81_FR_47190 81 FR 47051 - National Environmental Policy Act Implementing Procedures

81 FR 47051 - National Environmental Policy Act Implementing Procedures

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 139 (July 20, 2016)

Page Range47051-47071
FR Document2016-17138

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.

Federal Register, Volume 81 Issue 139 (Wednesday, July 20, 2016)
[Federal Register Volume 81, Number 139 (Wednesday, July 20, 2016)]
[Proposed Rules]
[Pages 47051-47071]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                                    47051

                                                      Dutchess                                               proposed changes are intended to                      effective and efficient compliance with
                                                      Putnam                                                 update the regulations and improve                    NEPA requirements and integration of
                                                      Richmond                                               their clarity and effectiveness.                      other environmental review
                                                      Rockland                                                                                                     requirements under NEPA (e.g., 40 CFR
                                                                                                             DATES: We will consider all comments
                                                    Pennsylvania:
                                                      Pike                                                   that we receive on or before September                1500.2(c) and 40 CFR 1500.4(k)).
                                                                                                             19, 2016.                                             Consistent with the requirements of the
                                                       *         *         *      *                    *     ADDRESSES: You may submit comments                    CEQ NEPA implementing regulations,
                                                                     PENNSYLVANIA                            by either of the following methods:                   the APHIS regulations supplement the
                                                                                                               • Federal eRulemaking Portal: Go to                 CEQ regulations and the USDA NEPA
                                                       *         *         *              *            *     http://www.regulations.gov/                           implementing regulations to take into
                                                                      Philadelphia                           #!docketDetail;D=APHIS–2013–0049.                     account APHIS missions, authorities,
                                                                      Survey Area                              • Postal Mail/Commercial Delivery:                  and decision-making. The APHIS
                                                    New Jersey:                                              Send your comment to Docket No.                       regulations include definitions,
                                                      Burlington (Excluding the Joint Base                   APHIS–2013–0049, Regulatory Analysis                  categories of actions, major planning
                                                        McGuire-Dix-Lakehurst portion)                       and Development, PPD, APHIS, Station                  and decision points, opportunities for
                                                      Camden                                                                                                       public involvement, and methods of
                                                                                                             3A–03.8, 4700 River Road Unit 118,
                                                      Gloucester                                                                                                   processing different types of
                                                    Pennsylvania:                                            Riverdale, MD 20737–1238.
                                                      Bucks                                                    Supporting documents and any                        environmental documents.
                                                      Chester                                                comments we receive on this docket                       The APHIS regulations were last
                                                      Delaware                                               may be viewed at http://                              amended in a final rule published in the
                                                      Montgomery                                             www.regulations.gov/                                  Federal Register on February 1, 1995
                                                      Philadelphia                                           #!docketDetail;D=APHIS–2013–0049 or                   (60 FR 6000–6005, Docket No. 93–165–
                                                       Area of Application. Survey area plus:                in our reading room, which is located in              3; corrected on March 10, 1995, at 60 FR
                                                    New Jersey:                                              room 1141 of the USDA South Building,                 13212). The CEQ regulations at 40 CFR
                                                      Atlantic                                               14th Street and Independence Avenue                   1507.3(a) indicate that agencies ‘‘shall
                                                      Cape May                                               SW., Washington, DC. Normal reading                   continue to review their policies and
                                                      Cumberland                                             room hours are 8 a.m. to 4:30 p.m.,                   procedures and in consultation with the
                                                      Mercer                                                 Monday through Friday, except                         Council to revise them as necessary to
                                                      Warren                                                 holidays. To be sure someone is there to
                                                    Pennsylvania:                                                                                                  ensure full compliance with the
                                                      Carbon
                                                                                                             help you, please call (202) 799–7039                  purposes and provisions of the Act.’’
                                                      Lehigh                                                 before coming.                                        Since 1995, APHIS has begun several
                                                      Northampton                                            FOR FURTHER INFORMATION CONTACT: Dr.                  new types of actions (e.g., the Plant
                                                                                                             Elizabeth E. Nelson, APHIS Federal                    Protection Act of 2000) that are not
                                                       *         *           *            *            *     NEPA Contact, Environmental and Risk                  covered in the current regulations, and
                                                    [FR Doc. 2016–17029 Filed 7–19–16; 8:45 am]              Analysis Services, PPD, APHIS, 4700                   gathered further data on the
                                                    BILLING CODE 6325–39–P                                   River Road Unit 149, Riverdale, MD                    environmental impacts of those actions
                                                                                                             20737–1238; (301) 851–3089.                           that are covered in the regulations.
                                                                                                             SUPPLEMENTARY INFORMATION:                            Accordingly, we have evaluated our
                                                    DEPARTMENT OF AGRICULTURE                                                                                      regulations and identified changes that
                                                                                                             Background                                            would reflect those new authorities,
                                                    Animal and Plant Health Inspection                         The National Environmental Policy                   activities, and data. The changes we are
                                                    Service                                                  Act of 1969 (NEPA), as amended (42                    proposing would also clarify certain
                                                                                                             U.S.C. 4321 et seq.), is the United States’           areas of the regulations. APHIS has been
                                                    7 CFR Part 372                                           basic charter for protection of the                   and is consulting with CEQ regarding
                                                                                                             environment. The President’s Council                  these changes, as required. In addition
                                                    [Docket No. APHIS–2013–0049]
                                                                                                             on Environmental Quality (CEQ)                        to reflecting APHIS’ current
                                                    RIN 0579–AC60                                            Regulations for Implementing the                      responsibilities, the changes we are
                                                                                                             Procedural Provisions of the NEPA,                    proposing reflect CEQ NEPA guidance
                                                    National Environmental Policy Act                        published in 40 CFR parts 1500 through                that has been issued since the APHIS
                                                    Implementing Procedures                                  1508 (referred to below as the CEQ                    regulations were last amended. This
                                                    AGENCY:  Animal and Plant Health                         regulations) regulate the                             guidance describes how Federal
                                                    Inspection Service, USDA                                 implementation of NEPA across Federal                 agencies can establish, revise,
                                                    ACTION: Proposed rule.
                                                                                                             agencies.                                             substantiate, and apply categorical
                                                                                                               The Office of the Secretary of the U.S.             exclusions, and how agencies can
                                                    SUMMARY:    We are proposing to amend                    Department of Agriculture (USDA) has                  periodically review categorical
                                                    the regulations that set out our National                set forth departmental policy on the                  exclusions to assure that they remain
                                                    Environmental Policy Act implementing                    implementation of NEPA in 7 CFR part                  useful.1
                                                    procedures. The amendments include                       1b. Within USDA, the Animal and Plant                    NEPA and the CEQ regulations
                                                    clarifying and amending the categories                   Health Inspection Service (APHIS) has                 require all agencies of the Federal
                                                    of action for which we would normally                    regulations that set out its procedures
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                                                                                                                                                                   Government to include a detailed
                                                    complete an environmental impact                         for implementing NEPA in 7 CFR part                   statement by the responsible official
                                                    statement or an environmental                            372 (referred to below as the                         with every recommendation or report on
                                                    assessment for an action, expanding the                  regulations). APHIS’ regulations are                  proposals for legislation and other major
                                                    list of actions subject to categorical                   designed to ensure early and                          Federal actions significantly affecting
                                                    exclusion from further environmental                     appropriate consideration of potential
                                                    documentation, and setting out an                        environmental effects when APHIS                        1 You may view the CEQ guidance document on
                                                    environmental documentation process                      programs formulate policy and make                    the Internet at https://ceq.doe.gov/ceq_regulations/
                                                    that could be used in emergencies. The                   decisions. The regulations also promote               NEPA_CE_Guidance_Nov232010.pdf.



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                                                    47052                       Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    the quality of the human environment.                            determining whether to prepare an EIS                          categories of APHIS actions can and
                                                    This statement must cover:                                       or a finding of no significant impact                          should be categorically excluded. In
                                                      • The environmental impact of the                              (FONSI). Actions taken by an agency                            addition, we are proposing to provide
                                                    proposed action,                                                 that do not individually or cumulatively                       examples for broad categories of actions
                                                      • Any adverse environmental effects                            have a significant effect on the human                         that would be categorically excluded
                                                    which cannot be avoided should the                               environment, may be categorically                              and to further explain the process for
                                                    proposal be implemented,                                         excluded from the requirement to                               using those categorical exclusions. For
                                                      • Reasonable alternatives to the                               prepare either an EA or an EIS.                                ease of reading, therefore, we are
                                                    proposed action,                                                                                                                proposing to differentiate the categorical
                                                      • The relationship between local                               Proposed Reorganization
                                                    short-term uses of man’s environment                                                                                            exclusions currently found in § 372.5
                                                    and the maintenance and enhancement                                The CEQ regulations at 40 CFR                                into new sections. These new sections
                                                    of long-term productivity, and                                   1507.3(b)(2) require agencies to develop                       would be numbered §§ 372.8 through
                                                      • Any irreversible and irretrievable                           specific criteria for and identification of                    372.10 with 372.5 addressing
                                                    commitments of resources which would                             those typical classes of action that                           environmental impact statements, 372.6
                                                    be involved in the proposed action                               normally require an EIS or an EA, as                           addressing environmental assessments,
                                                    should it be implemented.                                        well as those that normally do not                             372.7 addressing categorical exclusions
                                                      Such a detailed environmental                                  require further analysis in either an EIS                      in general, and 372.8 through 372.10
                                                    statement is defined in the CEQ                                  or an EA and are thus categorically                            describing categorical exclusions.
                                                    regulations as an environmental impact                           excludable actions. APHIS’ regulations                         Consequently, current sections §§ 372.6
                                                    statement (EIS). The EIS is                                      accomplishing this are currently found                         through 372.10 would be redesignated.
                                                    distinguished from the environmental                             in § 372.5, ‘‘Classification of actions.’’                     The proposed sections are listed in
                                                    assessment (EA), which is a concise                                Since the last time the regulations                          Table 1, along with the paragraph in
                                                    public document that briefly provides                            were updated in 1995, APHIS has                                current § 372.5 to which they
                                                    sufficient evidence and analysis for                             determined that many additional                                correspond.2

                                                          TABLE 1—CURRENT AND PROPOSED ORGANIZATION OF CATEGORIES OF ACTIONS IN APHIS’ NEPA REGULATIONS
                                                                                                                                                                                                       Current paragraph(s)
                                                      Proposed section                                                              Title                                                                   in § 372.5

                                                    372.5 .......................   Actions normally requiring environmental impact statements ...............................               (a).
                                                    372.6 .......................   Actions normally requiring environmental assessments but not necessarily envi-                           (b).
                                                                                      ronmental impact statements.
                                                    372.7 .......................   Categorical exclusions; general provisions ...........................................................   Introductory text of (c) and (d), (d)(1).
                                                    372.8 .......................   Categorical exclusions; conventional measures ....................................................       (c)(1).
                                                    372.9 .......................   Categorical exclusions; licensing, permitting, and authorization or approval .......                     (c)(3).
                                                    372.10 .....................    Categorical exclusions; other categories of actions ..............................................       (c)(2), (c)(4).



                                                    Actions Normally Requiring                                       hazard management actions at John F.                           mitigate against the risk of bird strikes
                                                    Environmental Impact Statements                                  Kennedy International Airport. These                           on airplanes or rabies in wildlife. We
                                                       The introductory text of paragraph (a)                        actions were not part of a policymaking                        would add these actions to the
                                                    of current § 372.5 sets out a description                        or a rulemaking.                                               regulations.
                                                    of actions APHIS takes that normally                                We also are proposing to modify the                            The current text states that actions in
                                                    require environmental impact                                     regulations to add several types of EIS                        this category are characterized by their
                                                    statements.                                                      eligible actions. The current text                             broad scope and potential effect. We are
                                                       We are proposing to make several                              indicates that risks to animal and plant                       proposing to qualify this statement by
                                                    changes to the introductory text. First,                         health are the only reasons APHIS takes                        indicating that these characteristics
                                                    we are proposing to refer to a category                          action. However, APHIS takes other                             typically characterize actions in this
                                                    of actions rather than a class of actions.                       types of actions, including those that                         category. Sometimes, APHIS takes
                                                    This change would be consistent with                             protect or preserve property, natural                          actions that have a broad scope, but
                                                    the CEQ regulations that use the phrase                          resources, and human health and safety.                        whose impacts on the environment are
                                                    ‘‘category of actions.’’ We would make                           For example, under the Plant Protection                        not significant. The program to reduce
                                                    this change in the rest of our regulations                       Act (7 U.S.C. 7701 et seq.), APHIS may                         the spread of rabies in wildlife is one
                                                    as well.                                                         designate a plant as a noxious weed                            example of such an action. The action
                                                       Second, rather than referring to                              based on the damage it causes to                               may have a broad scope, but we can
                                                    policymakings and rulemakings, we are                            irrigation, navigation, the natural                            easily determine and characterize the
                                                    proposing to simply refer to ‘‘actions.’’                        resources of the United States, the                            likely potential effects as not significant.
                                                    APHIS takes actions that are not                                 public health, or the environment, and                            We are proposing to provide more
                                                    policymakings or rulemakings but                                 may take action to address the weed’s                          detail on what we mean by potential
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                                                    which could nevertheless have a                                  harmful effects. APHIS’ Wildlife                               effects on the human environment. We
                                                    significant impact on the human                                  Services program also undertakes                               would specify that, for the purposes of
                                                    environment and thus warrant an EIS.                             actions to manage wildlife damage in                           determining whether an action warrants
                                                    For example, APHIS’ Wildlife Services                            order to promote or protect human                              an EIS, we are interested in the intensity
                                                    (WS) program prepared an EIS for gull                            health and safety, such as actions to                          of the potential effects, which refers to
                                                      2 A detailed accounting of the rationale for each              National Environmental Policy Act Implementing                 available on the Internet at http://
                                                    of the proposed changes may be found in the                      Procedures (7 CFR part 372), Substantiating                    www.regulations.gov/#!docketDetail;D=APHIS–
                                                    document entitled ‘‘Proposed Amendments to                       Document for Proposed Amendments,’’ which is                   2013–0049.



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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                           47053

                                                    the severity of impact and is defined in                 consider to determine when to prepare                 typically be adequately assessed in an
                                                    40 CFR 1508.27(b) where the regulations                  an EIS.                                               EA. We would also indicate that
                                                    state that the following 10 factors                         We would remove the sentence that                  activities may involve a specific species
                                                    should be considered in evaluating                       states that the use of new or untried                 or similar species. We have found that
                                                    intensity: (1) Impacts that may be both                  methodologies, strategies, or techniques              impacts associated with actions
                                                    beneficial and adverse. A significant                    to deal with pervasive threats to animal              involving multiple, similar species are
                                                    effect may exist even if the Federal                     and plant health would lead us to                     not significantly different than actions
                                                    agency believes that on balance the                      complete an EIS. The fact that a method               involving a particular species.
                                                    effect will be beneficial; (2) The degree                is novel does not by itself mean its use                 We would expand the current
                                                    to which the proposed action affects                     will have significant environmental                   discussion of potential effects. To
                                                    public health or safety; (3) Unique                      impacts warranting an EIS. For example,               contrast with our proposed text
                                                    characteristics of the geographic area                   APHIS may develop a new method that                   regarding actions that normally require
                                                    such as proximity to historic or cultural                involves noninvasive procedures or                    an EIS, we would state that any effects
                                                    resources, park lands, prime farmlands,                  whose potential impacts, either positive              of the action on environmental
                                                    wetlands, wild and scenic rivers, or                     or negative, are well understood.                     resources (such as air, water, soil, plant
                                                    ecologically critical areas; (4) The                     Neither of these actions would                        communities, animal populations, or
                                                    degree to which the effects on the                       necessarily warrant an EIS.                           others) or indicators (such as dissolved
                                                                                                                We would also remove the sentence                  oxygen content of water) can be
                                                    quality of the human environment are
                                                                                                             stating that, for actions that warrant an             reasonably identified, and mitigation
                                                    likely to be highly controversial; (5) The
                                                                                                             EIS, alternative means of dealing with a              measures are generally available and
                                                    degree to which the possible effects on
                                                                                                             threat to animal and plant health                     have previously been successful. Again,
                                                    the human environment are highly                         usually have not been well developed.                 the intensity and likelihood of the
                                                    uncertain or involve unique or                           The presence or absence of alternatives               potential effects are our primary
                                                    unknown risks; (6) The degree to which                   by themselves does not determine the                  concern.
                                                    the action may establish a precedent for                 potential impacts an agency action                       We would remove the sentences
                                                    future actions with significant effects or               would have on the human environment.                  discussing the novelty of
                                                    represents a decision in principle about                    Paragraph (a)(1) of § 372.5 currently              methodologies, strategies, and
                                                    a future consideration; (7) Whether the                  lists ‘‘formulation of contingent                     techniques used to deal with issues and
                                                    action is related to other actions with                  response strategies to combat future                  the alternative means of dealing with
                                                    individually insignificant but                           widespread outbreaks of animal and                    those issues, for the same reasons we
                                                    cumulatively significant impacts.                        plant diseases’’ as an action that might              would remove them in our discussion of
                                                    Significance exists if it is reasonable to               normally requires an EIS. This category               the actions that normally require an EIS.
                                                    anticipate a cumulatively significant                    of actions is still appropriate, and we                  Finally, the regulations currently list
                                                    impact on the environment.                               would retain it. Paragraph (a)(2) of                  several categories of actions as actions
                                                    Significance cannot be avoided by                        § 372.5 would be slightly modified to                 that normally require an EA but not
                                                    terming an action temporary or by                        read as follows: ‘‘Adoption of strategic              necessarily an EIS. However, within
                                                    breaking it down into small component                    or other long-range plans that prescribe              those general categories, there are
                                                    parts; (8) The degree to which the action                a preferred course of action for future               several specific categories of action that
                                                    may adversely affect districts, sites,                   actions implementing the plan.’’ This                 we have determined should be subject
                                                    highways, structures, or objects listed in               modification more fully captures our                  to categorical exclusions.
                                                    or eligible for listing in the National                  intent that both the overarching strategic               In current § 372.5, paragraphs (b)(1)
                                                    Register of Historic Places or may cause                 or long-range plan itself and actions                 through (b)(5) list specific categories of
                                                    loss or destruction of significant                       taken to implement that plan should be                actions that normally require an EA but
                                                    scientific, cultural, or historical                      considered in an EIS.                                 not necessarily an EIS. Along with our
                                                    resources; (9) The degree to which the                      The current categories of action that              proposed move of these categories to
                                                    action may adversely affect an                           normally require an EIS would be found                § 372.6, we are proposing to remove one
                                                    endangered or threatened species or its                  in paragraphs (a) and (b) of proposed                 category, amend two of the other current
                                                    habitat that has been determined to be                   § 372.5.                                              categories, and add two new categories.
                                                    critical under the Endangered Species                                                                             Current paragraph (b)(1) lists
                                                    Act of 1973; and (10) Whether the action                 Actions Normally Requiring                            policymakings and rulemakings that
                                                    threatens a violation of Federal, State, or              Environmental Assessments But Not                     seek to remedy specific animal and
                                                    local law or requirements imposed for                    Necessarily Environmental Impact                      plant health risks or that may affect
                                                    the protection of the environment.                       Statements                                            opportunities on the part of the public
                                                    Instead of referring to environmental                        The introductory text of paragraph (b)            to influence agency environmental
                                                    quality values, we would refer to                        of current § 372.5 sets out a description             planning and decisionmaking as actions
                                                    environmental components, and give                       of actions APHIS takes that normally                  that would normally require an EA. We
                                                    the examples of air, water, soil, plant                  require environmental assessments but                 would move this category to paragraph
                                                    communities, and animal populations.                     not necessarily environmental impact                  (a) in proposed § 372.6 and add the
                                                    This change would add clarity to the                     statements. We are proposing to make                  word ‘‘actions’’ to ‘‘policymakings and
                                                    regulations, as ‘‘environmental quality                  this text the introductory text of a new              rulemakings.’’ This change would
                                                    values’’ has proven to cause confusion.                  § 372.6 and to make several changes to                ensure that the regulations reflect the
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                                                    It would also increase transparency                      it.                                                   broad range of activities for which
                                                    regarding those environmental elements                       The current text explains that                    APHIS prepares environmental
                                                    we consider when writing an EIS. We                      ‘‘limited scope’’ means actions                       compliance documentation.
                                                    would also provide an example of an                      involving particular sites, species, or                  Paragraph (b)(2) of § 372.5 lists
                                                    indicator, including, but not limited to                 activities. We would expand this                      planning, design, construction, or
                                                    the dissolved oxygen content of water.                   explanation to add State-wide or                      acquisition of new facilities, or
                                                    These would help the reader to                           district-wide programs. We have found                 proposals for modifications to existing
                                                    understand the types of effects we                       that agency actions of this scope can                 facilities as actions that would normally


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                                                    47054                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    require an EA. We would move it to                       appropriate to establish this category of             Most actions APHIS takes are designed
                                                    paragraph (b) of proposed § 372.6, but                   actions as requiring an EA but not                    to prevent damage or harm to animals,
                                                    would otherwise leave it unchanged                       necessarily an EIS.                                   plants, and human enterprises related to
                                                    apart from specifying that the                              Paragraph (b)(5) of § 372.5 currently              those animals and plants. Making these
                                                    substantial modifications to existing                    lists two examples of research and                    actions subject to a categorical
                                                    facilities under discussion are also                     testing actions that normally require an              exclusion, when appropriate, in
                                                    included.                                                EA: Research and testing that will be                 accordance with criteria in §§ 372.7
                                                       Paragraph (b)(3) of § 372.5 lists the                 conducted outside of a laboratory or                  through 372.10, benefits the human
                                                    disposition of waste and other                           other containment area, and research                  environment by allowing APHIS to take
                                                    hazardous toxic materials at laboratories                and testing that reaches a stage of                   action to prevent or reduce the damage
                                                    and other APHIS facilities, except when                  development (e.g., formulation of                     or harm more quickly than would be
                                                    categorically excluded, as normally                      premarketing strategies) that forecasts               possible if the agency had to complete
                                                    requiring an EA. We would move it to                     an irretrievable commitment to the                    an EA or EIS for the action.
                                                    paragraph (c) of proposed § 372.6, but                   resulting products or technology. We are                 Paragraph (a) of proposed § 372.7
                                                    would otherwise leave it unchanged.                      proposing to retain this category of                  would set out general provisions for
                                                       Paragraph (b)(4) of current § 372.5                   action, as paragraph (f) of proposed                  APHIS’ use of categorical exclusions.
                                                    lists approvals and issuance of permits                  § 372.6.                                              Currently, these provisions are found in
                                                    for proposals involving genetically                         We would add a new category of                     the introductory text of paragraph (c) of
                                                    engineered or nonindigenous species,                     action as paragraph (g): Determination                § 372.5. We would make two changes to
                                                    except for actions that are categorically                of nonregulated status for genetically                the current provisions. First, the
                                                    excluded, as normally requiring an EA                    engineered organisms. Under current                   introductory text of this paragraph
                                                    but not necessarily an EIS. We are                       paragraph (b)(4) of § 372.5, APHIS has                currently states that categorically
                                                    proposing to amend this category of                      been preparing EAs when it determines                 excluded actions are similar to actions
                                                    action to include issuance of licenses, as               a genetically engineered organism is not              that normally require an EA but not
                                                    well as permits, to reflect the                          a plant pest risk and does not present                necessarily an EIS in terms of their
                                                    terminology used by APHIS animal                         significant environmental impacts.                    extent of program involvement and the
                                                    health and biotechnology programs as                     However, determining that a genetically               scope and effect of and availability of
                                                    well as to specify that we are referring                 engineered organism should not be                     alternatives to proposed actions.
                                                    only to regulated genetically engineered                 regulated is not an action that fits                  Because we are proposing to remove the
                                                    or nonindigenous species. We would                       within the category of an approval or an              text dealing with alternatives from the
                                                    also move this category of action to                     issuance of a permit or license; such                 EIS and EA sections, we are proposing
                                                    paragraph (d) of proposed § 372.6.                       actions are addressed in the                          to remove it here as well.
                                                       We are proposing to add a new                         corresponding proposed paragraph (d)                     In addition, paragraph (c) of § 372.5
                                                    category of actions as paragraph (e) of                  of § 372.6. Adding this example as a                  currently states that the major difference
                                                    proposed § 372.6. This paragraph would                   separate paragraph would provide                      between categorically excluded actions
                                                    indicate that programs to reduce damage                  transparency and clarification about                  and actions that require an EA, but not
                                                    or harm by a specific wildlife species or                how APHIS addresses potential                         necessarily an EIS, is that for
                                                    group of species (such as deer or birds),                environmental impacts associated with                 categorically excluded actions, the
                                                    or to reduce a specific type of damage                   actions on petitions for nonregulated                 means through which adverse
                                                    or harm, such as protection of                           status of genetically engineered                      environmental impacts may be avoided
                                                    agriculture from wildlife depredation                    organisms as described in 7 CFR 340.6.                or minimized have actually been built
                                                    and disease, management of rabies in                     The significance factors listed in 40 CFR             into the actions themselves. The
                                                    wildlife, or protection of threatened or                 1508.27 are considered when                           paragraph goes on to state that the
                                                    endangered species, normally require an                  determining the appropriate                           efficacy of this approach generally has
                                                    EA but not necessarily an EIS. Such                      environmental documentation for these                 been established through testing and/or
                                                    programs are managed by APHIS’ WS                        actions, and our NEPA analyses have                   monitoring.
                                                    program. Since 1994, WS has prepared                     repeatedly demonstrated that the level                   We are proposing to indicate that
                                                    and worked under hundreds of EAs for                     of potential environmental impact is                  mitigation measures alone are not the
                                                    these types of program activities. WS’                   usually not significant, making an EA                 sole key factor. Rather, there are several
                                                    EAs for program activities include                       appropriate for such actions unless the               key factors that we should consider
                                                    review of potential environmental                        significance factors listed in 40 CFR                 when determining whether a category of
                                                    impacts on target species, nontarget                     1508.27 apply.4                                       actions is categorically excluded, which
                                                    species including threatened and                                                                               are (1) the extent to which mitigation
                                                                                                             Categorical Exclusions; General                       measures to avoid or minimize adverse
                                                    endangered species, aesthetic values,                    Provisions
                                                    and any additional issues identified                                                                           environmental impacts have been built
                                                                                                               The bulk of the changes we are                      into the actions themselves and, in some
                                                    through the NEPA process. WS monitors
                                                                                                             proposing to the regulations relate to                cases, standard operating procedures;
                                                    impacts of actions taken under these
                                                                                                             categorical exclusions. When experience               (2) Agency expertise and experience
                                                    EAs to ensure that the EAs’ analyses
                                                                                                             and monitoring indicate that an action                implementing the actions; and (3)
                                                    continue to adequately evaluate
                                                                                                             or a type of action does not have a                   whether testing or monitoring have
                                                    program goals, actions, and impacts. In                  significant or substantial impact on the              demonstrated there normally is no
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                                                    no instance have WS’ monitoring                          human environment, establishing a
                                                    evaluations indicated that WS’ actions                                                                         potential for significant environmental
                                                                                                             categorical exclusion for that action                 impacts.
                                                    under these types of EAs had impacts                     benefits both APHIS and the public.
                                                    warranting preparation of an EIS.3 For                                                                            We would also add evaluation criteria
                                                                                                                                                                   which must be met prior to any
                                                    these reasons, we believe it is                             4 You may view specific examples on the Internet
                                                                                                                                                                   determination of categorical exclusion.
                                                                                                             at https://www.aphis.usda.gov/myportal/aphis/
                                                      3 For a current list and examples of active WS         resources/lawsandregs/SA_Environmental_
                                                                                                                                                                   These would be found in new
                                                    EAs, see http://www.aphis.usda.gov/regulations/ws/       Protection/SA_Statutes/                               paragraphs 372.7(a)(1)(i) through
                                                    ws_nepa_environmental_documents.shtml.                   SupplementalNEPAAmendments.                           (a)(1)(iii). The first evaluation criterion


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                          47055

                                                    is to determine whether the action has                   action may have the potential to                      conventional measures in proposed
                                                    not been segmented in order to meet the                  significantly affect the quality of the               § 372.7(c) and in proposed § 372.8.
                                                    definition of a categorical exclusion.                   human environment, an EA or an EIS                       We are proposing to change the
                                                    Segmentation may occur when an action                    will be prepared. (In § 372.4, which                  current list of conventional measures
                                                    is intentionally broken down into                        contains definitions of various terms                 slightly. The current list includes
                                                    component parts in order to avoid the                    used in the APHIS NEPA implementing                   sampling that does not cause physical
                                                    appearance of significance of the total                  regulations, we would add a definition                alteration of the environment. We are
                                                    action. The second evaluation criterion                  of Agency official responsible for                    proposing to instead refer to monitoring,
                                                    would be to determine whether any                        environmental review, which would be                  including surveys and surveillance, that
                                                    extraordinary circumstances exist that                   consistent with the CEQ regulations.)                 does not cause physical alteration of the
                                                    would require us to preclude the use of                    We are also proposing to add a new                  environment. This terminology is more
                                                    a categorical exclusion. An example of                   paragraph § 372.7(c), which would                     commonly used within and outside
                                                    an extraordinary circumstance would be                   describe the extraordinary                            APHIS to describe these activities,
                                                    when a proposed action that is normally                  circumstances for individual                          which will be discussed in more detail
                                                    categorically excluded may have the                      categorically excluded actions that                   later in this document.
                                                    potential for significant adverse                        would preclude the use of a categorical                  Paragraph (c)(1) of current § 372.5
                                                    environmental impacts to nontarget                       exclusion. A list of specific                         goes on to describe the appropriate use
                                                    species. The third evaluation criterion                  extraordinary circumstances for these                 of chemicals and other products as part
                                                    would be whether the action occurs in                    actions would be provided in                          of routine measures. Specifically, it
                                                    a limited area, does not permanently                     paragraphs (c)(1) through (c)(17).                    states that such measures may include
                                                    adversely affect the area, and is                          Please note that the following sections             the use—according to any label
                                                    performed with well-established                          include examples of activities that we                instructions or other lawful
                                                    procedures (e.g., permits for GE                         expect would result in categorical                    requirements and consistent with
                                                    organism field testing under specified                   exclusions. These lists are not intended              standard, published program practices
                                                    conditions).                                             to be comprehensive accounts of all                   and precautions—of chemicals,
                                                       These changes would emphasize that                    possible categorical exclusions. Any                  pesticides, or other potentially
                                                    actions we take do not individually or                   activity not listed would still have to               hazardous or harmful substances,
                                                    cumulatively have a significant effect on                meet the requirements for a categorical               materials, and target-specific devices or
                                                    the environment, as demonstrated                         exclusion.                                            remedies, provided that such use meets
                                                    through long-term application or testing                                                                       certain criteria.
                                                                                                             Categorical Exclusions; Conventional                     In paragraph (a) of proposed § 372.8,
                                                    and monitoring, without the need to                      Measures
                                                    build in means to avoid or minimize                                                                            we are proposing to expand the list of
                                                    environmental impacts. Many examples                        Paragraph (c)(1) of § 372.5 currently              substances that may be used as part of
                                                    of such actions will be discussed later                  lists various categorically excluded                  a conventional measure, subject to
                                                    in this document.                                        actions under the heading of ‘‘routine                certain conditions, to include the use of
                                                       Paragraph (d) of current § 372.5                      measures.’’ We are proposing to list                  pesticides, chemicals, drugs,
                                                    discusses exceptions for categorically                   such measures, and explanations and                   pheromones, contraceptives, or other
                                                    excluded actions and lists examples of                   examples of such measures, in a new                   potentially harmful substances,
                                                    such exceptions. As part of our                          § 372.8.                                              materials, and target-specific devices or
                                                    reorganization of the list of actions                       As described in current paragraph                  remedies.
                                                    subject to categorical exclusions, we are                (c)(1), routine measures include                         APHIS uses contraceptives, such as
                                                    proposing to list common exceptions to                   identifications, inspections, surveys,                GonaCon, to manage populations of
                                                    categorical exclusions next to the                       sampling that does not cause physical                 animals and mitigate their impacts on
                                                    categorical exclusions themselves in the                 alteration of the environment, testing,               the environment and natural resources.
                                                    regulatory text. We hope that this                       seizures, quarantines, removals,                      APHIS uses drugs, such as the nonlethal
                                                    change would highlight the potential                     sanitizing, inoculations, control, and                sedative alpha chloralose, to
                                                    exceptions for users of the regulations.                 monitoring employed by agency                         temporarily immobilize animals for
                                                    We are proposing to refer to such                        programs to pursue their missions and                 relocation or other management.
                                                    exceptions as ‘‘extraordinary                            functions. The designation of these                   Previous APHIS NEPA evaluations
                                                    circumstances,’’ consistent with CEQ’s                   measures as ‘‘routine’’ has caused some               concluded that normal use patterns of
                                                    instructions in the definition of                        uncertainty among agency personnel                    both contraceptives and drugs do not
                                                    ‘‘categorical exclusion’’ in 40 CFR                      and the public. Certain actions that                  individually or cumulatively have a
                                                    1508.4 to provide for ‘‘extraordinary                    APHIS performs on a regular basis may                 significant effect on the human
                                                    circumstances in which a normally                        nonetheless require us to prepare an EA               environment based on the limited
                                                    excluded action may have a significant                   or EIS each time we perform them,                     duration and scope of their use and the
                                                    environmental effect.’’ (In § 372.4,                     depending on the potential for the                    design of the contraceptives and drugs,
                                                    which contains definitions of various                    actions to significantly affect the human             which limit effects on nontarget species.
                                                    terms used in the APHIS NEPA                             environment. What the current                            APHIS uses pheromones to control
                                                    implementing regulations, we would                       regulations describe is an action that                plant pests; the pheromones mask the
                                                    add a definition of extraordinary                        occurs in a limited area, does not                    chemical scent of the target organism,
                                                    circumstances, which would be                            permanently adversely affect the area,                making it difficult for the organism to
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                                                    consistent with the CEQ regulations.)                    and is performed in accordance with                   find mates and reproduce. As long as
                                                       We would retain the introductory text                 well-established procedures. We believe               pheromones are used in accordance
                                                    of paragraph (d) of current § 372.5 as                   that a better description for such                    with Environmental Protection Agency
                                                    paragraph (b) of proposed § 372.7. It                    measures is ‘‘conventional.’’ Therefore,              (EPA) labeling requirements, we have
                                                    would continue to indicate that,                         we are proposing to refer to such                     found that they do not individually or
                                                    whenever the Agency official                             measures as conventional measures both                cumulatively have a significant effect on
                                                    responsible for environmental review                     in our proposed description of general                the human environment. In practice, we
                                                    determines that a categorically excluded                 extraordinary circumstances for                       expect pheromones to have


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                                                    47056                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

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


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                           47057

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


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                                                    47058                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    surrounding environment that the use of                  practices as part of a disease control or             authorizations and approvals as well as
                                                    irradiation does not have a significant                  eradication program. As these practices               licensing and permitting, in a new
                                                    impact.                                                  are designed to prevent the spread of                 § 372.9.
                                                       • Treatment of a facility, container, or              animal disease, and as they are                          The introductory text of proposed
                                                    cargo hold at the port of entry to                       conducted in accordance with                          § 372.9 would indicate that licensing
                                                    mitigate pest threats.                                   applicable Federal, State, and local                  and permitting refers to the issuance of
                                                       • Cleaning and disinfection of                        regulations, they do not have a                       a license, permit, or authorization to
                                                    equipment, cages, facilities, or premises.               significant impact, as demonstrated by                entities, including individuals,
                                                       • Treatment of animal carcasses,                      the findings of VS’s EAs and FONSIs.                  manufacturers, distributors, agencies,
                                                    using methods such as incineration,                      Examples of animal handling methods                   organizations, or universities for field
                                                    alkaline digestion, or rendering as a                    included in this categorical exclusion                testing, environmental release, or
                                                    method to devitalize infectious material.                include, but are not limited to:                      importation or movement of animals;
                                                       Inoculations. An inoculation would                       • Restraining or handling livestock,               plants; animal, plant, or veterinary
                                                    be described as the introduction of a                    poultry, or wildlife to facilitate                    biological products; or any other
                                                    pathogen or antigen into a living                        examination or other activities.                      regulated article. Authorization and
                                                    organism in order to invoke an immune                       • Cultural methods and basic habitat               approval would be for an entity to
                                                    response to treat or prevent a disease.                  management such as nonlethal                          participate in a program or perform an
                                                    Inoculations are administered to                         management activities such as removal                 action.
                                                    individual identifiable organisms at                     of food sources, modification of planting                Generally, APHIS has put in place
                                                    limited locations and times to produce                   systems, modification of animal                       restrictions on the importation and
                                                    internal immune responses. The limited                   husbandry practices, water control
                                                    scope and timespan of inoculations                                                                             interstate movement of many articles to
                                                                                                             devices for beaver dams, limited beaver               prevent the introduction or
                                                    means that they do not individually or                   dam removal, and pruning trees.
                                                    cumulatively have a significant effect on                                                                      dissemination within the United States
                                                                                                                • Site-specific applications of                    of animal and plant pests and diseases.
                                                    the human environment. Examples are:                     nonlethal wildlife damage management
                                                       • Inoculation or treatment of discrete                                                                      Decisions to allow the importation or
                                                                                                             practices such as frightening devices,                interstate movement of such articles are
                                                    herds of livestock or wildlife                           exclusion, capture and release, and
                                                    undertaken in contained areas (such as                                                                         made only after determining that any
                                                                                                             capture and relocation.                               risk presented by the movement of the
                                                    a barn or corral, a zoo, an exhibition, or                  Recordkeeping and labeling. This
                                                    an aviary).                                                                                                    article has been adequately mitigated.
                                                                                                             categorical exclusion would cover
                                                       • Use of vaccinations or inoculations,                requiring regulated parties to keep
                                                                                                                                                                   Such actions therefore would not be
                                                    including new vaccines (including                                                                              expected to have a significant impact on
                                                                                                             records demonstrating compliance with                 the human environment.
                                                    genetically engineered vaccines) and                     APHIS requirements or to label
                                                    applications of existing vaccines to new                                                                          APHIS also licenses, authorizes, or
                                                                                                             regulated articles to indicate compliance             approves entities to carry out activities
                                                    species provided that the project is                     or set out restrictions on the movement
                                                    conducted in a controlled and limited                                                                          to further their purposes or goals. Such
                                                                                                             of the article. Recordkeeping and                     licensing, authorization, or approval is
                                                    manner, and the impacts of the vaccine                   labeling are used as part of other
                                                    can be predicted. An extraordinary                                                                             done only when APHIS has determined
                                                                                                             measures or programs to ensure                        that the entity will effectively fulfill its
                                                    circumstance would apply if a                            documentation of events in compliance
                                                    previously licensed or approved                                                                                designated responsibilities. These
                                                                                                             with the regulations and other                        actions are administrative for the
                                                    biologic has been subsequently shown                     requirements. Recordkeeping and
                                                    to be unsafe, or will be used at                                                                               agency, and generally occur in support
                                                                                                             labeling thus facilitate compliance and               of actions that undergo programmatic
                                                    substantially higher dosage levels or for                enforcement. Such activities involve
                                                    substantially different applications or                                                                        analysis in an EIS or EA. To require a
                                                                                                             paperwork only and thus are not                       separate NEPA analysis for each license,
                                                    circumstances than in the use for which                  expected to have an impact on the
                                                    the product was previously approved.                                                                           authorization, or approval would not
                                                                                                             human environment. Examples include,                  allow expedient action to serve the
                                                    (This extraordinary circumstance comes                   but are not limited to requiring
                                                    from current paragraph (d)(2) of                                                                               public, and would promote piece-meal
                                                                                                             regulated parties to:                                 analyses. Even collectively, these
                                                    § 372.5.)                                                   • Maintain records documenting the
                                                       Animal handling and management.                                                                             licenses, authorizations, and approvals
                                                                                                             results of trapping for insects.
                                                    This would include nonlethal methods                        • Maintain records of the application              are not expected to individually or
                                                    not addressed elsewhere in part 372 that                 of treatments.                                        cumulatively have significant effect on
                                                    are used to prevent, monitor for, reduce,                   • Prepare labels indicating that the               the human environment because they
                                                    or stop disease, damage, or harm caused                  movement of a regulated article to                    are part of programs where mitigations
                                                    by animals. (Some animal handling and                    certain areas within the United States is             reduce potential effects.
                                                    management methods, such as removal                      illegal.                                                 We are proposing to list specific
                                                    and testing, are addressed earlier in                       • Retain records at approved                       examples of these actions, organized by
                                                    proposed § 372.8.) APHIS’ WS program                     livestock facilities and listed                       APHIS program area, in paragraphs (a)
                                                    has conducted many EAs examining the                     slaughtering or rendering                             through (c) of proposed § 372.9.
                                                    use of nonlethal animal handling and                     establishments under 9 CFR part 71.                   Paragraph (a) would set out examples of
                                                    management methods in the context of                                                                           animal health-related actions. These are:
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                                                    State-wide programs. These EAs                           Categorical Exclusions; Licensing,                       • Approval of interstate movement or
                                                    concluded that such methods have no                      Permitting, Authorization, and                        importation of animals via regulations
                                                    significant impact on the human                          Approval                                              or permits. APHIS’ VS program
                                                    environment and resulted in FONSIs.                         Paragraph (c)(3) of § 372.5 currently              approves such movement based on the
                                                    Similarly, APHIS’ Veterinary Services                    lists various categorically excluded                  requirements set forth in the Federal
                                                    (VS) program may require livestock                       actions under the heading of ‘‘licensing              disease program regulations as reflected
                                                    producers within quarantined areas to                    and permitting.’’ We are proposing to                 in the 9 CFR. Risk assessments provide
                                                    use generally accepted biosecurity                       list such actions, expanded to include                the basis for determining the


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                           47059

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


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                                                    47060                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

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


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                          47061

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


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                                                    47062                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    regulated article is presumed to interact                would be eligible for a categorical                   amend this exclusion to include the
                                                    with the environment in the same way                     exclusion under proposed § 372.10 are                 development and/or production of
                                                    as the antecedent. EAs for extensions of                 those limited in magnitude, frequency,                program materials, devices, reagents,
                                                    nonregulated status incorporate the                      and scope. This would clarify why                     and biologics that are for evaluation in
                                                    antecedent organism as part of the                       research and development activities                   confined animal, plant, or insect
                                                    baseline or no action alternative. We                    usually have minimal effects on the                   populations under conditions that
                                                    have completed nine EAs for extensions                   environment.                                          prevent exposure to the general
                                                    of nonregulated status since 2000.                          Paragraph (c)(2)(ii) of current § 372.5            population (e.g., conducted in
                                                    Because the regulated organism (the                      lists three examples of research and                  laboratories or other facilities with
                                                    subject of the request) is so similar to                 development activities that are                       established environmental and human
                                                    non-regulated organisms that are                         categorically excluded:                               safety protocols). Since the use is
                                                    currently in the environment, the EAs                       • The development and/or                           limited and the general population
                                                    have found no difference with respect to                 production (including formulation,                    should not be exposed, the development
                                                    the impacts on biological or physical                    repackaging, movement, and                            or production of these articles would
                                                    environment between the two                              distribution) of previously approved                  not have a significant impact on the
                                                    organisms. Moreover, all of the                          and/or licensed program materials,                    human environment.
                                                    assessments have resulted in findings of                 devices, reagents, and biologics;                        Paragraph (a)(4) would provide a new
                                                    no significant impact. For these reasons,                   • Research, testing, and development               categorical exclusion for research using
                                                    we believe it would be appropriate to                    of animal repellents; and                             chemicals, management tools, or
                                                    establish a categorical exclusion for this                  • Development and production of                    devices to test the efficacy of methods;
                                                    category of actions.                                     sterile insects.                                      new vaccinations not currently
                                                       • Notifications for environmental                                                                           approved to test in the natural
                                                                                                             We are proposing to amend these
                                                    release, importation, or interstate                                                                            environment; the use of mechanical
                                                                                                             examples and add three more in
                                                    movement of articles regulated under 7                                                                         devices (such as noise and light
                                                                                                             paragraphs (a)(1) through (a)(6) of
                                                    CFR part 340. The notification process                                                                         deterrence); and existing vaccinations,
                                                                                                             proposed § 372.10.
                                                    is described in 7 CFR 340.3. It is an                                                                          chemicals, or devices used in a new way
                                                                                                                Paragraph (a)(1) would provide a new
                                                    administratively streamlined alternative                                                                       on an animal, pest, or disease similar to
                                                                                                             categorical exclusion for vaccination
                                                    to a permit for the introduction of an                                                                         those on which they have previously
                                                                                                             trials that occur on groups of animals in             been used.
                                                    article regulated under that part. The
                                                    article must meet certain eligibility                    areas designed to limit interaction with                 Paragraph (a)(5) would expand on the
                                                    criteria designed to reduce risk, and the                similar animals, or that include other                current categorical exclusion for the
                                                    introduction must meet six performance                   controls needed to mitigate potential                 research, testing, and development of
                                                    standards. These include confinement                     risk. The study design in these cases                 animal repellents. As amended, the
                                                    and devitalization methods that are                      eliminates the potential for impacts on               categorical exclusion would include all
                                                    designed to further mitigate potential                   organisms other than the test subjects.               research related to the development and
                                                    environmental impacts, if any.                              Paragraph (a)(2) would provide a new               evaluation of wildlife management
                                                                                                             categorical exclusion for the evaluation              tools, such as animal repellents, scare
                                                    Categorical Exclusions; Other                            of uses for chemicals not specifically                devices, fencing, and pesticides. As
                                                    Categories of Actions                                    listed on the product label, as long as               indicated in the introductory text of
                                                       Paragraph (c)(2) of § 372.5 currently                 they are used in a manner designed to                 proposed paragraph (a), APHIS research
                                                    lists various categorically excluded                     limit potential effects to nontarget                  using the methods described in
                                                    actions under the heading of ‘‘research                  species such that there are no individual             proposed paragraphs (a)(4) and (a)(5) is
                                                    and development.’’ In addition,                          or cumulative impacts on the human                    limited in magnitude, frequency, and
                                                    paragraph (c)(4) provides a categorical                  environment. Such evaluation is                       duration, meaning it is not likely to
                                                    exclusion for the rehabilitation of                      necessary to determine whether                        have a significant impact on the human
                                                    APHIS facilities. As the descriptions of                 chemicals may be effective against                    environment. APHIS has conducted
                                                    these categorical exclusions are not as                  organisms not listed on the label as                  many EAs on the operational use of
                                                    extensive as the descriptions of                         targets, or whether means of applying                 functionally similar methods, and those
                                                    conventional measures and of licensing,                  the chemical other than those listed on               methods have had no significant impact.
                                                    permitting, and authorization or                         the label may be effective and safe.                  APHIS research involving modifications
                                                    approval, we are proposing to combine                    Many of these evaluations will be                     of commonly used techniques is
                                                    these categories of actions and list them                subject to experimental use permits                   generally intended to improve the
                                                    in a new § 372.10.                                       issued by EPA with associated                         efficacy and selectivity of these methods
                                                       Paragraph (c)(2)(i) of § 372.5 currently              conditions to limit potential effects such            and would be expected to have similar
                                                    provides a description of research and                   that there are no individual or                       or less risk of adverse impact than the
                                                    development activities; we are                           cumulatively significant impacts on the               methods operationally in use.
                                                    proposing to provide this description in                 human environment. Other evaluations                     Paragraph (a)(6) would contain the
                                                    the introductory text of paragraph (a) of                may have products that have been                      current categorical exclusion for the
                                                    proposed § 372.10. Such activities are                   identified by EPA as mimimum risk and                 development and production of sterile
                                                    currently described as activities that are               therefore do not require a full Federal               insects. We would amend this
                                                    carried out in laboratories, facilities, or              Insecticide, Fungicide, and Rodenticide               categorical exclusion to include the
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                                                    other areas designed to eliminate the                    Act registration. However, APHIS still                release of sterile insects as well. Sterile
                                                    potential for harmful environmental                      does an environmental review to ensure                insects are bred in captivity, sterilized,
                                                    effects—internal or external—and to                      safe use and no extraordinary                         and released into the environment,
                                                    provide for lawful waste disposal.                       circumstances.                                        where they reduce the fecundity of pest
                                                       We are proposing to make a few                           Paragraph (a)(3) would expand on the               populations. Environmental effects are
                                                    changes to this text. We would indicate                  current categorical exclusion that                    limited due to the lack of offspring
                                                    at the beginning of this description that                applies to the development and/or                     resulting from mating with the wild
                                                    research and development activities that                 production of certain articles. We would              population. Research activities included


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                           47063

                                                    in this category can differ from field                   impacts of the action would remain                    analysis and documentation, the
                                                    releases discussed in proposed § 372.9                   relatively small.                                     responsible APHIS official shall take
                                                    because they may be done with novel                                                                            into account the probable
                                                                                                             Process for Rapid Response to
                                                    organisms and for limited duration.                                                                            environmental consequences of the
                                                                                                             Emergencies
                                                    Research may also include novel                                                                                emergency action and mitigate
                                                    methods for inducing sterility.                             We are proposing to add a new                      foreseeable adverse environmental
                                                       Paragraph (b) of proposed § 372.10                    section describing the process APHIS                  effects to the extent practicable.
                                                    would expand on the categorical                          follows to develop environmental
                                                                                                             documentation when conducting a                          Proposed paragraph (b) of § 372.15
                                                    exclusion for the rehabilitation of                                                                            would specify that, if a proposed
                                                    APHIS facilities currently found in                      rapid response to an emergency. The
                                                                                                             new section reflects the CEQ guidance                 emergency action is normally analyzed
                                                    paragraph (c)(4) of § 372.5. Paragraph                                                                         in an EA and the nature and scope of
                                                    (c)(4) currently indicates that                          discussed previously. Adding new
                                                                                                             §§ 372.6 through 372.10 would require                 proposed emergency actions are such
                                                    rehabilitation of existing laboratories                                                                        that there is insufficient time to prepare
                                                    and other APHIS facilities, functional                   us to move the other sections in part
                                                                                                             372. We are proposing to combine                      an EA and FONSI before commencing
                                                    replacement of parts and equipment,                                                                            the proposed action, the Administrator
                                                    and minor additions to existing APHIS                    current §§ 372.6 and 372.7, which deal
                                                                                                             with early planning and consultation on               shall consult with APHIS’ Chief of
                                                    facilities are subject to categorical                                                                          Environmental and Risk Analysis
                                                    exclusion. We would retain this list,                    NEPA matters, because they are quite
                                                                                                             short and discuss related subjects. For               Services (ERAS) about completing the
                                                    replacing the word ‘‘rehabilitation’’ with                                                                     required NEPA compliance
                                                    ‘‘renovation,’’ as the term better                       this reason, the last section of the
                                                                                                             current NEPA regulations would be                     documentation and may authorize
                                                    captures the nature of the work. We
                                                                                                             § 372.14 under this proposal, and we are              alternative arrangements for completing
                                                    would also add categorical exclusions
                                                                                                             therefore proposing to add this section               the required NEPA compliance
                                                    for the improvement, maintenance, and
                                                                                                             as § 372.15.                                          documentation. Any alternative
                                                    construction of APHIS facilities.
                                                                                                                APHIS frequently takes important                   arrangements should focus on
                                                       APHIS frequently needs to improve                     emergency actions to prevent the spread               minimizing adverse environmental
                                                    and maintain its facilities. Such                        of animal and plant pests and diseases.               impacts of the proposed action and the
                                                    improvement and maintenance often                        Without emergency action to control the               emergency, and they are limited to those
                                                    involves minor excavations and repairs                   spread of these pests and diseases there              actions that are necessary to control the
                                                    to sidewalks and grounds. We would                       is a potential for significant impacts on             immediate aspects of the emergency. To
                                                    add these as actions that are                            the human environment. Many actions                   the maximum extent practicable, these
                                                    categorically excluded, provided that                    APHIS takes in emergencies would be                   alternative arrangements should include
                                                    they involve disturbances with                           categorically excluded from the need to               the content, interagency coordination,
                                                    negligible adverse impacts on the                        prepare further NEPA documentation                    and public notification and involvement
                                                    environment.                                             under this proposal, as these actions                 that would normally be undertaken for
                                                       More extensive improvements may                       often fall into the categories described              an EA concerning the action and cannot
                                                    involve construction, expansion, or                      in proposed §§ 372.8 through 372.10.                  alter the requirements of the CEQ
                                                    improvement of a facility when the                       Primary examples of such actions can                  regulations at 40 CFR 1508.9(a)(1) and
                                                    permitting and approval process                          include quarantine, surveillance,                     (b). Any alternative arrangement also
                                                    requires measures that address potential                 decontamination and/or cleaning, and                  must be documented, and APHIS’ Chief
                                                    environmental effects. (For example,                     depopulation and disposal. However,                   of ERAS will inform CEQ of the
                                                    local or State regulations may require                   particularly when emergency actions are               alternative arrangements at the earliest
                                                    that certain construction techniques be                  not categorically excluded, it is                     opportunity.
                                                    used to reduce the effect of the                         important to minimize the potential
                                                    construction on the human                                                                                         Proposed paragraph (c) of § 372.15
                                                                                                             environmental effects of those actions.
                                                    environment.) We are proposing to add                       The proposed introductory section of               would state that APHIS shall
                                                    a categorical exclusion for these more                   § 372.15 would first state that, an                   immediately inform CEQ, through
                                                    extensive improvements, if they meet                     emergency exists when immediate                       APHIS’ interagency NEPA contact,
                                                    the following requirements:                              threats to human health and safety or                 when the proposed action is expected to
                                                       • The structure and proposed use are                  immediate threats to sensitive or                     result in significant environmental
                                                    in compliance with all Federal, State,                   protected resources require that action               effects and there is insufficient time to
                                                    Tribal and local requirements (including                 be taken in a timeframe that does not                 allow for the preparation of an EIS.
                                                    Executive Order 13423, ‘‘Strengthening                   allow sufficient time to follow the                   APHIS would consult CEQ and request
                                                    Federal Environmental, Energy, and                       procedures for environmental review                   alternative arrangements for preparing
                                                    Transportation Management,’’ and other                   established in the CEQ regulations and                the EIS documentation in accordance
                                                    Federal Executive orders);                               these regulations.                                    with CEQ regulations.
                                                       • The site and the scale of                              Proposed paragraph (a) of § 372.15                    These procedures are consistent with
                                                    construction are consistent with those of                would then stipulate that when the                    the CEQ regulations and guidance, and
                                                    existing adjacent or nearby buildings;                   Administrator of APHIS or the                         they provide clear direction to APHIS
                                                    and                                                      Administrator’s delegated Agency                      staff and the public on how APHIS will
                                                       • The size, purpose and location of                   official responsible for environmental                approach emergency NEPA compliance.
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                                                    the structure is unlikely to have                        review determines that an emergency                   By explicitly providing for these
                                                    significant environmental consequences                   exists that makes it necessary to take                emergency situations within our
                                                    or create public controversy.                            immediate action to prevent imminent                  implementing regulations, we would
                                                       A facility construction, expansion, or                damage to public health or safety, or                 ensure that timely emergency actions to
                                                    improvement that met these criteria                      sensitive or protected environmental                  counter disease and pest risks can be
                                                    would not be expected to have a                          resources in a timeframe that precludes               implemented and also ensure
                                                    significant effect on the human                          preparing and completing the usual                    appropriate compliance with NEPA
                                                    environment because the scope and                        NEPA review, which is comprised of                    requirements.


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                                                    47064                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    Miscellaneous Changes                                    potential economic effects of this rule               Health Inspection Service has
                                                      The name and address provided for                      on small entities, as required by the                 determined that this action would not
                                                    the Agency’s NEPA contact (§§ 372.3                      Regulatory Flexibility Act. The                       have a significant economic impact on
                                                    and 372.4) are outdated. This proposal                   economic analysis is summarized                       a substantial number of small entities.
                                                    would update that information. The                       below. Copies of the full analysis are
                                                                                                                                                                   Executive Order 12372
                                                    present agency contact for APHIS is                      available by contacting the person listed
                                                                                                             under FOR FURTHER INFORMATION                           This program/activity is listed in the
                                                    Environmental and Risk Analysis
                                                    Services, PPD, APHIS, USDA, 4700                         CONTACT or on the Regulations.gov Web                 catalog of Federal Domestic Assistance
                                                    River Road, Unit 149, Riverdale, MD                      site (see ADDRESSES above for                         under No. 10.025 and is subject to
                                                    20737–1238; (301) 851–3089.                              instructions for accessing                            Executive Order 12372, which requires
                                                      Due to the proposed reorganization of                  Regulations.gov).                                     intergovernmental consultation with
                                                    APHIS’ NEPA implementing                                    The proposed rule would amend                      State and local officials. (See 2 CFR
                                                    regulations, paragraph (a)(3) of current                 regulations that guide APHIS’                         chapter IV.)
                                                    § 372.9 would be found in § 372.13. This                 implementation of the National
                                                                                                                                                                   Executive Order 12988
                                                    paragraph has indicated that, when                       Environmental Policy Act (NEPA). The
                                                                                                             amended regulations would clarify                        This proposed rule has been reviewed
                                                    changes are made to EAs and findings
                                                                                                             when an environmental impact                          under Executive Order 12988, Civil
                                                    of no significant impact, all commenters
                                                                                                             statement (EIS) or an environmental                   Justice Reform. If this proposed rule is
                                                    on the EA will be mailed copies of
                                                    changes directly. Due to the high                        analysis (EA) for an action is normally               adopted: (1) All State and local laws and
                                                    volume of comments we receive that do                    required, provide additional categories               regulations that are inconsistent with
                                                    not include mailing addresses, this                      of actions for which we would prepare                 this rule will be preempted; (2) no
                                                    provision is impractical, and we are                     such documents, expand the list of                    retroactive effect will be given to this
                                                    proposing to remove it from the                          actions subject to categorical exclusion              rule; and (3) administrative proceedings
                                                    regulations. Consistent with the CEQ                     from further environmental                            will not be required before parties may
                                                    regulations at 40 CFR 1506.6(b)(1),                      documentation and provide examples of                 file suit in court challenging this rule.
                                                    paragraph (a)(3) of proposed § 372.13                    such actions, and establish an
                                                                                                                                                                   Executive Order 13175
                                                    would indicate that we would mail                        environmental documentation process
                                                                                                             for use in regulatory emergencies.                      This proposed rule has been reviewed
                                                    notice to those who provide a mailing
                                                                                                                Potentially affected entities include              in accordance with the requirements of
                                                    address and who have specifically
                                                                                                             individuals, businesses, organizations,               Executive Order 13175, Consultation
                                                    requested it on an individual action. We
                                                                                                             governmental jurisdictions, and other                 and Coordination with Indian Tribal
                                                    would continue to make all our
                                                                                                             entities involved with APHIS in the                   Governments. Executive Order 13175
                                                    environmental documentation publicly
                                                                                                             NEPA process. A small number of these                 requires Federal agencies to consult and
                                                    available on the APHIS Web site and
                                                                                                             entities may experience time and money                coordinate with tribes on a government-
                                                    interested parties can sign up for
                                                                                                             savings. For example, in 2014 we                      to-government basis on policies that
                                                    notifications from Regulations.gov to be
                                                                                                             estimate that 7 of 62 EAs would have                  have tribal implications, including
                                                    emailed when new documents are
                                                    added to the docket for a regulatory                     qualified for a categorical exclusion                 regulations, legislative comments or
                                                    action. Interested parties can also sign                 under the amended regulations. In 2015                proposed legislation, and other policy
                                                    up on APHIS’ Stakeholder Registry 5 to                   and 2016 respectively, we estimated                   statements or actions that have
                                                    receive email notification on any                        that 10 of 87 and 7 of 25 EAs would                   substantial direct effects on one or more
                                                    specific actions.                                        have qualified for a categorical                      Indian tribes, on the relationship
                                                                                                             exclusion under the amended                           between the Federal Government and
                                                    Executive Orders 12866 and 13563 and                     regulations. Resulting cost savings for               Indian tribes, or on the distribution of
                                                    Regulatory Flexibility Act                               APHIS and the affected entities are                   power and responsibilities between the
                                                       This proposed rule has been                           difficult to quantify and would vary by               Federal Government and Indian tribes.
                                                    determined to be significant for the                     the nature of the proposed actions. It                  APHIS has assessed the potential
                                                    purposes of Executive Order 12866 and,                   typically takes 1 week to 3 months to                 impact of this proposed rule and
                                                    therefore, has been reviewed by the                      prepare an EA to begin clearance. It                  determined that this rule does not, to
                                                    Office of Management and Budget.                         typically takes 2 to 3 years to prepare an            our knowledge, have tribal implications
                                                       We have prepared an economic                          EIS to begin clearance.                               that require tribal consultation under
                                                    analysis for this rule. The economic                        The proposal would make APHIS’                     Executive Order 13175. If a Tribe
                                                    analysis provides a cost-benefit analysis,               NEPA process more transparent and                     requests consultation, APHIS will work
                                                    as required by Executive Orders 12866                    efficient. The effects would be                       with the Office of Tribal Relations to
                                                    and 13563, which direct agencies to                      beneficial, but not significant. A small              ensure meaningful consultation is
                                                    assess all costs and benefits of available               number of entities may experience time                provided where changes, additions, and
                                                    regulatory alternatives and, if regulation               and money savings as a result of not                  modifications identified herein are not
                                                    is necessary, to select regulatory                       having to provide the information                     expressly mandated by Congress.
                                                    approaches that maximize net benefits                    necessary for completion of an EA.
                                                                                                             Affected small entities would include                 National Environmental Policy Act
                                                    (including potential economic,
                                                    environmental, public health and safety                  university researchers, research                        This proposed rule would revise the
                                                                                                             companies that produce veterinary                     regulations that guide APHIS employees
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                                                    effects, and equity). Executive Order
                                                    13563 emphasizes the importance of                       biologics, research and diagnostic labs               in NEPA analysis and documentation
                                                    quantifying both costs and benefits, of                  serving farmers, and producers of                     for animal and plant health
                                                    reducing costs, of harmonizing rules,                    biocontrol agends, including Tribal                   management, wildlife damage
                                                    and of promoting flexibility. The                        entities. The proposed rule would not                 management, and animal welfare
                                                    economic analysis also examines the                      have a significant economic impact on                 management activities. CEQ regulations
                                                                                                             a substantial number of small entities.               do not require agencies to prepare a
                                                     5 At https://public.govdelivery.com/accounts/              Under these circumstances, the                     NEPA analysis or document before
                                                    USDAAPHIS/subscriber/new.                                Administrator of the Animal and Plant                 establishing agency procedures that


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                                 47065

                                                    supplement the CEQ regulations for                       ■  4. Section 372.4 is amended as                     but not limited to air, water, soil, plant
                                                    implementing NEPA, and thus no NEPA                      follows:                                              communities, or animal populations) or
                                                    document was prepared for this                           ■ a. In the introductory text, by adding              indicators (including, but not limited to
                                                    proposed rule. Agencies are required to                  the words ‘‘and definitions’’ after the               dissolved oxygen content of water),
                                                    adopt NEPA procedures that establish                     word ‘‘terminology’’, by removing the                 whether or not affected individuals or
                                                    specific criteria for, and identification                word ‘‘(CEQ)’’, and by removing the                   systems can be reasonably completely
                                                    of, three categories of actions: Those                   word ‘‘is’’ and adding the word ‘‘are’’ in            identified at the time. An environmental
                                                    that require preparation of an EIS; those                its place;                                            impact statement will also normally be
                                                    that require preparation of an EA; and                   ■ b. By revising the definitions of                   prepared when an environmental
                                                    those that are categorically excluded                    decisionmaker and environmental unit;                 assessment identifies a potential for
                                                    from further NEPA review (40 CFR                         and                                                   significant impacts based upon the
                                                    1507.3(b)). Agency NEPA procedures                       ■ c. By adding, in alphabetical order,                context and intensity factors listed by
                                                    assist agencies in the fulfillment of                    definitions of Agency official                        the Council on Environmental Quality
                                                    agency responsibilities under NEPA, but                  responsible for environmental review                  (CEQ) at 40 CFR 1508.27. An EIS would
                                                    are not the agency’s final determination                 and extraordinary circumstances.                      also be required for an action whose
                                                    of what level of NEPA analysis is                           The additions and revisions read as                scope is limited to a relatively small
                                                    required for a particular proposed                       follows:                                              geographic area where there is the
                                                    action. The requirements for                             § 372.4   Definitions.                                potential for significant impacts or there
                                                    establishing agency NEPA procedures                                                                            is a high degree of uncertainty
                                                    are set forth at 40 CFR 1505.1 and                       *     *     *    *      *
                                                                                                                Agency official responsible for                    concerning the potential impacts.
                                                    1507.3.                                                                                                        Examples include, but are not limited
                                                                                                             environmental review. The Chief of
                                                    Paperwork Reduction Act                                  APHIS’ Environmental and Risk                         to:
                                                                                                             Analysis Services.                                       (a) Formulation of contingent
                                                       This proposed rule contains no                                                                              response strategies to combat future
                                                    information collection or recordkeeping                  *     *     *    *      *                             widespread outbreaks of animal and
                                                    requirements under the Paperwork                            Decisionmaker. The agency official                 plant diseases.
                                                    Reduction Act of 1980 (44 U.S.C. 3501                    responsible for signing the categorical                  (b) Adoption of strategic or other long-
                                                    et seq.).                                                exclusion or findings of no significant               range plans that prescribe a preferred
                                                                                                             impact (FONSI) and environmental                      course of action for future actions
                                                    List of Subjects in 7 CFR Part 372
                                                                                                             assessment or the record of decision                  implementing the plan.
                                                      Administrative practice and                            following the environmental impact
                                                    procedure, Environmental assessment,                     statement (EIS) process.                              § 372.6    [Redesignated as § 372.11]
                                                    Environmental impact statement.                          *     *     *    *      *                             ■ 6. Section 372.6 is redesignated as
                                                      Accordingly, we are proposing to                          Environmental unit. The analytical                 § 372.11.
                                                    amend 7 CFR part 372 as follows:                         unit in Policy and Program
                                                                                                             Development responsible for                           § 372.7    [Removed]
                                                    PART 372–NATIONAL                                        coordinating APHIS’ compliance with                   ■ 7. Section 372.7 is removed.
                                                    ENVIRONMENTAL POLICY ACT                                 NEPA and other environmental laws                       §§ 372.8 through 372.10
                                                    IMPLEMENTING PROCEDURES                                  and regulations.                                      [Redesignated as §§ 372.12 through
                                                                                                                Extraordinary circumstances.                       372.14]
                                                    ■ 1. The authority citation for part 372
                                                                                                             Circumstances in which an action that                 ■ 8. Sections 372.8 through 372.10 are
                                                    continues to read as follows:
                                                                                                             is normally categorically excluded may                redesignated as §§ 372.12 through
                                                      Authority: 42 U.S.C. 4321 et seq.; 40 CFR              have the potential for a significant                  372.14, respectively.
                                                    parts 1500–1508; 7 CFR parts 1b, 2.22, 2.80,                                                                   ■ 9. New §§ 372.6 through 372.10 are
                                                    and 371.9.
                                                                                                             environmental effect. When an
                                                                                                             extraordinary circumstance occurs,                    added to read as follows:
                                                    § 372.1   [Amended]                                      APHIS will determine whether those
                                                                                                                                                                   § 372.6    Environmental assessments.
                                                    ■ 2. Section 372.1 is amended by adding                  circumstances raise potential
                                                                                                             environmental issues that merit further                  Actions normally requiring
                                                    the word ‘‘(NEPA)’’ after the word ‘‘Act’’
                                                    the first time it occurs; and by removing                analysis in an environmental impact                   environmental assessments. This
                                                    the second and third occurrences of the                  statement or environmental assessment.                category of actions is typically related to
                                                    words ‘‘the National Environmental                       ■ 5. Section 372.5 is revised to read as              a more discrete program component but
                                                    Policy Act’’ and adding the word                         follows:                                              could be programmatic; however, the
                                                    ‘‘NEPA’’ in their place.                                                                                       potential environmental impacts
                                                                                                             § 372.5   Environmental impact statements.            associated with the proposed action are
                                                    ■ 3. Section 372.3 is revised to read as
                                                    follows:                                                   Actions normally requiring                          not considered potentially significant at
                                                                                                             environmental impact statements.                      the outset of the planning process. An
                                                    § 372.3   Information and assistance.                    Actions in this category typically                    action in this category is typically
                                                      Information, including the status of                   involve the agency, an entire program,                characterized by its limited scope
                                                    studies, and the availability of reference               or a substantial program component;                   (particular sites, State-wide or district-
                                                    materials, as well as the informal                       and may include programmatic for                      wide programs, specific or similar
                                                    interpretations of APHIS’ NEPA                           reducing risks to animal and plant                    species, or particular activities). Any
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                                                    procedures and other forms of                            health and other human interests such                 effects of the action on environmental
                                                    assistance, will be made available upon                  as property, natural resources, and                   resources (such as air, water, soil, plant
                                                    request to the APHIS NEPA contact at:                    human health and safety. Actions in this              communities, animal populations, or
                                                    Policy and Program Development,                          category are typically characterized by               others) or indicators (such as dissolved
                                                    APHIS, USDA, Attention: NEPA                             their broad scope (often nationwide) or               oxygen content of water) can be
                                                    Contact, 4700 River Road, Unit 149,                      their intensity of potential effects                  reasonably identified, and mitigation
                                                    Riverdale, MD 20737–1238, (301) 851–                     (impacting a wide range of                            measures are generally available and
                                                    3089.                                                    environmental components including,                   have previously been successful.


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                                                    47066                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    Actions normally requiring an                            into the actions themselves and, in some              can be attached to the record of
                                                    environmental assessment, but not                        cases, standard operating procedures;                 environmental consideration. Example
                                                    necessarily an environmental impact                      Agency expertise and experience                       conclusions that may be reached after a
                                                    statement, include:                                      implementing the actions; and whether                 review of extraordinary circumstances
                                                       (a) Policymakings, rulemakings, and                   testing or monitoring have demonstrated               include:
                                                    actions that seek to remedy specific                     there normally is no potential for                       (i) The U.S. Fish and Wildlife Service
                                                    animal and plant health risks or that                    significant environmental impacts. The                concurred through informal
                                                    may affect opportunities on the part of                  use of a categorical exclusion requires               consultation that endangered or
                                                    the public to influence agency                           the following three evaluation criteria               threatened species or designated habitat
                                                    environmental planning and                               be met:                                               are not likely to be adversely affected.
                                                    decisionmaking. Examples of this                            (i) The action has not been                           (ii) The U.S. Army Corps of Engineers
                                                    category of actions include:                             segmented. Determine whether the                      determined that the action is covered by
                                                       (1) Development of program plans to                   action has not been segmented to meet                 a nationwide general permit.
                                                    adopt strategies, methods, and                           the definition of a categorical exclusion.               (iii) State and/or local natural
                                                    techniques as the means of dealing with                  Segmentation may occur when an action                 resource agencies have been consulted
                                                    particular animal and plant health risks                 is intentionally broken down into                     to ensure compliance with applicable
                                                    that may arise in the future; and                        component parts in order to avoid the                 environmental laws and regulations for
                                                       (2) Implementation of program plans                   appearance of significance of the total               protecting and managing natural
                                                    at the site-specific action level.                       action. An action can be too narrowly                 resources such as native plant and
                                                       (b) Planning, design, construction, or                defined, minimizing potential impacts                 animal species.
                                                    acquisition of new facilities, or                        in an effort to avoid a higher level of                  (b) Whenever the Agency official
                                                    proposals for substantial modifications                  NEPA documentation. The scope of an                   responsible for environmental review
                                                    to existing facilities.                                  action must include the consideration of              determines that an extraordinary
                                                       (c) Disposition of waste and other                    connected actions, and the effects when               circumstance is present such that a
                                                    hazardous or toxic materials at                          applying extraordinary circumstances                  normally categorically excluded action
                                                    laboratories and other APHIS facilities.                 must consider cumulative impacts.                     may have the potential to significantly
                                                       (d) Approvals and issuance of permits                    (ii) No extraordinary circumstances                affect the quality of the human
                                                    or licenses for proposals involving                      exist. Determine whether the action                   environment, an environmental
                                                    regulated genetically engineered or                      involves any extraordinary                            assessment or an environmental impact
                                                    nonindigenous species.                                   circumstances that would require us to                statement will be prepared. Specific
                                                       (e) Programs to reduce damage or                      preclude the use of a categorical                     extraordinary circumstances for
                                                    harm by a specific wildlife species or                   exclusion.                                            individual categorically excluded
                                                    group of species, such as deer or birds,                    (iii) The action occurs in a limited               actions are listed with those actions in
                                                    or to reduce a specific type of damage                   area, does not permanently adversely                  §§ 372.8 through 372.10.
                                                    or harm, such as protection of                           affect the area, and is performed with                   (c) General extraordinary
                                                    agriculture from wildlife depredation                    well-established procedures.                          circumstance for conventional
                                                    and disease; for the management of                          (2) The Department has promulgated                 measures. An environmental assessment
                                                    rabies in wildlife; or for the protection                a listing of categorical exclusions that              or environmental impact statement will
                                                    of threatened or endangered species.                     are applicable to all agencies within the             be prepared when an extraordinary
                                                       (f) Research or testing that will be                  Department unless their procedures                    circumstance is present such that a
                                                    conducted outside of a laboratory or                     provide otherwise. The Departmental                   normally categorically excludable
                                                    other containment area or reaches a                      categorical exclusions, codified at                   action, as identified in §§ 372.8 through
                                                    stage of development (e.g., formulation                  § 1b.3(a) of this title, apply to APHIS.              372.10, has the potential to significantly
                                                    of premarketing strategies) that forecasts               Additional categorical exclusions                     affect the quality of the human
                                                    an irretrievable commitment to the                       specific to APHIS are provided in                     environment. General extraordinary
                                                    resulting products or technology.                        §§ 372.8 through 372.10.                              circumstances that preclude the use of
                                                       (g) Determination of nonregulated                        (3) The use of a categorical exclusion             a categorical exclusion are:
                                                    status for genetically engineered                        does not relieve the responsible Agency                  (1) A reasonable likelihood of
                                                    organisms.                                               official from compliance with other                   significant impact on public health or
                                                                                                             statutes, such as the Resource                        safety.
                                                    § 372.7 Categorical exclusions; general                  Conservation and Recovery Act, the                       (2) A reasonable likelihood of
                                                    provisions.                                              Endangered Species Act, or the National               significant environmental effects (direct,
                                                      (a)(1) Categorically excluded actions                  Historic Preservation Act. Such                       indirect, and cumulative).
                                                    share many of the same characteristics—                  consultations may be required to                         (3) A reasonable likelihood of
                                                    particularly in terms of the extent of                   determine the applicability of the                    involving effects on the environment
                                                    program involvement, as well as the                      categorical exclusion screening criteria.             that involve risks that are highly
                                                    scope and effect of proposed actions—                       (4) For categorical exclusions                     uncertain, unique, or are scientifically
                                                    as actions that normally require                         requiring a brief presentation of                     controversial.
                                                    environmental assessments but not                        conclusions reached during screening                     (4) A reasonable likelihood of
                                                    necessarily environmental impact                         and review of extraordinary                           violating any Executive Order, Federal
                                                    statements. APHIS considers that                         circumstances, determinations should                  law, or requirements imposed for the
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                                                    mitigation measures alone are not the                    be presented in a record of                           protection of the environment.
                                                    sole key factor. Rather, there are several               environmental consideration. This                        (5) A reasonable likelihood of
                                                    factors that should be included in                       determination can be made using                       adversely affecting environmentally
                                                    determining whether a category of                        current information and expertise as                  sensitive resources, unless the impact
                                                    actions is categorically excluded: The                   long as the basis for the determination               has been resolved through another
                                                    extent to which mitigation measures to                   is included in the record of                          environmental process (e.g., the Coastal
                                                    avoid or minimize adverse                                environmental consideration. Copies of                Zone Management Act, National
                                                    environmental impacts have been built                    appropriate interagency correspondence                Historic Preservation Act, Clean Water


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                            47067

                                                    Act, etc.). Environmentally sensitive                    existence, or spread of federally                        (2) Issuance of a specific
                                                    resources include:                                       recognized noxious weeds or non-native                identification number;
                                                       (i) Proposed federally listed,                        invasive species known to occur in the                   (3) Animal tags;
                                                    threatened, or endangered species or                     area; or actions that may promote the                    (4) Radio transmitters;
                                                    their designated critical habitats.                      introduction, growth, or expansion of                    (5) Microchips; and
                                                       (ii) Properties listed or eligible for                the range of noxious weed species.                       (6) Chemicals (such as tetracycline or
                                                    listing on the National Register of                         (14) A greater scope or size than is               rhodamine B ingestion).
                                                    Historic Places.                                         normal for this category of action.                      (c) Inspections. Inspections of articles
                                                       (iii) Areas having special designation                   (15) A reasonable likelihood of                    (including fruits and vegetables) to
                                                    or recognition such as prime or unique                   degrading already existing poor                       determine if there are any plant pests
                                                    agricultural lands; coastal zones;                       environmental conditions. Also,                       present, which could involve cutting
                                                    designated wilderness or wilderness                      initiation of a degrading influence,                  fruit for inspection; the physical
                                                    study areas; wild and scenic rivers;                     activity, or effect in areas not already              inspection of animals upon entry into
                                                    National Historic Landmarks                              significantly modified from their natural             the United States; facility and records
                                                    (designated by the Secretary of the                      condition.                                            inspections; inspections of
                                                    Interior); floodplains; wetlands; sole                      (16) A precedent (or makes decisions               commodities, facilities, or fields,
                                                    source aquifers; National Wildlife                       in principle) for future or subsequent                including paperwork and records, for
                                                    Refuges; National Parks; areas of critical               actions that have a reasonable                        approval and to assure compliance with
                                                    environmental concern; or other areas of                 likelihood of having a future significant             regulations and program standards.
                                                    high environmental sensitivity.                          effect.                                               Inspections usually follow a prescribed
                                                       (iv) Cultural, scientific, or historic                   (17) A reasonable likelihood of:                   protocol and document findings on an
                                                    resources.                                                  (i) Releases of petroleum, oils, and               inspection report form. Examples
                                                       (6) A reasonable likelihood of                        lubricants (except from a properly                    include, but are not limited to:
                                                    dividing or disrupting an established                    functioning engine or vehicle) or                        (1) Physical examination of plants,
                                                    community or planned development.                        reportable releases of hazardous or toxic             plant products, and animals at the port
                                                       (7) A reasonable likelihood of causing                substances as specified in 40 CFR part                of entry.
                                                    a substantial increase in surface                        302, Designation, Reportable Quantities,
                                                    transportation congestion that will                                                                               (2) Review of containment facilities.
                                                                                                             and Notification); or
                                                    decrease the level of service below                                                                               (3) Review of paperwork and records
                                                                                                                (ii) Where the proposed action
                                                    acceptable levels.                                                                                             to assure compliance with program
                                                                                                             requires development or amendment of
                                                       (8) A reasonable likelihood of                                                                              regulations and standards.
                                                                                                             a Spill Prevention, Control, or
                                                    adversely impacting air quality,                                                                                  (d) Monitoring, including surveys,
                                                                                                             Countermeasures Plan.
                                                    exceeding, or violating Federal, State,                                                                        surveillance, and trapping, that does not
                                                    local, or Tribal air quality standards                   § 372.8 Categorical exclusions;                       cause physical alteration of the
                                                    under the Clean Air Act, as amended.                     conventional measures.                                environment. Surveys include
                                                       (9) A reasonable likelihood of                          (a) Overview. Conventional measures                 questionnaires to collect information
                                                    adversely impacting water quality, sole                  include activities such as                            and data to assess a current state or
                                                    source aquifers, public water supply                     identifications; inspections; monitoring,             trend in activities, to determine
                                                    systems or State, local, or Tribal water                 including surveys and surveillance, that              compliance, or to determine whether a
                                                    quality standards established under the                  does not cause physical alteration of the             pest or disease exists in a specific area.
                                                    Clean Water Act and the Safe Drinking                    environment; testing; seizures;                       Surveillance includes activities to
                                                    Water Act.                                               quarantines; removals; sanitizing,                    collect test samples from part or all of
                                                       (10) A reasonable likelihood of effects               cleaning and disinfection; inoculations;              the target population using routine
                                                    on the quality of the environment that                   and animal handling and management                    collection techniques. Trapping refers to
                                                    are highly controversial on                              employed by agency programs to pursue                 the use of capture devices that are
                                                    environmental grounds. The term                          their missions and functions.                         designed to efficiently capture, restrain,
                                                    ‘‘controversial’’ means a substantial                    Paragraphs (b) through (l) of this section            or kill targeted individual animals or a
                                                    scientific dispute exists as to the size,                explain and give examples of                          group of animals (e.g., fruit flies and
                                                    nature, or effect of the proposed action                 conventional measures. Such measures                  other insects, a raccoon, a sounder of
                                                    rather than to the existence of                          may include the use—according to any                  feral swine). Capture devices used in
                                                    opposition to a proposed action, the                     label instructions or other lawful                    trapping are foothold; cage; drive; quick-
                                                    effect of which is relatively undisputed.                requirements and consistent with                      kill; pit (for insects and some small
                                                       (11) A reasonable likelihood of a                     standard, published program practices                 rodents, reptiles and amphibians);
                                                    disproportionately high and adverse                      and precautions—of pesticides,                        insect and sticky traps; snares and other
                                                    effect on low income or minority                         chemicals, drugs, pheromones,                         cable restraints; nets; hands; contained
                                                    populations.                                             contraceptives, or other potentially                  animal drugs (e.g., dart guns,
                                                       (12) Limit access to or ceremonial use                harmful substances, materials, and                    tranquilizer tab devices); and
                                                    of Indian sacred sites on Federal lands                  target-specific devices or remedies.                  insecticides. Attractants used with some
                                                    by Indian religious practitioners, or                      (b) Identifications. Detection and                  types of trapping are food, odor baits or
                                                    significantly adversely affect the                       identification of premises or animals, or             lures, pheromones, shapes, and colors.
                                                    physical integrity of sacred sites.                      identification of organisms, diseases, or             Trapping avoids risks to the viability of
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                                                       (13) Unless releases are supported by                 species causing damage or harm. These                 native nontarget species populations
                                                    a biocontrol risk analysis or expert                     range from biological or physical                     through use of attractants designed for
                                                    panel recommendation that                                marking and tracking of animals, to                   specific target animals, device design
                                                    accompanies the administrative record                    premises identification, and/or the use               and proper application, and device
                                                    for the categorical exclusion                            of other markers such as inert particles              placement. Examples include, but are
                                                    documentation, the proposed action has                   in feed and branding. Examples include,               not limited to:
                                                    a reasonable likelihood of contributing                  but are not limited to:                                  (1) Collection of biological or
                                                    to the introduction, continued                             (1) Commodity labels;                               environmental samples, such as tissue,


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                                                    47068                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    soil, or water samples and samples of                    other articles whose movement could                      (1) Treatment of regulated articles at
                                                    fecal matter.                                            spread the pest or disease.                           existing facilities, such as irradiation
                                                       (2) Continual checking, by testing,                      (2) Changes in pest or disease status              treatment and methyl bromide special
                                                    trapping, or observing for the presence,                 for an area or country, such as                       use treatment.
                                                    absence, or prevalence of animals, pests,                expansion or rescission of existing                      (2) Treatment of a facility, container,
                                                    or disease. Information may be used to                   quarantines.                                          or cargo hold at the port of entry to
                                                    support a pest or disease status (such as                   (3) Removal of quarantine restrictions             mitigate pest threats.
                                                    pest-free or disease-free status).                       when APHIS determines that it is                         (3) Cleaning and disinfection of
                                                       (3) Surveying and monitoring for                      appropriate to do so.                                 equipment, cages, facilities, or premises.
                                                    disease may or may not require the                          (h) Removals. Relocation or lethal                    (4) Treatment of animal carcasses,
                                                    lethal removal of the animal and can                     removal of living organisms, or                       using methods such as incineration,
                                                    often be conducted using nonlethal                       destruction of materials. Examples                    alkaline digestion, or rendering as a
                                                    methods, such as collection of samples                   include, but are not limited to:                      method to devitalize infectious material.
                                                    from animals killed or removed for                          (1) Removal of animals in accordance                  (j) Inoculations. Introduction of a
                                                    reasons related to disease monitoring                    with permits and agreements from the                  pathogen or antigen into a living
                                                    (i.e., damage management action                          appropriate management agencies, or                   organism in order to invoke an immune
                                                    addressed in an environmental                            otherwise in accordance with                          response to treat or prevent a disease.
                                                    assessment, or hunter-killed animals).                   regulations governing management of a                 Examples are:
                                                       (4) Randomly selecting animals and                    species, for the purpose of approved                     (1) Inoculation or treatment of
                                                    obtaining blood samples to survey for                    research studies, surveillance and                    discrete herds of livestock or wildlife
                                                    disease, or collection of test samples.                  monitoring, or disease or damage                      undertaken in contained areas (such as
                                                       (e) Testing. The examination or                       management, or due to pest concerns.                  a barn or corral, a zoo, an exhibition, or
                                                    analysis of a collected sample. This                        (2) Removal of animals or materials                an aviary).
                                                    activity often occurs in a laboratory, but               from premises.                                           (2) Use of vaccinations or inoculations
                                                    also includes nonlethal tests that require                  (3) Removal of trees or shrubs and                 including new vaccines (for example,
                                                    animal-side or chute-side injection and                  plants.                                               genetically engineered vaccines) and
                                                    observation in the field. Testing may                       (4) Disposal or destruction of                     applications of existing vaccines to new
                                                    require the use of specialized equipment                 materials for which the Agency has                    species provided that the project is
                                                    and/or diagnostic test kits. Examples                    regulatory authority due to, for example,             conducted in a controlled and limited
                                                    include, but are not limited to,                         completion of acknowledged or                         manner, and the impacts of the vaccine
                                                    intradermal tuberculosis testing of                      permitted activities, completion of                   can be predicted. Extraordinary
                                                    livestock and germplasm testing of plant                 regulated activities, or noncompliance                circumstance: A previously licensed or
                                                    material for viral infections.                           and disposal of animals. This can
                                                       (f) Seizures. Taking possession of                                                                          approved biologic has been
                                                                                                             include disposal of regulated articles                subsequently shown to be unsafe, or
                                                    conveyances, materials, regulated                        (fruits, meat, regulated genetically
                                                    articles, plants and plant products,                                                                           will be used at substantially higher
                                                                                                             engineered organisms, etc.) at ports of               dosage levels or for substantially
                                                    animals and animal products, other                       entry designated by U.S. Customs and
                                                    articles infested with a pest or                                                                               different applications or circumstances
                                                                                                             Border Protection (CBP).1 Approved                    than in the use for which the product
                                                    determined to be diseased or exposed to                  methods of disposal range from burial,
                                                    a disease, a regulated article that is                                                                         was previously approved.
                                                                                                             feeding to animals, composting, to co-                   (k) Animal handling and
                                                    mixed in a commodity, or contaminated                    burning for power generation.
                                                    shipping material. Examples include,                                                                           management. Nonlethal methods not
                                                                                                                (5) Routine disposal of carcasses using            addressed elsewhere in this part that are
                                                    but are not limited to:                                  other approved methods, such as
                                                       (1) Confiscation of a commodity that                                                                        used to prevent, monitor for, reduce, or
                                                                                                             donation for human consumption,                       stop disease, damage, or harm caused by
                                                    could be a vector for a plant or animal                  composting, chemical digestion, burial,
                                                    disease or pest, or an animal or plant                                                                         animals. Examples include, but are not
                                                                                                             and incineration.                                     limited to:
                                                    determined to be infested, infected,                        (6) Depopulation of domestic
                                                    exposed, or not in compliance with                                                                                (1) Restraining or handling livestock,
                                                                                                             livestock and captive wildlife due to the
                                                    APHIS regulations (such as one moved                                                                           poultry, or wildlife to facilitate
                                                                                                             presence of an animal disease or the
                                                    illegally or without proper paperwork).                                                                        examination or other activities.
                                                                                                             reasonable suspicion of the presence of
                                                       (2) Seizure of a nonregulated                                                                                  (2) Cultural methods and basic habitat
                                                                                                             an animal disease. Extraordinary
                                                    commodity, seed, or propagative                                                                                management, such as nonlethal
                                                                                                             circumstance: An outbreak of a foreign
                                                    material containing regulated                                                                                  management activities such as removal
                                                                                                             animal disease that would require the
                                                    genetically engineered material.                                                                               of food sources, modification of planting
                                                                                                             depopulation of a large number of
                                                       (g) Quarantines. Actions to restrict or                                                                     systems, modification of animal
                                                                                                             animals potentially resulting in
                                                    prohibit movement from an area,                                                                                husbandry practices, water control
                                                                                                             substantial or significant adverse
                                                    including the creation, expansion,                                                                             devices for beaver dams, limited beaver
                                                                                                             impacts on the human environment.
                                                    removal, or modification of quarantines.                                                                       dam removal, and pruning trees.
                                                                                                                (i) Sanitizing, cleaning, and
                                                    The establishment of a quarantine can                                                                             (3) Site-specific applications of
                                                                                                             disinfection. Treatment of an infested
                                                    include mitigations to allow for                                                                               nonlethal wildlife damage management
                                                                                                             commodity, cleaning, and disinfection
                                                    movement of animals or commodities                                                                             practices, such as frightening devices,
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                                                                                                             that occurs when a disease is found or
                                                    while preventing the spread of the                                                                             exclusion, capture and release, and
                                                                                                             there is an emergency disease outbreak,
                                                    animal or plant pest or disease. These                                                                         capture and relocation.
                                                                                                             treatment of a regulated article, or
                                                    mitigations are evaluated separately                                                                              (l) Recordkeeping and labeling.
                                                                                                             treatment for carcass disposal. Examples
                                                    from the establishment of the quarantine                                                                       Requiring regulated parties to keep
                                                                                                             include, but are not limited to:
                                                    itself. Examples of quarantines are:                                                                           records demonstrating compliance with
                                                       (1) Quarantine of an area in which a                    1 Further information on CBP-approved ports is      APHIS requirements or to label
                                                    pest or disease is known to occur to                     available on the Internet at http://www.cbp.gov/      regulated articles to indicate compliance
                                                    prevent movement of animals, plants, or                  contact/ports.                                        or set out restrictions on the movement


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                             47069

                                                    of the article. Examples include, but are                   (7) Approval of herd and premises                  strains of quarantine concern and occur
                                                    not limited to:                                          plans that have environmental or waste                or are likely to occur in a State’s
                                                       (1) Records documenting the results                   management components.                                environment, and issuance of permits
                                                    of trapping for insects.                                    (8) Approval of herd accreditation for             for the interstate movement of
                                                       (2) Records of the application of                     tuberculosis or certification for                     organisms that occur or are likely to
                                                    treatments.                                              brucellosis to document the herd’s                    occur in a State’s environment.
                                                       (3) Labels indicating that the                        freedom from disease.                                    (4) Issuance of permits or approvals
                                                    movement of a regulated article to                          (9) Funding the depopulation of                    for the importation of articles that are
                                                    certain areas within the United States is                diseased herds, including indemnity                   regulated due to plant health concerns,
                                                    illegal.                                                 and carcass disposal; authorization and               when the permit contains conditions
                                                       (4) Records retained by approved                      funding of the collection and                         that will mitigate any plant pest risk
                                                    livestock facilities and listed                          submission of tissue samples for testing.             associated with the articles.
                                                    slaughtering or rendering                                   (10) Approval of participation in the                 (5) Issuance of certificates or limited
                                                    establishments under 9 CFR part 71.                      National Poultry Improvement Plan by                  permits for the movement of regulated
                                                                                                             issuance of a permanent approval                      articles from areas quarantined due to
                                                    § 372.9 Categorical exclusions; licensing,               number in accordance with 9 CFR                       plant pests.
                                                    permitting, authorization, and approval.                 145.4.                                                   (6) Issuance of permits for the
                                                       Licensing and permitting refer to the                    (11) Authorization to ship and field               importation or interstate movement of
                                                    issuance of a license, permit, or                        test previously unlicensed veterinary                 regulated noxious weeds and other
                                                    authorization to entities including                      biologics including veterinary biologics              regulated seeds.
                                                    individuals, manufacturers, distributors,                containing genetically engineered                        (7) Issuance of permits for prohibited
                                                    agencies, organizations, or universities                 organisms (such as vector-based                       or restricted articles unloaded and
                                                    for field testing, environmental release,                vaccines and nucleic-acid based                       landed for immediate transshipment or
                                                    or importation or movement of animals;                   vaccines).                                            transportation and exportation.
                                                    plants; animal, plant, or veterinary                        (12) Issuance of a license or permit for              (c) Biotechnology-related. (1) Issuance
                                                    biological products; or any other                        previously unlicensed veterinary                      of permits for the importation, interstate
                                                    regulated article. Authorization and                     biologics including veterinary biologics              movement, or environmental releases of
                                                    approval are for an entity to participate                containing genetically engineered                     regulated genetically engineered
                                                    in a program or perform an action.                       organisms (such as vector-based                       organisms, provided that confinement
                                                    Examples of this category of action are:                 vaccines and nucleic-acid based                       measures (the permit conditions or
                                                       (a) Animal health-related. (1)                        vaccines).                                            performance measures), such as
                                                    Approval of interstate movement or                          (13) Issuance of a license, permit,                isolation distances from compatible
                                                    importation of animals via regulations                   authorization, or approval for uses of                relatives, control of flowering, or
                                                    or permits. Examples include, but are                    pure cultures of organisms (relatively                physical barriers, minimize the
                                                    not limited to:                                          free of extraneous micro-organisms and                interaction of the regulated article with
                                                                                                             extraneous material) that are not strains             the environment. Extraordinary
                                                       (i) Use of permits to control the
                                                                                                             of quarantine concern and occur, or are               circumstance: Uncertainty of
                                                    interstate movement of restricted
                                                                                                             likely to occur, in a State’s environment.            confinement measures and the ability of
                                                    animals, such as issuance of an official
                                                                                                                (14) Issuance of permits and approval              such to prevent the interaction of the
                                                    document or a State form allowing the
                                                                                                             of facilities to import, transport,                   regulated genetically engineered
                                                    movement of restricted animals to a
                                                                                                             introduce, or release live animals and                organism with the environment.
                                                    particular destination.
                                                                                                             products or byproducts thereof, or other                 (2) Extension of nonregulated status
                                                       (ii) Use of permits for entry, such as                organisms for which proven risk
                                                    pre-movement authorization for entry of                                                                        under part 340 of this chapter to
                                                                                                             mitigation measures are applied and                   organisms similar to those already
                                                    animals into a State from the State                      will require no substantial modification
                                                    animal health official of the State of                                                                         deregulated.
                                                                                                             for the specific articles under                          (3) Notifications for environmental
                                                    destination.                                             consideration. This includes
                                                       (iii) Approval of international                                                                             release, importation, or interstate
                                                                                                             importation or interstate movement of                 movement of regulated genetically
                                                    movements through the use of import                      meat, milk/milk products, eggs, hides,
                                                    and export health certificates and                                                                             engineered organisms.
                                                                                                             bones, animal tissue extracts, etc.,
                                                    import or export movement permits.                       which present no disease risk or for                  § 372.10 Categorical exclusions; research
                                                       (iv) Authorization to move animals                    which there are proven animal disease                 and development and facilities.
                                                    out of the quarantine or buffer zone for                 risk mitigation measures, such as                        (a) Research and development
                                                    cattle fever ticks by documentation (a                   heating, acidification, or standard                   activities. Activities limited in
                                                    State form) that confirms the animals                    chemical treatment.                                   magnitude, frequency, and scope that
                                                    have been inspected and found to be                         (b) Plant health-related. (1) Issuance             occur in laboratories, facilities, pens, or
                                                    tick-free.                                               of permits for the importation or                     field sites. Examples are:
                                                       (2) Licensing of swine garbage feeding                interstate movement of organisms into                    (1) Vaccination trials that occur on
                                                    operations.                                              containment facilities, for the interstate            groups of animals in areas designed to
                                                       (3) Accreditation of private                          movement of organisms between                         limit interaction with similar animals,
                                                    veterinarians.                                           containment facilities, and continued                 or that include other controls needed to
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                                                       (4) Approval and permitting of                        maintenance and use of these                          mitigate potential risk.
                                                    laboratories to conduct official tests.                  organisms.                                               (2) Evaluation of uses for chemicals
                                                       (5) Approval of identification                           (2) Issuance of permits for the use of             not specifically listed on the product
                                                    manufacturers to produce identification,                 organisms biologically incapable of                   label, if they are used in a manner
                                                    tests, and identification devices.                       persisting in the permitted environment.              designed to limit potential effects to
                                                       (6) Listing of slaughter and rendering                   (3) Issuance of permits for uses                   nontarget species.
                                                    establishments for surveillance under 9                  outside of containment that are pure                     (3) The development and/or
                                                    CFR 71.21.                                               cultures of organisms and that are not                production (including formulation,


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                                                    47070                  Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules

                                                    packaging or repackaging, movement,                      CFR 1502.21), to the fullest extent                   § 372.14 Supplementing environmental
                                                    and distribution) of articles such as                    practicable, surveys and studies                      impact statements.
                                                    program materials, devices, reagents,                    required by other environmental                          Once a decision to supplement an
                                                    and biologics that were approved and/                    statutes.                                             environmental impact statement is
                                                    or licensed in accordance with existing                  ■ 11. Newly redesignated § 372.12 is                  made, a notice of intent will be
                                                    regulations, or that are for evaluation in               amended as follows:                                   published. The administrative record
                                                    confined animal, plant, or insect                        ■ a. By revising the section heading;                 kept in connection with the EIS will
                                                    populations under conditions that                        ■ b. In the paragraph heading for                     thereafter be reopened if the
                                                    prevent exposure to the general                          paragraph (a), by removing the words                  supplemental environmental impact
                                                    population.                                              ‘‘Major planning’’ and adding in their                statement is issued after the record of
                                                       (4) Research using chemicals,                         place the word ‘‘Planning’’;                          decision is issued. The supplemental
                                                    management tools, or devices to test the                 ■ c. In paragraph (b), introductory text,             document will then be processed in the
                                                    efficacy of methods; new vaccinations                    by adding the words ‘‘and                             same fashion (exclusive of scoping) as a
                                                    not currently approved to test in the                    environmental assessment process’’                    draft and a final statement (unless
                                                    natural environment; the use of                          after the words ‘‘environmental impact                alternative procedures are approved by
                                                    mechanical devices (such as noise and                    statement process’’; and                              CEQ) and will become part of the
                                                    light deterrence); and existing                          ■ d. By revising paragraphs (b)(2) and                administrative record.
                                                    vaccinations, chemicals, or devices used                 (b)(4).                                               ■ 14. A new § 372.15 is added to read
                                                    in a new way on an animal, pest, or                         The revisions read as follows:                     as follows:
                                                    disease similar to those on which they
                                                                                                             § 372.12 Planning and decision points and             § 372.15 Process for rapid response to
                                                    have previously been used.                                                                                     emergencies.
                                                       (5) Research related to the                           public involvement.
                                                                                                             *      *     *    *      *                               An emergency exists when immediate
                                                    development and evaluation of wildlife
                                                                                                                (b) * * *                                          threats to human health and safety or
                                                    management tools, such as animal
                                                                                                                (2) Opportunities for public                       immediate threats to sensitive or
                                                    repellents, scare devices, fencing, and
                                                                                                             involvement in the environmental                      protected resources require that action
                                                    pesticides.
                                                       (6) Development, production, and                      assessment process will be announced                  be taken in a timeframe that does not
                                                    release of sterile insects.                              in the same fashion as the opportunities              allow sufficient time to follow the
                                                       (b) Renovation, improvement,                          for public involvement in the                         procedures for environmental review
                                                    maintenance, and construction of                         environmental impact statement                        established in the CEQ regulations and
                                                    facilities. Examples are:                                process.                                              the regulations in this part.
                                                       (1) Renovation of existing laboratories                                                                        (a) When the Administrator or the
                                                                                                             *      *     *    *      *                            Administrator’s delegated Agency
                                                    and other APHIS facilities.                                 (4) All environmental documents and
                                                       (2) Functional replacement of parts                                                                         official responsible for environmental
                                                                                                             comments received will be made                        review determines that an emergency
                                                    and equipment.                                           available to the public via
                                                       (3) Minor additions to existing APHIS                                                                       exists that makes it necessary to take
                                                                                                             Regulations.gov.                                      immediate action to prevent imminent
                                                    facilities.                                              ■ 12. Newly redesignated § 372.13 is
                                                       (4) Minor excavations of land and                                                                           damage to public health or safety, or
                                                                                                             amended as follows:                                   sensitive or protected environmental
                                                    repairs to properties.                                   ■ a. In paragraph (a), introductory text,
                                                       (5) Construction, expansion, or                                                                             resources in a timeframe that precludes
                                                                                                             by adding a new sentence after the end                preparing and completing the usual
                                                    improvement of a facility if:                            of the first sentence;
                                                       (i) The structure and proposed use are                                                                      NEPA review, which is comprised of
                                                                                                             ■ b. In paragraph (a)(1), by removing the             analysis and documentation, the
                                                    in compliance with all Federal, State,                   citation ‘‘§ 372.8’’ and adding the
                                                    Tribal, and local requirements;                                                                                responsible APHIS official shall take
                                                                                                             citation ‘‘§ 372.12’’ in its place; and               into account the probable
                                                       (ii) The site and scale of construction
                                                                                                             ■ c. By revising paragraph (a)(3).                    environmental consequences of the
                                                    are consistent with those of existing
                                                                                                                The addition and revision read as                  emergency action and mitigate
                                                    adjacent or nearby buildings; and
                                                                                                             follows:                                              foreseeable adverse environmental
                                                       (iii) The size, purpose and location of
                                                    the structure is unlikely to have                        § 372.13 Processing and use of                        effects to the extent practicable.
                                                    significant environmental consequences                   environmental documents.                                 (b) If a proposed emergency action is
                                                    or create public controversy.                                                                                  normally analyzed in an environmental
                                                                                                               (a) * * * This determination is based
                                                    ■ 10. Newly redesignated § 372.11 is                                                                           assessment as described in § 372.6 and
                                                                                                             on information provided in the NEPA
                                                    revised to read as follows:                                                                                    the nature and scope of proposed
                                                                                                             document and available in the
                                                                                                                                                                   emergency actions are such that there is
                                                    § 372.11 Early planning and consultation                 administrative record.
                                                                                                                                                                   insufficient time to prepare an EA and
                                                    for applicants and non-APHIS entities.                   *     *     *     *     *                             FONSI before commencing the proposed
                                                      Prospective applicants who anticipate                    (3) Changes to environmental                        action, the Administrator shall consult
                                                    the need for approval of proposed                        assessments and findings of no                        with APHIS’ Chief of Environmental
                                                    activities classified as normally                        significant impact that are prompted by               and Risk Analysis Services about
                                                    requiring environmental documentation                    comments, new information, or any                     completing the required NEPA
                                                    should contact, at their earliest                        other source, will normally be                        compliance documentation and may
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                                                    opportunity, APHIS’ program staff.                       announced in the same manner as the                   authorize alternative arrangements for
                                                    APHIS program officials will help them                   notice of availability prior to                       completing the required NEPA
                                                    determine the types of environmental                     implementing the proposed action or                   compliance documentation. Any
                                                    analyses or documentation, if any, that                  any alternative. APHIS will mail notice               alternative arrangements must be
                                                    need to be prepared and how they may                     upon request.                                         documented and notice of their use
                                                    inform decisions. The NEPA documents                     *     *     *     *     *                             provided to CEQ.
                                                    will incorporate by reference (as                        ■ 13. Newly redesignated § 372.14 is                     (c) APHIS shall immediately inform
                                                    required by the CEQ regulations in 40                    revised as follows:                                   the CEQ, through APHIS’ interagency


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                                                                           Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Proposed Rules                                             47071

                                                    NEPA contact, when the proposed                          no later than August 19, 2016. See                    contact Ms. Lucy deButts at (202) 287–
                                                    action is expected to result in significant              section V, ‘‘Public Participation,’’ for              1604 or by email: Lucy.deButts@
                                                    environmental effects and there is                       details.                                              ee.doe.gov.
                                                    insufficient time to allow for the                       ADDRESSES:    Any comments submitted                  FOR FURTHER INFORMATION CONTACT:      Ms.
                                                    preparation of an EIS. APHIS will                        must identify the SNOPR for Test                      Lucy deButts, U.S. Department of
                                                    consult CEQ and request alternative                      Procedures for Certain Categories of                  Energy, Office of Energy Efficiency and
                                                    arrangements in accordance with CEQ                      General Service Lamps, and provide                    Renewable Energy, Building
                                                    regulations at 40 CFR 1506.11. Such                      docket number EERE–2016–BT–TP–                        Technologies Office, EE–2J, 1000
                                                    alternative arrangements will apply only                 0005 and/or regulatory information                    Independence Avenue SW.,
                                                    to the proposed actions necessary to                                                                           Washington, DC, 20585–0121.
                                                                                                             number (RIN) 1904–AD64. Comments
                                                    control the immediate impacts of the                                                                           Telephone: (202) 287–1604. Email:
                                                                                                             may be submitted using any of the
                                                    emergency. Other proposed actions                                                                              Lucy.deButts@ee.doe.gov.
                                                                                                             following methods:
                                                    remain subject to NEPA analysis and                         1. Federal eRulemaking Portal:                        Mr. Pete Cochran, U.S. Department of
                                                    documentation in accordance with the                     www.regulations.gov. Follow the                       Energy, Office of the General Counsel,
                                                    CEQ regulations and the regulations in                   instructions for submitting comments.                 GC–71, 1000 Independence Avenue
                                                    this part.                                                  2. Email: GSL2016TP0005@                           SW., Washington, DC, 20585–0121.
                                                      Done in Washington, DC, this 14th day of               ee.doe.gov. Include the docket number                 Telephone: (202) 586–9496. Email:
                                                    July 2016.                                               EERE–2016–BT–TP–0005 and/or RIN                       Peter.Cochran@hq.doe.gov.
                                                    Edward Avalos,                                           1904–AD64 in the subject line of the                  SUPPLEMENTARY INFORMATION: DOE
                                                    Under Secretary, Marketing and Regulatory                message.                                              proposes to incorporate by reference
                                                    Programs.                                                   3. Mail: Ms. Lucy deButts, U.S.                    into 10 CFR part 430 specific sections of
                                                    [FR Doc. 2016–17138 Filed 7–19–16; 8:45 am]              Department of Energy, Building                        the following industry standards:
                                                    BILLING CODE 3410–34–P                                   Technologies Office, Mailstop EE–5B,                     (1) IEC 62301 (‘‘IEC 62301–DD’’),
                                                                                                             1000 Independence Avenue SW.,                         Household electrical appliances—
                                                                                                             Washington, DC, 20585–0121. If                        Measurement of standby power (Edition
                                                    DEPARTMENT OF ENERGY                                     possible, please submit all items on a                2.0, 2011–01).
                                                                                                             CD, in which case it is not necessary to                 A copy of IEC 62301–DD may be
                                                    10 CFR Parts 429 and 430                                 include printed copies.                               obtained from the International
                                                    [Docket No. EERE–2016–BT–TP–0005]                           4. Hand Delivery/Courier: Ms. Lucy                 Electrotechnical Commission, available
                                                                                                             deButts, U.S. Department of Energy,                   from the American National Standards
                                                    RIN 1904–AD64                                            Building Technologies Office, 950                     Institute, 25 W. 43rd Street, 4th Floor,
                                                                                                             L’Enfant Plaza SW., Suite 600,                        New York, NY 10036, (212) 642–4900,
                                                    Energy Conservation Program: Test
                                                                                                             Washington, DC, 20024. Telephone:                     or go to http://webstore.ansi.org.
                                                    Procedures for Certain Categories of
                                                                                                             (202) 586–2945. If possible, please                      (2) IES LM–9–09 (‘‘IES LM–9–09–
                                                    General Service Lamps
                                                                                                             submit all items on a CD, in which case               DD’’), IES Approved Method for the
                                                    AGENCY:  Office of Energy Efficiency and                 it is not necessary to include printed                Electrical and Photometric
                                                    Renewable Energy, Department of                          copies.                                               Measurement of Fluorescent Lamps.
                                                    Energy.                                                     For detailed instructions on                          (3) IES LM–20–13, IES Approved
                                                    ACTION: Supplemental notice of                           submitting comments and additional                    Method of Photometry of Reflector Type
                                                    proposed rulemaking.                                     information on the rulemaking process,                Lamps.
                                                                                                             see section V of this SNOPR, ‘‘Public                    (4) IES LM–45–15, IES Approved
                                                    SUMMARY:   This supplemental notice of                   Participation.’’                                      Method for the Electrical and
                                                    proposed rulemaking (SNOPR) proposes                        Docket: The docket, which includes                 Photometric Measurement of General
                                                    to establish test procedures for certain                 Federal Register notices, public meeting              Service Incandescent Filament Lamps.
                                                    categories of general service lamps                      attendee lists and transcripts,                          (5) IES LM–79–08 (‘‘IES LM–79–08–
                                                    (GSLs) to support the ongoing energy                     comments, and other supporting                        DD’’), IES Approved Method for the
                                                    conservation standards rulemaking.                       documents/materials, is available for                 Electrical and Photometric
                                                    Specifically, this rulemaking proposes                   review at www.regulations.gov. All                    Measurement of Solid-State Lighting
                                                    new test procedures for determining the                  documents in the docket are listed in                 Products.
                                                    initial lumen output, input power, lamp                  the www.regulations.gov index.                           Copies of IES LM–9–09–DD, IES LM–
                                                    efficacy, power factor, and standby                      However, some documents listed in the                 20–13, IES LM–45–15, and IES LM–79–
                                                    mode power of GSLs that are not                          index, such as those containing                       08–DD can be obtained from
                                                    integrated light-emitting diode (LED)                    information that is exempt from public                Illuminating Engineering Society of
                                                    lamps, compact fluorescent lamps                         disclosure, may not be publicly                       North America, 120 Wall Street, Floor
                                                    (CFLs), or general service incandescent                  available.                                            17, New York, NY 10005–4001, or by
                                                    lamps (GSILs). This SNOPR revises the                       A link to the docket Web page can be               going to www.ies.org/store.
                                                    previous proposed test procedures for                    found at https://www.regulations.gov/#!                  See section IV.M for a further
                                                    GSLs by referencing Illuminating                         docketDetail;D=EERE-2016-BT-TP-0005.                  discussion of these standards.
                                                    Engineering Society (IES) LM–79–08 for                   The docket Web page contains simple                   Table of Contents
                                                    the testing of non-integrated LED lamps.                 instructions on how to access all
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                                                    The U.S. Department of Energy (DOE) is                   documents, including public comments,                 I. Authority and Background
                                                    also proposing to clarify references to                  in the docket. See section V, ‘‘Public                II. Synopsis of the Supplemental Notice of
                                                    the existing lamp test methods and                                                                                   Proposed Rulemaking
                                                                                                             Participation,’’ for information on how
                                                    sampling plans for determining the                                                                             III. Discussion
                                                                                                             to submit comments through                               A. Scope of Applicability
                                                    represented values of integrated LED                     www.regulations.gov.                                     B. Proposed Method for Determining Initial
                                                    lamps, CFLs, and GSILs.                                     For further information on how to                        Lumen Output, Input Power, Lamp
                                                    DATES: DOE will accept comments, data,                   submit a comment or review other                            Efficacy, and Power Factor
                                                    and information regarding this SNOPR                     public comments and the docket,                          C. Laboratory Accreditation



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Document Created: 2018-02-08 07:57:05
Document Modified: 2018-02-08 07:57:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesWe will consider all comments that we receive on or before September 19, 2016.
ContactDr. 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.
FR Citation81 FR 47051 
RIN Number0579-AC60
CFR AssociatedAdministrative Practice and Procedure; Environmental Assessment and Environmental Impact Statement

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