actions. The current text indicates that risks to 
animal and plant health are the only reasons APHIS takes action. 
However, APHIS takes other types of actions, including those that 
protect or preserve property, natural resources, and human health and 
safety. For example, under the Plant Protection Act (7 U.S.C. 7701 et 
seq.), APHIS may designate a plant as a noxious weed based on the 
damage it causes to irrigation, navigation, the natural resources of 
the United States, the public health, or the environment, and may take 
action to address the weed's harmful effects. APHIS' Wildlife Services 
program also undertakes actions to manage wildlife damage in order to 
promote or protect human health and safety, such as actions to mitigate 
against the risk of bird strikes on airplanes or rabies in wildlife. We 
would add these actions to the regulations.
    The current text states that actions in this category are 
characterized by their broad scope and potential effect. We are 
proposing to qualify this statement by indicating that these 
characteristics typically characterize actions in this category. 
Sometimes, APHIS takes actions that have a broad scope, but whose 
impacts on the environment are not significant. The program to reduce 
the spread of rabies in wildlife is one example of such an action. The 
action may have a broad scope, but we can easily determine and 
characterize the likely potential effects as not significant.
    We are proposing to provide more detail on what we mean by 
potential effects on the human environment. We would specify that, for 
the purposes of determining whether an action warrants an EIS, we are 
interested in the intensity of the potential effects, which refers to

[[Page 47053]]

the severity of impact and is defined in 40 CFR 1508.27(b) where the 
regulations state that the following 10 factors should be considered in 
evaluating intensity: (1) Impacts that may be both beneficial and 
adverse. A significant effect may exist even if the Federal agency 
believes that on balance the effect will be beneficial; (2) The degree 
to which the proposed action affects public health or safety; (3) 
Unique characteristics of the geographic area such as proximity to 
historic or cultural resources, park lands, prime farmlands, wetlands, 
wild and scenic rivers, or ecologically critical areas; (4) The degree 
to which the effects on the quality of the human environment are likely 
to be highly controversial; (5) The degree to which the possible 
effects on the human environment are highly uncertain or involve unique 
or unknown risks; (6) The degree to which the action may establish a 
precedent for future actions with significant effects or represents a 
decision in principle about a future consideration; (7) Whether the 
action is related to other actions with individually insignificant but 
cumulatively significant impacts. Significance exists if it is 
reasonable to anticipate a cumulatively significant impact on the 
environment. Significance cannot be avoided by terming an action 
temporary or by breaking it down into small component parts; (8) The 
degree to which the action may adversely affect districts, sites, 
highways, structures, or objects listed in or eligible for listing in 
the National Register of Historic Places or may cause loss or 
destruction of significant scientific, cultural, or historical 
resources; (9) The degree to which the action may adversely affect an 
endangered or threatened species or its habitat that has been 
determined to be critical under the Endangered Species Act of 1973; and 
(10) Whether the action threatens a violation of Federal, State, or 
local law or requirements imposed for the protection of the 
environment. Instead of referring to environmental quality values, we 
would refer to environmental components, and give the examples of air, 
water, soil, plant communities, and animal populations. This change 
would add clarity to the regulations, as ``environmental quality 
values'' has proven to cause confusion. It would also increase 
transparency regarding those environmental elements we consider when 
writing an EIS. We would also provide an example of an indicator, 
including, but not limited to the dissolved oxygen content of water. 
These would help the reader to understand the types of effects we 
consider to determine when to prepare an EIS.
    We would remove the sentence that states that the use of new or 
untried methodologies, strategies, or techniques to deal with pervasive 
threats to animal and plant health would lead us to complete an EIS. 
The fact that a method is novel does not by itself mean its use will 
have significant environmental impacts warranting an EIS. For example, 
APHIS may develop a new method that involves noninvasive procedures or 
whose potential impacts, either positive or negative, are well 
understood. Neither of these actions would necessarily warrant an EIS.
    We would also remove the sentence stating that, for actions that 
warrant an EIS, alternative means of dealing with a threat to animal 
and plant health usually have not been well developed. The presence or 
absence of alternatives by themselves does not determine the potential 
impacts an agency action would have on the human environment.
    Paragraph (a)(1) of Sec.  372.5 currently lists ``formulation of 
contingent response strategies to combat future widespread outbreaks of 
animal and plant diseases'' as an action that might normally requires 
an EIS. This category of actions is still appropriate, and we would 
retain it. Paragraph (a)(2) of Sec.  372.5 would be slightly modified 
to read as follows: ``Adoption of strategic or other long-range plans 
that prescribe a preferred course of action for future actions 
implementing the plan.'' This modification more fully captures our 
intent that both the overarching strategic or long-range plan itself 
and actions taken to implement that plan should be considered in an 
EIS.
    The current categories of action that normally require an EIS would 
be found in paragraphs (a) and (b) of proposed Sec.  372.5.

Actions Normally Requiring Environmental Assessments But Not 
Necessarily Environmental Impact Statements

    The introductory text of paragraph (b) of current Sec.  372.5 sets 
out a description of actions APHIS takes that normally require 
environmental assessments but not necessarily environmental impact 
statements. We are proposing to make this text the introductory text of 
a new Sec.  372.6 and to make several changes to it.
    The current text explains that ``limited scope'' means actions 
involving particular sites, species, or activities. We would expand 
this explanation to add State-wide or district-wide programs. We have 
found that agency actions of this scope can typically be adequately 
assessed in an EA. We would also indicate that activities may involve a 
specific species or similar species. We have found that impacts 
associated with actions involving multiple, similar species are not 
significantly different than actions involving a particular species.
    We would expand the current discussion of potential effects. To 
contrast with our proposed text regarding actions that normally require 
an EIS, we would state that any effects of the action on environmental 
resources (such as air, water, soil, plant communities, animal 
populations, or others) or indicators (such as dissolved oxygen content 
of water) can be reasonably identified, and mitigation measures are 
generally available and have previously been successful. Again, the 
intensity and likelihood of the potential effects are our primary 
concern.
    We would remove the sentences discussing the novelty of 
methodologies, strategies, and techniques used to deal with issues and 
the alternative means of dealing with those issues, for the same 
reasons we would remove them in our discussion of the actions that 
normally require an EIS.
    Finally, the regulations currently list several categories of 
actions as actions that normally require an EA but not necessarily an 
EIS. However, within those general categories, there are several 
specific categories of action that we have determined should be subject 
to categorical exclusions.
    In current Sec.  372.5, paragraphs (b)(1) through (b)(5) list 
specific categories of actions that normally require an EA but not 
necessarily an EIS. Along with our proposed move of these categories to 
Sec.  372.6, we are proposing to remove one category, amend two of the 
other current categories, and add two new categories.
    Current paragraph (b)(1) lists 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 as actions that would 
normally require an EA. We would move this category to paragraph (a) in 
proposed Sec.  372.6 and add the word ``actions'' to ``policymakings 
and rulemakings.'' This change would ensure that the regulations 
reflect the broad range of activities for which APHIS prepares 
environmental compliance documentation.
    Paragraph (b)(2) of Sec.  372.5 lists planning, design, 
construction, or acquisition of new facilities, or proposals for 
modifications to existing facilities as actions that would normally

[[Page 47054]]

require an EA. We would move it to paragraph (b) of proposed Sec.  
372.6, but would otherwise leave it unchanged apart from specifying 
that the substantial modifications to existing facilities under 
discussion are also included.
    Paragraph (b)(3) of Sec.  372.5 lists the disposition of waste and 
other hazardous toxic materials at laboratories and other APHIS 
facilities, except when categorically excluded, as normally requiring 
an EA. We would move it to paragraph (c) of proposed Sec.  372.6, but 
would otherwise leave it unchanged.
    Paragraph (b)(4) of current Sec.  372.5 lists approvals and 
issuance of permits for proposals involving genetically engineered or 
nonindigenous species, except for actions that are categorically 
excluded, as normally requiring an EA but not necessarily an EIS. We 
are proposing to amend this category of action to include issuance of 
licenses, as well as permits, to reflect the terminology used by APHIS 
animal health and biotechnology programs as well as to specify that we 
are referring only to regulated genetically engineered or nonindigenous 
species. We would also move this category of action to paragraph (d) of 
proposed Sec.  372.6.
    We are proposing to add a new category of actions as paragraph (e) 
of proposed Sec.  372.6. This paragraph would indicate that programs to 
reduce damage or harm by a specific wildlife species or group of 
species (such as deer or birds), or to reduce a specific type of damage 
or harm, such as protection of agriculture from wildlife depredation 
and disease, management of rabies in wildlife, or protection of 
threatened or endangered species, normally require an EA but not 
necessarily an EIS. Such programs are managed by APHIS' WS program. 
Since 1994, WS has prepared and worked under hundreds of EAs for these 
types of program activities. WS' EAs for program activities include 
review of potential environmental impacts on target species, nontarget 
species including threatened and endangered species, aesthetic values, 
and any additional issues identified through the NEPA process. WS 
monitors impacts of actions taken under these EAs to ensure that the 
EAs' analyses continue to adequately evaluate program goals, actions, 
and impacts. In no instance have WS' monitoring evaluations indicated 
that WS' actions under these types of EAs had impacts warranting 
preparation of an EIS.\3\ For these reasons, we believe it is 
appropriate to establish this category of actions as requiring an EA 
but not necessarily an EIS.
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    \3\ For a current list and examples of active WS EAs, see http://www.aphis.usda.gov/regulations/ws/ws_nepa_environmental_documents.shtml.
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    Paragraph (b)(5) of Sec.  372.5 currently lists two examples of 
research and testing actions that normally require an EA: Research and 
testing that will be conducted outside of a laboratory or other 
containment area, and research and testing that reaches a stage of 
development (e.g., formulation of premarketing strategies) that 
forecasts an irretrievable commitment to the resulting products or 
technology. We are proposing to retain this category of action, as 
paragraph (f) of proposed Sec.  372.6.
    We would add a new category of action as paragraph (g): 
Determination of nonregulated status for genetically engineered 
organisms. Under current paragraph (b)(4) of Sec.  372.5, APHIS has 
been preparing EAs when it determines a genetically engineered organism 
is not a plant pest risk and does not present significant environmental 
impacts. However, determining that a genetically engineered organism 
should not be regulated is not an action that fits within the category 
of an approval or an issuance of a permit or license; such actions are 
addressed in the corresponding proposed paragraph (d) of Sec.  372.6. 
Adding this example as a separate paragraph would provide transparency 
and clarification about how APHIS addresses potential environmental 
impacts associated with actions on petitions for nonregulated status of 
genetically engineered organisms as described in 7 CFR 340.6. The 
significance factors listed in 40 CFR 1508.27 are considered when 
determining the appropriate environmental documentation for these 
actions, and our NEPA analyses have repeatedly demonstrated that the 
level of potential environmental impact is usually not significant, 
making an EA appropriate for such actions unless the significance 
factors listed in 40 CFR 1508.27 apply.\4\
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    \4\ You may view specific examples on the Internet at https://www.aphis.usda.gov/myportal/aphis/resources/lawsandregs/SA_Environmental_Protection/SA_Statutes/SupplementalNEPAAmendments.
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Categorical Exclusions; General Provisions

    The bulk of the changes we are proposing to the regulations relate 
to categorical exclusions. When experience and monitoring indicate that 
an action or a type of action does not have a significant or 
substantial impact on the human environment, establishing a categorical 
exclusion for that action benefits both APHIS and the public. Most 
actions APHIS takes are designed to prevent damage or harm to animals, 
plants, and human enterprises related to those animals and plants. 
Making these actions subject to a categorical exclusion, when 
appropriate, in accordance with criteria in Sec. Sec.  372.7 through 
372.10, benefits the human environment by allowing APHIS to take action 
to prevent or reduce the damage or harm more quickly than would be 
possible if the agency had to complete an EA or EIS for the action.
    Paragraph (a) of proposed Sec.  372.7 would set out general 
provisions for APHIS' use of categorical exclusions. Currently, these 
provisions are found in the introductory text of paragraph (c) of Sec.  
372.5. We would make two changes to the current provisions. First, the 
introductory text of this paragraph currently states that categorically 
excluded actions are similar to actions that normally require an EA but 
not necessarily an EIS in terms of their extent of program involvement 
and the scope and effect of and availability of alternatives to 
proposed actions. Because we are proposing to remove the text dealing 
with alternatives from the EIS and EA sections, we are proposing to 
remove it here as well.
    In addition, paragraph (c) of Sec.  372.5 currently states that the 
major difference between categorically excluded actions and actions 
that require an EA, but not necessarily an EIS, is that for 
categorically excluded actions, the means through which adverse 
environmental impacts may be avoided or minimized have actually been 
built into the actions themselves. The paragraph goes on to state that 
the efficacy of this approach generally has been established through 
testing and/or monitoring.
    We are proposing to indicate that mitigation measures alone are not 
the sole key factor. Rather, there are several key factors that we 
should consider when determining whether a category of actions is 
categorically excluded, which are (1) the extent to which mitigation 
measures to avoid or minimize adverse environmental impacts have been 
built into the actions themselves and, in some cases, standard 
operating procedures; (2) Agency expertise and experience implementing 
the actions; and (3) whether testing or monitoring have demonstrated 
there normally is no potential for significant environmental impacts.
    We would also add evaluation criteria which must be met prior to 
any determination of categorical exclusion. These would be found in new 
paragraphs 372.7(a)(1)(i) through (a)(1)(iii). The first evaluation 
criterion

[[Page 47055]]

is to determine whether the action has not been segmented in order to 
meet the definition of a categorical exclusion. Segmentation may occur 
when an action is intentionally broken down into component parts in 
order to avoid the appearance of significance of the total action. The 
second evaluation criterion would be to determine whether any 
extraordinary circumstances exist that would require us to preclude the 
use of a categorical exclusion. An example of an extraordinary 
circumstance would be when a proposed action that is normally 
categorically excluded may have the potential for significant adverse 
environmental impacts to nontarget species. The third evaluation 
criterion would be whether the action occurs in a limited area, does 
not permanently adversely affect the area, and is performed with well-
established procedures (e.g., permits for GE organism field testing 
under specified conditions).
    These changes would emphasize that actions we take do not 
individually or cumulatively have a significant effect on the 
environment, as demonstrated through long-term application or testing 
and monitoring, without the need to build in means to avoid or minimize 
environmental impacts. Many examples of such actions will be discussed 
later in this document.
    Paragraph (d) of current Sec.  372.5 discusses exceptions for 
categorically excluded actions and lists examples of such exceptions. 
As part of our reorganization of the list of actions subject to 
categorical exclusions, we are proposing to list common exceptions to 
categorical exclusions next to the categorical exclusions themselves in 
the regulatory text. We hope that this change would highlight the 
potential exceptions for users of the regulations. We are proposing to 
refer to such exceptions as ``extraordinary circumstances,'' consistent 
with CEQ's instructions in the definition of ``categorical exclusion'' 
in 40 CFR 1508.4 to provide for ``extraordinary circumstances in which 
a normally excluded action may have a significant environmental 
effect.'' (In Sec.  372.4, which contains definitions of various terms 
used in the APHIS NEPA implementing regulations, we would add a 
definition of extraordinary circumstances, which would be consistent 
with the CEQ regulations.)
    We would retain the introductory text of paragraph (d) of current 
Sec.  372.5 as paragraph (b) of proposed Sec.  372.7. It would continue 
to indicate that, whenever the Agency official responsible for 
environmental review determines that a categorically excluded action 
may have the potential to significantly affect the quality of the human 
environment, an EA or an EIS will be prepared. (In Sec.  372.4, which 
contains definitions of various terms used in the APHIS NEPA 
implementing regulations, we would add a definition of Agency official 
responsible for environmental review, which would be consistent with 
the CEQ regulations.)
    We are also proposing to add a new paragraph Sec.  372.7(c), which 
would describe the extraordinary circumstances for individual 
categorically excluded actions that would preclude the use of a 
categorical exclusion. A list of specific extraordinary circumstances 
for these actions would be provided in paragraphs (c)(1) through 
(c)(17).
    Please note that the following sections include examples of 
activities that we expect would result in categorical exclusions. These 
lists are not intended to be comprehensive accounts of all possible 
categorical exclusions. Any activity not listed would still have to 
meet the requirements for a categorical exclusion.

Categorical Exclusions; Conventional Measures

    Paragraph (c)(1) of Sec.  372.5 currently lists various 
categorically excluded actions under the heading of ``routine 
measures.'' We are proposing to list such measures, and explanations 
and examples of such measures, in a new Sec.  372.8.
    As described in current paragraph (c)(1), routine measures include 
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. The designation 
of these measures as ``routine'' has caused some uncertainty among 
agency personnel and the public. Certain actions that APHIS performs on 
a regular basis may nonetheless require us to prepare an EA or EIS each 
time we perform them, depending on the potential for the actions to 
significantly affect the human environment. What the current 
regulations describe is an action that occurs in a limited area, does 
not permanently adversely affect the area, and is performed in 
accordance with well-established procedures. We believe that a better 
description for such measures is ``conventional.'' Therefore, we are 
proposing to refer to such measures as conventional measures both in 
our proposed description of general extraordinary circumstances for 
conventional measures in proposed Sec.  372.7(c) and in proposed Sec.  
372.8.
    We are proposing to change the current list of conventional 
measures slightly. The current list includes sampling that does not 
cause physical alteration of the environment. We are proposing to 
instead refer to monitoring, including surveys and surveillance, that 
does not cause physical alteration of the environment. This terminology 
is more commonly used within and outside APHIS to describe these 
activities, which will be discussed in more detail later in this 
document.
    Paragraph (c)(1) of current Sec.  372.5 goes on to describe the 
appropriate use of chemicals and other products as part of routine 
measures. Specifically, it states that 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 certain criteria.
    In paragraph (a) of proposed Sec.  372.8, we are proposing to 
expand the list of substances that may be used as part of a 
conventional measure, subject to certain conditions, to include the use 
of pesticides, chemicals, drugs, pheromones, contraceptives, or other 
potentially harmful substances, materials, and target-specific devices 
or remedies.
    APHIS uses contraceptives, such as GonaCon, to manage populations 
of animals and mitigate their impacts on the environment and natural 
resources. APHIS uses drugs, such as the nonlethal sedative alpha 
chloralose, to temporarily immobilize animals for relocation or other 
management. Previous APHIS NEPA evaluations concluded that normal use 
patterns of both contraceptives and drugs do not individually or 
cumulatively have a significant effect on the human environment based 
on the limited duration and scope of their use and the design of the 
contraceptives and drugs, which limit effects on nontarget species.
    APHIS uses pheromones to control plant pests; the pheromones mask 
the chemical scent of the target organism, making it difficult for the 
organism to find mates and reproduce. As long as pheromones are used in 
accordance with Environmental Protection Agency (EPA) labeling 
requirements, we have found that they do not individually or 
cumulatively have a significant effect on the human environment. In 
practice, we expect pheromones to have

[[Page 47056]]

substantially less potential for adverse impacts than other chemical 
controls, given that they are highly species-specific and have 
extremely low toxicity to people and organisms (including target and 
nontarget organisms).
    The introductory text of current Sec.  372.5(c)(1) indicates that 
potentially harmful substances must be used according to any label 
instructions or other lawful requirements and consistent with standard, 
published program practices and precautions. We would retain this 
language in proposed Sec.  372.8(a).
    Paragraphs (c)(1)(ii)(A) through (c)(1)(ii)(C) of current Sec.  
372.5 contain three examples of routine measures. To assure clarity, we 
are proposing to explain in proposed Sec.  372.8 every conventional 
measure listed in the introductory text and to provide examples of each 
conventional measure. These explanations and examples can be found in 
paragraphs (b) through (l) of proposed Sec.  372.8. The proposed lists 
of examples are intended to illustrate each of the conventional 
measures, not to be exhaustive. The proposed conventional measures and 
their explanations and examples are discussed below.
    Identifications. Identifications would include detection and 
identification of premises or animals, or identification of organisms, 
diseases, or species causing damage or harm. These processes in and of 
themselves do not have any significant impacts on the human 
environment. Examples would include, but would not be limited to: 
Issuance of a specific identification number and application of 
commodity labels, animal tags, radio transmitters, microchips, and 
chemicals (such as tetracycline or rhodamine B ingestion).
    Inspections. Inspections would include inspections of articles 
(including fruits and vegetables) to determine if there are any plant 
pests present, which could involve cutting fruit for inspection; the 
physical inspection of animals upon entry into the United States; 
facility and records inspections; or inspections of commodities, 
facilities, or fields, including paperwork and records, for approval 
and to assure compliance with regulations and program standards. 
Inspections usually follow a prescribed protocol and document findings 
on an inspection report form. Examples would include, but would not be 
limited to, the physical examination of plants, plant products, and 
animals at the port of entry; review of containment facilities; and 
review of paperwork and records to assure compliance with program 
regulations and standards.
    Inspection methods typically rely on visual observation or 
destruction of a small number of subsamples (for example, cutting of 
fruit to detect larvae) and do not individually or cumulatively have a 
significant effect on the human environment. Inspection of animals 
usually involves restraint, which is performed following established 
animal care and animal welfare guidelines. Inspection may also involve 
visual inspection of facilities, such as inspection of facilities 
holding animals covered under the Animal Welfare Act to verify that the 
animals are being held in compliance with the regulations promulgated 
under that act, inspection of packinghouses to verify compliance with 
plant health regulations, or inspections of facilities performing 
animal health work. These activities are not expected to have any 
impact on the human environment, and years of data have indicated that 
they do not.
    Monitoring, including surveys, surveillance, and trapping, that 
does not cause physical alteration of the environment. Surveys would 
include questionnaires to collect information and data to assess a 
current state or trend in activities, to determine compliance, or to 
determine whether a pest or disease exists in a specific area. Surveys 
are administrative processes only and thus do not individually or 
cumulatively have a significant effect on the human environment.
    Surveillance would include activities to collect test samples from 
part or all of the target population using routine collection 
techniques. Monitoring and surveillance generally involves limited 
numbers of animals (relative to State and regional populations) and a 
limited area. If warranted, inspection may involve the collection of a 
biological sample for submission to a laboratory for diagnostic 
testing. The quantity of any biologic samples collected is negligible 
(for example, 2 to 5 milliliters of blood, a punch biopsy, or a swab). 
Monitoring chemical residue involves the collection of small samples of 
environmental components (for example, water, leaves, or soil) to test 
for the presence of a chemical. Sample collection occurs at limited 
locations and times. These are standard practices used by scientists 
daily with no impact to the environment being sampled or to people.
    Trapping would be described as the use of capture devices that are 
designed to efficiently capture, restrain, or kill targeted individual 
animals or a group of animals (e.g., fruit flies and other insects, a 
raccoon, a sounder of feral swine). Capture devices used in trapping 
would be described as foothold; cage; drive; quick-kill; pit (for 
insects and some small rodents, reptiles and amphibians); insect and 
sticky traps; snares and other cable restraints; nets; hands; contained 
animal drugs (e.g., dart guns, tranquilizer tab devices); and 
insecticides. Attractants used with some types of trapping are food, 
odor baits or lures, pheromones, shapes, and colors. Only organisms 
that become caught in the trap are affected. While some nontarget 
captures may be inevitable, the design of the traps minimizes this 
effect. Nevertheless, the capture of even a small number of federally 
listed threatened or endangered species is of concern. To address such 
captures, APHIS would conduct an Endangered Species Act (ESA) analysis. 
If the ESA analysis and other NEPA reviews indicate that the viability 
of a nontarget species population could be affected, we would prepare 
an EA for trapping.
    Examples of these activities would include, but would not be 
limited to:
     Collection of biological or environmental samples such as 
tissue, soil, or water samples and samples of fecal matter.
     Continual checking, by testing, trapping, or observing for 
the presence, absence, or prevalence of animals, pests, or disease. 
This information may be used to support a pest or disease status (such 
as pest-free or disease-free status).
     Surveying and monitoring for disease may or may not 
require the lethal removal of the animal and can often be conducted 
using nonlethal methods, such as collection of samples from animals 
killed or removed for reason related to disease monitoring (i.e., 
damage management action addressed in an EA, or hunter-killed animals).
     Randomly selecting animals and obtaining blood samples to 
survey for disease, or collection of test samples.
    Testing. Testing would be described as the examination or analysis 
of a collected sample. This activity often occurs in a laboratory, but 
also includes nonlethal tests that require animal-side or chute-side 
injection and observation in the field. Testing may require the use of 
specialized equipment and/or diagnostic test kits. APHIS programs 
conduct testing using standard operating procedures that are designed 
to eliminate the potential for harmful environmental effects, and years 
of monitoring have indicated that testing itself does not have any 
effect on the human environment. Examples would include, but would not 
be limited to, intradermal tuberculosis testing of

[[Page 47057]]

livestock and germplasm testing of plant material for viral infections.
    Seizures. Seizures would include taking possession of conveyances, 
materials, regulated articles, plants and plant products, animals and 
animal products, other articles infested with a pest or determined to 
be diseased or exposed to a disease, a regulated article that is mixed 
in a commodity, or contaminated shipping material. APHIS programs seize 
articles to prevent the importation or interstate movement of articles 
that could introduce or spread pests or diseases, or to prevent the 
movement of articles whose movement is not authorized because its risk 
has not been determined. The act of seizing an article simply results 
in a change of the entity with control of the article and, in itself, 
has no significant impacts on the environment. Examples of seizures 
would include, but would not be limited to:
     Confiscation of a commodity that could be a vector for a 
plant or animal disease or pest, or an animal or plant determined to be 
infested, infected, exposed, or not in compliance with APHIS 
regulations (such as one moved illegally or without proper paperwork).
     Seizure of a nonregulated commodity, seed, or propagative 
material containing regulated genetically engineered material.
    Quarantines. Quarantines would be described as actions to restrict 
or prohibit movement from an area, including the creation, expansion, 
removal, or modification of quarantines. Stopping or otherwise 
restricting the movement of animals, plants, or other regulated 
articles has no impact on human health or the environment and therefore 
falls within the definition of ``categorical exclusion'' in 40 CFR 
1508.4.
    The proposed regulations would state that the establishment of a 
quarantine can include mitigations to allow for movement of animals or 
commodities while preventing the spread of the animal or plant pest or 
disease; for example, we may require chemical treatment of regulated 
articles that are moved from the quarantined area to ensure that the 
articles do not spread a pest. Such mitigations would be evaluated 
separately from the establishment of the quarantine itself, which would 
be covered by this categorical exclusion.
    Examples of quarantines are:
     Quarantine of an area in which a pest or disease is known 
to occur to prevent movement of animals, plants, or other articles 
whose movement could spread the pest or disease.
     Changes in pest or disease status for an area or country, 
such as expansion or rescission of existing quarantines.
     Removal of quarantine restrictions when APHIS determines 
that it is appropriate to do so.
    Removals. Removals would include the relocation or lethal removal 
of living organisms, or destruction of materials. Only when the 
magnitude and scope of the removal is limited would a removal qualify 
as a categorical exclusion, among other things. In such circumstances, 
removals do not individually or cumulatively have a significant impact 
on the human environment. (As noted earlier, an EA or EIS would be 
prepared when any conventional measure, the incremental impact of 
which, when added to other past, present, and reasonably foreseeable 
future actions, has the potential for significant environmental 
impact.)
    Some of the examples for removals would indicate the specific 
circumstances in which a removal would qualify for a categorical 
exclusion. In addition, a few of the proposed examples of removals have 
extraordinary circumstances in which they would not be eligible for a 
categorical exclusion.
    Examples of removals that qualify for a categorical exclusion would 
include, but would not be limited to:
     Removal of animals in accordance with permits and 
agreements from the appropriate management agencies, or otherwise in 
accordance with regulations governing management of a species, for the 
purpose of approved research studies, surveillance and monitoring, or 
disease or damage management, or due to pest concerns. Such movement is 
typically for quarantine or testing purposes. Most confirmed cases of 
disease involve a very limited number of animals; therefore, the impact 
to the total population is negligible, especially in comparison to the 
potential number of animals that could be affected if the diseased 
animals are not removed.
     Removal of animals or material from premeses.
     Removal of trees or shrubs and plants.
     Disposal or destruction of materials for which the Agency 
has regulatory authority due to, for example, completion of 
acknowledged or permitted activities, completion of regulated 
activities, or noncompliance and disposal of animals. This could 
include disposal of regulated articles (fruit, meat, regulated 
genetically engineered organisms, etc.) at ports of entry designated by 
U.S. Customs and Border Protection. Approved methods of disposal would 
range from burial, feeding to animals, composting, to co-burning for 
power generation. These removals would be considered on a case-by-case 
basis and only when they are standalone actions, not tied to additional 
control activities on a larger scale.
     Routine disposal of carcasses using other approved 
methods, such as donation for human consumption, composting, chemical 
digestion, burial, and incineration. Carcass and waste material 
disposal is conducted in appropriately licensed and approved 
facilities, or in accordance with appropriate Federal, State and local 
restrictions and regulations, so any impact to human health, animal 
health, or the environment has been mitigated.
     Depopulation of domestic livestock and captive wildlife 
due to the presence of an animal disease or the reasonable suspicion of 
the presence of an animal disease. An extraordinary circumstance would 
apply, and we would prepare an EIS, if an outbreak of an animal disease 
would require the depopulation of a large number of animals potentially 
resulting in substantial or significant adverse impacts on the human 
environment.
    Sanitizing, cleaning, and disinfection. This category of actions 
would include treatment of an infested commodity (such as fruits or 
vegetables), cleaning and disinfection that occurs when a disease is 
found or there is an emergency disease outbreak, treatment of a 
regulated article, or treatment of carcasses for disposal. Any 
treatment or cleaning and disinfection that uses chemicals, pesticides, 
or other products would have to be conducted in accordance with the 
criteria for the use of such substances at the beginning of proposed 
Sec.  372.8 in order to be eligible for a categorical exclusion. Since 
such products are used in accordance with applicable label 
instructions, there should be no significant impact on the human 
environment. Nonchemical treatments, such as cold treatment or hot 
water dip treatment, are conducted in enclosed, temperature-controlled 
environments that do not affect the natural environment. Examples of 
sanitizing, cleaning, and disinfection would include, but would not be 
limited to:
     Treatment of regulated articles at existing facilities, 
such as irradiation treatment and methyl bromide special use treatment. 
For example, irradiation treatment is conducted in approved facilities 
that must be approved by other Federal and State agencies as 
sufficiently isolated from the

[[Page 47058]]

surrounding environment that the use of irradiation does not have a 
significant impact.
     Treatment of a facility, container, or cargo hold at the 
port of entry to mitigate pest threats.
     Cleaning and disinfection of equipment, cages, facilities, 
or premises.
     Treatment of animal carcasses, using methods such as 
incineration, alkaline digestion, or rendering as a method to 
devitalize infectious material.
    Inoculations. An inoculation would be described as the introduction 
of a pathogen or antigen into a living organism in order to invoke an 
immune response to treat or prevent a disease. Inoculations are 
administered to individual identifiable organisms at limited locations 
and times to produce internal immune responses. The limited scope and 
timespan of inoculations means that they do not individually or 
cumulatively have a significant effect on the human environment. 
Examples are:
     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).
     Use of vaccinations or inoculations, including new 
vaccines (including genetically engineered vaccines) and applications 
of existing vaccines to new species provided that the project is 
conducted in a controlled and limited manner, and the impacts of the 
vaccine can be predicted. An extraordinary circumstance would apply if 
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. (This extraordinary 
circumstance comes from current paragraph (d)(2) of Sec.  372.5.)
    Animal handling and management. This would include nonlethal 
methods not addressed elsewhere in part 372 that are used to prevent, 
monitor for, reduce, or stop disease, damage, or harm caused by 
animals. (Some animal handling and management methods, such as removal 
and testing, are addressed earlier in proposed Sec.  372.8.) APHIS' WS 
program has conducted many EAs examining the use of nonlethal animal 
handling and management methods in the context of State-wide programs. 
These EAs concluded that such methods have no significant impact on the 
human environment and resulted in FONSIs. Similarly, APHIS' Veterinary 
Services (VS) program may require livestock producers within 
quarantined areas to use generally accepted biosecurity practices as 
part of a disease control or eradication program. As these practices 
are designed to prevent the spread of animal disease, and as they are 
conducted in accordance with applicable Federal, State, and local 
regulations, they do not have a significant impact, as demonstrated by 
the findings of VS's EAs and FONSIs. Examples of animal handling 
methods included in this categorical exclusion include, but are not 
limited to:
     Restraining or handling livestock, poultry, or wildlife to 
facilitate examination or other activities.
     Cultural methods and basic habitat management such as 
nonlethal management activities such as removal of food sources, 
modification of planting systems, modification of animal husbandry 
practices, water control devices for beaver dams, limited beaver dam 
removal, and pruning trees.
     Site-specific applications of nonlethal wildlife damage 
management practices such as frightening devices, exclusion, capture 
and release, and capture and relocation.
    Recordkeeping and labeling. This categorical exclusion would cover 
requiring regulated parties to keep records demonstrating compliance 
with APHIS requirements or to label regulated articles to indicate 
compliance or set out restrictions on the movement of the article. 
Recordkeeping and labeling are used as part of other measures or 
programs to ensure documentation of events in compliance with the 
regulations and other requirements. Recordkeeping and labeling thus 
facilitate compliance and enforcement. Such activities involve 
paperwork only and thus are not expected to have an impact on the human 
environment. Examples include, but are not limited to requiring 
regulated parties to:
     Maintain records documenting the results of trapping for 
insects.
     Maintain records of the application of treatments.
     Prepare labels indicating that the movement of a regulated 
article to certain areas within the United States is illegal.
     Retain records at approved livestock facilities and listed 
slaughtering or rendering establishments under 9 CFR part 71.

Categorical Exclusions; Licensing, Permitting, Authorization, and 
Approval

    Paragraph (c)(3) of Sec.  372.5 currently lists various 
categorically excluded actions under the heading of ``licensing and 
permitting.'' We are proposing to list such actions, expanded to 
include authorizations and approvals as well as licensing and 
permitting, in a new Sec.  372.9.
    The introductory text of proposed Sec.  372.9 would indicate that 
licensing and permitting refers to the issuance of a license, permit, 
or authorization to entities, including individuals, manufacturers, 
distributors, agencies, organizations, or universities for field 
testing, environmental release, or importation or movement of animals; 
plants; animal, plant, or veterinary biological products; or any other 
regulated article. Authorization and approval would be for an entity to 
participate in a program or perform an action.
    Generally, APHIS has put in place restrictions on the importation 
and interstate movement of many articles to prevent the introduction or 
dissemination within the United States of animal and plant pests and 
diseases. Decisions to allow the importation or interstate movement of 
such articles are made only after determining that any risk presented 
by the movement of the article has been adequately mitigated. Such 
actions therefore would not be expected to have a significant impact on 
the human environment.
    APHIS also licenses, authorizes, or approves entities to carry out 
activities to further their purposes or goals. Such licensing, 
authorization, or approval is done only when APHIS has determined that 
the entity will effectively fulfill its designated responsibilities. 
These actions are administrative for the agency, and generally occur in 
support of actions that undergo programmatic analysis in an EIS or EA. 
To require a separate NEPA analysis for each license, authorization, or 
approval would not allow expedient action to serve the public, and 
would promote piece-meal analyses. Even collectively, these licenses, 
authorizations, and approvals are not expected to individually or 
cumulatively have significant effect on the human environment because 
they are part of programs where mitigations reduce potential effects.
    We are proposing to list specific examples of these actions, 
organized by APHIS program area, in paragraphs (a) through (c) of 
proposed Sec.  372.9. Paragraph (a) would set out examples of animal 
health-related actions. These are:
     Approval of interstate movement or importation of animals 
via regulations or permits. APHIS' VS program approves such movement 
based on the requirements set forth in the Federal disease program 
regulations as reflected in the 9 CFR. Risk assessments provide the 
basis for determining the

[[Page 47059]]

requirements. Examples of how VS issues approvals would include:
    [cir] Use of permits to control the interstate movement of 
restricted animals, such as issuance of an official document or a State 
form allowing the movement of restricted animals to a particular 
destination.
    [cir] Use of permits for entry, such as pre-movement authorization 
for entry of animals into a State from the State animal health official 
of the State of destination.
    [cir] Approval of international movements through the use of import 
and export health certificates and import or export movement permits.
    [cir] Authorization to move animals out of the quarantine or buffer 
zone for cattle fever ticks by documentation (a State form) that 
confirms the animals have been inspected and found to be tick-free.
     Licensing of swine garbage feeding operations. This 
licensing occurs after a site visit finds and documents that all 
applicable requirements (9 CFR part 166--Swine Health Protection) have 
been met, ensuring that the operations will conduct this activity 
properly and thus will have no impact on the human environment.
     Accreditation of private veterinarians. VS accredits 
veterinarians only if they are licensed and only after they complete an 
orientation, certify that they can complete certain tasks, and meet 
other requirements.
     Approval and permitting of laboratories to conduct 
official tests. VS approves laboratories to conduct official tests only 
after a site visit verifies that the tests are being conducted, 
recorded, and reported properly. Proper testing procedures reduce the 
overall likelihood that an animal disease could have an impact on the 
human environment by ensuring correct and timely identification of 
disease threats.
     Approval of identification manufacturers to produce 
identification, tests, and identification devices.
     Listing of slaughter and rendering establishments for 
surveillance under 9 CFR 71.21. The regulations in 9 CFR 71.21 require 
listed establishments to allow personnel from APHIS and the USDA's Food 
Safety and Inspection Service to conduct surveillance at the 
establishments.
     Approval of herd and premises plans that have 
environmental or waste management components. VS develops herd and 
premises plans in response to findings of disease in a herd or on a 
premises. The plans are designed to ensure that the herds remain 
disease-free and that animals can be safely introduced or reintroduced 
to the premises. Herd and premises plans may include cleaning and 
disinfection requirements. All cleaning and disinfection performed with 
cleaners and chemical disinfectants would need to be in compliance with 
our proposed requirements for the use of such substances as part of 
conventional measures, discussed earlier in this document. Herd and 
premises plans may also include environmental and waste management 
requirements to address the presence of disease, such as the removal of 
all manure, some removal of a certain depth of topsoil in a feedyard, 
spreading of lime on the soil to make the soil too basic for the 
organism to survive, or, as is often recommended, simply letting the 
pastures lay dormant (without livestock) and exposed to natural 
sunlight to assure elimination of the disease organism over time. For 
the reasons mentioned above, these practices are not expected 
individually or cumulatively to have a significant impact on the human 
environment.
     Approval of herd accreditation for tuberculosis or 
certification for brucellosis to document the herd's freedom from 
disease. This is an administrative action that poses no adverse impacts 
to the environment.
     Funding the depopulation of diseased herds, including 
indemnity and carcass disposal; authorization and funding of the 
collection and submission of tissue samples for testing. These are 
decisions that allow VS to undertake certain conventional measures 
described in proposed Sec.  372.8, such as removals and implementation 
of biosecurity methods.
     Approval of participation in the National Poultry 
Improvement Plan (the Plan) by issuance of a permanent approval number 
in accordance with 9 CFR 145.4. This is an administrative action taken 
after VS has determined that a flock owner is qualified to participate 
in the Plan.
     Currently, paragraph (c)(3)(i) of Sec.  372.5 sets out a 
categorical exclusion for the issuance of a license, permit, or 
authorization to ship for field testing previously unlicensed 
veterinary biological products. We are proposing to amend this 
categorical exclusion in several ways. First, we are proposing to 
separate authorization to ship for field testing from issuance of a 
license or permit. Typically, field testing must occur before a license 
or permit can be issued, assuming the veterinary biological product 
meets the requirements of the regulations. We would list these actions 
in two separate categorical exclusions. Second, we would expand these 
categorical exclusions to explicitly include previously unlicensed 
veterinary biological products containing genetically engineered 
organisms, such as vector-based vaccines and nucleic acid-based 
vaccines. Although such field testing could be considered to be 
included in the current categorical exclusion, VS' Center for 
Veterinary Biologics (CVB) has been completing EAs for such activities 
as a matter of policy, due to uncertainty about the environmental 
effects associated with the use of genetically engineered organisms. 
Accordingly, CVB has completed risk assessments and EAs for numerous 
vaccines containing genetically engineered organisms. The routine 
licensing requirements of CVB, which apply to these vaccines as well, 
ensure the vaccines' purity, identity, safety, potency, and efficacy. 
All of the EAs prepared for vaccines containing genetically engineered 
organisms have resulted in findings of no significant impact, and 
subsequent monitoring has not identified any impact these vaccines have 
had on the human environment. Accordingly, we believe it is appropriate 
to include these types of vaccines in the proposed categorical 
exclusions. The new categorical exclusions would read: ``Authorization 
to ship and field test previously unlicensed veterinary biologics 
including veterinary biologics containing genetically engineered 
organisms (such as vector-based vaccines and nucleic-acid based 
vaccines)'' and ``Issuance of a license or permit for previously 
unlicensed veterinary biologics including veterinary biologics 
containing genetically engineered organisms (such as vector-based 
vaccines and nucleic-acid based vaccines).'' Such categorical 
exclusions are based on field safety data and laboratory testing 
conducted since CVB's inception in 1976. In addition, just because an 
action qualifies for a categorical exclusion, it will be examined. In 
the unlikely event that there were a vaccine with GE organisms that 
were deemed likely to signifantly impact the human environment, the EA 
process would be initiated.
     Current paragraph (d)(3) of Sec.  372.5 provides an 
extraordinary circumstance for the issuance of licenses, permits, or 
authorizations for shipping and field testing previously unlicensed 
veterinary biologics. The extraordinary circumstance applies when a 
previously unlicensed veterinary biological product to be shipped for 
field testing contains live micro-organisms or will not be used 
exclusively for in vitro diagnostic testing. However, as described 
above,

[[Page 47060]]

we have prepared extensive environmental documentation for the testing 
of such products and have not found there to be a significant impact on 
the human environment. Accordingly, we are not including this 
extraordinary circumstance in the current proposal.
     Currently, paragraph (c)(3)(iii)(C) of Sec.  372.5 sets 
out a categorical exclusion for permitting of releases into a State's 
environment of pure cultures of organisms that are either native or are 
established introductions. With respect to VS activities, the term 
``pure cultures'' refers to seeds that are used to manufacture 
veterinary biologics. In accordance with the definition of ``pure'' 
found in 9 CFR 101.5(c), they must be tested as determined by test 
methods or procedures established by APHIS and found relatively free of 
extraneous micro-organisms and extraneous material (organic or 
inorganic).
    We are proposing to make minor changes to this categorical 
exclusion. First, we would indicate that the issuance of any license, 
permit, authorization, or approval for the use of a pure culture would 
be subject to a categorical exclusion, to cover all possible uses. 
Second, we would add a parenthetical explaining that pure cultures are 
relatively free of extraneous micro-organisms and extraneous material. 
Third, rather than refer to cultures that are ``native or established 
introductions,'' we would instead refer to cultures that occur or are 
likely to occur in a State's environment. It is not necessary for the 
purposes of assessing environmental impact to distinguish between 
native organisms and established introductions of organisms, since both 
occur in the environment, making it unlikely for the release of a pure 
culture to have environmental impacts. We would determine whether an 
organism is likely to occur in a State based on the known distribution 
of the organism, environmental factors, and any other available 
evidence. For example, if an organism is present in all the surrounding 
States, it is likely to occur in the surrounded State even if the 
organism has not been reported there. The use of a pure culture of an 
organism in a State where the organism is likely to occur is not 
expected to have significant environmental effects due to the presumed 
previous presence of the organism. Finally, we would add a qualifier to 
the existing categorical exclusion indicating that the release of a 
pure culture of an organism would not qualify for a categorical 
exclusion if the organism is of quarantine concern. Organisms of 
quarantine concern are typically subject to control or eradication 
efforts to prevent impacts on the environment, and releases of pure 
cultures of such organisms could hinder such efforts.
    The revised categorical exclusion would read: ``Issuance of a 
license, permit, authorization, or approval for uses of pure cultures 
of organisms (relatively free of extraneous micro-organisms and 
extraneous material) that are not strains of quarantine concern and 
occur or are likely to occur in a State's environment.''
     Issuance of permits and approval of facilities to import, 
transport, introduce, or release live animals and products or 
byproducts thereof, or other organisms for which proven risk mitigation 
measures are applied and will require no substantial modification for 
the specific articles under consideration. This would include 
importation or interstate movement of meat, milk/milk products, eggs, 
hides, bones, animal tissue extracts, etc., which present no disease 
risk or for which there are proven animal disease risk mitigation 
measures, such as heating, acidification, or standard chemical 
treatment. VS has developed common mitigations for many diseases, 
including sourcing only from healthy animals and from regions free of 
diseases of concern, quarantine and testing samples for evidence of 
disease, laboratory containment, and product processing procedures such 
as heating (including cooking or pasteurization), acidification, 
curing, storage, standard chemical treatment, and purification. VS 
conducts extensive monitoring of animal diseases to verify the efficacy 
of its disease mitigation approaches.
    Paragraph (b) of proposed Sec.  372.9 would set out examples of 
plant health-related actions that would be categorically excluded. 
These would include, but would not be limited to:
     Issuance of permits under 7 CFR part 330 for the 
importation or interstate movement of organisms into containment 
facilities, for the interstate movement of organisms between 
containment facilities, and continued maintenance and use of these 
organisms. The regulations in 7 CFR part 330 govern the importation and 
interstate movement of plant pests. Such pests, when imported or moved 
interstate, must be moved into containment facilities designed to 
prevent the escape of the pests into the surrounding environment. 
APHIS' Plant Protection and Quarantine (PPQ) program also amends 
permits to allow permit holders to continue to keep pests at the 
facility to which they have been transported. PPQ operates a compliance 
and enforcement program that involves reporting, periodic inspections, 
and consequences for variance from required features and procedures, up 
to and including destruction of organisms. In the last decade, there 
has been no evidence indicating that the issuance of such permits has 
any adverse environmental impacts. Therefore, the continued permitting 
for the importation and interstate movement of organisms in accordance 
with 7 CFR part 330 is not expected to have significant environmental 
effects.
     Issuance of permits for the use of organisms biologically 
incapable of persisting in the permitted environment. PPQ may permit 
the use of organisms under 7 CFR part 330 based on the environment 
surrounding the facility and using information about distribution, 
biology, and climate tolerances of organisms to ensure mismatch to the 
climate and season of release. For example, tropical organisms might be 
subject to a winter study in a greenhouse, or field study only in 
northern, temperate areas. Because the organisms are unable to persist 
in the permitted environment and are maintained in compliance with 
permit conditions, issuance of the permits is not expected individually 
or cumulatively to have a significant effect on the human environment.
     As noted earlier, paragraph (c)(3)(iii)(C) of Sec.  372.5 
currently provides a categorical exclusion for permitting of releases 
into a State's environment of pure cultures of organisms that are 
either native or are established introductions. Besides veterinary 
biologics, this categorical exclusion also applies to release of pure 
cultures of organisms to be released as biological control agents. 
However, the activities have some major differences, and we are 
therefore proposing to separate the current categorical exclusion into 
two separate exclusions.
    In the area of biological control, a ``pure culture'' is loosely 
defined to include field collections of predators and parasites that 
are identified on sight as the desired organism. There is no reason or 
need to ``sterilize'' or remove contaminants prior to re-release.
    Rather than refer to cultures that are ``native or established 
introductions,'' we would instead refer to organisms that occur, or are 
likely to occur, in a State's environment. For the purposes of 
assessing environmental impact, distinguishing between native organisms 
and established introductions of organisms would require identification 
of distinguishing traits. These types of traits may not exist, and even 
if they do exist, would require specific testing to confirm. 
Additionally,

[[Page 47061]]

gaps in the reported distributions in the scientific literature remain 
because often there are few incentives to publish ``new finds'' of an 
organism in a State. Based on the last decade of permitting experience, 
when contiguous States have confirmed reports of the organism, the 
release of that organism into a nearby State lacking confirmed reports 
is not expected to have significant environmental effects. For these 
types of permits, we would continue to determine whether an organism is 
likely to occur in a State based on the known distribution of the 
organism, environmental factors, and any other available evidence.
    We would not categorically exclude the release of an organism of 
quarantine concern. Organisms of quarantine concern typically are 
subject to control or eradication efforts to prevent impacts on the 
environment, and releases of these organisms could hinder such efforts. 
We would restrict the permitted use of organisms of quarantine concern 
to containment facilities for research purposes.
    Finally, besides the movement of pure cultures, other organisms may 
also be moved interstate for field release, for purposes such as field 
research outside containment facilities. PPQ only permits such movement 
when the organism occurs or is likely to occur in a State's 
environment; as described above, the movement of an organism to a State 
where PPQ has determined it is likely to occur is not expected to have 
a significant impact on the human environment, and has not over the 
past decade. As these two processes are similar, we would address them 
in the same categorical exclusion.
    Therefore, the new plant health-specific categorical exclusion 
would read: ``Issuance of permits for uses outside of containment that 
are pure cultures of organisms and that are not strains of quarantine 
concern and occur or are likely to occur in a State's environment, and 
issuance of permits for the interstate movement of organisms that occur 
or are likely to occur in a State's environment.''
     Issuance of permits or approvals for the importation of 
articles that are regulated due to plant health concerns, when the 
permit contains conditions that will mitigate any plant pest risk 
associated with the articles. PPQ issues permits and approvals for the 
importation of plants, plant products, and other articles that could 
introduce quarantine pests into the United States. PPQ does so only 
after determining that any risk associated with the importation of the 
articles has been mitigated, thus ensuring that the importation would 
not have a significant impact on the human environment. Mitigations are 
typically conventional measures, as described in proposed Sec.  372.8; 
if mitigations have impacts on the human environment, their use would 
be evaluated separately from the decision to issue a permit to ensure 
that appropriate NEPA documentation is completed.
     Issuance of certificates or limited permits for the 
movement of regulated articles from areas quarantined due to plant 
pests. PPQ establishes domestic quarantines for quarantine pests and 
conditions for the movement of articles that could spread those pests 
under its regulations in 7 CFR parts 301, 302, and 318. Similar to 
importation of articles, PPQ issues certificates or limited permits for 
the interstate movement of such articles only after determining that 
any risk associated with the importation of the articles has been 
mitigated, thus ensuring that the movement would not have a significant 
impact on the human environment.
     Issuance of permits for the importation or interstate 
movement of noxious weeds and other regulated seeds. PPQ designates 
certain plants as noxious weeds in accordance with the Plant Protection 
Act (7 U.S.C. 7701 et seq.). The regulations in 7 CFR part 360 require 
permits for the importation and interstate movement of regulated 
noxious weeds. PPQ only issues permits when conditions are available to 
prevent the release of the regulated noxious weed into the environment, 
thus mitigating any potential risk to the environment. Similarly, PPQ 
enforces certain restrictions on the importation of seed under the 
Federal Seed Act and under the regulations in 7 CFR part 361. PPQ's 
enforcement of these restrictions mitigates any risk to the human 
environment that could arise from these importations.
     Issuance of permits for prohibited or restricted articles 
unloaded and landed for immediate transshipment or transportation and 
exportation. Transshipment or transportation and exportation of 
restricted articles is regulated under 7 CFR part 352. Permits for such 
movement are granted only when sufficient safeguards are in place to 
prevent any plant pests that may have infested the shipment from being 
introduced into the United States. This ensures that such activities do 
not have any effect on the human environment.
    Paragraph (c) of proposed Sec.  372.9 would set out examples of 
biotechnology-related actions that would be categorically excluded. 
These would include, but would not be limited to:
     Issuance of permits for the importation, interstate 
movement, or environmental release of regulated genetically engineered 
organisms, provided that confinement measures (the permit conditions or 
performance measures), such as isolation distances from compatible 
relatives, control of flowering, or physical barriers, minimize the 
interaction of the regulated article with the environment. APHIS' 
Biotechnology Regulatory Services (BRS) program issues permits for 
importation or interstate movement of such articles only after 
determining that any risk associated with the importation or interstate 
movement of the articles has been sufficiently mitigated, thus ensuring 
that the importation or movement would not have a significant impact on 
the human environment. The regulations in 7 CFR part 340 govern the 
issuance of permits for the importation and interstate movement of 
certain genetically engineered organisms and products. Confinement 
measures are included in the permits; the confinement process is 
designed to ensure that the environmental release will not have a 
significant impact on the human environment.
    Current paragraph (d)(4) of Sec.  372.5 indicates that an 
extraordinary circumstance will apply when a confined field release of 
genetically engineered organisms or products involves new species or 
organisms or novel modifications that raise new issues. We are 
proposing that an extraordinary circumstance would apply when new 
permit conditions are included to address uncertainty about whether 
existing confinement measures will be sufficient to prevent the 
interaction of the genetically engineered organism with the 
environment. We believe the added specificity of our proposed 
extraordinary circumstance will better communicate the types of 
concerns that might lead us to prepare an EA for a confined field 
release.
     Extension of nonregulated status under 7 CFR part 340 to 
organisms similar to those already deregulated. The regulations in that 
part allow for an applicant to request an extension or for BRS to 
initiate an extension based on the similarity of a regulated organism 
to an antecedent organism that has been deregulated. BRS then examines 
information and assesses whether the regulated article in question 
raises no serious new issues meriting a separate review under the 
petition process. Because requests for extensions of nonregulated 
status assess regulated articles that are similar to the deregulated 
antecedent organism, the

[[Page 47062]]

regulated article is presumed to interact with the environment in the 
same way as the antecedent. EAs for extensions of nonregulated status 
incorporate the antecedent organism as part of the baseline or no 
action alternative. We have completed nine EAs for extensions of 
nonregulated status since 2000. Because the regulated organism (the 
subject of the request) is so similar to non-regulated organisms that 
are currently in the environment, the EAs have found no difference with 
respect to the impacts on biological or physical environment between 
the two organisms. Moreover, all of the assessments have resulted in 
findings of no significant impact. For these reasons, we believe it 
would be appropriate to establish a categorical exclusion for this 
category of actions.
     Notifications for environmental release, importation, or 
interstate movement of articles regulated under 7 CFR part 340. The 
notification process is described in 7 CFR 340.3. It is an 
administratively streamlined alternative to a permit for the 
introduction of an article regulated under that part. The article must 
meet certain eligibility criteria designed to reduce risk, and the 
introduction must meet six performance standards. These include 
confinement and devitalization methods that are designed to further 
mitigate potential environmental impacts, if any.

Categorical Exclusions; Other Categories of Actions

    Paragraph (c)(2) of Sec.  372.5 currently lists various 
categorically excluded actions under the heading of ``research and 
development.'' In addition, paragraph (c)(4) provides a categorical 
exclusion for the rehabilitation of APHIS facilities. As the 
descriptions of these categorical exclusions are not as extensive as 
the descriptions of conventional measures and of licensing, permitting, 
and authorization or approval, we are proposing to combine these 
categories of actions and list them in a new Sec.  372.10.
    Paragraph (c)(2)(i) of Sec.  372.5 currently provides a description 
of research and development activities; we are proposing to provide 
this description in the introductory text of paragraph (a) of proposed 
Sec.  372.10. Such activities are currently described as 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.
    We are proposing to make a few changes to this text. We would 
indicate at the beginning of this description that research and 
development activities that would be eligible for a categorical 
exclusion under proposed Sec.  372.10 are those limited in magnitude, 
frequency, and scope. This would clarify why research and development 
activities usually have minimal effects on the environment.
    Paragraph (c)(2)(ii) of current Sec.  372.5 lists three examples of 
research and development activities that are categorically excluded:
     The development and/or production (including formulation, 
repackaging, movement, and distribution) of previously approved and/or 
licensed program materials, devices, reagents, and biologics;
     Research, testing, and development of animal repellents; 
and
     Development and production of sterile insects.

We are proposing to amend these examples and add three more in 
paragraphs (a)(1) through (a)(6) of proposed Sec.  372.10.
    Paragraph (a)(1) would provide a new categorical exclusion for 
vaccination trials that occur on groups of animals in areas designed to 
limit interaction with similar animals, or that include other controls 
needed to mitigate potential risk. The study design in these cases 
eliminates the potential for impacts on organisms other than the test 
subjects.
    Paragraph (a)(2) would provide a new categorical exclusion for the 
evaluation of uses for chemicals not specifically listed on the product 
label, as long as they are used in a manner designed to limit potential 
effects to nontarget species such that there are no individual or 
cumulative impacts on the human environment. Such evaluation is 
necessary to determine whether chemicals may be effective against 
organisms not listed on the label as targets, or whether means of 
applying the chemical other than those listed on the label may be 
effective and safe. Many of these evaluations will be subject to 
experimental use permits issued by EPA with associated conditions to 
limit potential effects such that there are no individual or 
cumulatively significant impacts on the human environment. Other 
evaluations may have products that have been identified by EPA as 
mimimum risk and therefore do not require a full Federal Insecticide, 
Fungicide, and Rodenticide Act registration. However, APHIS still does 
an environmental review to ensure safe use and no extraordinary 
circumstances.
    Paragraph (a)(3) would expand on the current categorical exclusion 
that applies to the development and/or production of certain articles. 
We would amend this exclusion to include the development and/or 
production of program materials, devices, reagents, and biologics that 
are for evaluation in confined animal, plant, or insect populations 
under conditions that prevent exposure to the general population (e.g., 
conducted in laboratories or other facilities with established 
environmental and human safety protocols). Since the use is limited and 
the general population should not be exposed, the development or 
production of these articles would not have a significant impact on the 
human environment.
    Paragraph (a)(4) would provide a new categorical exclusion for 
research using chemicals, management tools, or devices to test the 
efficacy of methods; new vaccinations not currently approved to test in 
the natural environment; the use of mechanical devices (such as noise 
and light deterrence); and existing vaccinations, chemicals, or devices 
used in a new way on an animal, pest, or disease similar to those on 
which they have previously been used.
    Paragraph (a)(5) would expand on the current categorical exclusion 
for the research, testing, and development of animal repellents. As 
amended, the categorical exclusion would include all research related 
to the development and evaluation of wildlife management tools, such as 
animal repellents, scare devices, fencing, and pesticides. As indicated 
in the introductory text of proposed paragraph (a), APHIS research 
using the methods described in proposed paragraphs (a)(4) and (a)(5) is 
limited in magnitude, frequency, and duration, meaning it is not likely 
to have a significant impact on the human environment. APHIS has 
conducted many EAs on the operational use of functionally similar 
methods, and those methods have had no significant impact. APHIS 
research involving modifications of commonly used techniques is 
generally intended to improve the efficacy and selectivity of these 
methods and would be expected to have similar or less risk of adverse 
impact than the methods operationally in use.
    Paragraph (a)(6) would contain the current categorical exclusion 
for the development and production of sterile insects. We would amend 
this categorical exclusion to include the release of sterile insects as 
well. Sterile insects are bred in captivity, sterilized, and released 
into the environment, where they reduce the fecundity of pest 
populations. Environmental effects are limited due to the lack of 
offspring resulting from mating with the wild population. Research 
activities included

[[Page 47063]]

in this category can differ from field releases discussed in proposed 
Sec.  372.9 because they may be done with novel organisms and for 
limited duration. Research may also include novel methods for inducing 
sterility.
    Paragraph (b) of proposed Sec.  372.10 would expand on the 
categorical exclusion for the rehabilitation of APHIS facilities 
currently found in paragraph (c)(4) of Sec.  372.5. Paragraph (c)(4) 
currently indicates that rehabilitation of existing laboratories and 
other APHIS facilities, functional replacement of parts and equipment, 
and minor additions to existing APHIS facilities are subject to 
categorical exclusion. We would retain this list, replacing the word 
``rehabilitation'' with ``renovation,'' as the term better captures the 
nature of the work. We would also add categorical exclusions for the 
improvement, maintenance, and construction of APHIS facilities.
    APHIS frequently needs to improve and maintain its facilities. Such 
improvement and maintenance often involves minor excavations and 
repairs to sidewalks and grounds. We would add these as actions that 
are categorically excluded, provided that they involve disturbances 
with negligible adverse impacts on the environment.
    More extensive improvements may involve construction, expansion, or 
improvement of a facility when the permitting and approval process 
requires measures that address potential environmental effects. (For 
example, local or State regulations may require that certain 
construction techniques be used to reduce the effect of the 
construction on the human environment.) We are proposing to add a 
categorical exclusion for these more extensive improvements, if they 
meet the following requirements:
     The structure and proposed use are in compliance with all 
Federal, State, Tribal and local requirements (including Executive 
Order 13423, ``Strengthening Federal Environmental, Energy, and 
Transportation Management,'' and other Federal Executive orders);
     The site and the scale of construction are consistent with 
those of existing adjacent or nearby buildings; and
     The size, purpose and location of the structure is 
unlikely to have significant environmental consequences or create 
public controversy.
    A facility construction, expansion, or improvement that met these 
criteria would not be expected to have a significant effect on the 
human environment because the scope and impacts of the action would 
remain relatively small.

Process for Rapid Response to Emergencies

    We are proposing to add a new section describing the process APHIS 
follows to develop environmental documentation when conducting a rapid 
response to an emergency. The new section reflects the CEQ guidance 
discussed previously. Adding new Sec. Sec.  372.6 through 372.10 would 
require us to move the other sections in part 372. We are proposing to 
combine current Sec. Sec.  372.6 and 372.7, which deal with early 
planning and consultation on NEPA matters, because they are quite short 
and discuss related subjects. For this reason, the last section of the 
current NEPA regulations would be Sec.  372.14 under this proposal, and 
we are therefore proposing to add this section as Sec.  372.15.
    APHIS frequently takes important emergency actions to prevent the 
spread of animal and plant pests and diseases. Without emergency action 
to control the spread of these pests and diseases there is a potential 
for significant impacts on the human environment. Many actions APHIS 
takes in emergencies would be categorically excluded from the need to 
prepare further NEPA documentation under this proposal, as these 
actions often fall into the categories described in proposed Sec. Sec.  
372.8 through 372.10. Primary examples of such actions can include 
quarantine, surveillance, decontamination and/or cleaning, and 
depopulation and disposal. However, particularly when emergency actions 
are not categorically excluded, it is important to minimize the 
potential environmental effects of those actions.
    The proposed introductory section of Sec.  372.15 would first state 
that, an emergency exists when immediate threats to human health and 
safety or immediate threats to sensitive or protected resources require 
that action be taken in a timeframe that does not allow sufficient time 
to follow the procedures for environmental review established in the 
CEQ regulations and these regulations.
    Proposed paragraph (a) of Sec.  372.15 would then stipulate that 
when the Administrator of APHIS or the Administrator's delegated Agency 
official responsible for environmental review determines that an 
emergency exists that makes it necessary to take immediate action to 
prevent imminent damage to public health or safety, or sensitive or 
protected environmental resources in a timeframe that precludes 
preparing and completing the usual NEPA review, which is comprised of 
analysis and documentation, the responsible APHIS official shall take 
into account the probable environmental consequences of the emergency 
action and mitigate foreseeable adverse environmental effects to the 
extent practicable.
    Proposed paragraph (b) of Sec.  372.15 would specify that, if a 
proposed emergency action is normally analyzed in an EA and the nature 
and scope of proposed emergency actions are such that there is 
insufficient time to prepare an EA and FONSI before commencing the 
proposed action, the Administrator shall consult with APHIS' Chief of 
Environmental and Risk Analysis Services (ERAS) about completing the 
required NEPA compliance documentation and may authorize alternative 
arrangements for completing the required NEPA compliance documentation. 
Any alternative arrangements should focus on minimizing adverse 
environmental impacts of the proposed action and the emergency, and 
they are limited to those actions that are necessary to control the 
immediate aspects of the emergency. To the maximum extent practicable, 
these alternative arrangements should include the content, interagency 
coordination, and public notification and involvement that would 
normally be undertaken for an EA concerning the action and cannot alter 
the requirements of the CEQ regulations at 40 CFR 1508.9(a)(1) and (b). 
Any alternative arrangement also must be documented, and APHIS' Chief 
of ERAS will inform CEQ of the alternative arrangements at the earliest 
opportunity.
    Proposed paragraph (c) of Sec.  372.15 would state that APHIS shall 
immediately inform CEQ, through APHIS' interagency NEPA contact, when 
the proposed action is expected to result in significant environmental 
effects and there is insufficient time to allow for the preparation of 
an EIS. APHIS would consult CEQ and request alternative arrangements 
for preparing the EIS documentation in accordance with CEQ regulations.
    These procedures are consistent with the CEQ regulations and 
guidance, and they provide clear direction to APHIS staff and the 
public on how APHIS will approach emergency NEPA compliance. By 
explicitly providing for these emergency situations within our 
implementing regulations, we would ensure that timely emergency actions 
to counter disease and pest risks can be implemented and also ensure 
appropriate compliance with NEPA requirements.

[[Page 47064]]

Miscellaneous Changes

    The name and address provided for the Agency's NEPA contact 
(Sec. Sec.  372.3 and 372.4) are outdated. This proposal would update 
that information. The present agency contact for APHIS is Environmental 
and Risk Analysis Services, PPD, APHIS, USDA, 4700 River Road, Unit 
149, Riverdale, MD 20737-1238; (301) 851-3089.
    Due to the proposed reorganization of APHIS' NEPA implementing 
regulations, paragraph (a)(3) of current Sec.  372.9 would be found in 
Sec.  372.13. This paragraph has indicated that, when changes are made 
to EAs and findings of no significant impact, all commenters on the EA 
will be mailed copies of changes directly. Due to the high volume of 
comments we receive that do not include mailing addresses, this 
provision is impractical, and we are proposing to remove it from the 
regulations. Consistent with the CEQ regulations at 40 CFR 
1506.6(b)(1), paragraph (a)(3) of proposed Sec.  372.13 would indicate 
that we would mail notice to those who provide a mailing address and 
who have specifically requested it on an individual action. We would 
continue to make all our environmental documentation publicly available 
on the APHIS Web site and interested parties can sign up for 
notifications from Regulations.gov to be emailed when new documents are 
added to the docket for a regulatory action. Interested parties can 
also sign up on APHIS' Stakeholder Registry \5\ to receive email 
notification on any specific actions.
---------------------------------------------------------------------------

    \5\ At https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new.
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Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also examines the potential economic effects of this rule on small 
entities, as required by the Regulatory Flexibility Act. The economic 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The proposed rule would amend regulations that guide APHIS' 
implementation of the National Environmental Policy Act (NEPA). The 
amended regulations would clarify when an environmental impact 
statement (EIS) or an environmental analysis (EA) for an action is 
normally required, provide additional categories of actions for which 
we would prepare such documents, expand the list of actions subject to 
categorical exclusion from further environmental documentation and 
provide examples of such actions, and establish an environmental 
documentation process for use in regulatory emergencies.
    Potentially affected entities include individuals, businesses, 
organizations, governmental jurisdictions, and other entities involved 
with APHIS in the NEPA process. A small number of these entities may 
experience time and money savings. For example, in 2014 we estimate 
that 7 of 62 EAs would have qualified for a categorical exclusion under 
the amended regulations. In 2015 and 2016 respectively, we estimated 
that 10 of 87 and 7 of 25 EAs would have qualified for a categorical 
exclusion under the amended regulations. Resulting cost savings for 
APHIS and the affected entities are difficult to quantify and would 
vary by the nature of the proposed actions. It typically takes 1 week 
to 3 months to prepare an EA to begin clearance. It typically takes 2 
to 3 years to prepare an EIS to begin clearance.
    The proposal would make APHIS' NEPA process more transparent and 
efficient. The effects would be beneficial, but not significant. A 
small number of entities may experience time and money savings as a 
result of not having to provide the information necessary for 
completion of an EA. Affected small entities would include university 
researchers, research companies that produce veterinary biologics, 
research and diagnostic labs serving farmers, and producers of 
biocontrol agends, including Tribal entities. The proposed rule would 
not have a significant economic impact on a substantial number of small 
entities.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. Executive Order 13175 requires Federal 
agencies to consult and coordinate with tribes on a government-to-
government basis on policies that have tribal implications, including 
regulations, legislative comments or proposed legislation, and other 
policy statements or actions that have substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.
    APHIS has assessed the potential impact of this proposed rule and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under Executive Order 
13175. If a Tribe requests consultation, APHIS will work with the 
Office of Tribal Relations to ensure meaningful consultation is 
provided where changes, additions, and modifications identified herein 
are not expressly mandated by Congress.

National Environmental Policy Act

    This proposed rule would revise the regulations that guide APHIS 
employees in NEPA analysis and documentation for animal and plant 
health management, wildlife damage management, and animal welfare 
management activities. CEQ regulations do not require agencies to 
prepare a NEPA analysis or document before establishing agency 
procedures that

[[Page 47065]]

supplement the CEQ regulations for implementing NEPA, and thus no NEPA 
document was prepared for this proposed rule. Agencies are required to 
adopt NEPA procedures that establish specific criteria for, and 
identification of, three categories of actions: Those that require 
preparation of an EIS; those that require preparation of an EA; and 
those that are categorically excluded from further NEPA review (40 CFR 
1507.3(b)). Agency NEPA procedures assist agencies in the fulfillment 
of agency responsibilities under NEPA, but are not the agency's final 
determination of what level of NEPA analysis is required for a 
particular proposed action. The requirements for establishing agency 
NEPA procedures are set forth at 40 CFR 1505.1 and 1507.3.

Paperwork Reduction Act

    This proposed rule contains 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.

    Accordingly, we are proposing to amend 7 CFR part 372 as follows:

PART 372-NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES

0
1. The authority citation for part 372 continues to read as follows:

    Authority:  42 U.S.C. 4321 et seq.; 40 CFR parts 1500-1508; 7 
CFR parts 1b, 2.22, 2.80, and 371.9.


Sec.  372.1  [Amended]

0
2. Section 372.1 is amended by adding the word ``(NEPA)'' after the 
word ``Act'' the first time it occurs; and by removing the second and 
third occurrences of the words ``the National Environmental Policy 
Act'' and adding the word ``NEPA'' in their place.
0
3. Section 372.3 is revised to read as follows:


Sec.  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 the APHIS NEPA contact at: Policy and Program 
Development, APHIS, USDA, Attention: NEPA Contact, 4700 River Road, 
Unit 149, Riverdale, MD 20737-1238, (301) 851-3089.
0
4. Section 372.4 is amended as follows:
0
a. In the introductory text, by adding the words ``and definitions'' 
after the word ``terminology'', by removing the word ``(CEQ)'', and by 
removing the word ``is'' and adding the word ``are'' in its place;
0
b. By revising the definitions of decisionmaker and environmental unit; 
and
0
c. By adding, in alphabetical order, definitions of Agency official 
responsible for environmental review and extraordinary circumstances.
    The additions and revisions read as follows:


Sec.  372.4  Definitions.

* * * * *
    Agency official responsible for environmental review. The Chief of 
APHIS' Environmental and Risk Analysis Services.
* * * * *
    Decisionmaker. The agency official responsible for signing the 
categorical exclusion or findings of no significant impact (FONSI) and 
environmental assessment or the record of decision following the 
environmental impact statement (EIS) process.
* * * * *
    Environmental unit. The analytical unit in Policy and Program 
Development responsible for coordinating APHIS' compliance with NEPA 
and other environmental laws and regulations.
    Extraordinary circumstances. Circumstances in which an action that 
is normally categorically excluded may have the potential for a 
significant environmental effect. When an extraordinary circumstance 
occurs, APHIS will determine whether those circumstances raise 
potential environmental issues that merit further analysis in an 
environmental impact statement or environmental assessment.
0
5. Section 372.5 is revised to read as follows:


Sec.  372.5  Environmental impact statements.

    Actions normally requiring environmental impact statements. Actions 
in this category typically involve the agency, an entire program, or a 
substantial program component; and may include programmatic for 
reducing risks to animal and plant health and other human interests 
such as property, natural resources, and human health and safety. 
Actions in this category are typically characterized by their broad 
scope (often nationwide) or their intensity of potential effects 
(impacting a wide range of environmental components including, but not 
limited to air, water, soil, plant communities, or animal populations) 
or indicators (including, but not limited to dissolved oxygen content 
of water), whether or not affected individuals or systems can be 
reasonably completely identified at the time. An environmental impact 
statement will also normally be prepared when an environmental 
assessment identifies a potential for significant impacts based upon 
the context and intensity factors listed by the Council on 
Environmental Quality (CEQ) at 40 CFR 1508.27. An EIS would also be 
required for an action whose scope is limited to a relatively small 
geographic area where there is the potential for significant impacts or 
there is a high degree of uncertainty concerning the potential impacts. 
Examples include, but are not limited to:
    (a) Formulation of contingent response strategies to combat future 
widespread outbreaks of animal and plant diseases.
    (b) Adoption of strategic or other long-range plans that prescribe 
a preferred course of action for future actions implementing the plan.


Sec.  372.6  [Redesignated as Sec.  372.11]

0
6. Section 372.6 is redesignated as Sec.  372.11.


Sec.  372.7  [Removed]

0
7. Section 372.7 is removed.
    Sec. Sec.  372.8 through 372.10 [Redesignated as Sec. Sec.  372.12 
through 372.14]
0
8. Sections 372.8 through 372.10 are redesignated as Sec. Sec.  372.12 
through 372.14, respectively.
0
9. New Sec. Sec.  372.6 through 372.10 are added to read as follows:


Sec.  372.6  Environmental assessments.

    Actions normally requiring environmental assessments. This category 
of actions is typically related to a more discrete program component 
but could be programmatic; however, the potential environmental impacts 
associated with the proposed action are not considered potentially 
significant at the outset of the planning process. An action in this 
category is typically characterized by its limited scope (particular 
sites, State-wide or district-wide programs, specific or similar 
species, or particular activities). Any effects of the action on 
environmental resources (such as air, water, soil, plant communities, 
animal populations, or others) or indicators (such as dissolved oxygen 
content of water) can be reasonably identified, and mitigation measures 
are generally available and have previously been successful.

[[Page 47066]]

Actions normally requiring an environmental assessment, but not 
necessarily an environmental impact statement, include:
    (a) Policymakings, rulemakings, and actions 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:
    (1) Development of program plans to adopt strategies, methods, and 
techniques as the means of dealing with particular animal and plant 
health risks that may arise in the future; and
    (2) Implementation of program plans at the site-specific action 
level.
    (b) Planning, design, construction, or acquisition of new 
facilities, or proposals for substantial modifications to existing 
facilities.
    (c) Disposition of waste and other hazardous or toxic materials at 
laboratories and other APHIS facilities.
    (d) Approvals and issuance of permits or licenses for proposals 
involving regulated genetically engineered or nonindigenous species.
    (e) Programs to reduce damage or harm by a specific wildlife 
species or group of species, such as deer or birds, or to reduce a 
specific type of damage or harm, such as protection of agriculture from 
wildlife depredation and disease; for the management of rabies in 
wildlife; or for the protection of threatened or endangered species.
    (f) Research or testing that will be conducted outside of a 
laboratory or other containment area or reaches a stage of development 
(e.g., formulation of premarketing strategies) that forecasts an 
irretrievable commitment to the resulting products or technology.
    (g) Determination of nonregulated status for genetically engineered 
organisms.


Sec.  372.7  Categorical exclusions; general provisions.

    (a)(1) Categorically excluded actions share many of the same 
characteristics--particularly in terms of the extent of program 
involvement, as well as the scope and effect of proposed actions--as 
actions that normally require environmental assessments but not 
necessarily environmental impact statements. APHIS considers that 
mitigation measures alone are not the sole key factor. Rather, there 
are several factors that should be included in determining whether a 
category of actions is categorically excluded: The extent to which 
mitigation measures to avoid or minimize adverse environmental impacts 
have been built into the actions themselves and, in some cases, 
standard operating procedures; Agency expertise and experience 
implementing the actions; and whether testing or monitoring have 
demonstrated there normally is no potential for significant 
environmental impacts. The use of a categorical exclusion requires the 
following three evaluation criteria be met:
    (i) The action has not been segmented. Determine whether the action 
has not been segmented to meet the definition of a categorical 
exclusion. Segmentation may occur when an action is intentionally 
broken down into component parts in order to avoid the appearance of 
significance of the total action. An action can be too narrowly 
defined, minimizing potential impacts in an effort to avoid a higher 
level of NEPA documentation. The scope of an action must include the 
consideration of connected actions, and the effects when applying 
extraordinary circumstances must consider cumulative impacts.
    (ii) No extraordinary circumstances exist. Determine whether the 
action involves any extraordinary circumstances that would require us 
to preclude the use of a categorical exclusion.
    (iii) The action occurs in a limited area, does not permanently 
adversely affect the area, and is performed with well-established 
procedures.
    (2) The Department has promulgated a listing of categorical 
exclusions that are applicable to all agencies within the Department 
unless their procedures provide otherwise. The Departmental categorical 
exclusions, codified at Sec.  1b.3(a) of this title, apply to APHIS. 
Additional categorical exclusions specific to APHIS are provided in 
Sec. Sec.  372.8 through 372.10.
    (3) The use of a categorical exclusion does not relieve the 
responsible Agency official from compliance with other statutes, such 
as the Resource Conservation and Recovery Act, the Endangered Species 
Act, or the National Historic Preservation Act. Such consultations may 
be required to determine the applicability of the categorical exclusion 
screening criteria.
    (4) For categorical exclusions requiring a brief presentation of 
conclusions reached during screening and review of extraordinary 
circumstances, determinations should be presented in a record of 
environmental consideration. This determination can be made using 
current information and expertise as long as the basis for the 
determination is included in the record of environmental consideration. 
Copies of appropriate interagency correspondence can be attached to the 
record of environmental consideration. Example conclusions that may be 
reached after a review of extraordinary circumstances include:
    (i) The U.S. Fish and Wildlife Service concurred through informal 
consultation that endangered or threatened species or designated 
habitat are not likely to be adversely affected.
    (ii) The U.S. Army Corps of Engineers determined that the action is 
covered by a nationwide general permit.
    (iii) State and/or local natural resource agencies have been 
consulted to ensure compliance with applicable environmental laws and 
regulations for protecting and managing natural resources such as 
native plant and animal species.
    (b) Whenever the Agency official responsible for environmental 
review determines that an extraordinary circumstance is present such 
that a normally categorically excluded action may have the potential to 
significantly affect the quality of the human environment, an 
environmental assessment or an environmental impact statement will be 
prepared. Specific extraordinary circumstances for individual 
categorically excluded actions are listed with those actions in 
Sec. Sec.  372.8 through 372.10.
    (c) General extraordinary circumstance for conventional measures. 
An environmental assessment or environmental impact statement will be 
prepared when an extraordinary circumstance is present such that a 
normally categorically excludable action, as identified in Sec. Sec.  
372.8 through 372.10, has the potential to significantly affect the 
quality of the human environment. General extraordinary circumstances 
that preclude the use of a categorical exclusion are:
    (1) A reasonable likelihood of significant impact on public health 
or safety.
    (2) A reasonable likelihood of significant environmental effects 
(direct, indirect, and cumulative).
    (3) A reasonable likelihood of involving effects on the environment 
that involve risks that are highly uncertain, unique, or are 
scientifically controversial.
    (4) A reasonable likelihood of violating any Executive Order, 
Federal law, or requirements imposed for the protection of the 
environment.
    (5) A reasonable likelihood of adversely affecting environmentally 
sensitive resources, unless the impact has been resolved through 
another environmental process (e.g., the Coastal Zone Management Act, 
National Historic Preservation Act, Clean Water

[[Page 47067]]

Act, etc.). Environmentally sensitive resources include:
    (i) Proposed federally listed, threatened, or endangered species or 
their designated critical habitats.
    (ii) Properties listed or eligible for listing on the National 
Register of Historic Places.
    (iii) Areas having special designation or recognition such as prime 
or unique agricultural lands; coastal zones; designated wilderness or 
wilderness study areas; wild and scenic rivers; National Historic 
Landmarks (designated by the Secretary of the Interior); floodplains; 
wetlands; sole source aquifers; National Wildlife Refuges; National 
Parks; areas of critical environmental concern; or other areas of high 
environmental sensitivity.
    (iv) Cultural, scientific, or historic resources.
    (6) A reasonable likelihood of dividing or disrupting an 
established community or planned development.
    (7) A reasonable likelihood of causing a substantial increase in 
surface transportation congestion that will decrease the level of 
service below acceptable levels.
    (8) A reasonable likelihood of adversely impacting air quality, 
exceeding, or violating Federal, State, local, or Tribal air quality 
standards under the Clean Air Act, as amended.
    (9) A reasonable likelihood of adversely impacting water quality, 
sole source aquifers, public water supply systems or State, local, or 
Tribal water quality standards established under the Clean Water Act 
and the Safe Drinking Water Act.
    (10) A reasonable likelihood of effects on the quality of the 
environment that are highly controversial on environmental grounds. The 
term ``controversial'' means a substantial scientific dispute exists as 
to the size, nature, or effect of the proposed action rather than to 
the existence of opposition to a proposed action, the effect of which 
is relatively undisputed.
    (11) A reasonable likelihood of a disproportionately high and 
adverse effect on low income or minority populations.
    (12) Limit access to or ceremonial use of Indian sacred sites on 
Federal lands by Indian religious practitioners, or significantly 
adversely affect the physical integrity of sacred sites.
    (13) Unless releases are supported by a biocontrol risk analysis or 
expert panel recommendation that accompanies the administrative record 
for the categorical exclusion documentation, the proposed action has a 
reasonable likelihood of contributing to the introduction, continued 
existence, or spread of federally recognized noxious weeds or non-
native invasive species known to occur in the area; or actions that may 
promote the introduction, growth, or expansion of the range of noxious 
weed species.
    (14) A greater scope or size than is normal for this category of 
action.
    (15) A reasonable likelihood of degrading already existing poor 
environmental conditions. Also, initiation of a degrading influence, 
activity, or effect in areas not already significantly modified from 
their natural condition.
    (16) A precedent (or makes decisions in principle) for future or 
subsequent actions that have a reasonable likelihood of having a future 
significant effect.
    (17) A reasonable likelihood of:
    (i) Releases of petroleum, oils, and lubricants (except from a 
properly functioning engine or vehicle) or reportable releases of 
hazardous or toxic substances as specified in 40 CFR part 302, 
Designation, Reportable Quantities, and Notification); or
    (ii) Where the proposed action requires development or amendment of 
a Spill Prevention, Control, or Countermeasures Plan.


Sec.  372.8  Categorical exclusions; conventional measures.

    (a) Overview. Conventional measures include activities such as 
identifications; inspections; monitoring, including surveys and 
surveillance, that does not cause physical alteration of the 
environment; testing; seizures; quarantines; removals; sanitizing, 
cleaning and disinfection; inoculations; and animal handling and 
management employed by agency programs to pursue their missions and 
functions. Paragraphs (b) through (l) of this section explain and give 
examples of conventional measures. 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 pesticides, chemicals, drugs, pheromones, contraceptives, or other 
potentially harmful substances, materials, and target-specific devices 
or remedies.
    (b) Identifications. Detection and identification of premises or 
animals, or identification of organisms, diseases, or species causing 
damage or harm. These range from biological or physical marking and 
tracking of animals, to premises identification, and/or the use of 
other markers such as inert particles in feed and branding. Examples 
include, but are not limited to:
    (1) Commodity labels;
    (2) Issuance of a specific identification number;
    (3) Animal tags;
    (4) Radio transmitters;
    (5) Microchips; and
    (6) Chemicals (such as tetracycline or rhodamine B ingestion).
    (c) Inspections. Inspections of articles (including fruits and 
vegetables) to determine if there are any plant pests present, which 
could involve cutting fruit for inspection; the physical inspection of 
animals upon entry into the United States; facility and records 
inspections; inspections of commodities, facilities, or fields, 
including paperwork and records, for approval and to assure compliance 
with regulations and program standards. Inspections usually follow a 
prescribed protocol and document findings on an inspection report form. 
Examples include, but are not limited to:
    (1) Physical examination of plants, plant products, and animals at 
the port of entry.
    (2) Review of containment facilities.
    (3) Review of paperwork and records to assure compliance with 
program regulations and standards.
    (d) Monitoring, including surveys, surveillance, and trapping, that 
does not cause physical alteration of the environment. Surveys include 
questionnaires to collect information and data to assess a current 
state or trend in activities, to determine compliance, or to determine 
whether a pest or disease exists in a specific area. Surveillance 
includes activities to collect test samples from part or all of the 
target population using routine collection techniques. Trapping refers 
to the use of capture devices that are designed to efficiently capture, 
restrain, or kill targeted individual animals or a group of animals 
(e.g., fruit flies and other insects, a raccoon, a sounder of feral 
swine). Capture devices used in trapping are foothold; cage; drive; 
quick-kill; pit (for insects and some small rodents, reptiles and 
amphibians); insect and sticky traps; snares and other cable 
restraints; nets; hands; contained animal drugs (e.g., dart guns, 
tranquilizer tab devices); and insecticides. Attractants used with some 
types of trapping are food, odor baits or lures, pheromones, shapes, 
and colors. Trapping avoids risks to the viability of native nontarget 
species populations through use of attractants designed for specific 
target animals, device design and proper application, and device 
placement. Examples include, but are not limited to:
    (1) Collection of biological or environmental samples, such as 
tissue,

[[Page 47068]]

soil, or water samples and samples of fecal matter.
    (2) Continual checking, by testing, trapping, or observing for the 
presence, absence, or prevalence of animals, pests, or disease. 
Information may be used to support a pest or disease status (such as 
pest-free or disease-free status).
    (3) Surveying and monitoring for disease may or may not require the 
lethal removal of the animal and can often be conducted using nonlethal 
methods, such as collection of samples from animals killed or removed 
for reasons related to disease monitoring (i.e., damage management 
action addressed in an environmental assessment, or hunter-killed 
animals).
    (4) Randomly selecting animals and obtaining blood samples to 
survey for disease, or collection of test samples.
    (e) Testing. The examination or analysis of a collected sample. 
This activity often occurs in a laboratory, but also includes nonlethal 
tests that require animal-side or chute-side injection and observation 
in the field. Testing may require the use of specialized equipment and/
or diagnostic test kits. Examples include, but are not limited to, 
intradermal tuberculosis testing of livestock and germplasm testing of 
plant material for viral infections.
    (f) Seizures. Taking possession of conveyances, materials, 
regulated articles, plants and plant products, animals and animal 
products, other articles infested with a pest or determined to be 
diseased or exposed to a disease, a regulated article that is mixed in 
a commodity, or contaminated shipping material. Examples include, but 
are not limited to:
    (1) Confiscation of a commodity that could be a vector for a plant 
or animal disease or pest, or an animal or plant determined to be 
infested, infected, exposed, or not in compliance with APHIS 
regulations (such as one moved illegally or without proper paperwork).
    (2) Seizure of a nonregulated commodity, seed, or propagative 
material containing regulated genetically engineered material.
    (g) Quarantines. Actions to restrict or prohibit movement from an 
area, including the creation, expansion, removal, or modification of 
quarantines. The establishment of a quarantine can include mitigations 
to allow for movement of animals or commodities while preventing the 
spread of the animal or plant pest or disease. These mitigations are 
evaluated separately from the establishment of the quarantine itself. 
Examples of quarantines are:
    (1) Quarantine of an area in which a pest or disease is known to 
occur to prevent movement of animals, plants, or other articles whose 
movement could spread the pest or disease.
    (2) Changes in pest or disease status for an area or country, such 
as expansion or rescission of existing quarantines.
    (3) Removal of quarantine restrictions when APHIS determines that 
it is appropriate to do so.
    (h) Removals. Relocation or lethal removal of living organisms, or 
destruction of materials. Examples include, but are not limited to:
    (1) Removal of animals in accordance with permits and agreements 
from the appropriate management agencies, or otherwise in accordance 
with regulations governing management of a species, for the purpose of 
approved research studies, surveillance and monitoring, or disease or 
damage management, or due to pest concerns.
    (2) Removal of animals or materials from premises.
    (3) Removal of trees or shrubs and plants.
    (4) Disposal or destruction of materials for which the Agency has 
regulatory authority due to, for example, completion of acknowledged or 
permitted activities, completion of regulated activities, or 
noncompliance and disposal of animals. This can include disposal of 
regulated articles (fruits, meat, regulated genetically engineered 
organisms, etc.) at ports of entry designated by U.S. Customs and 
Border Protection (CBP).\1\ Approved methods of disposal range from 
burial, feeding to animals, composting, to co-burning for power 
generation.
---------------------------------------------------------------------------

    \1\ Further information on CBP-approved ports is available on 
the Internet at http://www.cbp.gov/contact/ports.
---------------------------------------------------------------------------

    (5) Routine disposal of carcasses using other approved methods, 
such as donation for human consumption, composting, chemical digestion, 
burial, and incineration.
    (6) Depopulation of domestic livestock and captive wildlife due to 
the presence of an animal disease or the reasonable suspicion of the 
presence of an animal disease. Extraordinary circumstance: An outbreak 
of a foreign animal disease that would require the depopulation of a 
large number of animals potentially resulting in substantial or 
significant adverse impacts on the human environment.
    (i) Sanitizing, cleaning, and disinfection. Treatment of an 
infested commodity, cleaning, and disinfection that occurs when a 
disease is found or there is an emergency disease outbreak, treatment 
of a regulated article, or treatment for carcass disposal. Examples 
include, but are not limited to:
    (1) Treatment of regulated articles at existing facilities, such as 
irradiation treatment and methyl bromide special use treatment.
    (2) Treatment of a facility, container, or cargo hold at the port 
of entry to mitigate pest threats.
    (3) Cleaning and disinfection of equipment, cages, facilities, or 
premises.
    (4) Treatment of animal carcasses, using methods such as 
incineration, alkaline digestion, or rendering as a method to 
devitalize infectious material.
    (j) Inoculations. Introduction of a pathogen or antigen into a 
living organism in order to invoke an immune response to treat or 
prevent a disease. Examples are:
    (1) 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).
    (2) Use of vaccinations or inoculations including new vaccines (for 
example, genetically engineered vaccines) and applications of existing 
vaccines to new species provided that the project is conducted in a 
controlled and limited manner, and the impacts of the vaccine can be 
predicted. Extraordinary circumstance: 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.
    (k) Animal handling and management. Nonlethal methods not addressed 
elsewhere in this part that are used to prevent, monitor for, reduce, 
or stop disease, damage, or harm caused by animals. Examples include, 
but are not limited to:
    (1) Restraining or handling livestock, poultry, or wildlife to 
facilitate examination or other activities.
    (2) Cultural methods and basic habitat management, such as 
nonlethal management activities such as removal of food sources, 
modification of planting systems, modification of animal husbandry 
practices, water control devices for beaver dams, limited beaver dam 
removal, and pruning trees.
    (3) Site-specific applications of nonlethal wildlife damage 
management practices, such as frightening devices, exclusion, capture 
and release, and capture and relocation.
    (l) Recordkeeping and labeling. Requiring regulated parties to keep 
records demonstrating compliance with APHIS requirements or to label 
regulated articles to indicate compliance or set out restrictions on 
the movement

[[Page 47069]]

of the article. Examples include, but are not limited to:
    (1) Records documenting the results of trapping for insects.
    (2) Records of the application of treatments.
    (3) Labels indicating that the movement of a regulated article to 
certain areas within the United States is illegal.
    (4) Records retained by approved livestock facilities and listed 
slaughtering or rendering establishments under 9 CFR part 71.


Sec.  372.9  Categorical exclusions; licensing, permitting, 
authorization, and approval.

    Licensing and permitting refer to the issuance of a license, 
permit, or authorization to entities including individuals, 
manufacturers, distributors, agencies, organizations, or universities 
for field testing, environmental release, or importation or movement of 
animals; plants; animal, plant, or veterinary biological products; or 
any other regulated article. Authorization and approval are for an 
entity to participate in a program or perform an action. Examples of 
this category of action are:
    (a) Animal health-related. (1) Approval of interstate movement or 
importation of animals via regulations or permits. Examples include, 
but are not limited to:
    (i) Use of permits to control the interstate movement of restricted 
animals, such as issuance of an official document or a State form 
allowing the movement of restricted animals to a particular 
destination.
    (ii) Use of permits for entry, such as pre-movement authorization 
for entry of animals into a State from the State animal health official 
of the State of destination.
    (iii) Approval of international movements through the use of import 
and export health certificates and import or export movement permits.
    (iv) Authorization to move animals out of the quarantine or buffer 
zone for cattle fever ticks by documentation (a State form) that 
confirms the animals have been inspected and found to be tick-free.
    (2) Licensing of swine garbage feeding operations.
    (3) Accreditation of private veterinarians.
    (4) Approval and permitting of laboratories to conduct official 
tests.
    (5) Approval of identification manufacturers to produce 
identification, tests, and identification devices.
    (6) Listing of slaughter and rendering establishments for 
surveillance under 9 CFR 71.21.
    (7) Approval of herd and premises plans that have environmental or 
waste management components.
    (8) Approval of herd accreditation for tuberculosis or 
certification for brucellosis to document the herd's freedom from 
disease.
    (9) Funding the depopulation of diseased herds, including indemnity 
and carcass disposal; authorization and funding of the collection and 
submission of tissue samples for testing.
    (10) Approval of participation in the National Poultry Improvement 
Plan by issuance of a permanent approval number in accordance with 9 
CFR 145.4.
    (11) Authorization to ship and field test previously unlicensed 
veterinary biologics including veterinary biologics containing 
genetically engineered organisms (such as vector-based vaccines and 
nucleic-acid based vaccines).
    (12) Issuance of a license or permit for previously unlicensed 
veterinary biologics including veterinary biologics containing 
genetically engineered organisms (such as vector-based vaccines and 
nucleic-acid based vaccines).
    (13) Issuance of a license, permit, authorization, or approval for 
uses of pure cultures of organisms (relatively free of extraneous 
micro-organisms and extraneous material) that are not strains of 
quarantine concern and occur, or are likely to occur, in a State's 
environment.
    (14) Issuance of permits and approval of facilities to import, 
transport, introduce, or release live animals and products or 
byproducts thereof, or other organisms for which proven risk mitigation 
measures are applied and will require no substantial modification for 
the specific articles under consideration. This includes importation or 
interstate movement of meat, milk/milk products, eggs, hides, bones, 
animal tissue extracts, etc., which present no disease risk or for 
which there are proven animal disease risk mitigation measures, such as 
heating, acidification, or standard chemical treatment.
    (b) Plant health-related. (1) Issuance of permits for the 
importation or interstate movement of organisms into containment 
facilities, for the interstate movement of organisms between 
containment facilities, and continued maintenance and use of these 
organisms.
    (2) Issuance of permits for the use of organisms biologically 
incapable of persisting in the permitted environment.
    (3) Issuance of permits for uses outside of containment that are 
pure cultures of organisms and that are not strains of quarantine 
concern and occur or are likely to occur in a State's environment, and 
issuance of permits for the interstate movement of organisms that occur 
or are likely to occur in a State's environment.
    (4) Issuance of permits or approvals for the importation of 
articles that are regulated due to plant health concerns, when the 
permit contains conditions that will mitigate any plant pest risk 
associated with the articles.
    (5) Issuance of certificates or limited permits for the movement of 
regulated articles from areas quarantined due to plant pests.
    (6) Issuance of permits for the importation or interstate movement 
of regulated noxious weeds and other regulated seeds.
    (7) Issuance of permits for prohibited or restricted articles 
unloaded and landed for immediate transshipment or transportation and 
exportation.
    (c) Biotechnology-related. (1) Issuance of permits for the 
importation, interstate movement, or environmental releases of 
regulated genetically engineered organisms, provided that confinement 
measures (the permit conditions or performance measures), such as 
isolation distances from compatible relatives, control of flowering, or 
physical barriers, minimize the interaction of the regulated article 
with the environment. Extraordinary circumstance: Uncertainty of 
confinement measures and the ability of such to prevent the interaction 
of the regulated genetically engineered organism with the environment.
    (2) Extension of nonregulated status under part 340 of this chapter 
to organisms similar to those already deregulated.
    (3) Notifications for environmental release, importation, or 
interstate movement of regulated genetically engineered organisms.


Sec.  372.10  Categorical exclusions; research and development and 
facilities.

    (a) Research and development activities. Activities limited in 
magnitude, frequency, and scope that occur in laboratories, facilities, 
pens, or field sites. Examples are:
    (1) Vaccination trials that occur on groups of animals in areas 
designed to limit interaction with similar animals, or that include 
other controls needed to mitigate potential risk.
    (2) Evaluation of uses for chemicals not specifically listed on the 
product label, if they are used in a manner designed to limit potential 
effects to nontarget species.
    (3) The development and/or production (including formulation,

[[Page 47070]]

packaging or repackaging, movement, and distribution) of articles such 
as program materials, devices, reagents, and biologics that were 
approved and/or licensed in accordance with existing regulations, or 
that are for evaluation in confined animal, plant, or insect 
populations under conditions that prevent exposure to the general 
population.
    (4) Research using chemicals, management tools, or devices to test 
the efficacy of methods; new vaccinations not currently approved to 
test in the natural environment; the use of mechanical devices (such as 
noise and light deterrence); and existing vaccinations, chemicals, or 
devices used in a new way on an animal, pest, or disease similar to 
those on which they have previously been used.
    (5) Research related to the development and evaluation of wildlife 
management tools, such as animal repellents, scare devices, fencing, 
and pesticides.
    (6) Development, production, and release of sterile insects.
    (b) Renovation, improvement, maintenance, and construction of 
facilities. Examples are:
    (1) Renovation of existing laboratories and other APHIS facilities.
    (2) Functional replacement of parts and equipment.
    (3) Minor additions to existing APHIS facilities.
    (4) Minor excavations of land and repairs to properties.
    (5) Construction, expansion, or improvement of a facility if:
    (i) The structure and proposed use are in compliance with all 
Federal, State, Tribal, and local requirements;
    (ii) The site and scale of construction are consistent with those 
of existing adjacent or nearby buildings; and
    (iii) The size, purpose and location of the structure is unlikely 
to have significant environmental consequences or create public 
controversy.
0
10. Newly redesignated Sec.  372.11 is revised to read as follows:


Sec.  372.11  Early planning and consultation for applicants and non-
APHIS entities.

    Prospective applicants who anticipate the need for approval of 
proposed activities classified as normally requiring environmental 
documentation should contact, at their earliest opportunity, APHIS' 
program staff. APHIS program officials will help them determine the 
types of environmental analyses or documentation, if any, that need to 
be prepared and how they may inform decisions. The NEPA documents will 
incorporate by reference (as required by the CEQ regulations in 40 CFR 
1502.21), to the fullest extent practicable, surveys and studies 
required by other environmental statutes.
0
11. Newly redesignated Sec.  372.12 is amended as follows:
0
a. By revising the section heading;
0
b. In the paragraph heading for paragraph (a), by removing the words 
``Major planning'' and adding in their place the word ``Planning'';
0
c. In paragraph (b), introductory text, by adding the words ``and 
environmental assessment process'' after the words ``environmental 
impact statement process''; and
0
d. By revising paragraphs (b)(2) and (b)(4).
    The revisions read as follows:


Sec.  372.12  Planning and decision points and public involvement.

* * * * *
    (b) * * *
    (2) Opportunities for public involvement in the environmental 
assessment process will be announced in the same fashion as the 
opportunities for public involvement in the environmental impact 
statement process.
* * * * *
    (4) All environmental documents and comments received will be made 
available to the public via Regulations.gov.
0
12. Newly redesignated Sec.  372.13 is amended as follows:
0
a. In paragraph (a), introductory text, by adding a new sentence after 
the end of the first sentence;
0
b. In paragraph (a)(1), by removing the citation ``Sec.  372.8'' and 
adding the citation ``Sec.  372.12'' in its place; and
0
c. By revising paragraph (a)(3).
    The addition and revision read as follows:


Sec.  372.13  Processing and use of environmental documents.

    (a) * * * This determination is based on information provided in 
the NEPA document and available in the administrative record.
* * * * *
    (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 prior to implementing the proposed action or any 
alternative. APHIS will mail notice upon request.
* * * * *
0
13. Newly redesignated Sec.  372.14 is revised as follows:


Sec.  372.14  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 
kept in connection with the EIS will thereafter be reopened if the 
supplemental environmental impact statement is issued after the record 
of decision is issued. 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.
0
14. A new Sec.  372.15 is added to read as follows:


Sec.  372.15  Process for rapid response to emergencies.

    An emergency exists when immediate threats to human health and 
safety or immediate threats to sensitive or protected resources require 
that action be taken in a timeframe that does not allow sufficient time 
to follow the procedures for environmental review established in the 
CEQ regulations and the regulations in this part.
    (a) When the Administrator or the Administrator's delegated Agency 
official responsible for environmental review determines that an 
emergency exists that makes it necessary to take immediate action to 
prevent imminent damage to public health or safety, or sensitive or 
protected environmental resources in a timeframe that precludes 
preparing and completing the usual NEPA review, which is comprised of 
analysis and documentation, the responsible APHIS official shall take 
into account the probable environmental consequences of the emergency 
action and mitigate foreseeable adverse environmental effects to the 
extent practicable.
    (b) If a proposed emergency action is normally analyzed in an 
environmental assessment as described in Sec.  372.6 and the nature and 
scope of proposed emergency actions are such that there is insufficient 
time to prepare an EA and FONSI before commencing the proposed action, 
the Administrator shall consult with APHIS' Chief of Environmental and 
Risk Analysis Services about completing the required NEPA compliance 
documentation and may authorize alternative arrangements for completing 
the required NEPA compliance documentation. Any alternative 
arrangements must be documented and notice of their use provided to 
CEQ.
    (c) APHIS shall immediately inform the CEQ, through APHIS' 
interagency

[[Page 47071]]

NEPA contact, when the proposed action is expected to result in 
significant environmental effects and there is insufficient time to 
allow for the preparation of an EIS. APHIS will consult CEQ and request 
alternative arrangements in accordance with CEQ regulations at 40 CFR 
1506.11. Such alternative arrangements will apply only to the proposed 
actions necessary to control the immediate impacts of the emergency. 
Other proposed actions remain subject to NEPA analysis and 
documentation in accordance with the CEQ regulations and the 
regulations in this part.

    Done in Washington, DC, this 14th day of July 2016.
Edward Avalos,
Under Secretary, Marketing and Regulatory Programs.
[FR Doc. 2016-17138 Filed 7-19-16; 8:45 am]
BILLING CODE 3410-34-P