National Environmental Policy Act Implementing Procedures, 24003-24011 [2018-11083]
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24003
Rules and Regulations
Federal Register
Vol. 83, No. 101
Thursday, May 24, 2018
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
We are amending the
regulations that set out our National
Environmental Policy Act implementing
procedures. The amendments include
clarifying the categories of actions for
which we would normally complete an
environmental impact statement or an
environmental assessment for an action,
as well as updating examples of
categorically excluded actions and
setting out an environmental
documentation process that could be
used in emergencies. The changes will
serve to update the regulations and
improve their clarity and effectiveness.
DATES: Effective June 25, 2018.
FOR FURTHER INFORMATION CONTACT: Dr.
Eileen Sutker, APHIS Federal NEPA
Contact, Environmental and Risk
Analysis Services, PPD, APHIS, 4700
River Road, Unit 149, Riverdale, MD
20737–1238; (301) 851–3043.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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 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), provide a basic regulatory
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framework for 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
CEQ’s NEPA implementing regulations
in 40 CFR 1507.3, 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.
NEPA and the CEQ regulations
require all agencies of the Federal
Government to incorporate
environmental considerations in their
planning and decisionmaking. This may
include the development of an
Environmental Impact Statement (EIS),
a detailed statement by the responsible
official with every recommendation or
report on proposals for legislation and
other major Federal actions significantly
affecting 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 the human
environment and the maintenance and
enhancement of long-term productivity,
and
• Any irreversible and irretrievable
commitments of resources which would
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be involved in the proposed action,
should it be implemented.
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.
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) state 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.’’
Accordingly, on July 20, 2016, we
published in the Federal Register (81
FR 47051–47071, Docket No. APHIS–
2013–0049) a proposal 1 to amend the
regulations by adding several new types
of actions that were not previously
covered in the regulations. Accordingly,
we also evaluated our regulations and
identified changes that would reflect
new authorities, activities, and data.
The changes we proposed also clarified
certain areas of the regulations.
We also proposed to establish or
revise categorical exclusions and
extraordinary circumstances under
which those categorical exclusions
would not apply and to revise the
requirements generally relating to
classification of various actions (e.g.,
actions normally requiring EISs, actions
normally requiring EAs but not
necessarily EISs). Upon further
consideration and in light of the
comments we received, we decided not
to finalize the proposed extraordinary
circumstances and most of the proposed
new program categorical exclusions.
Instead, we are making minor
adjustments to the language currently
found in § 372.5 concerning these
subjects to improve clarity and provide
further examples of activities that fall
1 To view the proposed rule and the comments
we received, go to https://www.regulations.gov/
docket?D=APHIS-2013-0049.
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into a given class of action or may be
subject to categorical exclusion. The
proposed additions were accompanied
by a reorganization of the regulations,
which we are also not finalizing. The
structure of the regulations will remain
largely identical to that of the current
regulations. We may revisit the issue of
categorical exclusions, extraordinary
circumstances, and classification of
actions in a future rulemaking.
We solicited comments concerning
our proposal for 60 days ending
September 19, 2016. We received 12
comments by that date from advocacy
groups, industry associations, and
private citizens. They are discussed
below by topic, with the exception of
any comments received on those
portions of the proposed rule we are not
finalizing, as described above.
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Comments Regarding Categorical
Exclusions and Extraordinary
Circumstances
The bulk of the comments we
received related to changes we proposed
to our categorical exclusions and their
associated extraordinary circumstances
exceptions. As stated above, in
considering those comments, which
covered a broad variety of issues in
detail, we came to recognize the need to
reevaluate our proposed categories and
reconsider the scope and effect of those
categories.
General Comments
One commenter stated that since the
changes and additions may affect
species protected under the Endangered
Species Act of 1973 and their
designated critical habitats, APHIS must
conduct a programmatic consultation
with the Fish and Wildlife Service
(FWS) and the National Marine
Fisheries Service (NMFS).
This rule is administrative in nature
and does not affect any listed threatened
or endangered species. We consult with
FWS and/or NMFS when an analysis of
listed species is necessary to arrive at an
environmental effects determination.
We will continue to consult on any
future actions that may affect protected
species.
The same commenter said that we
should coordinate our efforts
concerning NEPA with the existing
initiative involving APHIS, the
Environmental Protection Agency
(EPA), and the Food and Drug
Administration (FDA) to modernize
agency activities under the Coordinated
Framework for the Regulation of
Biotechnology.2
2 Further information on the Coordinated
Framework for the Regulation of Biotechnology may
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APHIS is involved in updating the
Coordinated Framework for the
Regulation of Biotechnology, which
clarifies the relevant existing authorities
and roles of the USDA, the FDA, and the
EPA. On January 4, 2017, EPA, FDA,
and USDA released the 2017 Draft
Update to the Coordinated Framework
for the Regulation of Biotechnology and
accompanying National Strategy for
Modernizing the Regulatory System for
Biotechnology Products. The original
Coordinated Framework for the
Regulation of Biotechnology and the
2017 Draft Update identify which types
of topics trigger NEPA analyses within
each agency. The finalized update of the
Coordinated Framework for the
Regulation of Biotechnology will
continue to align with the regulations,
and may facilitate further regulations.
Another commenter characterized the
proposed action as APHIS scaling back
its NEPA obligations, despite ongoing
disputes over the scope of APHIS’
duties in this area.
Contrary to the commenter’s
assertion, this rule will improve
transparency and clarity regarding
APHIS activities under NEPA. Further,
we will continue to apply an
appropriate level of environmental
documentation to every action.
Another commenter stated that they
had included suggestions for
corresponding changes to the NEPA
implementing regulations discussed
here as part of a comment submitted in
connection with a notice of intent to
prepare an EIS published in the Federal
Register on February 5, 2016 (81 FR
6225–6229, Docket No. APHIS–2014–
0054) titled ‘‘Environmental Impact
Statement; Introduction of the Products
of Biotechnology.’’ 3 The commenter
also said that this action may need to be
revised in light of any changes to the
NEPA regulations made in this final
rule.
Due to the nature of APHIS
rulemaking, we cannot consider the
content of comments submitted on other
rules. The notice referenced by the
commenter has yet to be finalized;
however, if changes to the NEPA
implementing regulations are necessary
as a result of that action, we will make
those changes accordingly via
subsequent rulemaking.
One commenter pointed out several
typographical errors in the preamble
language and the regulatory text of the
be found here: https://obama
whitehouse.archives.gov/sites/default/files/
microsites/ostp/2017_coordinated_framework_
update.pdf.
3 To view that notice and the comments we
received go to https://www.regulations.gov/
docket?D=APHIS-2014-0054.
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proposed rule. We have corrected the
errors in the regulatory text. The
preamble language is not repeated in
this final rule.
Comments Regarding Definitions
In § 372.4, which contains definitions
of various terms used in the regulations,
we proposed to revise two existing
definitions and add definitions for two
additional terms. We are not finalizing
the two proposed additional definitions.
We determined that a definition for
‘‘Agency official responsible for
environmental review’’ is unnecessary
because the information we wished to
convey can already be found in the
definition for ‘‘Environmental unit.’’ We
are not finalizing the definition for
‘‘Extraordinary circumstances’’ because,
as stated previously, we are not
finalizing the proposed revisions
concerning extraordinary
circumstances. The revisions we are
finalizing remain consistent with the
CEQ regulations.
One commenter suggested we add a
definition for the term ‘‘conventional,’’
given that we proposed a change from
‘‘routine measures’’ to ‘‘conventional
measures’’ throughout the regulations
due to prior confusion about the
meaning of ‘‘routine.’’ The commenter
argued that the word ‘‘conventional’’
has as much potential to cause
confusion as the word ‘‘routine.’’
Uses of the term ‘‘conventional
measures’’ in place of ‘‘routine
measures’’ were only found in those
sections we are not finalizing in this
document.
Comments Regarding Actions Normally
Requiring Environmental Assessments
But Not Necessarily Environmental
Impact Statements
We proposed to set out a description
of actions APHIS takes that normally
require EAs but not necessarily EISs in
§ 372.6 (§ 372.5(b) in the final rule). An
action in this class will typically be
characterized by its limited scope
(particular sites, species, or activities).
We are clarifying the way in which
we assess potential environmental
impacts in connection with an action
normally requiring an EA but not
necessarily an EIS. 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.
Proposed paragraph (d) of § 372.6
(§ 372.5(b)(4) in the final rule) indicated
that approvals and issuance of licenses
and permits for proposals involving
regulated genetically engineered or
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regulated nonindigenous species would
normally require an EA but not
necessarily an EIS, unless they are
categorically excluded. One commenter
proposed that we refer to ‘‘genetically
engineered organisms’’ separately from
regulated nonindigenous species. Two
commenters pointed out that we
neglected to specifically exclude actions
that are categorically excluded in the
language of this section.
We agree with the first commenter’s
suggestion to use the word ‘‘organisms’’
and have changed the term used in that
section to ‘‘genetically engineered
organisms or products.’’ Reference to
genetically engineered products is
necessary in some parts of the
regulations to adequately cover
veterinary biologics products, such as
genetically engineered subunit proteins,
plasmid vectors, and other constructs
that are not organisms. We agree with
the point raised by the last two
commenters and have added the
requested language to the introductory
paragraph of § 372.5(b).
Another commenter made a
recommendation regarding the
comingling threshold level for
genetically engineered and conventional
products. The commenter also stated
that third-party field testing on crops
with a high risk of comingling should
occur.
As the proposal did not relate to such
a threshold or such inspections, these
comments are outside the scope of this
rulemaking.
Proposed paragraph (e) of § 372.6
(§ 372.5(b)(5) in the final rule) indicated
that activities 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, unless they are
categorically excluded.
One commenter stated that a Federal
court has determined that State-wide
analysis of Wildlife Services’ (WS) wolf
damage management activities in the
State of Washington violated NEPA due
to the absence of an EIS in the case of
Cascadia Wildlands v. Woodruff (151 F.
Supp. 3d 1153 (W.D. Wash. 2015)). The
commenter argued that such State-wide
plans have significant environmental
impacts and thus must appropriately be
analyzed in an EIS. The commenter
went on to say that State-wide or
district-wide program analyses will
allow WS to evade any assessments of
compliance with Federal land-use plans
(e.g., forest plans and resource
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management plans) that govern
management of lands on which it
conducts its activities. The commenter
argued that State-wide or district-wide
analyses fail to consider that impacts
may be concentrated in certain areas, as
WS generally relies upon average
numbers killed State-wide or districtwide.
We disagree with the commenter’s
characterization of Cascadia Wildlands
v. Woodruff and with the commenter’s
assertion that the case sets a precedent
whereby all State-wide plans require
preparation of an EIS. The court did not
order WS to complete an EIS for its wolf
damage management activities in
Washington. WS coordinates all
activities with land management
agencies on lands under their
jurisdiction. For example, memoranda
of understanding between WS and the
U.S. Forest Service, and between WS
and the Bureau of Land Management
identify the authorities, coordination
requirements, and responsibilities of
each agency, ensuring that land-use
plans are considered, and that potential
conflicts with other land uses are
identified and avoided or minimized. In
addition, WS uses EAs to involve other
agencies with applicable jurisdiction,
including land and wildlife
management agencies, inviting formal
agency cooperation and or comments as
appropriate. WS also includes a formal
public comment period on all of its EAs
to ensure that all issues and concerns
are considered. As shown in the
document entitled ‘‘Proposed
Amendments to National Environmental
Policy Act Implementing Procedures (7
CFR part 372) Substantiating Document
for Proposed Amendments,’’ WS EAs
have repeatedly demonstrated that its
activities have not had significant
impacts on the environment.4
Proposed paragraph (g) of § 372.6
(§ 372.5(b)(7) in the final rule) indicated
that determinations of nonregulated
status for genetically engineered
organisms normally requires an EA but
not necessarily an EIS, unless
categorically excluded. One commenter
suggested that we add language
specifically stating that an EA would be
required except in those cases where the
action fits into one of the categorical
exclusion categories associated with
such actions.
While we are not adding language
specifying that an EA would be required
except in those cases where the action
fits into one of the categorical exclusion
categories associated with such actions
in § 372.5(b)(7) as suggested by the
4 Pages 26–27 of the document located at https://
www.regulations.gov/docket?D=APHIS-2013-0049.
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commenter, we added language in the
introductory paragraph of § 372.5(b)
stipulating that all of the example
actions described in § 372.5(b)(1)
through (7) normally require an EA but
not necessarily an EIS, unless
categorically excluded.
Another commenter stated that
extensions of determinations of
nonregulated status for genetically
engineered organisms were in violation
of NEPA. The commenter argued that
while such extensions are often granted
to similar organisms, there may still be
agronomic or geographic differences
that would result in significant
environmental impacts. At a minimum,
the commenter said, these extensions
warrant the preparation of EAs in order
to better evaluate the potential
environmental impacts of the
genetically engineered organisms. This
rule does not address whether
extensions of genetically engineered
organisms are in violation of NEPA.
Moreover, we do not explicitly identify
extensions of determinations of
nonregulated status for genetically
engineered organisms in the discussion
of exceptions for categorically excluded
actions found in § 372.5(d). If the
decisionmaker determines that a
categorically excluded action may have
the potential to affect significantly the
quality of the human environment, then
an EA or an EIS will be prepared.
Agronomic and geographic differences
are among the factors that the
decisionmaker will consider when
determining whether a particular
extension application will be
categorically excluded or if preparation
of an EA or EIS is required.
Another commenter suggested that we
add licensing and permitting of
commercial breeding operations
regulated under the Animal Welfare Act
to the list of actions normally requiring
EAs but not necessarily EISs.
Commercial breeding operations are
not specifically listed as one of the
examples of such actions given in
§ 372.5(b) for EAs. APHIS intends to
assess all animal welfare licensing and
registration applications to determine if
they are eligible for a categorical
exclusion or if circumstances exist that
will necessitate the preparation of an EA
or EIS. We will document our
conclusions.
We received a number of additional
comments relating to the need for EAs
or EISs in connection with the licensing
of commercial breeding operations.
Those comments are addressed below in
a section entitled, ‘‘Comments
Regarding Commercial Breeding
Operations.’’
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Comments Regarding Categorical
Exclusions
Proposed § 372.8 (§ 372.5(c) in the
final rule) lists various categorically
excluded actions. We proposed to make
changes to paragraph (a) of § 372.8
(§ 372.5(c)(1)(i) in the final rule) in order
to expand the list of substances that may
be used as part of a conventional
measure (a term not finalized in this
rule; instead we have retained the
original term, ‘‘routine 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. Previously, the list of
substances referred only to chemicals,
pesticides, or other potentially
hazardous or harmful substances,
materials, and target-specific devices or
remedies.
While we are not finalizing the
proposed language, we will respond to
the comment because the current
regulations cite the use of pesticides,
chemicals, and other potentially
hazardous or harmful substances. Two
commenters objected to the inclusion of
such elements in any categorically
excluded action, saying that their use
often has significant impacts, which
require NEPA analysis. One commenter
specifically cited the growth-promotion
drugs ractopamine and monensin,
which the commenter argued can leach
into groundwater, and the growthpromotion drug tylosin, which has been
linked to antibiotic resistance.
APHIS does not use these or other
growth-promotion drugs in any
programs, and there are no actions in
which we would consider their usage.
The other commenter used as an
example those pesticides classified as
‘‘restricted use pesticides’’ by the EPA,
stating these are pesticides that EPA has
determined are likely to cause
‘‘unreasonable adverse effects on the
environment’’ if they are used ‘‘without
additional regulatory restrictions.’’ The
commenter went on to classify the
EPA’s oversight of restricted use
pesticides as predominantly focused on
acute exposure and therefore inadequate
to protect against risks posed by regular
low-level exposure, even though the
pesticides may aggregate in the
environment, causing harm via longterm, low-level exposure to humans and
animals.
APHIS develops and uses methods
that are proven to be effective, efficient
in their performance, and safe in their
execution. APHIS uses pesticides in
accordance with all EPA requirements.
As shown in the document entitled
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‘‘Proposed Amendments to National
Environmental Policy Act Implementing
Procedures (7 CFR Part 372)
Substantiating Document for Proposed
Amendments,’’ these methods were
analyzed in prior environmental
reviews, risk assessments, and/or are
monitored to demonstrate or determine
whether their use could significantly
impact the human environment. This
includes a number of use patterns and
any program mitigation measures
(including contained facilities, field
sites, and pens) for pesticides,
chemicals, or other potentially
hazardous or harmful agents. Many of
these use patterns have long been
known and studied by APHIS, and
APHIS has seen no record of significant
environmental impacts. Our NEPA
analyses consider chemical movement,
degradation, environmental impacts,
exposure, and risk for all actions,
including those actions subject to
categorical exclusion.5 This includes
both potential acute and chronic risks.
If any proposed activity meets any of the
criteria listed in § 372.5(d), then an EA
or EIS will be prepared.
We are finalizing a group of
categorically excluded actions that
concern research and development
activities limited in magnitude,
frequency, and scope that occur in
laboratories, facilities, pens, or field
sites. The location and organization of
this section is taken from the current
regulations; however, we are
incorporating some of our proposed
language in a new list of examples of
such activities.
In § 372.8(j)(1) (§ 372.5(c)(2)(i)(A) in
the final rule) we proposed to allow for
the categorical exclusion of the
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). One commenter requested
that we provide further guidance on the
concept of ‘‘discrete herds of livestock
or wildlife undertaken in contained
areas’’ either via final rule or through
issuance of a guidance document.
For clarity, we revised this language
to cover only those vaccination trials
that occur on groups of animals in areas
designed to limit interaction with
similar animals, or include other
controls as needed to mitigate potential
risk.
Section 372.8(j)(2) (§ 372.5(c)(2)(i)(D)
in the final rule) states that an example
of a categorically excluded research and
development activity is the use of
5 Pages 14–16 and 47 of the document located at
https://www.regulations.gov/docket?D=APHIS2013-0049.
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vaccinations or inoculations, including
new vaccines (e.g., vaccines with
components inserted through genetic
engineering technologies) 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. A commenter stated
that the use of genetically engineered
vaccines and other novel technologies
may result in impacts that require
analysis under NEPA.
In the case of genetically engineered
vaccines and other novel technologies,
if any the criteria in § 372.5(d) apply
then an EA or EIS will be prepared. As
shown in the document entitled
‘‘Proposed Amendments to National
Environmental Policy Act Implementing
Procedures (7 CFR Part 372)
Substantiating Document for Proposed
Amendments,’’ we note that, based on
more than 20 years of experience,
APHIS’ Center for Veterinary Biologics
has found that the impact of new
vaccines and inoculations stays within
the vaccinated animal.6
We also proposed that activities could
not be categorically excluded if a
previously licensed or approved
biologic has been subsequently shown
to be unsafe, or if it would be used at
substantially higher dosage levels or for
substantially different applications or
circumstances than the use for which
the product was previously approved.
One commenter argued that an EA
should not necessarily be required in
every instance where a substantially
higher dose or substantially different
application or use circumstance is being
developed and recommended we
remove that language from the
regulations. The commenter said that
APHIS should evaluate each situation
on a case-by-case basis.
While we agree that an EA is not
always required where a substantially
higher dose or substantially different
application or use circumstance is
proposed, we are making no changes to
the proposed language. We will
continue to consider each case
individually, as the commenter
suggested. An EA or EIS would not need
to be prepared if we determine that a
substantially higher dose or
substantially different application or use
circumstance for a previously licensed
or approved biologic will not impact the
environmental or safety factors
associated with use of that biologic.
6 Pages 35–36 of the document located at https://
www.regulations.gov/docket?D=APHIS-2013-0049.
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Comments Regarding Categorical
Exclusions; Licensing, Permitting,
Authorization, and Approval
Proposed § 372.9 (§ 372.5(c)(3) in the
final rule) contained examples of
various categorically excluded actions
under the heading of licensing and
permitting. In the preamble to the
proposed rule, we explained that
licensing and permitting are
administrative actions for the agency,
and generally occur in support of
actions that later undergo analysis in an
EIS or EA. To require a separate NEPA
analysis for each license or permit does
not allow expedient action to serve the
public, and would promote piecemeal
analyses.
One commenter objected to this
characterization, saying that it would be
a contravention of APHIS’ obligations
under NEPA because any individual
action within a program may have
significant effects and must be subject to
individualized NEPA review. The
commenter also argued that it is in the
public interest to undertake
individualized reviews where
warranted.
APHIS is not trying to evade or ignore
its obligations under NEPA. The CEQ
regulations at 40 CFR 1508.4 give
agencies the authority to identify
categorical exclusions in their NEPA
implementing regulations, which is
what APHIS seeks to do here. It is
important to understand that, in
addition to EAs and EISs, categorical
exclusions are consistent with NEPA.
Categorical exclusions are categories of
actions, which do not individually or
cumulatively have a significant effect on
the human environment, and are
recognized as such in the agency’s
implementing procedures. Use of a
categorical exclusion has, and will
continue to include, individualized
reviews prior to issuance.
Another commenter said that we
provided insufficient analysis for the
determination that licensing and
permitting are categorically exempt. The
commenter went on to say that it is
unclear whether this provision is meant
to apply to licensing conducted under
Animal Welfare Act (AWA; Laboratory
Animal Welfare Act of 1966, as
amended Public Law 89–544, 7 U.S.C.
2131–2159) licensing. The commenter
argued that AWA licensing actions have
enormous potential for environmental
harm, and so will frequently warrant at
least preparation of an EA. The
commenter stated that, even if there
were a categorical exclusion for
commercial breeder licensing, at a
minimum it should specify exceptions
to that categorical exclusion. The
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commenter found that the proposed
definition, evaluation criteria, and list of
extraordinary circumstances set too high
a bar for judging whether an action may
have a significant environmental effect.
The regulations already provide a
categorical exclusion for licensing and
permitting, and identify a wide variety
of routine measures that could result in
authorizations and approvals. Since
these categories already existed within
the regulations and were effective for
years, we did not include additional
analysis in the proposed rule. We do not
agree with the commenter’s position
regarding our ability to evaluate an
action for significant environmental
effect. On the contrary, we find that the
general exceptions to categorical
exclusions identified in § 372.5(d) will
allow us to adequately address concerns
about the potential for significant
impacts to the environment pursuant to
AWA licensing, because this section
allows the decisionmaker to determine
that a categorically excluded action may
have the potential to affect
‘‘significantly’’ the quality of the
‘‘human environment.’’ For additional
discussion on the rest of the
commenter’s points specific to licensing
of commercial breeding operations,
please see the section below entitled,
‘‘Comments Regarding Commercial
Breeding Operations.’’
Proposed paragraph (a)(2) of § 372.10
(§ 372.5(c)(2)(i)(B) in the final rule)
contained a 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. A commenter
stated that categorical exclusions for
evaluation of novel chemical uses
cannot be employed under NEPA
because their application and contact
with nontarget species may result in
unintended environmental, human
health, or ecological impacts.
Our research and testing in this area
is limited to serving Agency needs, and
does not encompass broadly based or
basic research. We have added the
stipulation that such evaluation and use
must be pursuant to applicable Federal
authorizations to clarify the relatively
narrow application of this categorical
exclusion. Use must be limited in
magnitude, frequency, and scope, and it
can only occur in laboratories, facilities,
pens, or field sites. We also note that
this is not a new categorical exclusion,
only an enhanced description of
activities that did not demonstrate
environmental impacts in the past.
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24007
Proposed paragraph (a)(6)
(§ 372.5(c)(2)(ii) in the final rule)
contained the prior categorical
exclusion for the development and
production of sterile insects. We are also
including the release of sterile insects as
well.
The same commenter argued that the
development and production of sterile
insects may include novel methods for
inducing sterility, which would require
NEPA analysis. The commenter said
that the field release of genetically
engineered insects may have significant
human health and ecological impacts.
APHIS does not develop, approve, or
release genetically engineered sterile
insects. Were that to change in the
future, we would consider any potential
environmental impacts. Any novel
methods to develop sterile insects
would be subject to the criteria listed in
§ 372.5(d).
Comments on the Process for Rapid
Response to Emergencies
We are adding a new section
describing the process APHIS follows to
develop environmental documentation
when conducting a rapid response to an
emergency. 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. One commenter
encouraged APHIS to take the need to
control a plant disease outbreak or other
exigency into account under NEPA,
including in situations where a
categorical exclusion does not apply.
APHIS will take NEPA into account in
the event there is a need to control a
plant disease outbreak or other
exigency. We recognize the need to deal
quickly, effectively, and efficiently with
any emergency situation that may arise.
We mitigate foreseeable environmental
effects to the extent practicable.
Another commenter observed that our
proposed text was based on CEQ
regulations, but added that there have
been legal challenges to this portion of
those regulations. The commenter stated
that, while there has been no ruling on
whether the portion of the CEQ
regulations dealing with rapid response
to an emergency is invalid, it was noted
that allowing an emergency to
encompass anything more than
significant, unanticipated occurrences,
such as natural disasters, as opposed to
circumstances of the agency’s own
making, seemed at odds with NEPA as
this may allow for the evasion of NEPA
review. The commenter concluded that
APHIS should therefore specify that an
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emergency exists in instances of
significant, unanticipated occurrences,
such as natural disasters only, and that
an emergency cannot be a result of the
agency’s own making.
Merely adding the concept that an
emergency cannot be a result of the
agency’s own making does not account
for the types of emergency actions
APHIS may need to cope with, such as
unanticipated or unforeseen impacts
associated with a pest or disease
outbreak. In an emergency, our primary
concerns include the consequences of a
delayed response. The intent of this
section is to create the flexibility
necessary to begin a response to the
emergency, regardless of cause. This
section does not allow APHIS to evade
NEPA analyses; instead, it adjusts the
usual timeframe and sequence for
analysis of any potential impact during
emergencies. The timing for NEPA
compliance for all non-emergency and
post-emergency actions remains
unchanged.
Comments Regarding Commercial
Breeding Operations
As stated previously, we received a
number of comments from the Humane
Society of the United States (HSUS)
relating to the need for EAs or EISs in
connection with the licensing of
commercial breeding operations. HSUS
expressed surprise that we did not
mention the licensing of commercial
breeding operations in the proposed
rule and observed that we provided no
guidance for applying NEPA standards
to the licensing and regulation of these
operations. They disagreed with our
assessment that the approval and
issuance of licenses is properly
categorized as administrative, and stated
that we failed to articulate what
mitigation measures are in place related
to the environmental damage at
commercial breeding facilities, nor how
any such measures would render those
environmental effects insignificant.
Finally, they argued that a
programmatic assessment of commercial
breeders, brokers, and transporters is
compulsory, and the regulations should
clearly convey that certain individual
AWA license approvals may require an
individual EA or EIS.
The AWA provides for the licensing
of dealers, exhibitors, and registration of
research facilities, and transporters
(intermediate handlers and carriers).
The associated standards provide
specific requirements for regulated
entities under this Act (7 CFR 371.7; 9
CFR chapter 1, parts 1 through 12
(particularly part 3, Standards)). When
we propose modifications to the AWA
regulations, we solicit and consider
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public comments to those specific
provisions. The NEPA regulations are
not the correct place to create or modify
requirements for licensing under the
authority of the AWA.
Under the AWA, the action of issuing
a license consists of administrative
handling of applications. In practice,
this means we assess forms for
completeness and schedule appropriate
inspections. We inspect the facilities,
and they must be in compliance prior to
the issuance of a license or registration.
The criteria for denial of an initial
application are not discretionary (9 CFR
2.11)—all who meet the requirements
are licensed or registered. Potential
impacts to the environment do not
occur through the act of processing an
application to issue a license or
registration; instead, they may occur
when an individual facility is
noncompliant with the standards of
humane care, handling, and
transportation. Regulated entities are
required to comply with the standards
associated with their license or
registration. Based on the frequency of
inspections for facilities, potential
environmental impacts resulting from
noncompliance are expected to be
localized to a specific site, short-term in
duration, and completely mitigated by
the corrective actions of the facility to
comply with the regulations. We
carefully considered the suggestion that
a programmatic assessment is necessary,
and find changes to the NEPA
regulations are not the correct place to
address these concerns. Programmatic
reviews precede proposed changes to
topic-specific regulations as they occur.
HSUS said that common aerosols
associated with feces and urine at
puppy mills that impact air quality the
most are ammonia, hydrogen sulfide,
methane, and carbon dioxide. They
further pointed out that dogs themselves
also produce methane, a potent
greenhouse gas, and these combined
emissions pose a serious environmental
threat. Additionally, they stated that
vehicle emissions from animal
transporters compound this threat and
should be taken into consideration,
arguing that while very little is known
about the bacterial and particulate
emissions of animal transport vehicles
which travel across the United States,
they undoubtedly emit tons of harmful
gases and particulates into the air while
traveling between breeder and broker or
pet shop.
As stated previously, APHIS’
authority under the AWA is limited to
the issuance of licenses, which is an
administrative act with no
environmental implications. EPA, not
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APHIS, has authority to regulate waste
materials, disposal, and emissions.
HSUS also said that decomposition of
dead dogs at commercial breeding
operations can contribute to soil, air,
and water pollution. They stated that
improper mortality management can
lead to environmental contamination
and claimed that dead dogs have been
found scattered or improperly disposed
of at a number of USDA licensed
facilities.
The AWA regulations in 9 CFR 3.1(f)
require facilities with dogs to properly
dispose of waste and dead animals in a
manner that minimizes contamination
and disease risks. APHIS standards (9
CFR part 3) are established by species,
and do not differ by licensee or
registrant. Beyond that, State and local
laws determine how dead animals are
disposed of within any given
jurisdiction, and APHIS works with
local jurisdictions during emergencies.
If a mass animal health event were to
lead to high mortality levels, then
APHIS would likely be involved in the
disposal of those carcasses as part of a
joint local, State, and Federal emergency
response effort.
HSUS identified noise pollution as
another environmental harm associated
with large-scale commercial dog
breeders. They claimed that barking
dogs can reach decibel levels on par
with abrasive blasting or demolition at
a construction site or even an
ambulance siren and recommended that
noise studies, as commonly performed
by many localities, should be
incorporated into EAs of commercial
breeding operations.
As the commenter correctly points
out, localities vary in their approaches
to the regulation of noise. We believe
that local and State regulators are better
situated to assess and regulate ambient
noise standards, which are then
applicable to all residents of that
jurisdiction.
HSUS stated that, even if an EIS is not
automatically warranted in most cases,
large-scale commercial breeding
operations raise enough environmental
concerns that APHIS should routinely
be preparing EAs prior to issuing a new
license for a breeding facility.
Applicants, excepting those whose
operations meet the de minimis
standards set out by APHIS, must
demonstrate compliance with the AWA
and its regulations in order to receive a
license. The regulations establish
specifications for the humane handling,
care, treatment, and transportation of
the species. While it is possible the
regulations may change based on public
comments we receive as we consider
modifying program-specific rules, this
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NEPA implementing regulation is not
the correct place to consider this issue.
We ensure appropriate NEPA
documentation is prepared for all of our
proposed actions. That may take the
form of a categorical exclusion, an EA,
or an EIS.
sradovich on DSK3GMQ082PROD with RULES
Miscellaneous Changes
We are changing all references to the
‘‘administrative record’’ to references to
the ‘‘record’’ because the term
‘‘administrative record’’ is not the
accurate use of a legal term of art.
We are also making several minor
edits to improve the clarity, focus, and
brevity of the regulations overall.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule as a final
rule, with the changes discussed in this
document.
Executive Orders 12866, 13563, 13771,
and Regulatory Flexibility Act
This final 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.
This final rule is expected to be an
Executive Order 13771 deregulatory
action as it imposes no additional costs
on affected entities and individuals, and
will likely benefit those businesses and
individuals regulated by APHIS that
participate in the NEPA process.
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 on the Regulations.gov website
(see footnote 1 in this document for a
link to Regulations.gov) or by contacting
the person listed under FOR FURTHER
INFORMATION CONTACT.
The rule amends the APHIS
regulations that set forth the procedures
for implementing NEPA. The
amendments to the regulations are
designed to improve the clarity and
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effectiveness of the procedures for
implementing NEPA, such as by
providing new examples for when we
will complete an environmental impact
statement or an environmental analysis
for an action and outlining an
environmental documentation process
to be used in emergencies.
APHIS has determined that the rule
will not have a significant economic
impact on a substantial number of small
entities. Some entities will experience
time and money savings, but the savings
will benefit only a few entities each
year. The rule will also serve to clarify
the regulations and make the NEPA
process more transparent. These actions,
although beneficial, are not expected to
have a significant economic impact on
affected entities. The rule imposes no
additional costs on affected entities and
individuals or on APHIS.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action will 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 13175
This 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 governmentto-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 impact of this
rule and determined that this rule does
not, to our knowledge, have Tribal
implications that require tribal
consultation under Executive Order
13175.
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts
all State and local laws and regulations
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24009
that are inconsistent with this rule; (2)
has no retroactive effect; and (3) does
not require administrative proceedings
before parties may file suit in court
challenging this rule.
National Environmental Policy Act
This final rule revises 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 supplement the CEQ regulations for
implementing NEPA, and thus no NEPA
document was prepared for this final
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 final rule contains no
information collection or recordkeeping
requirements under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects in 7 CFR Part 372
Administrative practice and
procedure, Environmental assessment,
Environmental impact statement,
National Environmental Policy Act.
Accordingly, we are amending 7 CFR
part 372 as follows:
PART 372—NATIONAL
ENVIRONMENTAL POLICY ACT
IMPLEMENTING PROCEDURES
1. The authority citation for part 372
continues to read as follows:
■
Authority: 42 U.S.C. 4321 et seq.; 40 CFR
1500–1508; 7 CFR 1b, 2.22, 2.80, and 371.9.
§ 372.1
[Amended]
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.
■
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3. Section 372.3 is revised to read as
follows:
■
§ 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–
3043.
■ 4. Section 372.4 is amended as
follows:
■ a. In the introductory text, by adding
the words ‘‘and definitions’’ after the
word ‘‘terminology’’ and by removing
the word ‘‘is’’ and adding the word
‘‘are’’ in its place; and
■ b. By revising the definitions of
decisionmaker and environmental unit.
The revisions read as follows:
§ 372.4
Definitions.
sradovich on DSK3GMQ082PROD with RULES
*
*
*
*
*
Decisionmaker. The agency official
responsible for signing the document
based on a 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.
■ 5. Section 372.5 is amended as
follows:
■ a. By revising the introductory text of
paragraph (b);
■ b. In paragraph (b)(1)(i), by adding the
word ‘‘and’’ after the semicolon;
■ c. In paragraphs (b)(1)(ii) and (b)(3), by
removing the words ‘‘, except for actions
that are categorically excluded, as
provided in paragraph (c) of this
section’’;
■ d. By revising paragraph (b)(4);
■ e. By redesignating paragraph (b)(5) as
paragraph (b)(6) and adding a new
paragraph (b)(5);
■ f. By revising newly redesignated
paragraph (b)(6);
■ g. By adding paragraph (b)(7);
■ h. By revising paragraphs (c)(1)(ii)(B),
(c)(2), and (c)(3)(i);
■ i. By redesignating paragraphs
(c)(3)(ii) and (iii) as paragraphs (c)(3)(iii)
and (iv), respectively;
■ j. By adding a new paragraph (c)(3)(ii);
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k. By revising paragraph (c)(4);
l. By adding paragraph (c)(5);
m. In paragraph (d)(2), by adding the
word ‘‘or’’ after the semicolon; and
■ n. By removing paragraph (d)(3) and
redesignating paragraph (d)(4) as
paragraph (d)(3).
The additions and revisions read as
follows:
■
■
■
§ 372.5
Classification of actions.
*
*
*
*
*
(b) Actions normally requiring
environmental assessments but not
necessarily environmental impact
statements. This class of APHIS actions
may involve the agency as a whole or
an entire program, but generally is
related to a more discrete program
component and is characterized by its
limited scope (particular sites, species,
or activities) and potential effect
(impacting relatively few environmental
values or systems). Potential
environmental impacts associated with
the proposed action are not considered
potentially significant at the outset of
the planning process. 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 been
successfully employed. Unless the
actions are categorically excluded as
provided in paragraph (c) of this
section, actions in this class include:
*
*
*
*
*
(4) Approvals and issuance of permits
for proposals involving regulated
genetically engineered organisms or
products, or regulated nonindigenous
species.
(5) Programs or statewide activities 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.
(6) 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.
(7) Determination of nonregulated
status for genetically engineered
organisms.
(c) * * *
(1) * * *
(ii) * * *
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(B) Use of vaccinations or
inoculations including new vaccines
(e.g., 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; and
*
*
*
*
*
(2) Research and development
activities. (i) Activities limited in
magnitude, frequency, and scope that
occur in laboratories, facilities, pens, or
field sites. Examples are:
(A) Vaccination trials that occur on
groups of animals in areas designed to
limit interaction with similar animals,
or include other controls needed to
mitigate potential risk.
(B) Laboratory research involving the
evaluation and use of chemicals in a
manner not specifically listed on the
product label pursuant to applicable
Federal authorizations.
(C) The development and/or
production (including formulation,
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.
(D) Research evaluating wildlife
management products or tools, such as
animal repellents, frightening devices,
or fencing, that is carried out in a
manner and area designed to eliminate
the potential for harmful environmental
effects and in accordance with
applicable regulatory requirements.
(ii) Development, production, and
release of sterile insects.
(3) * * *
(i) Issuance of a license, permit,
authorization, or approval to ship or
field test previously unlicensed
veterinary biologics, including
veterinary biologics containing
genetically engineered organisms (such
as vector-based vaccines and nucleic
acid-based vaccines);
(ii) Issuance of a license, permit,
authorization, or approval for movement
or uses of pure cultures of organisms
(relatively free of extraneous microorganisms and extraneous material) that
are not strains of quarantine concern
and occur, or are likely to occur, in a
State’s environment; or
*
*
*
*
*
(4) Extending deregulations for
genetically engineered organisms.
Extension of nonregulated status under
part 340 of this chapter to organisms
similar to those already deregulated.
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(5) Minor renovation, improvement,
and maintenance of facilities. Examples
are:
(i) Renovation of existing laboratories
and other facilities.
(ii) Functional replacement of parts
and equipment.
(iii) Minor additions to existing
facilities.
(iv) Minor excavations of land and
repairs to properties.
*
*
*
*
*
§ 372.6
■
[Removed]
7. Section 372.6 is removed.
§§ 372.7 through 372.10
§§ 372.6 through 372.9]
[Redesignated as
8. Sections 372.7 through 372.10 are
redesignated as §§ 372.6 through 372.9,
respectively.
■ 9. Newly redesignated § 372.6 is
revised to read as follows:
■
§ 372.6
Early planning.
Prospective applicants are encouraged
to contact APHIS program officials to
determine what types of environmental
analyses or documentation, if any, need
to be prepared.
■ 10. Newly redesignated § 372.7 is
amended by revising the section
heading and paragraph (b)(4) to read as
follows:
§ 372.7 Planning and decision points and
public involvement.
*
*
*
*
*
(b) * * *
(4) All environmental documents and
comments received will be made
available to the public via
Regulations.gov.
■ 11. Newly redesignated § 372.8 is
amended as follows:
■ a. In paragraph (a) introductory text,
by adding a sentence at the end of the
paragraph;
■ b. In paragraph (a)(1), by removing the
citation ‘‘§ 372.8’’ and adding the
citation ‘‘§ 372.7’’ in its place; and
■ c. By revising paragraph (a)(3).
The addition and revision read as
follows:
sradovich on DSK3GMQ082PROD with RULES
§ 372.8 Processing and use of
environmental documents.
(a) * * * This determination is based
on information provided in the NEPA
document and available in the 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
VerDate Sep<11>2014
18:07 May 23, 2018
Jkt 244001
any alternative. APHIS will mail notice
upon request.
*
*
*
*
*
§ 372.9
[Amended]
12. Newly redesignated § 372.9 is
amended by removing the second
sentence and the word ‘‘administrative’’
in the last sentence.
■ 13. A new § 372.10 is added to read
as follows:
■
§ 372.10 Process for rapid response to
emergencies.
When it is determined (by the
Administrator or the delegated Agency
official responsible for environmental
review) that an emergency exists that
requires immediate action before
preparing and completing the usual
NEPA review, then the provisions of
this section apply.
(a) The Administrator or the delegated
Agency official responsible for
environmental review may take actions
that are necessary to control the
immediate impacts of the emergency
and that are urgently needed to prevent
imminent damage to public health or
safety, or prevent threats to valuable
resources. When taking such actions,
the Administrator or the delegated
Agency official responsible for
environmental review will consider 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 § 372.5 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
alternative arrangements for NEPA
compliance. APHIS’ Chief of
Environmental and Risk Analysis
Services may authorize emergency
alternative arrangements for completing
the required NEPA compliance
documentation. Any alternative
arrangements must be documented and
notice of their use provided to CEQ.
(c) If a proposed emergency action is
likely to result in significant
environmental impacts, then APHIS
will immediately consult with 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
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
24011
documentation in accordance with the
CEQ regulations and these regulations.
Done in Washington, DC, this 18th day of
May 2018.
Greg Ibach,
Under Secretary, Marketing and Regulatory
Programs.
[FR Doc. 2018–11083 Filed 5–23–18; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Rural Utilities Service
7 CFR Part 1773
RIN 0572–AC33
Policy on Audits of RUS Borrowers
and Grantees
Rural Utilities Service, USDA.
Final rule with request for
comment; correction; delay of effective
date; extension of comment period.
AGENCY:
ACTION:
The Rural Utilities Service
(RUS) is correcting a final rule with
request for comment that appeared in
the Federal Register on May 7, 2018,
and is extending the comment period
and delaying the effective date. The
document amended regulations
regarding its Policy on Audits to
incorporate 2011 revisions to the
Generally Accepted Government
Auditing Standards (GAGAS) issued by
the Government Accountability Office
(GAO), the clarified audit standards
issued by the American Institute of
Certified Public Accountants (AICPA) in
2011, and Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements for Federal Awards,
Subpart F, Audit Requirements, issued
by the Office of Management and
Budget on December 26, 2013, and
adopted by USDA on December 26,
2014. The document also expanded and
clarified the regulations to: Include
grant recipients, amend peer review
requirements, amend reporting
requirements, expand the options for
the electronic filing of audits, and
clarify a number of existing audit
requirements, and amended the title to
reflect this change.
DATES:
Effective Dates: The correction is
effective May 24, 2018. The effective
date for the final rule published in the
Federal Register on Monday, May 7,
2018 (83 FR 19905), is delayed from July
6, 2018, to July 23, 2018.
Applicability Date: The final rule
published in the Federal Register on
Monday, May 7, 2018 (83 FR 19905), is
applicable for financial audits for
SUMMARY:
E:\FR\FM\24MYR1.SGM
24MYR1
Agencies
[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Rules and Regulations]
[Pages 24003-24011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11083]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Rules
and Regulations
[[Page 24003]]
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations that set out our National
Environmental Policy Act implementing procedures. The amendments
include clarifying the categories of actions for which we would
normally complete an environmental impact statement or an environmental
assessment for an action, as well as updating examples of categorically
excluded actions and setting out an environmental documentation process
that could be used in emergencies. The changes will serve to update the
regulations and improve their clarity and effectiveness.
DATES: Effective June 25, 2018.
FOR FURTHER INFORMATION CONTACT: Dr. Eileen Sutker, APHIS Federal NEPA
Contact, Environmental and Risk Analysis Services, PPD, APHIS, 4700
River Road, Unit 149, Riverdale, MD 20737-1238; (301) 851-3043.
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 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), provide a basic regulatory framework for 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 CEQ's NEPA implementing regulations in 40 CFR 1507.3,
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.
NEPA and the CEQ regulations require all agencies of the Federal
Government to incorporate environmental considerations in their
planning and decisionmaking. This may include the development of an
Environmental Impact Statement (EIS), a detailed statement by the
responsible official with every recommendation or report on proposals
for legislation and other major Federal actions significantly affecting
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 the
human 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.
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.
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) state 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.'' Accordingly, on July 20, 2016, we
published in the Federal Register (81 FR 47051-47071, Docket No. APHIS-
2013-0049) a proposal \1\ to amend the regulations by adding several
new types of actions that were not previously covered in the
regulations. Accordingly, we also evaluated our regulations and
identified changes that would reflect new authorities, activities, and
data. The changes we proposed also clarified certain areas of the
regulations.
---------------------------------------------------------------------------
\1\ To view the proposed rule and the comments we received, go
to https://www.regulations.gov/docket?D=APHIS-2013-0049.
---------------------------------------------------------------------------
We also proposed to establish or revise categorical exclusions and
extraordinary circumstances under which those categorical exclusions
would not apply and to revise the requirements generally relating to
classification of various actions (e.g., actions normally requiring
EISs, actions normally requiring EAs but not necessarily EISs). Upon
further consideration and in light of the comments we received, we
decided not to finalize the proposed extraordinary circumstances and
most of the proposed new program categorical exclusions. Instead, we
are making minor adjustments to the language currently found in Sec.
372.5 concerning these subjects to improve clarity and provide further
examples of activities that fall
[[Page 24004]]
into a given class of action or may be subject to categorical
exclusion. The proposed additions were accompanied by a reorganization
of the regulations, which we are also not finalizing. The structure of
the regulations will remain largely identical to that of the current
regulations. We may revisit the issue of categorical exclusions,
extraordinary circumstances, and classification of actions in a future
rulemaking.
We solicited comments concerning our proposal for 60 days ending
September 19, 2016. We received 12 comments by that date from advocacy
groups, industry associations, and private citizens. They are discussed
below by topic, with the exception of any comments received on those
portions of the proposed rule we are not finalizing, as described
above.
Comments Regarding Categorical Exclusions and Extraordinary
Circumstances
The bulk of the comments we received related to changes we proposed
to our categorical exclusions and their associated extraordinary
circumstances exceptions. As stated above, in considering those
comments, which covered a broad variety of issues in detail, we came to
recognize the need to reevaluate our proposed categories and reconsider
the scope and effect of those categories.
General Comments
One commenter stated that since the changes and additions may
affect species protected under the Endangered Species Act of 1973 and
their designated critical habitats, APHIS must conduct a programmatic
consultation with the Fish and Wildlife Service (FWS) and the National
Marine Fisheries Service (NMFS).
This rule is administrative in nature and does not affect any
listed threatened or endangered species. We consult with FWS and/or
NMFS when an analysis of listed species is necessary to arrive at an
environmental effects determination. We will continue to consult on any
future actions that may affect protected species.
The same commenter said that we should coordinate our efforts
concerning NEPA with the existing initiative involving APHIS, the
Environmental Protection Agency (EPA), and the Food and Drug
Administration (FDA) to modernize agency activities under the
Coordinated Framework for the Regulation of Biotechnology.\2\
---------------------------------------------------------------------------
\2\ Further information on the Coordinated Framework for the
Regulation of Biotechnology may be found here: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf.
---------------------------------------------------------------------------
APHIS is involved in updating the Coordinated Framework for the
Regulation of Biotechnology, which clarifies the relevant existing
authorities and roles of the USDA, the FDA, and the EPA. On January 4,
2017, EPA, FDA, and USDA released the 2017 Draft Update to the
Coordinated Framework for the Regulation of Biotechnology and
accompanying National Strategy for Modernizing the Regulatory System
for Biotechnology Products. The original Coordinated Framework for the
Regulation of Biotechnology and the 2017 Draft Update identify which
types of topics trigger NEPA analyses within each agency. The finalized
update of the Coordinated Framework for the Regulation of Biotechnology
will continue to align with the regulations, and may facilitate further
regulations.
Another commenter characterized the proposed action as APHIS
scaling back its NEPA obligations, despite ongoing disputes over the
scope of APHIS' duties in this area.
Contrary to the commenter's assertion, this rule will improve
transparency and clarity regarding APHIS activities under NEPA.
Further, we will continue to apply an appropriate level of
environmental documentation to every action.
Another commenter stated that they had included suggestions for
corresponding changes to the NEPA implementing regulations discussed
here as part of a comment submitted in connection with a notice of
intent to prepare an EIS published in the Federal Register on February
5, 2016 (81 FR 6225-6229, Docket No. APHIS-2014-0054) titled
``Environmental Impact Statement; Introduction of the Products of
Biotechnology.'' \3\ The commenter also said that this action may need
to be revised in light of any changes to the NEPA regulations made in
this final rule.
---------------------------------------------------------------------------
\3\ To view that notice and the comments we received go to
https://www.regulations.gov/docket?D=APHIS-2014-0054.
---------------------------------------------------------------------------
Due to the nature of APHIS rulemaking, we cannot consider the
content of comments submitted on other rules. The notice referenced by
the commenter has yet to be finalized; however, if changes to the NEPA
implementing regulations are necessary as a result of that action, we
will make those changes accordingly via subsequent rulemaking.
One commenter pointed out several typographical errors in the
preamble language and the regulatory text of the proposed rule. We have
corrected the errors in the regulatory text. The preamble language is
not repeated in this final rule.
Comments Regarding Definitions
In Sec. 372.4, which contains definitions of various terms used in
the regulations, we proposed to revise two existing definitions and add
definitions for two additional terms. We are not finalizing the two
proposed additional definitions. We determined that a definition for
``Agency official responsible for environmental review'' is unnecessary
because the information we wished to convey can already be found in the
definition for ``Environmental unit.'' We are not finalizing the
definition for ``Extraordinary circumstances'' because, as stated
previously, we are not finalizing the proposed revisions concerning
extraordinary circumstances. The revisions we are finalizing remain
consistent with the CEQ regulations.
One commenter suggested we add a definition for the term
``conventional,'' given that we proposed a change from ``routine
measures'' to ``conventional measures'' throughout the regulations due
to prior confusion about the meaning of ``routine.'' The commenter
argued that the word ``conventional'' has as much potential to cause
confusion as the word ``routine.''
Uses of the term ``conventional measures'' in place of ``routine
measures'' were only found in those sections we are not finalizing in
this document.
Comments Regarding Actions Normally Requiring Environmental Assessments
But Not Necessarily Environmental Impact Statements
We proposed to set out a description of actions APHIS takes that
normally require EAs but not necessarily EISs in Sec. 372.6 (Sec.
372.5(b) in the final rule). An action in this class will typically be
characterized by its limited scope (particular sites, species, or
activities).
We are clarifying the way in which we assess potential
environmental impacts in connection with an action normally requiring
an EA but not necessarily an EIS. 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.
Proposed paragraph (d) of Sec. 372.6 (Sec. 372.5(b)(4) in the
final rule) indicated that approvals and issuance of licenses and
permits for proposals involving regulated genetically engineered or
[[Page 24005]]
regulated nonindigenous species would normally require an EA but not
necessarily an EIS, unless they are categorically excluded. One
commenter proposed that we refer to ``genetically engineered
organisms'' separately from regulated nonindigenous species. Two
commenters pointed out that we neglected to specifically exclude
actions that are categorically excluded in the language of this
section.
We agree with the first commenter's suggestion to use the word
``organisms'' and have changed the term used in that section to
``genetically engineered organisms or products.'' Reference to
genetically engineered products is necessary in some parts of the
regulations to adequately cover veterinary biologics products, such as
genetically engineered subunit proteins, plasmid vectors, and other
constructs that are not organisms. We agree with the point raised by
the last two commenters and have added the requested language to the
introductory paragraph of Sec. 372.5(b).
Another commenter made a recommendation regarding the comingling
threshold level for genetically engineered and conventional products.
The commenter also stated that third-party field testing on crops with
a high risk of comingling should occur.
As the proposal did not relate to such a threshold or such
inspections, these comments are outside the scope of this rulemaking.
Proposed paragraph (e) of Sec. 372.6 (Sec. 372.5(b)(5) in the
final rule) indicated that activities 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, unless they are
categorically excluded.
One commenter stated that a Federal court has determined that
State-wide analysis of Wildlife Services' (WS) wolf damage management
activities in the State of Washington violated NEPA due to the absence
of an EIS in the case of Cascadia Wildlands v. Woodruff (151 F. Supp.
3d 1153 (W.D. Wash. 2015)). The commenter argued that such State-wide
plans have significant environmental impacts and thus must
appropriately be analyzed in an EIS. The commenter went on to say that
State-wide or district-wide program analyses will allow WS to evade any
assessments of compliance with Federal land-use plans (e.g., forest
plans and resource management plans) that govern management of lands on
which it conducts its activities. The commenter argued that State-wide
or district-wide analyses fail to consider that impacts may be
concentrated in certain areas, as WS generally relies upon average
numbers killed State-wide or district-wide.
We disagree with the commenter's characterization of Cascadia
Wildlands v. Woodruff and with the commenter's assertion that the case
sets a precedent whereby all State-wide plans require preparation of an
EIS. The court did not order WS to complete an EIS for its wolf damage
management activities in Washington. WS coordinates all activities with
land management agencies on lands under their jurisdiction. For
example, memoranda of understanding between WS and the U.S. Forest
Service, and between WS and the Bureau of Land Management identify the
authorities, coordination requirements, and responsibilities of each
agency, ensuring that land-use plans are considered, and that potential
conflicts with other land uses are identified and avoided or minimized.
In addition, WS uses EAs to involve other agencies with applicable
jurisdiction, including land and wildlife management agencies, inviting
formal agency cooperation and or comments as appropriate. WS also
includes a formal public comment period on all of its EAs to ensure
that all issues and concerns are considered. As shown in the document
entitled ``Proposed Amendments to National Environmental Policy Act
Implementing Procedures (7 CFR part 372) Substantiating Document for
Proposed Amendments,'' WS EAs have repeatedly demonstrated that its
activities have not had significant impacts on the environment.\4\
---------------------------------------------------------------------------
\4\ Pages 26-27 of the document located at https://www.regulations.gov/docket?D=APHIS-2013-0049.
---------------------------------------------------------------------------
Proposed paragraph (g) of Sec. 372.6 (Sec. 372.5(b)(7) in the
final rule) indicated that determinations of nonregulated status for
genetically engineered organisms normally requires an EA but not
necessarily an EIS, unless categorically excluded. One commenter
suggested that we add language specifically stating that an EA would be
required except in those cases where the action fits into one of the
categorical exclusion categories associated with such actions.
While we are not adding language specifying that an EA would be
required except in those cases where the action fits into one of the
categorical exclusion categories associated with such actions in Sec.
372.5(b)(7) as suggested by the commenter, we added language in the
introductory paragraph of Sec. 372.5(b) stipulating that all of the
example actions described in Sec. 372.5(b)(1) through (7) normally
require an EA but not necessarily an EIS, unless categorically
excluded.
Another commenter stated that extensions of determinations of
nonregulated status for genetically engineered organisms were in
violation of NEPA. The commenter argued that while such extensions are
often granted to similar organisms, there may still be agronomic or
geographic differences that would result in significant environmental
impacts. At a minimum, the commenter said, these extensions warrant the
preparation of EAs in order to better evaluate the potential
environmental impacts of the genetically engineered organisms. This
rule does not address whether extensions of genetically engineered
organisms are in violation of NEPA. Moreover, we do not explicitly
identify extensions of determinations of nonregulated status for
genetically engineered organisms in the discussion of exceptions for
categorically excluded actions found in Sec. 372.5(d). If the
decisionmaker determines that a categorically excluded action may have
the potential to affect significantly the quality of the human
environment, then an EA or an EIS will be prepared. Agronomic and
geographic differences are among the factors that the decisionmaker
will consider when determining whether a particular extension
application will be categorically excluded or if preparation of an EA
or EIS is required.
Another commenter suggested that we add licensing and permitting of
commercial breeding operations regulated under the Animal Welfare Act
to the list of actions normally requiring EAs but not necessarily EISs.
Commercial breeding operations are not specifically listed as one
of the examples of such actions given in Sec. 372.5(b) for EAs. APHIS
intends to assess all animal welfare licensing and registration
applications to determine if they are eligible for a categorical
exclusion or if circumstances exist that will necessitate the
preparation of an EA or EIS. We will document our conclusions.
We received a number of additional comments relating to the need
for EAs or EISs in connection with the licensing of commercial breeding
operations. Those comments are addressed below in a section entitled,
``Comments Regarding Commercial Breeding Operations.''
[[Page 24006]]
Comments Regarding Categorical Exclusions
Proposed Sec. 372.8 (Sec. 372.5(c) in the final rule) lists
various categorically excluded actions. We proposed to make changes to
paragraph (a) of Sec. 372.8 (Sec. 372.5(c)(1)(i) in the final rule)
in order to expand the list of substances that may be used as part of a
conventional measure (a term not finalized in this rule; instead we
have retained the original term, ``routine 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. Previously, the
list of substances referred only to chemicals, pesticides, or other
potentially hazardous or harmful substances, materials, and target-
specific devices or remedies.
While we are not finalizing the proposed language, we will respond
to the comment because the current regulations cite the use of
pesticides, chemicals, and other potentially hazardous or harmful
substances. Two commenters objected to the inclusion of such elements
in any categorically excluded action, saying that their use often has
significant impacts, which require NEPA analysis. One commenter
specifically cited the growth-promotion drugs ractopamine and monensin,
which the commenter argued can leach into groundwater, and the growth-
promotion drug tylosin, which has been linked to antibiotic resistance.
APHIS does not use these or other growth-promotion drugs in any
programs, and there are no actions in which we would consider their
usage.
The other commenter used as an example those pesticides classified
as ``restricted use pesticides'' by the EPA, stating these are
pesticides that EPA has determined are likely to cause ``unreasonable
adverse effects on the environment'' if they are used ``without
additional regulatory restrictions.'' The commenter went on to classify
the EPA's oversight of restricted use pesticides as predominantly
focused on acute exposure and therefore inadequate to protect against
risks posed by regular low-level exposure, even though the pesticides
may aggregate in the environment, causing harm via long-term, low-level
exposure to humans and animals.
APHIS develops and uses methods that are proven to be effective,
efficient in their performance, and safe in their execution. APHIS uses
pesticides in accordance with all EPA requirements. As shown in the
document entitled ``Proposed Amendments to National Environmental
Policy Act Implementing Procedures (7 CFR Part 372) Substantiating
Document for Proposed Amendments,'' these methods were analyzed in
prior environmental reviews, risk assessments, and/or are monitored to
demonstrate or determine whether their use could significantly impact
the human environment. This includes a number of use patterns and any
program mitigation measures (including contained facilities, field
sites, and pens) for pesticides, chemicals, or other potentially
hazardous or harmful agents. Many of these use patterns have long been
known and studied by APHIS, and APHIS has seen no record of significant
environmental impacts. Our NEPA analyses consider chemical movement,
degradation, environmental impacts, exposure, and risk for all actions,
including those actions subject to categorical exclusion.\5\ This
includes both potential acute and chronic risks. If any proposed
activity meets any of the criteria listed in Sec. 372.5(d), then an EA
or EIS will be prepared.
---------------------------------------------------------------------------
\5\ Pages 14-16 and 47 of the document located at https://www.regulations.gov/docket?D=APHIS-2013-0049.
---------------------------------------------------------------------------
We are finalizing a group of categorically excluded actions that
concern research and development activities limited in magnitude,
frequency, and scope that occur in laboratories, facilities, pens, or
field sites. The location and organization of this section is taken
from the current regulations; however, we are incorporating some of our
proposed language in a new list of examples of such activities.
In Sec. 372.8(j)(1) (Sec. 372.5(c)(2)(i)(A) in the final rule) we
proposed to allow for the categorical exclusion of the 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). One commenter requested that we provide further guidance on
the concept of ``discrete herds of livestock or wildlife undertaken in
contained areas'' either via final rule or through issuance of a
guidance document.
For clarity, we revised this language to cover only those
vaccination trials that occur on groups of animals in areas designed to
limit interaction with similar animals, or include other controls as
needed to mitigate potential risk.
Section 372.8(j)(2) (Sec. 372.5(c)(2)(i)(D) in the final rule)
states that an example of a categorically excluded research and
development activity is the use of vaccinations or inoculations,
including new vaccines (e.g., vaccines with components inserted through
genetic engineering technologies) 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. A
commenter stated that the use of genetically engineered vaccines and
other novel technologies may result in impacts that require analysis
under NEPA.
In the case of genetically engineered vaccines and other novel
technologies, if any the criteria in Sec. 372.5(d) apply then an EA or
EIS will be prepared. As shown in the document entitled ``Proposed
Amendments to National Environmental Policy Act Implementing Procedures
(7 CFR Part 372) Substantiating Document for Proposed Amendments,'' we
note that, based on more than 20 years of experience, APHIS' Center for
Veterinary Biologics has found that the impact of new vaccines and
inoculations stays within the vaccinated animal.\6\
---------------------------------------------------------------------------
\6\ Pages 35-36 of the document located at https://www.regulations.gov/docket?D=APHIS-2013-0049.
---------------------------------------------------------------------------
We also proposed that activities could not be categorically
excluded if a previously licensed or approved biologic has been
subsequently shown to be unsafe, or if it would be used at
substantially higher dosage levels or for substantially different
applications or circumstances than the use for which the product was
previously approved. One commenter argued that an EA should not
necessarily be required in every instance where a substantially higher
dose or substantially different application or use circumstance is
being developed and recommended we remove that language from the
regulations. The commenter said that APHIS should evaluate each
situation on a case-by-case basis.
While we agree that an EA is not always required where a
substantially higher dose or substantially different application or use
circumstance is proposed, we are making no changes to the proposed
language. We will continue to consider each case individually, as the
commenter suggested. An EA or EIS would not need to be prepared if we
determine that a substantially higher dose or substantially different
application or use circumstance for a previously licensed or approved
biologic will not impact the environmental or safety factors associated
with use of that biologic.
[[Page 24007]]
Comments Regarding Categorical Exclusions; Licensing, Permitting,
Authorization, and Approval
Proposed Sec. 372.9 (Sec. 372.5(c)(3) in the final rule)
contained examples of various categorically excluded actions under the
heading of licensing and permitting. In the preamble to the proposed
rule, we explained that licensing and permitting are administrative
actions for the agency, and generally occur in support of actions that
later undergo analysis in an EIS or EA. To require a separate NEPA
analysis for each license or permit does not allow expedient action to
serve the public, and would promote piecemeal analyses.
One commenter objected to this characterization, saying that it
would be a contravention of APHIS' obligations under NEPA because any
individual action within a program may have significant effects and
must be subject to individualized NEPA review. The commenter also
argued that it is in the public interest to undertake individualized
reviews where warranted.
APHIS is not trying to evade or ignore its obligations under NEPA.
The CEQ regulations at 40 CFR 1508.4 give agencies the authority to
identify categorical exclusions in their NEPA implementing regulations,
which is what APHIS seeks to do here. It is important to understand
that, in addition to EAs and EISs, categorical exclusions are
consistent with NEPA. Categorical exclusions are categories of actions,
which do not individually or cumulatively have a significant effect on
the human environment, and are recognized as such in the agency's
implementing procedures. Use of a categorical exclusion has, and will
continue to include, individualized reviews prior to issuance.
Another commenter said that we provided insufficient analysis for
the determination that licensing and permitting are categorically
exempt. The commenter went on to say that it is unclear whether this
provision is meant to apply to licensing conducted under Animal Welfare
Act (AWA; Laboratory Animal Welfare Act of 1966, as amended Public Law
89-544, 7 U.S.C. 2131-2159) licensing. The commenter argued that AWA
licensing actions have enormous potential for environmental harm, and
so will frequently warrant at least preparation of an EA. The commenter
stated that, even if there were a categorical exclusion for commercial
breeder licensing, at a minimum it should specify exceptions to that
categorical exclusion. The commenter found that the proposed
definition, evaluation criteria, and list of extraordinary
circumstances set too high a bar for judging whether an action may have
a significant environmental effect.
The regulations already provide a categorical exclusion for
licensing and permitting, and identify a wide variety of routine
measures that could result in authorizations and approvals. Since these
categories already existed within the regulations and were effective
for years, we did not include additional analysis in the proposed rule.
We do not agree with the commenter's position regarding our ability to
evaluate an action for significant environmental effect. On the
contrary, we find that the general exceptions to categorical exclusions
identified in Sec. 372.5(d) will allow us to adequately address
concerns about the potential for significant impacts to the environment
pursuant to AWA licensing, because this section allows the
decisionmaker to determine that a categorically excluded action may
have the potential to affect ``significantly'' the quality of the
``human environment.'' For additional discussion on the rest of the
commenter's points specific to licensing of commercial breeding
operations, please see the section below entitled, ``Comments Regarding
Commercial Breeding Operations.''
Proposed paragraph (a)(2) of Sec. 372.10 (Sec. 372.5(c)(2)(i)(B)
in the final rule) contained a 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. A commenter stated that categorical
exclusions for evaluation of novel chemical uses cannot be employed
under NEPA because their application and contact with nontarget species
may result in unintended environmental, human health, or ecological
impacts.
Our research and testing in this area is limited to serving Agency
needs, and does not encompass broadly based or basic research. We have
added the stipulation that such evaluation and use must be pursuant to
applicable Federal authorizations to clarify the relatively narrow
application of this categorical exclusion. Use must be limited in
magnitude, frequency, and scope, and it can only occur in laboratories,
facilities, pens, or field sites. We also note that this is not a new
categorical exclusion, only an enhanced description of activities that
did not demonstrate environmental impacts in the past.
Proposed paragraph (a)(6) (Sec. 372.5(c)(2)(ii) in the final rule)
contained the prior categorical exclusion for the development and
production of sterile insects. We are also including the release of
sterile insects as well.
The same commenter argued that the development and production of
sterile insects may include novel methods for inducing sterility, which
would require NEPA analysis. The commenter said that the field release
of genetically engineered insects may have significant human health and
ecological impacts.
APHIS does not develop, approve, or release genetically engineered
sterile insects. Were that to change in the future, we would consider
any potential environmental impacts. Any novel methods to develop
sterile insects would be subject to the criteria listed in Sec.
372.5(d).
Comments on the Process for Rapid Response to Emergencies
We are adding a new section describing the process APHIS follows to
develop environmental documentation when conducting a rapid response to
an emergency. 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.
One commenter encouraged APHIS to take the need to control a plant
disease outbreak or other exigency into account under NEPA, including
in situations where a categorical exclusion does not apply.
APHIS will take NEPA into account in the event there is a need to
control a plant disease outbreak or other exigency. We recognize the
need to deal quickly, effectively, and efficiently with any emergency
situation that may arise. We mitigate foreseeable environmental effects
to the extent practicable.
Another commenter observed that our proposed text was based on CEQ
regulations, but added that there have been legal challenges to this
portion of those regulations. The commenter stated that, while there
has been no ruling on whether the portion of the CEQ regulations
dealing with rapid response to an emergency is invalid, it was noted
that allowing an emergency to encompass anything more than significant,
unanticipated occurrences, such as natural disasters, as opposed to
circumstances of the agency's own making, seemed at odds with NEPA as
this may allow for the evasion of NEPA review. The commenter concluded
that APHIS should therefore specify that an
[[Page 24008]]
emergency exists in instances of significant, unanticipated
occurrences, such as natural disasters only, and that an emergency
cannot be a result of the agency's own making.
Merely adding the concept that an emergency cannot be a result of
the agency's own making does not account for the types of emergency
actions APHIS may need to cope with, such as unanticipated or
unforeseen impacts associated with a pest or disease outbreak. In an
emergency, our primary concerns include the consequences of a delayed
response. The intent of this section is to create the flexibility
necessary to begin a response to the emergency, regardless of cause.
This section does not allow APHIS to evade NEPA analyses; instead, it
adjusts the usual timeframe and sequence for analysis of any potential
impact during emergencies. The timing for NEPA compliance for all non-
emergency and post-emergency actions remains unchanged.
Comments Regarding Commercial Breeding Operations
As stated previously, we received a number of comments from the
Humane Society of the United States (HSUS) relating to the need for EAs
or EISs in connection with the licensing of commercial breeding
operations. HSUS expressed surprise that we did not mention the
licensing of commercial breeding operations in the proposed rule and
observed that we provided no guidance for applying NEPA standards to
the licensing and regulation of these operations. They disagreed with
our assessment that the approval and issuance of licenses is properly
categorized as administrative, and stated that we failed to articulate
what mitigation measures are in place related to the environmental
damage at commercial breeding facilities, nor how any such measures
would render those environmental effects insignificant. Finally, they
argued that a programmatic assessment of commercial breeders, brokers,
and transporters is compulsory, and the regulations should clearly
convey that certain individual AWA license approvals may require an
individual EA or EIS.
The AWA provides for the licensing of dealers, exhibitors, and
registration of research facilities, and transporters (intermediate
handlers and carriers). The associated standards provide specific
requirements for regulated entities under this Act (7 CFR 371.7; 9 CFR
chapter 1, parts 1 through 12 (particularly part 3, Standards)). When
we propose modifications to the AWA regulations, we solicit and
consider public comments to those specific provisions. The NEPA
regulations are not the correct place to create or modify requirements
for licensing under the authority of the AWA.
Under the AWA, the action of issuing a license consists of
administrative handling of applications. In practice, this means we
assess forms for completeness and schedule appropriate inspections. We
inspect the facilities, and they must be in compliance prior to the
issuance of a license or registration. The criteria for denial of an
initial application are not discretionary (9 CFR 2.11)--all who meet
the requirements are licensed or registered. Potential impacts to the
environment do not occur through the act of processing an application
to issue a license or registration; instead, they may occur when an
individual facility is noncompliant with the standards of humane care,
handling, and transportation. Regulated entities are required to comply
with the standards associated with their license or registration. Based
on the frequency of inspections for facilities, potential environmental
impacts resulting from noncompliance are expected to be localized to a
specific site, short-term in duration, and completely mitigated by the
corrective actions of the facility to comply with the regulations. We
carefully considered the suggestion that a programmatic assessment is
necessary, and find changes to the NEPA regulations are not the correct
place to address these concerns. Programmatic reviews precede proposed
changes to topic-specific regulations as they occur.
HSUS said that common aerosols associated with feces and urine at
puppy mills that impact air quality the most are ammonia, hydrogen
sulfide, methane, and carbon dioxide. They further pointed out that
dogs themselves also produce methane, a potent greenhouse gas, and
these combined emissions pose a serious environmental threat.
Additionally, they stated that vehicle emissions from animal
transporters compound this threat and should be taken into
consideration, arguing that while very little is known about the
bacterial and particulate emissions of animal transport vehicles which
travel across the United States, they undoubtedly emit tons of harmful
gases and particulates into the air while traveling between breeder and
broker or pet shop.
As stated previously, APHIS' authority under the AWA is limited to
the issuance of licenses, which is an administrative act with no
environmental implications. EPA, not APHIS, has authority to regulate
waste materials, disposal, and emissions.
HSUS also said that decomposition of dead dogs at commercial
breeding operations can contribute to soil, air, and water pollution.
They stated that improper mortality management can lead to
environmental contamination and claimed that dead dogs have been found
scattered or improperly disposed of at a number of USDA licensed
facilities.
The AWA regulations in 9 CFR 3.1(f) require facilities with dogs to
properly dispose of waste and dead animals in a manner that minimizes
contamination and disease risks. APHIS standards (9 CFR part 3) are
established by species, and do not differ by licensee or registrant.
Beyond that, State and local laws determine how dead animals are
disposed of within any given jurisdiction, and APHIS works with local
jurisdictions during emergencies. If a mass animal health event were to
lead to high mortality levels, then APHIS would likely be involved in
the disposal of those carcasses as part of a joint local, State, and
Federal emergency response effort.
HSUS identified noise pollution as another environmental harm
associated with large-scale commercial dog breeders. They claimed that
barking dogs can reach decibel levels on par with abrasive blasting or
demolition at a construction site or even an ambulance siren and
recommended that noise studies, as commonly performed by many
localities, should be incorporated into EAs of commercial breeding
operations.
As the commenter correctly points out, localities vary in their
approaches to the regulation of noise. We believe that local and State
regulators are better situated to assess and regulate ambient noise
standards, which are then applicable to all residents of that
jurisdiction.
HSUS stated that, even if an EIS is not automatically warranted in
most cases, large-scale commercial breeding operations raise enough
environmental concerns that APHIS should routinely be preparing EAs
prior to issuing a new license for a breeding facility.
Applicants, excepting those whose operations meet the de minimis
standards set out by APHIS, must demonstrate compliance with the AWA
and its regulations in order to receive a license. The regulations
establish specifications for the humane handling, care, treatment, and
transportation of the species. While it is possible the regulations may
change based on public comments we receive as we consider modifying
program-specific rules, this
[[Page 24009]]
NEPA implementing regulation is not the correct place to consider this
issue. We ensure appropriate NEPA documentation is prepared for all of
our proposed actions. That may take the form of a categorical
exclusion, an EA, or an EIS.
Miscellaneous Changes
We are changing all references to the ``administrative record'' to
references to the ``record'' because the term ``administrative record''
is not the accurate use of a legal term of art.
We are also making several minor edits to improve the clarity,
focus, and brevity of the regulations overall.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Orders 12866, 13563, 13771, and Regulatory Flexibility Act
This final 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.
This final rule is expected to be an Executive Order 13771
deregulatory action as it imposes no additional costs on affected
entities and individuals, and will likely benefit those businesses and
individuals regulated by APHIS that participate in the NEPA process.
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
on the Regulations.gov website (see footnote 1 in this document for a
link to Regulations.gov) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
The rule amends the APHIS regulations that set forth the procedures
for implementing NEPA. The amendments to the regulations are designed
to improve the clarity and effectiveness of the procedures for
implementing NEPA, such as by providing new examples for when we will
complete an environmental impact statement or an environmental analysis
for an action and outlining an environmental documentation process to
be used in emergencies.
APHIS has determined that the rule will not have a significant
economic impact on a substantial number of small entities. Some
entities will experience time and money savings, but the savings will
benefit only a few entities each year. The rule will also serve to
clarify the regulations and make the NEPA process more transparent.
These actions, although beneficial, are not expected to have a
significant economic impact on affected entities. The rule imposes no
additional costs on affected entities and individuals or on APHIS.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
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 13175
This 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 impact of this rule and determined that this
rule does not, to our knowledge, have Tribal implications that require
tribal consultation under Executive Order 13175.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
National Environmental Policy Act
This final rule revises 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
supplement the CEQ regulations for implementing NEPA, and thus no NEPA
document was prepared for this final 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 final rule contains no information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects in 7 CFR Part 372
Administrative practice and procedure, Environmental assessment,
Environmental impact statement, National Environmental Policy Act.
Accordingly, we are amending 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 1500-1508; 7 CFR 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.
[[Page 24010]]
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) 851-3043.
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'' and by removing the word ``is'' and
adding the word ``are'' in its place; and
0
b. By revising the definitions of decisionmaker and environmental unit.
The revisions read as follows:
Sec. 372.4 Definitions.
* * * * *
Decisionmaker. The agency official responsible for signing the
document based on a 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.
0
5. Section 372.5 is amended as follows:
0
a. By revising the introductory text of paragraph (b);
0
b. In paragraph (b)(1)(i), by adding the word ``and'' after the
semicolon;
0
c. In paragraphs (b)(1)(ii) and (b)(3), by removing the words ``,
except for actions that are categorically excluded, as provided in
paragraph (c) of this section'';
0
d. By revising paragraph (b)(4);
0
e. By redesignating paragraph (b)(5) as paragraph (b)(6) and adding a
new paragraph (b)(5);
0
f. By revising newly redesignated paragraph (b)(6);
0
g. By adding paragraph (b)(7);
0
h. By revising paragraphs (c)(1)(ii)(B), (c)(2), and (c)(3)(i);
0
i. By redesignating paragraphs (c)(3)(ii) and (iii) as paragraphs
(c)(3)(iii) and (iv), respectively;
0
j. By adding a new paragraph (c)(3)(ii);
0
k. By revising paragraph (c)(4);
0
l. By adding paragraph (c)(5);
0
m. In paragraph (d)(2), by adding the word ``or'' after the semicolon;
and
0
n. By removing paragraph (d)(3) and redesignating paragraph (d)(4) as
paragraph (d)(3).
The additions and revisions read as follows:
Sec. 372.5 Classification of actions.
* * * * *
(b) Actions normally requiring environmental assessments but not
necessarily environmental impact statements. This class of APHIS
actions may involve the agency as a whole or an entire program, but
generally is related to a more discrete program component and is
characterized by its limited scope (particular sites, species, or
activities) and potential effect (impacting relatively few
environmental values or systems). Potential environmental impacts
associated with the proposed action are not considered potentially
significant at the outset of the planning process. 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 been successfully
employed. Unless the actions are categorically excluded as provided in
paragraph (c) of this section, actions in this class include:
* * * * *
(4) Approvals and issuance of permits for proposals involving
regulated genetically engineered organisms or products, or regulated
nonindigenous species.
(5) Programs or statewide activities 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.
(6) 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.
(7) Determination of nonregulated status for genetically engineered
organisms.
(c) * * *
(1) * * *
(ii) * * *
(B) Use of vaccinations or inoculations including new vaccines
(e.g., 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; and
* * * * *
(2) Research and development activities. (i) Activities limited in
magnitude, frequency, and scope that occur in laboratories, facilities,
pens, or field sites. Examples are:
(A) Vaccination trials that occur on groups of animals in areas
designed to limit interaction with similar animals, or include other
controls needed to mitigate potential risk.
(B) Laboratory research involving the evaluation and use of
chemicals in a manner not specifically listed on the product label
pursuant to applicable Federal authorizations.
(C) The development and/or production (including formulation,
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.
(D) Research evaluating wildlife management products or tools, such
as animal repellents, frightening devices, or fencing, that is carried
out in a manner and area designed to eliminate the potential for
harmful environmental effects and in accordance with applicable
regulatory requirements.
(ii) Development, production, and release of sterile insects.
(3) * * *
(i) Issuance of a license, permit, authorization, or approval to
ship or field test previously unlicensed veterinary biologics,
including veterinary biologics containing genetically engineered
organisms (such as vector-based vaccines and nucleic acid-based
vaccines);
(ii) Issuance of a license, permit, authorization, or approval for
movement or 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; or
* * * * *
(4) Extending deregulations for genetically engineered organisms.
Extension of nonregulated status under part 340 of this chapter to
organisms similar to those already deregulated.
[[Page 24011]]
(5) Minor renovation, improvement, and maintenance of facilities.
Examples are:
(i) Renovation of existing laboratories and other facilities.
(ii) Functional replacement of parts and equipment.
(iii) Minor additions to existing facilities.
(iv) Minor excavations of land and repairs to properties.
* * * * *
Sec. 372.6 [Removed]
0
7. Section 372.6 is removed.
Sec. Sec. 372.7 through 372.10 [Redesignated as Sec. Sec. 372.6
through 372.9]
0
8. Sections 372.7 through 372.10 are redesignated as Sec. Sec. 372.6
through 372.9, respectively.
0
9. Newly redesignated Sec. 372.6 is revised to read as follows:
Sec. 372.6 Early planning.
Prospective applicants are encouraged to contact APHIS program
officials to determine what types of environmental analyses or
documentation, if any, need to be prepared.
0
10. Newly redesignated Sec. 372.7 is amended by revising the section
heading and paragraph (b)(4) to read as follows:
Sec. 372.7 Planning and decision points and public involvement.
* * * * *
(b) * * *
(4) All environmental documents and comments received will be made
available to the public via Regulations.gov.
0
11. Newly redesignated Sec. 372.8 is amended as follows:
0
a. In paragraph (a) introductory text, by adding a sentence at the end
of the paragraph;
0
b. In paragraph (a)(1), by removing the citation ``Sec. 372.8'' and
adding the citation ``Sec. 372.7'' in its place; and
0
c. By revising paragraph (a)(3).
The addition and revision read as follows:
Sec. 372.8 Processing and use of environmental documents.
(a) * * * This determination is based on information provided in
the NEPA document and available in the 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.
* * * * *
Sec. 372.9 [Amended]
0
12. Newly redesignated Sec. 372.9 is amended by removing the second
sentence and the word ``administrative'' in the last sentence.
0
13. A new Sec. 372.10 is added to read as follows:
Sec. 372.10 Process for rapid response to emergencies.
When it is determined (by the Administrator or the delegated Agency
official responsible for environmental review) that an emergency exists
that requires immediate action before preparing and completing the
usual NEPA review, then the provisions of this section apply.
(a) The Administrator or the delegated Agency official responsible
for environmental review may take actions that are necessary to control
the immediate impacts of the emergency and that are urgently needed to
prevent imminent damage to public health or safety, or prevent threats
to valuable resources. When taking such actions, the Administrator or
the delegated Agency official responsible for environmental review will
consider 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. 372.5 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 alternative arrangements for NEPA
compliance. APHIS' Chief of Environmental and Risk Analysis Services
may authorize emergency alternative arrangements for completing the
required NEPA compliance documentation. Any alternative arrangements
must be documented and notice of their use provided to CEQ.
(c) If a proposed emergency action is likely to result in
significant environmental impacts, then APHIS will immediately consult
with 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
these regulations.
Done in Washington, DC, this 18th day of May 2018.
Greg Ibach,
Under Secretary, Marketing and Regulatory Programs.
[FR Doc. 2018-11083 Filed 5-23-18; 8:45 am]
BILLING CODE 3410-34-P