Rule2024-31203
Injurious Wildlife Species; Listing Salamanders Due to Risk of Salamander Chytrid Fungus
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 10, 2025
Effective
January 25, 2025
Issuing agencies
Interior DepartmentFish and Wildlife Service
Abstract
The U.S. Fish and Wildlife Service is affirming as final the 2016 interim rule that added all species of salamanders from 20 genera to the list of injurious amphibians. Under the injurious wildlife prohibitions of the Lacey Act, this final rule prohibits the importation into the United States and shipment between the continental United States, District of Columbia, Hawaii, Commonwealth of Puerto Rico, or any territory or possession of the United States of any live or dead specimen, including hybrids and parts, of those 20 genera of salamanders, except by permit for certain purposes or by Federal agencies solely for their own use. In addition to finalizing the listing of those 20 genera, we are publishing a new interim rule to add to the injurious amphibian list 16 genera that recent studies determined are also carriers of the fungus and to clarify some provisions from the final rule. This interim rule includes any live or dead specimen, hybrid, or parts of the 16 genera and opens a public comment period. We take these actions to protect U.S. ecosystems from the introduction, establishment, and spread of the lethal chytrid fungus Batrachochytrium salamandrivorans, which infects and is carried by salamanders, and which is not yet known to be found in the United States.
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[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Rules and Regulations]
[Pages 2170-2221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31203]
[[Page 2169]]
Vol. 90
Friday,
No. 6
January 10, 2025
Part III
Department of the Interior
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Fish and Wildlife Service
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50 CFR Part 16
Injurious Wildlife Species; Listing Salamanders Due to Risk of
Salamander Chytrid Fungus; Final Rule
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Rules
and Regulations
[[Page 2170]]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 16
RIN 1018-BA77
[Docket No. FWS-HQ-FAC-2015-0005; FXFR13360900000-245-FF09F14000]
Injurious Wildlife Species; Listing Salamanders Due to Risk of
Salamander Chytrid Fungus
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Affirmation of interim rule as final; second interim rule and
request for public comment.
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SUMMARY: The U.S. Fish and Wildlife Service is affirming as final the
2016 interim rule that added all species of salamanders from 20 genera
to the list of injurious amphibians. Under the injurious wildlife
prohibitions of the Lacey Act, this final rule prohibits the
importation into the United States and shipment between the continental
United States, District of Columbia, Hawaii, Commonwealth of Puerto
Rico, or any territory or possession of the United States of any live
or dead specimen, including hybrids and parts, of those 20 genera of
salamanders, except by permit for certain purposes or by Federal
agencies solely for their own use. In addition to finalizing the
listing of those 20 genera, we are publishing a new interim rule to add
to the injurious amphibian list 16 genera that recent studies
determined are also carriers of the fungus and to clarify some
provisions from the final rule. This interim rule includes any live or
dead specimen, hybrid, or parts of the 16 genera and opens a public
comment period. We take these actions to protect U.S. ecosystems from
the introduction, establishment, and spread of the lethal chytrid
fungus Batrachochytrium salamandrivorans, which infects and is carried
by salamanders, and which is not yet known to be found in the United
States.
DATES: Effective date: The interim rule published at 81 FR 1534 on
January 13, 2016, was effective January 28, 2016. This final rule
affirming the January 13, 2016, interim rule and the interim rule set
forth in this document are effective January 25, 2025.
Comment submission: Interested persons are invited to submit
written comments on the issues raised in the second interim rule as
described below under Information Requested on or before March 11,
2025.
ADDRESSES: Comment submission: You may submit comments by one of the
following methods:
(1) Electronically: Go to the Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. In the Search box, enter FWS-HQ-FAC-2015-0005,
which is the docket number for this action. You may submit a comment by
clicking on ``Comment.''
(2) By hard copy: Submit by U.S. mail to: Public Comments
Processing, Attn: FWS-HQ-FAC-2015-0005, U.S. Fish and Wildlife Service,
MS: PRB/3W, 5275 Leesburg Pike, Falls Church, VA 22041-3803.
We request that you send comments only by the methods described
above. We will post all comments on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. This
generally means that we will post any personal information you provide
us (see Information Requested, below, for more information).
Supplementary materials: Background documents related to this
rulemaking action, including the final economic analysis for the
affirmation of the 2016 interim rule, are available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in Docket No. FWS-HQ-FAC-2015-0005.
FOR FURTHER INFORMATION CONTACT: Kristen Sommers, Injurious Wildlife
Listing Coordinator, U.S. Fish and Wildlife Service, Branch of Aquatic
Invasive Species; MS: FAC; 5275 Leesburg Pike; Falls Church, VA 22041-
3803; 571-329-2214. Individuals in the United States who are deaf,
deafblind, hard of hearing, or have a speech disability may dial 711
(TTY, TDD, or TeleBraille) to access telecommunications relay services.
Individuals outside the United States should use the relay services
offered within their country to make international calls to the point-
of-contact in the United States.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Current Rulemaking Action
III. Final Rule to the 2016 Interim Rule
A. Background
B. Summary of Comments Received on the 2016 Interim Rule
C. Affirmation of the 2016 Interim Rule
D. Required Determinations
IV. Second Interim Rule
A. Species Information for Salamanders
B. Species Information for Batrachochytrium salamandrivorans
C. Population-Level and Ecosytem-Level Effects of Bsal
D. Invasiveness of Salamanders and Bsal
E. Pathway Analysis
F. Risk Assessments of Bsal
G. Factors That Contribute to Injuriousness of Salamanders
H. Measures That Reduce or Remove Injuriousness of Salamanders
I. Summary and Conclusion for Interim Rule
J. Required Determinations
K. Information Requested
I. Executive Summary
Why we need to publish a rule. We, the U.S. Fish and Wildlife
Service (Service or FWS), are charged with administering 18 U.S.C.
42(a), as amended (commonly known as the injurious wildlife provision
of the Lacey Act). Under this authority, the Secretary of the Interior
may list by regulation those wild mammals, wild birds, fish, mollusks,
crustaceans, amphibians, reptiles, and the offspring or eggs of any of
the foregoing that are injurious to human beings, to the interests of
agriculture, horticulture, or forestry, or to the wildlife or wildlife
resources of the United States.
We have determined that salamanders that can carry the fungus
Batrachochytrium salamandrivorans (Bsal) are injurious to wildlife and
wildlife resources of the United States. This determination was based
on a review of the literature and an evaluation under the criteria for
injuriousness by the Service. The purpose of listing these species as
injurious wildlife is to prevent the introduction, establishment, and
spread of Bsal in the wild in the United States. The fungus primarily
affects salamanders, has lethal effects on many salamander species, and
is not yet known to be found in ecosystems of the United States.
What this document does. This document serves two purposes: It
finalizes a rulemaking action initiated with publication of an interim
rule in 2016, and it promulgates a new and related interim rule.
On January 13, 2016, we published an interim rule that amended our
regulations pertaining to injurious wildlife (81 FR 1534). That interim
rule (hereafter referred to as ``the 2016 interim rule'') amended our
regulations to add all species of salamanders from 20 genera, of which
there were 201 species, to the list of injurious amphibians. Under the
injurious wildlife prohibitions of the Lacey Act, the 2016 interim rule
prohibited both importation into the United States and interstate
transportation between States, the District of Columbia, the
Commonwealth of Puerto Rico, or any territory or possession of the
United States (the latter was clarified by a court decision in 2017) of
any live or dead specimen, including parts, of these 20 genera of
salamanders, except by permit
[[Page 2171]]
for zoological, educational, medical, or scientific purposes (in
accordance with permit conditions) or by Federal agencies without a
permit solely for their own use.
A second interim rule is now needed because of recent studies
documenting additional genera that also share the same traits that make
them injurious as carriers of Bsal. We are also revising some
provisions from the 2016 interim rule in the final rule to make minor
corrections to and improve clarity of the rule.
The basis for our action. Defensible scientific evidence indicates
that we need to list a total of 36 genera of salamanders as injurious
wildlife to protect U.S. ecosystems. Therefore, we hereby affirm the
injurious wildlife listings in the 2016 interim rule of all species in
the following 20 genera: Chioglossa, Cynops, Euproctus, Hydromantes,
Hynobius, Ichthyosaura, Lissotriton, Neurergus, Notophthalmus,
Onychodactylus, Paramesotriton, Plethodon, Pleurodeles, Salamandra,
Salamandrella, Salamandrina, Siren, Taricha, Triturus, and
Tylototriton. We also add new injurious wildlife listings of all
species in the following 16 genera through the second interim rule:
Ambystoma, Andrias, Aneides, Aquiloeurycea, Calotriton,
Chiropterotriton, Cryptobranchus, Desmognathus, Ensatina, Eurycea,
Laotriton, Ommatotriton, Pachytriton, Proteus, Pseudobranchus, and
Pseudotriton.
The United States has the greatest diversity of salamanders in the
world, salamanders are a vital part of native ecosystems, and numerous
salamander populations are at risk of endangerment from Bsal. A risk
assessment conducted by the U.S. Geological Survey (USGS) concluded
that the potential for Bsal introduction into the United States is
high, the United States has suitable conditions for Bsal survival, and
the consequences of introduction into the United States are expected to
be severe and occur across a wide geographic range within the United
States. The most likely pathway of Bsal into the United States would be
on the bodies of salamanders in the commercial salamander trade. Aside
from our Bsal regulations, the ability and effectiveness of measures to
prevent or control Bsal is currently low. Trade in wildlife occurs on a
global scale, and amphibians are one of the most commonly traded
animals.
Therefore, listing the genera as determined in this rulemaking
action will help to reduce the likelihood that Bsal enters the United
States and presents a threat to native salamander species.
II. Current Rulemaking Action
This document does the following:
<bullet> Affirms the current listing of 20 genera of salamanders as
injurious species by the 2016 interim rule as described above and any
species within those genera.
<bullet> Revises provisions in the preamble of the 2016 interim
rule in response to a court decision that pertained to interstate
transport of injurious wildlife as described below.
<bullet> Removes the 201 itemized species names from the list in 50
CFR 16.14. This itemized list of scientific and common names is
unnecessary because the regulations in 50 CFR 16.14(a) state that the
prohibitions pertain to the 20 genera ``including but not limited to,
the species listed in this paragraph.'' We provided the itemized list
of species in the 2016 interim rule largely for the convenience of the
public and our law enforcement staff, but the taxonomy of salamanders
is evolving, and the list is not static. However, while many scientific
and common names have changed, all of the listed species remain in
their same genera.
<bullet> Clarifies prohibitions pertaining to hybrids and frozen
specimens; clarifies what is not prohibited (including eggs or gametes;
parts or tissues that have been chemically preserved, chemically
treated, or heat treated so that the pathogen Batrachochytrium
salamandrivorans, if present, is rendered non-viable; and molecular
specimens consisting of only the nucleic acids from organisms).
<bullet> Adds 16 genera to the list in 50 CFR 16.14(a), as
explained below, and solicits comments on these new genera.
III. Final Rule to the 2016 Interim Rule
A. Background
On January 13, 2016, under the authority of 18 U.S.C. 42(a)(1), as
amended, we, the U.S. Fish and Wildlife Service, published an interim
rule in the Federal Register (81 FR 1534) to add all species from 20
genera to the list of injurious amphibians and announced the
availability of the draft economic analysis and the draft environmental
assessment of the 2016 interim rule. The rule took effect on January
28, 2016, and revised the lists of injurious wildlife in part 16 of
title 50 of the Code of Federal Regulations (CFR), specifically the
list of injurious amphibians at 50 CFR 16.14. The 60-day public comment
period closed on March 14, 2016. We solicited comments and supporting
data to gain additional information. We also solicited peer review at
the same time.
In this document, we present our consideration of the public
comments and peer review received on the 2016 interim rule to inform
our final determinations. We present a summary of the peer-review
comments and the public comments and our responses to them in the
``Summary of Comments Received on the 2016 Interim Rule'' portion of
the preamble to this final rule. The comments did not provide any
substantive evidence that supported changing the genera in the interim
rule. However, some comments did provide justification for modifying
certain requirements stipulated in the 2016 interim rule.
The Service published an interim rule in 2016 instead of issuing a
proposed rule for the listing under the Administrative Procedure Act
(APA) (5 U.S.C. 551 et seq.). As explained in the 2016 interim rule, we
had good cause to forgo notice and public comment on a proposed rule
and instead take immediate action in the form of an interim rule to
help prevent the fungus Bsal from being introduced, established, or
spread in the United States for the reasons listed above. The fungus,
lethal to many salamander species in the United States, is carried on
the skin of salamanders and can be unintentionally imported by
salamanders in trade. The 2016 interim listing of the 20 genera of
salamanders has prohibited the importation of high-risk species under
the injurious wildlife prohibitions of the Lacey Act, and the fungus
has remained absent from the United States.
In this document, a clarification from the 2016 interim rule
reflects a court decision in 2017. Under the D.C. Circuit Court of
Appeals decision in United States Association of Reptile Keepers, Inc.
v. Zinke, 852 F.3d 1131 (D.C. Cir. 2017), import of injurious wildlife
into the United States remains prohibited. In addition, transport of
injurious wildlife between the enumerated jurisdictions in the shipment
clause of 18 U.S.C. 42(a) (the continental United States, the District
of Columbia, Hawaii, the Commonwealth of Puerto Rico, and any territory
or possession of the United States) remains prohibited. However, the
court held that 18 U.S.C. 42(a) does not prohibit interstate movement
between States within the continental United States. This means that
transportation of injurious wildlife between the 49 States within the
continental United States (the contiguous 48 States and Alaska) is not
prohibited by the statute, unless that movement of the wildlife is
restricted due to conditions associated with issued injurious wildlife
permits. We note that transport from the lower 48 States to
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Alaska through Canada, or vice versa, remains prohibited, because that
transport includes an import into the United States.
The language in 50 CFR 16.14(a) was, and still is, correct in that
it does not prohibit interstate transport between States within the
continental United States. The final economic analysis affirming the
2016 interim rule reflects the clarification of interstate transport
authority between States within the continental United States since the
court decision on April 7, 2017. However, injurious wildlife unlawfully
imported into the United States or transported between the enumerated
jurisdictions is still unlawful to transport within the continental
United States. Under the Lacey Act amendments of 1981, 16 U.S.C.
3372(a)(1), it is unlawful for any person to import, export, transport,
sell, receive, acquire, or purchase any wildlife transported in
violation of any law of the United States. This includes transport of
any injurious wildlife imported into the United States or transported
between the enumerated jurisdictions in violation of 18 U.S.C. 42.
B. Summary of Comments Received on the 2016 Interim Rule
The following comments were submitted during the peer and public
comment period for the 2016 interim rule. Knowledge about Bsal has
improved since then due to the many excellent studies by researchers
and our own understanding of the disease. In the following responses to
the comments under Peer Review Summary and Public Comments Summary,
respectively, we have endeavored to answer the comments both as they
related to the knowledge of Bsal, trade, and related issues at the time
of the 2016 interim rule and as of the current knowledge as
appropriate. The current knowledge from recent research affirms the
2016 interim rule, supports the second interim rule set forth in this
document, and can be found below in IV. Second Interim Rule. In our
responses to the comments, when we refer to ``this rule,'' we mean that
the information and the changes apply both to the final rule for the
2016 interim rule and the second interim rule.
Peer Review Comments and Our Responses
In accordance with peer review guidance of the Office of Management
and Budget ``Final Information Quality Bulletin for Peer Review,''
released December 16, 2004, we solicited expert opinion on information
contained in the 2016 interim rule from three knowledgeable individuals
selected from specialists in the relevant taxonomic group and
ecologists with scientific expertise that includes familiarity with
alien herpetological introductions and invasions, predictive tools for
risk assessment, and invasion biology. We posted our peer review plan
on the Service's Science website (<a href="https://www.fws.gov/media/peer-review-plan-listing-salamanders-injurious-due-risk-salamander-chytrid-fungus">https://www.fws.gov/media/peer-review-plan-listing-salamanders-injurious-due-risk-salamander-chytrid-fungus</a>), explaining the peer review process and providing the public
with an opportunity to comment on the peer review plan. No comments
were received regarding the peer review plan. The Service solicited
independent scientific reviewers who submitted individual comments in
written form. We avoided using individuals who had already expressed
strong support for or opposition to the subject and individuals who
were likely to experience personal gain or loss (such as financial or
prestige) or otherwise could be perceived as having a conflict of
interest as a result of the Service's decision. We received responses
from three peer reviewers. A scientist with the USGS served as one of
the peer reviewers.
We requested that the reviewers provide comments that were specific
to the 2016 interim rule and the draft economic analysis. We reviewed
all comments for substantive issues and any new information they
provided. We consolidated their comments (without attribute) and our
responses into key issues in this section. Some peer reviewer comments
that called for technical changes or more minor corrections have not
been noted, but we have made our best effort to correct those
grammatical or biological errors and clarify certain ambiguous
statements in the second interim rule and supporting documents. We
prepared the second interim rule and second draft economic analysis to
reflect peer reviewer comments and new scientific information where
appropriate.
The comments we received indicated support for the 2016 interim
rule and for the analysis that we conducted given the need to prevent
harm to native species from Bsal. All three peer reviewers concluded
that the data and analyses we used in the interim rule were appropriate
and the conclusions we drew were logical and reasonable. All three peer
reviewers provided additional insights (which we used to clarify points
in the second interim rule) or references to recently published
studies, which support the final rule. In general, the peer reviews
supported the Service's conclusions and agreed that they were
reasonable, though they did note that we generalized some of our
findings, such as the average temperature of salamander habitats as an
indicator of Bsal vulnerability with regards to salamanders nationwide.
We have clarified these issues where practical in the second interim
rule. The peer reviewers suggested that there was a need to expand our
discussion regarding possible treatment options, which we have added to
the second interim rule. The peer reviewers also acknowledged that,
while the rule is important, research questions remain that could shed
light on ways to better prevent the introduction of Bsal into the
United States.
General Comments
(PR1) Comment: In support of the 2016 interim rule, prevention
provides an environmental and biodiversity benefit; the probability of
introduction is at the very least reduced; and host species need not
become established in the environment to transmit Bsal. If an owner
houses multiple salamander species, transmission can occur in captivity
to other species that may be able to establish a population in the
wild. The commenter also agrees with the exclusion from the rule of
tailless amphibians (frogs and toads), which were uniformly resistant
in the tests by Martel et al. (2014).
Response: We concur with the comments. At the time of the 2016
interim rule publication, we lacked evidence of tailless amphibians as
carriers, and this final rule simply affirms our findings on
salamanders.
(PR2) Comment: The average temperature of salamander habitats as an
indicator of Bsal vulnerability with regard to salamanders nationwide
would be difficult to defend. The rule provides a very broad average,
and extrapolating it weakens the point.
Response: We have clarified the rule under Bsal Risk Assessments in
response to this comment to reflect more specifically the areas that
the risk assessments identified as highest risk. We intended to
demonstrate that most salamander species in the United States are not
protected from Bsal by living outside of the Bsal optimal growth range
or in areas beyond the threshold where Bsal can survive.
(PR3) Comment: If time allowed, a few simple tests to improve the
scientific foundation of the interim rule could have strengthened the
decision to include or exclude species.
Response: The Service is not a research agency, and we utilized
[[Page 2173]]
available research when we found in 2016 that there was good cause to
forgo notice and public comment on a proposed rule and instead take
immediate action in the form of an interim rule to help prevent Bsal
from being introduced, established, or spread in the United States. In
this rule, we also utilize newly published or otherwise available
research. In the years since the 2016 interim rule was published, many
of the relevant studies affirmed our interim findings, while others
support additional genera as documented in our second interim rule.
None substantively contradicted our findings.
(PR4) Comment: Given the long time that Bsal has been around (150
years), the massive number of imported salamanders, and only recent
characterization of Bsal, it may be possible that earlier Bsal was
characterized as a related chytrid fungus, Batrachochytrium
dendrobatidis (Bd).
Response: As of the completion of this rule, resource managers,
scientists and other researchers have been utilizing the latest
scientific techniques to actively look for Bsal in nonresearch captive
populations and in wild populations in the United States. The USGS
conducted a massive sampling effort of 11,189 samples from 594 sites in
223 counties within 35 U.S. States and 1 site in Mexico specifically
for Bsal in wild populations (Waddle et al. 2020). The sites were
chosen based on the species' susceptibility (including some frog
species) and highest risk geographically. No Bsal was found. As of the
completion of this rule, we are unaware of any positive Bsal detections
in the wild. Testing of archived samples by other laboratories has been
done, and no Bsal has been detected to our knowledge. The evidence is
not conclusive that Bsal has never been in the wild in the United
States, but there is no evidence that it has.
(PR5) Comment: When the rule repeats the information about invasive
species, the point should be made that, even if a salamander found to
be injurious could not establish a population in the wild, an infected
salamander in captivity can still transmit Bsal to native populations
if that salamander escapes or if material touching it is disposed of
improperly.
Response: We agree and have incorporated the suggested language
into the second interim rule.
(PR6) Comment: The 2016 interim rule states that the main pathway
for the global spread of Bsal is the international trade in salamanders
and that the most likely pathway of a salamander that is a host to Bsal
into the United States would include a pet store or online retailer.
Since neither the United Kingdom or Germany Bsal outbreaks were related
to a pet store or online retailer, the commenter recommends stating,
``The most likely pathway of a salamander that is a host to Bsal into
the United States would be the captive salamander commercial trade'' to
cover the diverse salamander trade.
Response: We have edited the second interim rule accordingly.
(PR7) Comment: Given that Bd was probably introduced by release of
laboratory animals as well as pets, institutional use of listed
salamanders should also be regulated to protect U.S. ecosystems from
Bsal.
Response: This rule is intended to prevent the introduction of
Bsal, whereas Bd was already widespread in the United States when that
fungus was identified as the cause of major amphibian mortality.
Importation of listed salamanders is regulated by this rule within the
authorities under the injurious wildlife provisions of 18 U.S.C. 42.
Any listed salamanders that are imported under a permit exception for
zoological, educational, medical, or scientific purposes are required
to observe sanitary procedures and double containment to prevent escape
and are not allowed to be released. The Service may also establish
additional permit conditions if deemed appropriate to ensure
responsible use, maintenance, and containment of injurious wildlife
specimens posing a risk of pathogen transfer and continued protection
of the public interest and health, under 18 U.S.C. 42(a)(3) and the
Service's permitting regulations in 50 CFR part 13 and part 16.
(PR8) Comment: What is the citation for the statements, ``Based on
scientific evidence, we know that the fungus is lethal to at least two
salamander species native to the United States. Of the 190 native U.S.
species, we find that at least 67 species are carriers and 20 are not
carriers''?
Response: Martel et al. 2014 was the source for the first sentence,
and we used a combination of sources for information about native
species and the testing that was done. We stated our sources and
findings for these statements in the relevant sections in this rule.
Vulnerability and Carrier Status of Native Species
(PR9) Comment: One of the considerations was that, even if a
salamander listed by the 2016 interim rule could not establish a
population in the wild, an infected salamander in captivity (or the
water and soil in which it came into contact) can transmit Bsal to
native populations. In addition to water and soil, how about if there
is affected foliage or paper that was used in transit?
Response: The commenter is correct that a variety of materials
could become contaminated with fungal spores if in contact with
infected salamanders. However, it is not possible to provide a complete
list of these potential fomites (materials, such as water, that can act
as passive carriers and can transfer pathogens) in the text of the
rule. Rather, we believe that listing the salamander species that may
be carriers of Bsal as injurious wildlife, thereby prohibiting the
importation of potentially infected individuals, reduces the risk for
pathogen spread by any substrate.
(PR10) Comment: The considerations say that controlling Bsal is not
practical. The peer reviewer recommends revising to note that, while
there are control methods available for infected individual salamanders
in captivity (Blooi et al. 2015a, 2015b), there are no practical
control measures for free-ranging salamanders.
Response: We agree with the comment. In the second interim rule, we
clarify that, while treatment options exist that may help reduce the
threat posed by Bsal for imported and captive-held specimens, those
options have not been standardized and their effectiveness remains
uncertain for large-scale application.
Pathways
(PR11) Comment: The pathway by which Bsal spreads is unknown,
except that water is involved. Thus, the States should be responsible
for implementing measures on waterways that prevent the introduction of
Bsal.
Response: We agree that the U.S. States should be strong partners
in helping to prevent the introduction, establishment, and spread of
Bsal. We conclude that the main pathway for the potential global spread
of Bsal is the introduction into the United States through
international trade in salamanders, and we are acting with this rule to
reduce those risks.
(PR12) Comment: The pathway analysis, epidemiology of the disease,
and investigation of the origins of the outbreak need more
investigation. In addition, no laws or regulations exist to control the
disposal of untreated water from captive salamander enclosures. Given
the virulence of the disease, how did Bsal enter the European
environment? Was it the result of open-system housing, such as outdoor
pens or open-system water flow? Intentional
[[Page 2174]]
release of pets seems an unlikely source since the course of the
disease is rapid with signs of infection within 8 days.
Response: While it is possible that Bsal can be transmitted through
other pathways and vectors, the comment does not provide any evidence
that other pathways are more likely than international trade. Drawing
on the evidence cited in this rule in the Pathway Analysis, we conclude
that the primary potential pathway for the entry of Bsal into the
United States is through the international trade in salamanders. Our
analysis concludes that Bsal can survive on infected animals long
enough for the pathogen to be introduced into the environment and
transmitted to species that are negatively impacted by Bsal.
(PR13) Comment: We suggest another pathway that should be addressed
is that fishes, plants, and invertebrates may be co-cultured with
newts. It is unknown if they can act as a fomite. For Bd, there is
evidence for foliage and invertebrates as substrates. Amphibians can
enter the United States as stowaways on agricultural and other imports.
For example, the Cuban tree frog that invaded Florida hitchhiked in
shipping crates coming from the Caribbean. It is also possible that
Bsal could be transported in contaminated water that is entering the
United States with imported fish for aquaculture or the pet trade.
Response: We concur with the comment. Other pathways are a concern;
however, the Service concludes that the trade pathway in salamanders is
the most significant means by which Bsal could be introduced into the
United States. The final and second interim rules will be protective
because a co-cultured salamander that has also been found to be a
carrier would be prohibited from importation into the United States.
The Service will also continue to seek opportunities to work with
partners to minimize the risk from other pathways.
Species Additions
(PR14) Comment: Some of the Bd infections observed in species from
Ambystoma may have been Bsal. California tiger salamanders (Ambystoma
californiense) can survive chytrid infections that would make them
likely carriers. Another peer reviewer stated that the rule states,
``At least four [native species] are resistant to Bsal infection, of
which one is expected to be a carrier because Bsal was able to invade
the skin of that species long enough to move or transmit the fungus to
other salamanders.'' This is a reasonable assumption. The commenter
makes the same assumption for Ambystoma based on their ability to be
infected by Bd.
Response: The testing results available to the Service at the time
of the 2016 interim rule provided no evidence that some species within
Ambystoma are carriers of Bsal. However, subsequent research provides
that evidence. Please see IV. Second Interim Rule below for that
evidence.
Prohibition on Interstate Transportation
(PR15) Comment: Enforcing the interstate prohibition will be
difficult. Also, it seems unnecessary if Bsal is not known to exist in
the United States. While it is possible that Bsal may be present on a
pet in the United States, the interstate transportation prohibition
could prevent movement of that pet.
Response: As stated above under A. Background in III. Final Rule to
the 2016 Interim Rule, the D.C. Circuit Court of Appeals held on April
7, 2017, that transportation of injurious wildlife between the 49
States within the continental United States (the contiguous 48 States
and Alaska) is not prohibited by the Lacey Act, unless that movement of
the wildlife is restricted due to conditions associated with issued
injurious wildlife permits. The language in 50 CFR 16.14(a) was and
still is correct in that it does not prohibit interstate transport
between States within the continental United States. Transport of
injurious wildlife between the enumerated jurisdictions set forth in
the shipment clause of 18 U.S.C. 42 (the continental United States, the
District of Columbia, Hawaii, the Commonwealth of Puerto Rico, and any
territory or possession of the United States), codified in Federal
regulations at 50 CFR 16.3, remains prohibited. The Service will
continue to seek opportunities to encourage affected members of the
public to take responsible actions related to listed species.
Prohibition on Preserved Specimens and Parts
(PR16) Comment: There is little risk of Bsal transmission from
chemically preserved specimens. Even if contaminated with Bsal DNA, it
is unlikely that the chytrid would be viable or lead to introduction of
Bsal into the United States. However, the prohibition should be
maintained for live or frozen specimens, because it is unclear whether
Bsal can survive freezing. Experimental studies are needed to elucidate
the viability of Bsal after preservation and freezing.
Response: In response to comments we received explaining that
preserved salamanders or their preserved parts pose a low risk of
transmitting Bsal, the Service is removing chemically preserved
specimens and body parts from the injurious wildlife listing as long as
chemical preservation is adequate to render the fungus inviable. Frozen
specimens remain regulated as parts of injurious wildlife as clarified
in A.
Species Capable of Carrying Bsal
(PR17) Comment: The 2016 interim rule states in the section
``Invasiveness and Transmission of Bsal'' that the rough-skinned newt
and the eastern newt are capable of carrying Bsal. What is the evidence
for this?
Response: Martel et al. (2014) found that the eastern newt and
rough-skinned newt were found to be lethally vulnerable to Bsal. Below
in E. Pathway Analysis, Introduction Pathways, we added that Bsal can
remain viable inside dead host tissue (Martel et al. 2013). We have
concluded that lethally vulnerable salamanders are also carriers. More
recent information affirms the newts as carriers (please see II.
Current Rulemaking Action below for that evidence).
Invasiveness of Salamanders
(PR18) Comment: The rule states that Oriental fire-bellied newts
(Cynops orientalis) and paddle-tailed newts (Paramesotriton
(Pachytriton) labiatus or brevipes), which are native to China, have
been found in the wild near an animal importer's facility in Florida.
Because they were found outside of the facility does not necessarily
mean that they are a breeding, invasive, reproducing population.
Response: We concur with the comment that being found outside of a
facility does not necessarily mean that the species in question is
actually invasive, although a released salamander could persist long
enough in the ecosystem to transmit Bsal if the salamander was exposed
to viable spores.
(PR19) Comment: The rule states that Picco and Collins (2008) found
that salamanders sold as bait were highly infected with both ranavirus
and Bd, thereby increasing the likelihood of pathogen transmission into
new areas of the United States through the act of fishing. Have
declines from this pathway been documented? If not, the point is rather
moot or at least weak.
Response: That comment refers to the section on invasiveness of
salamanders. The Picco and Collins (2008) reference demonstrates that
anglers routinely release salamanders into the areas where they fish,
which serves as one
[[Page 2175]]
pathway for salamanders being introduced into the environment,
including nonnative habitats. This pathway may also serve as a vector
for pathogens, including Bsal.
(PR20) Comment: The 2016 interim rule states that the four
salamander genera most commonly imported into the United States from
2004 to 2014 were Cynops, Paramesotriton, Triturus, and Pachytriton.
You should check Krysko et al. (2011) against the fire-bellied newt.
Response: Krysko et al. (2011) was cited by the USGS in its fact
sheet for the Oriental fire-bellied newt in reporting nonindigenous
occurrences, although none have been reported since 2010 (USGS
Nonindigenous Aquatic Species (NAS) 2021 [CYOR]).
(PR21) Comment: In evaluating the potential to eradicate or manage
established populations, the 2016 interim rule says that, while some
introduced salamanders in the United States have been successfully
controlled, others have not. However, evidence for control is sparse.
There is a difference between a small population living in exceptional
circumstances and an invasive species. In many cases, small populations
of animals will persist but not spread. These are not invasive and
should not be used as examples of the removal of invasives.
Response: Executive Order 13751 defines an invasive species as a
nonnative organism whose introduction causes or is likely to cause
economic or environmental harm or harm to human, animal, or plant
health. Establishment and spread can increase the threat that a
particular species causes, but establishment and spread are not in
themselves mandatory criteria for defining a species as invasive or
injurious. The analysis under Potential To Eradicate or Manage
Established Populations in the 2016 interim rule was intended to show
that there is a risk of harm from the introduction of Bsal even if a
nonnative salamander population could be successfully controlled or
eradicated in the environment.
(PR22) Comment: The 2016 interim rule states that the total risk of
Bsal to native salamanders is high. It should probably take Bsal
invasive risk into account.
Response: The total risk to native salamanders was based on a USGS
risk assessment (Richgels et al. 2016). We took invasive risk into
account in other sources. We discussed the issues related to invasion
risk of Bsal under Likelihood of Release or Escape. To make our listing
determination for salamanders, we drew upon the results of multiple
independent risk assessments and our own analysis and found that Bsal
is likely to be introduced into the United States if no additional risk
mitigation steps were taken by the Service.
Bsal Infection
(P23) Comment: The 2016 interim rule states that Bsal can also be
introduced into the environment through the improper disposal of
contaminated water or other materials used to transport salamanders and
that the fungus can likely persist in such materials independent of
whether a salamander is present. Although the fungus can persist in the
environment, it may not be at infectious levels.
Response: The number of fungal spores required to initiate a Bsal
infection has not been well researched, and this number may vary among
host species and with other disease-related factors (environmental and
Bsal-specific factors). The Service's analysis was based on whether the
available evidence showed that a given genera was capable of carrying
Bsal and introducing it into U.S. environments.
(PR24) Comment: The 2016 interim rule states that the discharge of
untreated water used to house infected, captive animals could be a
pathway for releasing infective zoospores into the environment and
exposing native salamanders to Bsal. There is some evidence for Bd,
such as the 30,000 zoospores detected after 10 hours in DiRenzo et al.
(2014), but a more direct experiment occurred in Carey et al. (2006),
where the solutions that had housed toadlets being tested were used to
infect other toads. This is strong evidence and should be included.
Response: We concur with the comment and have added the reference
to Carey et al. 2006 in the second interim rule.
Likelihood of Release or Escape
(PR25) Comment: An outbreak of Bsal in Germany was discovered in a
captive salamander collection (Sabino-Pinto et al. 2015).
Response: The comment is correctly stated, and this point is now
referenced in the second interim rule.
Ability To Prevent or Control the Spread of Pathogens or Parasites
(PR26) Comment: The two treatments from Blooi et al. 2015(a) should
be changed from ``in development'' to ``available.'' A sentence
explaining that this treatment is limited in feasibility and
applicability (that is, not all salamander species can tolerate the
temperature treatment recommended) should be added.
Response: We concur with the commenter's statements as reflected in
Blooi et al. 2015(b) and modified the second interim rule consistent
with the comment.
(PR27) Comment: Control measures are available for Bsal-infected
salamanders, but these would be more relevant for captive salamanders
rather than free-ranging salamanders.
Response: We have edited the second interim rule accordingly by
recognizing that control measures for Bsal-infected salamanders are
more relevant for captive rather than free-ranging salamanders.
Impacts on Wildlife Resources or Ecosystems
(PR28) Comment: The 2016 interim rule states that, ``[i]f rough-
skinned newts were to experience severe declines from Bsal infection, a
result could be significant additional inputs of carbon to the
atmosphere as has been observed with other species. The commenter
recommends modifying the sentence to read, ``If rough-skinned newt
populations were to experience severe declines from Bsal infection,
atmospheric inputs of carbon may be altered, as has been observed with
other species (Wyman 1998; Best and Welsh 2014).''
Response: We have edited the second interim rule consistent with
the peer reviewer's comment.
(PR29) Comment: The 2016 interim rule noted that scientists and
diagnostic laboratories are working to standardize laboratory
protocols. What happens if they do?
Response: Standardized laboratory protocols are an important part
of disease management, but the ability to validate, document, and
enforce disease testing requirements is also necessary. Additionally,
the capacity to implement quarantines and live-animal inspections may
be required. Publication of the final rule does not preclude future
regulatory action based on emerging science and increased capabilities.
Economic Analysis, Regulatory Flexibility Analysis, and Effect on
Industry
(PR30) Comment: Alternative 3 was preferred over Alternative 4 in
the draft economic analysis. It was not clear whether salamanders were
excluded from Alternative 3 because they were not tested or whether all
of the ones tested showed no infection. If they simply were not tested,
Alternative 4 seems like the more responsible option given a
precautionary approach since many salamander genera appear to be at
risk and given that the difference in cost
[[Page 2176]]
between Alternatives 3 and 4 seemed relatively small ($3.8 million
versus $4 million). Moreover, untested genera may become substitutes
when the genera under Alternative 3 are no longer available, which
remains a problem if it is reasonable to expect some risks associated
with the untested salamander genera.
Response: Under Alternative 3, we listed genera for which we have
evidence that at least one species in a genus is a carrier of Bsal with
no conclusive countervailing evidence that other species in that genus
are not carriers. Alternative 3 does not include species from genera
that have not been tested for Bsal vulnerability. Alternative 4 would
include the listing of all salamander species. The expected increase in
cost from Alternative 3 to Alternative 4 was not considered in our
determination about the injuriousness of the species because the
determination is based on defensible scientific evidence. The Service
determined that there was unknown risk from genera where no species
have yet been tested for Bsal and, therefore, could not list those
genera at this time.
(PR31) Comment: It was not clear in Alternative 5 whether there
would be administrative costs associated with health certificates and
whether there is a probability of making a mistake.
Response: While most of the testing costs of administering a
health-certificate program may not fall on the government or public,
there would still be costs to the Service involved in staff time to set
up the program and oversee it, as well as wildlife inspectors checking
import shipments for the additional requirements. The draft economic
analysis lumps the administrative costs with costs of testing, and both
are mentioned as a concern in sections 4.1.1.5 and 5.0. A health-
certificate program was not our preferred alternative for a nationwide
regulatory program by the Service at this time because of uncertainties
with its effectiveness, including the effectiveness and sensitivity of
current testing methods (including the return of false negatives); lack
of validation and sufficient testing capacity; lack of standardized
treatment methods; and lack of agency resources required to conduct
inspections, interpret results, and issue health certificates.
(PR32) Comment: Has inflation been taken into account in the
analyses of economic costs to adjust costs of today's dollar values?
Response: All prices in the draft economic analysis were updated
for the final economic analysis to the 2021 price level Consumer Price
Index for All Urban Consumers that was used for all indexing purposes
(see section 3.1.2). Salamander retail price data was received in 2015
dollars during the course of the study. Tables labeled as 2021$, or
2015$, have either been adjusted for inflation or did not need
adjustment. The original price level is the year for the citation
unless otherwise noted. Tables without a price level or data origin
year have been amended.
(PR33) Comment: The economic costs appear to reflect the maximum
costs since it does not appear that alternative sales were considered.
For example, if buyers cannot buy salamanders, would they buy other
amphibians instead or would they simply buy nothing? Only the latter
would result in the estimated costs. Similarly, the market for
``local'' salamanders may increase as a response.
Response: Section 3.1.2 of the analysis of economic costs explains
three points. Estimated importation losses are stated as maximums due
to the unknown effect on domestic breeding and consumer substitution.
Domestic losses are also estimated at the maximum (loss of entire
industry) due to the lack of data on transport between the enumerated
jurisdictions in the shipment clause of 18 U.S.C. 42 (codified in
Federal regulations at 50 CFR 16.3). We also added detail to this
section to clarify why the losses may range from zero to the maximums
stated in each alternative analysis section later in the report.
(PR34) Comment: The pet industry will not be altered significantly
by this rule, but Bsal would likely impact wild populations of
salamanders. Perhaps with the exception of breeders, pet sales would
probably shift to another animal with little loss of revenue.
Response: Exit from an industry or substituting a legal product is
dependent on multiple factors as discussed in the report beginning in
section 3.1.2 of the economic analysis. We added details and
clarification to this section in the final economic analysis.
Substitution can occur with other salamander species, an animal from
another order, or another category of goods altogether.
(PR35) Comment: The draft economic analysis states under ES 1.1
Economic Analysis, ``In addition, we used data from IMPLAN[supreg]
(Minnesota IMPLAN Group, 2013) to estimate the direct effects of this
rulemaking.'' MIG changed their name. They now go by IMPLAN Group LLC.
In addition, what data year did you use?
Response: We changed the name to ``IMPLAN Group LLC'' in the final
economic analysis. We used study area data from 2013 for the economic
analysis.
(PR36) Comment: Regarding the draft economic analysis under ES
1.4.5 Alternative 5, does the cost estimate of the loss of revenue to
companies or individuals involved in the importation or interstate
movement of any salamander species consider the cost of health-
certificate examinations and inspections by veterinarians affiliated
with the Department of Defense, zoos, and industry as well as private
practitioners?
Response: Due to data limitations, the final economic analysis does
not explicitly estimate the cost of health certificates. The analysis
assumes that any additional costs for examinations and inspections
would be absorbed by the importer or passed on to the consumer, but
data limitations restrict the analysis from estimating whether the
importer or consumer would pay. Thus, we assume the estimated losses
for all alternatives including Alternative 5 is the average sales price
of a salamander. On average, we assume the estimated maximum loss
(sales price) would include all testing costs.
(PR37) Comment: The commenter believes a job in IMPLAN is
annualized. IMPLAN's definition is ``A job in IMPLAN = the annual
average of monthly jobs in that industry.''
Response: We have changed the final economic analysis to reflect
the above definition.
(PR38) Comment: The draft economic analysis, at ES 1.6 Conclusion,
states that it is unclear how much testing, treatment, and the health
certification processes would cost.
Response: It is correct that these costs are unknown and could not
be estimated unless a compliance method is developed.
(PR39) Comment: The commenter found locating the tables and figures
in the draft economic analysis to be challenging. For example, figure 1
is not shown for several pages after first being noted in 2.2
Salamander Market.
Response: Placement of tables and figures was determined by the
progression of the analysis. As many numbers are referred to many
times, they will not always be near all discussions. Table and figure
numbers are given to allow the reader to find them.
(PR40) Comment: The draft economic analysis states in Table 3-Pet
Stores Industry that the annual payroll for all is less than the annual
payroll for small business. That does not seem right.
Response: We corrected the table in the final economic analysis.
[[Page 2177]]
(PR41) Comment: The draft economic analysis states in 2.3.5 U.S.
Bred Salamanders, ``Domestically bred salamanders would represent less
than one percent of the United States salamander sales between 2012
through 2014 if this data depicts the entire domestic supply.'' This is
confusing because table 10 states that 76 percent of commercial
salamanders are U.S. bred.
Response: The 1 percent refers to all salamanders, whereas the 76
percent refers to the species and genera listed in table 10. We amended
table 10 in the final economic analysis to clarify this point.
(PR42) Comment: The draft economic analysis states under 3.1.1
Analysis of Economic Benefits, ``Fewer outdoor recreationists could
lead to a decrease in expenditures; to demonstrate we use $25,000.
Implementing a fictional alternative, Alternative Y would reduce the
probability of Bsal establishment to 10 percent from 80 percent. The
expected costs in the current situation would be $20,000 ($25,000 x
0.8); with Alternative Y, the expected costs would be $2,500 ($25,000 x
0.1). Net avoided costs would be $17,500 ($20,000-$2,500), one measure
of the benefits of Alternative Y.'' The commenter finds this example to
be confusing and suggests omitting.
Response: We deleted the example in the final economic analysis.
(PR43) Comment: In the Executive Summary of the draft economic
analysis, you describe some of the potential costs of the regulation
(for example, lost consumer surplus for pet owners). It seems in the
discussion under 3.1.2 Analysis of Economic Costs that the costs in the
cost/benefit sense are being conflated with lost revenue and the
economic analysis. This is okay, but this section could be more clear.
Response: The Executive Summary indicates that consumer surplus
cannot be estimated under the scope of this report and that an
alternate methodology will be used. Sections 3.1.1-3.1.2 explain how
the analysis uses the maximum sales as a proxy for the direct economic
losses. No economic benefits are evaluated for the existence of a
species in this report.
(PR44) Comment: The draft economic analysis states under 3.1.2.2
Small Business, ``Estimates using the unique importers (average of 5 a
year), or one breeder, yield the maximum adverse impacts; no fewer
entities would be impacted under the status quo. Applying these two
methods brackets the impacts on importers and pet stores.'' It is
unclear what ``average of 5 a year'' means.
Response: We changed ``average of 5 a year'' to ``annual average''
in the final economic analysis. The analysis was also updated to an
annual average of six importers.
(PR45) Comment: In the draft economic analysis, the numbers in the
sectors columns of tables 12-14 do not seem to correspond to anything.
Could this column be omitted?
Response: The columns were deleted in the tables.
Public Comments and Our Responses
We reviewed all 280 comments we received during the public comment
period for the 2016 interim rule (81 FR 1534, January 13, 2016). We
received comments from Federal agencies, State agencies, commercial and
trade organizations, conservation organizations, nongovernmental
organizations, and private citizens. The comments provided a range of
views on the proposed listing as follows: (1) Unequivocal support for
the listing with no additional information included; (2) unequivocal
support for the listing with additional information provided; (3)
equivocal support for the listing with or without additional
information included; (4) unequivocal opposition to the listing with no
additional information included; and (5) unequivocal opposition to the
listing with additional information included.
While all comments were reviewed and considered, several comments
did not contain information that was new compared to other comments or
included substantial information that required analysis. Comments
included individual ideas, data, recommendations, or suggestions on the
interim listing and the draft economic analysis. Some commenters
addressed the 14 questions we posed in the 2016 interim rule. We
consolidated comments and responses into key issues in this section. We
edited some comments for brevity or grammar while maintaining the
intent. We combined comments that expressed similar perspectives.
Use of Scientific and Common Names
(1) Comment: The Service asked, for the species being listed in the
2016 interim rule, if the scientific and common names are the most
appropriate ones accepted by the scientific community. Most of the
herpetological community uses the Society for the Study of Amphibians
and Reptiles joint societies-endorsed list (Crother 2012); both the
Association of Fish and Wildlife Agencies (AFWA) and Partners in
Amphibian and Reptile Conservation (PARC) use this nomenclature in our
formal publications. However, some States use other nomenclature, while
some others use older nomenclature simply due to the inability to
update frequently.
Response: The comment identifies the disparate use of scientific
and common names used among herpetological and management entities. We
believe this approach supports our decision to remove the enumerated
list of species within each genus in 50 CFR 16.14 for the second
interim rule. Each species within each genus will therefore be included
as injurious wildlife in the list of injurious amphibians.
(2) Comment: There are quite a few errors (some species listed
twice under different Latin names) in the proposal.
Response: The commenter did not provide specific examples, so we
cannot check this comment with additional references. The comment does
support, however, our decision to remove the enumerated list of species
within each genus in 50 CFR 16.14 for the second interim rule.
Listing of Preserved Specimens, Parts, and Eggs and Gametes
(3) Comment: Scientific specimens of salamanders that are
desiccated or have been fixed or preserved in formalin or alcohol
should be exempt from this rule because Bsal is no longer viable.
Response: We concur that preserved specimens do not pose a risk for
pathogen transmission as long as chemical preservation is adequate to
kill Bsal, and we have removed chemically preserved specimens from the
reach of this final rule.
(4) Comment: What is included in the definition of ``parts of
salamanders'' and why? Listing swabs makes testing for disease more
difficult, which could adversely affect the intended effect of the
rule. Please provide an exemption for tissue samples (including
histological samples), molecular extractions, swabs, and other parts.
Response: Any item that contains cells or genetic material from a
listed species is considered a ``part'' of the listed animal. This
definition is not unique to the salamander rule but is consistent with
standard regulatory definitions used by the Service. Specimens, such as
skin swabs and tissue samples for microscopic analysis (histology), are
included as ``parts'' in the rule consistent with the definition of
``fish or wildlife'' outlined in 50 CFR 10.12, which includes ``any
part, product, egg, or offspring thereof.'' Also, 50 CFR 10.12 states
that ``amphibians'' means a member of the class, Amphibia, including,
but not limited to, frogs, toads, and salamanders; including any
[[Page 2178]]
part, product, egg, or offspring thereof, or the dead body or parts
thereof (excluding fossils), whether or not included in a manufactured
product or in a processed food product. Specimens such as swabs
intended for culture or in transport or growth media will require
permits. We may issue permits to facilitate all of the above-described
activities. For purposes of this rule, eggs and gametes and purified
extracted genetic material of salamanders are excluded from the
prohibitions as ``parts'' because they are unable to cause pathogen
transmission. However, swabs and histological samples that are
preserved or fixed in appropriate concentrations of ethanol or
formaldehyde-based solutions are also not injurious as long as chemical
preservation is adequate to kill Bsal as described in current peer-
reviewed literature. The appropriate concentration and minimum exposure
time for a given chemical preservative or fixative to render any Bsal
organisms non-viable varies with the precise chemical formulation and
should be utilized as described in association with such actions in the
peer-reviewed literature. Please also refer to IV. Second Interim Rule.
Purpose of Listing as Injurious
(5) Comment: Several comments provided feedback on whether eggs and
gametes should be included in this rule. As a comment noted, specimens
require transport with some form of medium, such as water or plant
materials, to remain viable, and that medium could harbor Bsal, thus
constituting a threat by indirectly moving disease vectors with the
eggs or gametes and increasing the risk of indirect Bsal transmission.
Further, eggs at certain stages of development could contain
keratinized tissues (for example, Xie and Yu (1992)), which could
transmit the Bsal pathogen. However, other comments noted that if
entire genera are excluded from the listing because they cannot be
infected, then the relative risk from the transport of eggs is no
greater.
Response: Our authority does not include the listing of the medium,
such as water or plant materials, that the specimens are transported
in. As noted in this rule, there is no evidence that salamander
reproductive material also contains keratin that might harbor Bsal.
Therefore, eggs and gametes are not listed by this rule.
Effect of Rule on Scientific Research
(6) Comment: The rule will have a negative impact on scientific
research, especially on native taxa. The prohibition should not apply
to scientific research, providing that the biologist in question is in
possession of an approved permit from the State where the specimen(s)
were originally collected.
Response: Permits from the Service for injurious listed species can
be obtained for scientific, zoological, educational, and medical use
for importation, shipment between the enumerated jurisdictions in 18
U.S.C. 42(a)(1) (codified in Federal regulations in 50 CFR 16.3), and
transport for a previously permitted salamander. The statute does not
cover collection of native species or transport of injurious listed
salamanders across State lines within the continental United States
(see PR15).
Species Not on the List
(7) Comment: Several commenters advocated for adding various genera
or listing at the family level, such as Salamandridae, while others
advocated for listing all species.
Response: The salamander species listed by this final rule and the
second interim rule are those found within a genus for which we have
confirmation that at least one species in that genus is a carrier of
Bsal, and there is no conclusive countervailing evidence suggesting
that some species within the genus are not carriers. Although
additional salamander species could be at risk from Bsal infection or
could serve as a carrier, we are not listing species in those genera
because they had not yet been tested. We considered listing more
species based on the comments we received. However, the logic we used
for listing at the genus level breaks down at the family level for one
family. In the family Plethodontidae, the genus Gyrinophilus is not
known to be a carrier, but the genera Hydromantes and Plethodon are
carriers. As a result, we cannot list all species within
Plethodontidae. We also cannot list a species without science-based
documentation. We can list for the statutorily defined purposes under
the statute codified at 18 U.S.C. 42(a); any other purpose is beyond
the scope of this rulemaking. Please see IV. Second Interim Rule below
for additional genera we have documented as injurious and are therefore
listing.
(8) Comment: Some comments noted that while some salamander species
appeared to be resistant to Bsal in infection experiments, it is
unclear how strong this resistance will be outside of the optimal
husbandry conditions found in laboratory settings.
Response: As part of the justification for listing, the Service
acknowledges that salamander species known to be tolerant of Bsal
infection under experimental conditions may demonstrate more severe
clinical disease when infection is combined with additional stressors
in the wild, as has been found for other diseases, including those in
amphibians (Wobeser 2007; Kerby et al. 2011; Kiesecker 2011). However,
the Service needed evidence that a species was a carrier or likely to
be a carrier before listing the genus as injurious.
(9) Comment: Tylototriton podichthys was recently described and
should be added to the list (Phimmachak et al. 2015).
Response: All species in a genus are also listed as injurious even
if they are not specifically identified in the rule. Because we
identified Tylototriton as one of the genera listed in the 2016 interim
rule and hereby affirmed, T. podichthys is one of the species listed as
injurious. The comment supports our decision to remove the enumerated
list of species within each genus in 50 CFR 16.14 for the second
interim rule.
(10) Comment: The Service should establish an expedited process by
which additional salamander species can be added to the list as new
information becomes available.
Response: Rulemaking under 18 U.S.C. 42 is governed by the APA,
under which we promulgated the 2016 interim rule and this final rule.
The Service is adding new genera to the list with the second interim
rule in this document.
Species Should Be Removed From the List
(11) Comment: Species from the genera Cynops, Salamandra,
Pleurodeles, Siren, Notophthalmus, and Triturus should be removed. They
are the most commonly kept species and listing will significantly
affect those who raise, study, or keep animals from these species.
Response: Due to shared characteristics by species within a genus,
other species within these genera are also likely to be carriers of
Bsal. The Service found that species from the genera Cynops,
Salamandra, Pleurodeles, Siren, Notophthalmus, and Triturus can carry
Bsal and, therefore, pose a substantive risk to native salamander
populations. The listing of these species as injurious wildlife does
not regulate possession, transport, breeding, or sale within the
continental United States unless regulated under permit. Other Federal,
State, Tribal, or Territorial laws may apply.
(12) Comment: No native species should be listed. Listing native
species as injurious wildlife solely on the basis of their
vulnerability or capacity to carry
[[Page 2179]]
an absent foreign pathogen is concerning. Additionally, most of the
animals tested that were lethally vulnerable were dead within about a
month, as per Martel et al. (2014), and the odds of any of these
animals being available for sale while carrying the disease are almost
nonexistent.
Response: We listed native species in the 2016 interim rule partly
because some native species that we concluded can be carriers of Bsal
are raised outside the United States and imported into the country and
partly because listing would prohibit transport of injurious
salamanders between the enumerated jurisdictions in the shipment clause
of 18 U.S.C. 42 (codified in Federal regulations at 50 CFR 16.3), in
order to prevent introduction, establishment, and spread of the
pathogen in U.S. ecosystems. Several native species of newts were
already known to be highly susceptible to dying from Bsal. Not all
species die immediately upon exposure to Bsal, and there is no evidence
that lethally vulnerable species cannot survive long enough for Bsal to
be transmitted within the United States if they are infected prior to
their movement. At the time of the drafting of the 2016 interim rule,
most of the research was being conducted on Asian and European species
to find out where the fungus may have originated and why wild European
salamanders were dying. After the 2016 interim rule published, many
studies by U.S. researchers began to provide information for the
conservation of native species in the event Bsal is introduced into the
American environment. These studies demonstrate that many native
salamanders are susceptible and can be Bsal carriers.
(13) Comment: Many of the listed species in some genera, such as
Plethodon, Taricha, and Notophthalmus, have never been found to carry
Bsal. These species should be delisted.
Response: New information confirms that species from the genera
Plethodon, Taricha, and Notophthalmus can carry Bsal based on
laboratory studies. As of the drafting of the second interim rule, all
three species of Notophthalmus have been found to be lethally
susceptible to Bsal (Gray et al. 2023), and two of the four Taricha
species are carriers (Gray et al. 2023).
(14) Comment: The listing of the entire genus Plethodon is based on
the Martel et al. (2014) study from a sample of two wild-caught P.
glutinous imported to Europe. Under the circumstances, the evidence
suggests that all species in the genus Plethodon should be removed from
the list.
Response: We disagree with the comment. While Martel et al. (2014)
classified the slimy salamander (Plethodon glutinous) as resistant to
infection, the study also demonstrated by histology that Bsal could
invade the skin of the slimy salamander, even though it apparently
cleared the infection and did not show signs of clinical disease. Our
examination of the supplementary data of Martel et al. (2014),
including histology (microscopy) tests and subsequent discussions with
the authors, indicates that there is sufficient evidence that Bsal was
able to invade the skin of this species long enough to move or transmit
the infection to other salamanders (Martel et al. 2014; A. Martel,
University of Ghent, pers. comm. 2015; K. Lips, University of Maryland,
pers. comm. 2015). Because we expect all species within a genus to
respond in a similar way for Bsal carrier status, we conclude that all
species of Plethodon are potential carriers. Since the 2016 interim
rule published, additional studies have shown multiple species in the
genus Plethodon can be carriers (DiRenzo et al. 2021); see IV. Second
Interim Rule.
(15) Comment: Some species from the genus Neurergus have been bred
over many generations and are in private collections (N. crocatus, N.
kaiseri, and N. strauchii). N. kaiseri, which is listed under the
Convention on International Trade in Endangered Species of Wild Fauna
and Flora (CITES) Appendix I, has not been imported for years, and most
of the animals in the United States are descendants of zoo colonies and
hobbyist captive-bred animals. Because they are protected by other laws
and not imported, they do not have any risk of transmitting Bsal and
there is no need to list them.
Response: Regardless of protection level under other laws, these
species are still injurious wildlife under 50 CFR 16.14 as part of the
genus Neurergus. Their protection level under these other laws does not
change the characteristics of the species that we find to be injurious
to wildlife and the wildlife resources of the United States by reason
of their potential to serve as vectors for the pathogen Bsal. Also,
there is no way to confirm that captive-bred salamanders have not been
exposed to Bsal through contact with other individuals. Neurergus has
been confirmed to carry Bsal in a European collection (Fitzpatrick et
al. 2018), and there is a chance a co-housed salamander of a different
species could be imported into the United States.
Need for Rule
(16) Comment: The rule is unnecessary. The prohibition can be
justified only if Bsal is found to be present in the United States.
Other commenters stated that the rule is unnecessary because Bsal must
be here already given the number of salamanders imported annually and
their belief in the low likelihood of a captive salamander coming into
contact with the wild populations and transmitting Bsal.
Response: Since the publication of the 2016 interim rule, Waddle et
al. (2020) conducted a large-scale surveillance for Bsal across 594
counties in 35 States and 1 site in Mexico with 11,189 swab samples of
wild salamanders and some frogs and toads, with no positive results for
Bsal. The purpose of listing these species as injurious wildlife is to
prevent the introduction of the Bsal fungus in the wild in the United
States. A species does not need to be already present in trade or in
the environment to be listed as injurious wildlife. In fact, it is
often difficult to achieve a prevention outcome once a species or
pathogen occurs in the environment. To make the listing determination
for salamanders, we drew upon the results of multiple independent risk
assessments and our own analysis and found that Bsal is likely to be
introduced into the United States if no additional risk mitigation
steps are taken. Additional discussion on this topic can be found in
IV. Second Interim Rule under the section Likelihood of Release or
Escape.
(17) Comment: To list a native species of wildlife as injurious
simply because it may act as a host to a rare but potentially
devastating pathogen that has not been detected in the United States is
an unmanageable proposition. Every native species of wildlife fits this
criterion and would need to be listed as injurious for some rare
pathogen detected in a very isolated outbreak on another continent, as
has occurred with Bsal.
Response: The purpose of listing these species as injurious
wildlife is to act preemptively to prevent the introduction,
establishment, and spread of the Bsal fungus in the wild in the United
States. The fungus affects many native salamanders, with lethal effects
on many salamander species, and it is not yet known to be found in the
wild in the United States. There is an existing pathway for the fungus
to arrive by importation of salamanders, including species native to
the United States that are raised in captivity outside of the United
States and then imported back
[[Page 2180]]
into the continental United States and the enumerated jurisdictions of
the shipment clause. This regulatory action is being taken to prevent
Bsal's arrival through the organisms-in-trade pathway. If we wait until
the fungus arrives, it will likely be impossible to eradicate. We will
continue to evaluate other species for possible risks and consider
injurious wildlife actions as appropriate and authorized under 18
U.S.C. 42(a).
(18) Comment: Bsal can be treated and cured in captivity, so there
is no reason to limit availability of the species in question.
Response: Voluntary actions, such as applying heat therapy as
described in Blooi et al. (2015a) and Blooi et al. (2015b), may help
reduce the threat posed by Bsal for specimens held in captivity.
However, at this time it is not possible to determine the likelihood of
success of such measures for all species or of achieving compliance
with prophylactic treatment or treatment following the onset of
symptoms. Therefore, it is unknown how effective treatment will be in
preventing Bsal's introduction, establishment, and spread in the United
States, and no Bsal control is known for salamanders in the wild.
(19) Comment: If a species that is not a carrier is similar in
appearance with another species, neither species should be removed from
the list unless both species are confirmed that they are not
susceptible to or carriers of Bsal.
Response: The Service does not have the authority under the statute
to list a species based solely on its similarity of appearance to
another species. We list based on our determination of injuriousness.
(20) Comment: There is no case in the United States where
salamanders, native or nonnative, have been proven as invasive or
injurious. The 2016 interim rule does not substantiate injury by
transplanted or exotic salamanders.
Response: The salamanders are listed because they are carriers of a
fungus that makes them harmful to other salamanders, not because the
salamanders are invasive. We concluded that even if the salamander
species listed by this rule do not become established, some species
capable of carrying Bsal and listed by this rule can survive long
enough in the wild to transmit Bsal. Our findings are discussed in
Potential To Survive, Become Established, and Spread in IV. Second
Interim Rule.
Listing Purpose Is To Regulate Disease or Manage Native Species
(21) Comment: Listing salamanders as injurious is not an
appropriate means to regulate an animal disease. The injurious wildlife
provisions of 18 U.S.C. 42 pertain to animals and not diseases or
pathogens. The focus of the 2016 interim rule is Bsal, a fungus that
the Service possesses no authority to regulate as acknowledged in the
interim rule. The law provides no provisions for testing, surveillance,
or certification of health to allow for movement in trade.
Response: As we described in Listing Species That Carry Pathogens
in the 2016 interim rule, the Service can list as injurious any member
of the enumerated taxa that are hosts to or carriers of pathogens that
cause the host or carrier to be harmful by its presence to one or more
of the interests listed in the statute. We have previously listed
species that serve as hosts to or carriers of pathogens, as in the case
of fishes in the salmon family (Salmonidae) (32 FR 20655, December 21,
1967). We noted in the 2016 interim rule that there are concerns
regarding the effectiveness and sensitivity of current testing methods
(including the return of false negatives), lack of validation and
sufficient testing capacity, and agency resources required to conduct
inspections, interpret results, and issue health certificates. If these
issues are resolved, it may be possible to establish a health
certificate for salamanders that are free of Bsal. A health certificate
was established for import of salmon under the authority of 18 U.S.C.
42. While the concerns remain, and therefore a Bsal health
certification has not been established, this does not mean that there
is no authority to establish a health certification if circumstances
were to change. Appropriate conditions may also be included in
injurious wildlife permits under the authority of and consistent with
the purposes of 18 U.S.C. 42.
(22) Comment: Several commenters noted that, by definition,
``pathogens'' are injurious and are regulated under the authority of
other agencies. The World Trade Organization and the United States
Department of Agriculture (USDA) recognize the World Organisation for
Animal Health [WOAH, formerly OIE] as the proper body to set animal
health standards. The WOAH helps develop and revise international
standards for the safe trade of animals and animal products. The proper
course to prevent the importation of salamanders carrying Bsal is to
list the pathogen as a WOAH reportable disease, and instead of the 2016
interim rule, there should be a cooperative effort to respond to the
disease threat as provided through the WOAH, World Trade Organization,
and the National Aquaculture Health Plan and Standards (formerly called
the National Aquatic Animal Health Plan) for the United States.
Response: The USDA and the Centers for Disease Control and
Prevention have authority to regulate wildlife pathogens when those
pathogens pose a risk to agriculture or human health, respectively. No
such effects are currently known in the case of Bsal. The Service has
authority to regulate the importation of certain species that pose a
risk to wildlife and the wildlife resources of our country. This
authority has been applied in the present case in response to a clear
and immediate risk.
After the 2016 interim rule took effect, the WOAH did add Bsal as a
reportable disease, but that action does not prevent importation. We
work through such mechanisms as those provided by the WOAH and National
Aquaculture Health Plan and Standards, and we support all efforts by
the international community to participate in the global response to
this pathogen. The Service, operating within its relevant regulatory
authority to list injurious wildlife, took action through the 2016
interim rule due to the urgent need required to manage the threat Bsal
poses to salamanders in the United States.
(23) Comment: This salamander rule not only prevents safe commerce,
it eliminates any incentive for industry to pursue research into the
detection and treatment of Bsal. Other comments expressed similar
issues and asked whether it would be possible to make testing mandatory
to allow interstate movement.
Response: While the Service acknowledges that some economic
incentive may have been removed due to the prohibitions imposed by the
injurious wildlife provisions of the Lacey Act as a result of listing
species of salamanders as injurious wildlife under this rule, many
salamander genera were not listed due to insufficient evidence at the
time as carriers, and they remain a possible threat. Furthermore,
research for detection and treatment of Bsal has increased considerably
in the United States since the rule took effect. Permits allowing
importation can be obtained for zoological, educational, medical, and
scientific use. This final rule explains that interstate transportation
between States within the continental United States is not prohibited
as of 2017; however, the injurious wildlife listing still prohibits
import into the United States, and transport of injurious wildlife
between the enumerated jurisdictions in the shipment clause of 18
U.S.C. 42(a)(1) (the continental United States, the District of
Columbia,
[[Page 2181]]
Hawaii, the Commonwealth of Puerto Rico, and any territory or
possession of the United States), codified in Federal regulations at 50
CFR 16.3.
(24) Comment: The Lacey Act does not provide authority to list
native species. The Lacey Act has been examined and critiqued over the
last few decades within a variety of peer-reviewed and gray-literature
publications (Dentler 1993, U.S. Congress 1993, Anderson 1995, Whalen
1998, Biber 1999, Jenkins et al. 2007, Alexander 2013). In no instance
did these authors construe Lacey Act provisions to allow the listing of
native animals as injurious. Notably, the U.S. Congress, Office of
Technology Assessment, recommended in 1993: Congress could provide the
Service with increased guidance on the purpose of this [injurious] list
and the specific criteria for adding species to it.
Response: The provisions of 18 U.S.C. 42(a)(1) do not limit
wildlife subject to the law to species not native to the United States.
Under the law, the Service may list species that are indigenous to the
United States if they cause injury to the interests enumerated in the
law. The publications mentioned reflect the interpretations of the
authors. Congress has also listed native species as injurious by
statute, such as the Mariana fruit bat (Pteropus mariannus), further
demonstrating that the authority of 18 U.S.C. 42 is not limited to
nonnative wildlife.
Additional Science and Data for Rule
(25) Comment: In the 2016 interim rule, the Service asked what
species listed as threatened or endangered by one or more States would
be affected by the introduction of Bsal. AFWA and several States
indicated that several salamander species are of interest to them,
though it is not yet evident how Bsal would affect all of these
species. A number of State threatened and endangered or protected
species (restricted or prohibited from take, possession, sale, or other
activities) were provided during the public-comment period.
Response: We appreciate the additional information on State
threatened and endangered species. While the Service concluded that
some species identified by the States are not carriers, others are,
such as species in the genus Plethodon. The carrier status of several
species, at the time the public-comment period closed, had not yet been
identified. However, more have been identified since then, including
affirming the genus Plethodon in this final rule. This additional
information helps provide additional justification for listing species
that are capable of carrying Bsal, as Bsal presents a risk to wildlife
and wildlife resources of the United States, including those identified
by the States as in need of protection.
Pathways and Spread
(26) Comment: The Service asked the question, ``Are there other
pathways for Bsal into the United States that we should address? If so,
what are they?'' According to AFWA, a pathway of concern that appears
to have little or no Federal regulatory authority or enforcement
pertains to biological supply companies. Others include internet sales
involving small shipments using couriers such as FedEx or UPS,
traditional medicine or foreign food markets, and ceremonial uses of
these species. AFWA is aware of interstate shipments of some
salamanders, though not necessarily the currently included species, for
the purposes of the bait trade, but AFWA would like to see some
exploration of whether there are imports for this purpose.
Another comment noted that, while the pet trade is an important
pathway, salamanders may stow away in nursery stock, as was observed
with northwestern salamanders (Ambystoma gracile) in Christmas trees
(Rochford et al. 2015). In addition to terrestrial nursery stock, the
aquatic plant and animal trade may also spread Bsal in shipment water.
Response: The Service's pathway analysis found that the main
pathway for the global spread of Bsal is the international trade in
salamanders, such as Martel et al. (2014) noted. While not explicitly
discussed, that international trade could include the uses noted in the
comment, whether intentional or as a hitchhiker. Biological supply and
bait companies are commercial entities. These companies have always had
to comply with import and export regulations under 50 CFR part 14. With
this injurious listing, these commercial businesses will be subject to
the same prohibitions as other entities. Likewise, animals
unintentionally imported or transported between the enumerated
jurisdictions in the shipment clause of 18 U.S.C. 42(a) (also set forth
at 50 CFR 16.3) through nursery stock or other pathways would also be
in violation of the injurious wildlife listing's prohibitions. As
explained in A. Background in Final Rule to the 2016 Interim Rule,
interstate transport between States within the continental United
States is not prohibited by the current prohibitions of 18 U.S.C.
42(a).
(27) Comment: Bsal is known to persist in a moist environment for
up to 7 weeks, even without an amphibian host. This ability creates an
alarming pathway for the potential spread of Bsal into the United
States through a variety of means not fully addressed by the 2016
interim rule. This unchecked pathway of Bsal into the United States
presents a major limitation in our ability to prevent introduction of
this potentially devastating infectious wildlife disease.
Response: Materials that can transmit pathogens, such as water,
represent a potential pathway. However, the Service does not have
authority under the injurious wildlife listing provisions in 18 U.S.C.
42(a) to prohibit importations of water and fomites that may be
infected with the Bsal pathogen. Listing the species that can carry
Bsal is expected to limit the movement of such materials, but they do
remain a concern. The Service will continue to explore opportunities to
address this issue with partners and stakeholders.
(28) Comment: A comment suggested that it is premature to discount
frogs and toads (anurans) and caecilians from getting Bsal.
Response: Under this final rule, we listed salamanders for which we
had affirmation at the time of the rule drafting that they could carry
Bsal into the United States, and subsequent evidence confirms the
determination. We do know about positive Bsal test results for several
species of anurans and will continue to monitor research on them and
caecilians and on salamanders for which data is currently unavailable.
(29) Comment: The rule is unnecessary and will only hurt hobbyists.
Hobbyists who keep salamanders may be tempted to release them into the
wild if they cannot find alternatives and do not want to euthanize
them. If so, the risk of Bsal being introduced into the wild might be
increased.
Response: We believe this regulatory action will safeguard the
health of wild salamanders and those kept in captivity. We have taken
action with this rule to list salamanders that we find can carry Bsal.
Pet owners will still be allowed to keep their salamanders and sell or
give them away within the enumerated jurisdictions of 18 U.S.C. 42,
also set forth at 50 CFR 16.3. In addition, many States have laws
making it illegal to release certain animals into the wild, and
injurious listed species cannot be released into the wild under Federal
law. Some States have amnesty programs that accept unwanted pets. The
Service believes that the majority of pet owners and hobbyists would
not intentionally release their animals into the wild; however, the pet
trade was
[[Page 2182]]
identified as the major vector for a potential Bsal invasion. To assist
pet owners who might need to find homes for their animals, we posted
information about responsible alternatives to releasing salamanders on
our website when we published the 2016 interim rule. That updated
information can be found at <a href="https://www.fws.gov/node/266100">https://www.fws.gov/node/266100</a>.
(30) Comment: The interstate prohibition will not help prevent the
spread as the zoospores are most likely going to be spread through
moving water. Also, many wildlife diseases are moved by wildlife
themselves, including migratory birds. Without evidence of infected
animals in the trade, it is inappropriate to indict an industry or to
blockade any trade based on speculation. Additional studies are needed
to determine sources and causes for outbreaks. Without further
surveillance and supportive data, it cannot be substantiated that the
international and interstate trade is the vector for spread of this
disease.
Response: As we note in the final rule, the interstate prohibition
has been clarified. In the 2016 interim rule, we did not indicate that
the absolute cause of the spread of Bsal is the wildlife trade,
although we concluded that the most likely pathway of Bsal into the
United States is on the bodies of salamanders in the commercial
salamander trade. We cited peer-reviewed journal articles that suggest
the spread of Bsal has been human mediated due to the discontinuity of
the global distribution of Bsal between Asia and Europe, and we cite
the detection of the pathogen in imported captive exotics. Both of
these pieces of information suggest the spread of Bsal has been human
mediated. Other pathways for Bsal introduction are not expected to be
as significant compared to the international-trade pathway. While the
Service is concerned about contaminated water, Bsal is not yet known to
be present in the United States. Listing is intended to prevent the
introduction, establishment, and spread of Bsal. Salamanders would have
to come into contact with Bsal-contaminated water for the pathogen to
be introduced. If no infected salamanders are here, they cannot
transmit the pathogen to waters that can further spread the pathogen.
Research suggests that waterfowl can carry Bd on their toes,
although Bd could not survive more than 60 minutes of desiccation on
the scale tissue (Garmyn et al. 2012). As a result, while Bd could be
transmitted from one habitat to another on short flights, transmission
is unlikely to be an intercontinental threat. Given the similarities
between Bd and Bsal, Bsal is not likely to be introduced to the United
States through bird migrations.
Border Interstate Transportation
(31) Comment: The prohibition on importation will help to prevent
the movement of Bsal into the United States provided that it is also
prevented from entering Canada. If an infected salamander enters
through Canada, Bsal could be transported via water and waterfowl into
the United States, negating the prohibition's benefits.
Response: In 2017, after the 2016 interim rule was published,
Canada passed a law prohibiting importation of all species of the order
Caudata, alive or dead, and their gametes (ECCC 2017, 2018). Canada,
Mexico, and the United States actively coordinate in wildlife
conservation issues through the Canada/Mexico/U.S. Trilateral Committee
of Wildlife and Ecosystem Conservation and Management meetings.
(32) Comment: The interstate prohibition will make it harder to
acquire scarce animals. Prohibiting interstate movement will hurt
honest hobbyists who are working hard to find or produce healthy
captive-bred animals. The prohibition should apply only to wild-caught
animals or importation only but allow for movement of captive-bred
animals in the United States that have been tested and found to be free
of Bsal, especially since Bsal has not been found in the United States.
Response: As explained under A. Background in II. Final Rule to the
2016 Interim Rule, the interstate prohibition has been clarified. Under
18 U.S.C. 42, the Service does not have the authority to selectively
prohibit the importation of wild-caught or captive-bred animals for a
species listed as injurious wildlife. Permits can be acquired for
zoological, educational, medical, or scientific purposes.
Effect on Hobbyists
(33) Comment: Captive-breeding should be legal for private and
hobbyist purposes.
Response: Captive-breeding is not prohibited by the injurious
wildlife provisions of the Lacey Act as a result of listing species of
salamanders as injurious wildlife under the rule.
(34) Comment: The rule will have a direct effect on both amphibian
business owners and hobbyists as well as native ecosystems. The species
that are listed are those most important to the hobby--animals that are
easy to breed and that do well in captivity. The rule effectively
transitions the hobby almost entirely away from captive-breeding.
Captive-bred animals are healthier, less likely to carry diseases, more
likely to thrive in captivity, and do not harm wild populations.
Commercially wild-collecting animals can cause long-term damages to
populations and has been known to play a role in disease transmission
as collectors travel between areas and do not disinfect their
equipment.
Response: The commenter states that captive-bred animals are
healthier and less likely to carry diseases but does not provide
evidence to support this statement. State wildlife agencies are
responsible for regulating the collection of most wild salamanders,
including injurious listed ones, and State authorities can be used to
protect populations from overharvest.
(35) Comment: The science is wrong on the number of salamanders
crossing State lines. The commenter knows one individual who sold 1,500
captive-bred tiger salamanders last year outside their State. The
interstate prohibition will cause a drop in the diversity of captive-
bred species and related expertise in the country. This prohibition
will severely limit many forms of research since expert American
salamander keepers will be unable to maintain and share their
experience through captive-breeding programs. Researchers will be
limited largely to axolotls (Ambystoma mexicanum), which may not work
for their needs. Even Martel et al. (2014) was largely dependent on
captive-bred animals; in a few years, a similar study will be
impossible from the United States.
Response: The rule will not end scientific endeavors that would
benefit the injurious listed species. Additionally, as explained in
this final rule, the prohibition on interstate movement between States
within the continental United States has been clarified.
(36) Comment: The rule interferes with educational opportunities
and exposes exhibitors, nature centers, wildlife rehabilitators,
private citizen hobbyists, and commercial breeders to Federal
prosecution and penalties under the Lacey Act.
Response: The rule is intended to protect native species, which
will help ensure that the public maintains the opportunity to enjoy
them in their wild habitats. Also, the injurious wildlife provisions of
the Lacey Act do not prohibit ownership or breeding of injurious
wildlife, unless unlawfully imported or transported between the
enumerated jurisdictions or otherwise restricted due to conditions
associated with issued permits. People and
[[Page 2183]]
zoological institutions can still own salamanders where consistent with
other Federal, State, and Tribal laws and regulations applicable to the
species. The listing also will not prevent the continued use of these
species for education, and prohibited activities may be authorized by
permit for zoological, educational, medical, or scientific purposes (in
accordance with permit conditions). Finally, as explained in the final
rule, the interstate prohibition between States within the continental
United States has been clarified.
Effect on Conservation Efforts
(37) Comment: Captive-breeding has been proven to be the most
reliable way of ensuring the survival of endangered (or common)
species. Furthermore, captive-breeding provides a backup gene pool for
wild populations that may be drastically reduced from Bsal. Also, the
listing would make it illegal to transport listed salamander species
across State lines and would devastate conservation programs across the
United States. The permitting process will keep many zoos and aquariums
from participating in propagation efforts of salamander species on the
list, many of which need help.
Response: While captive-breeding is useful in many cases to ensure
survival, it is less so when a novel, lethal pathogen is the cause.
Listing the species as injurious in this rule will not affect
legitimate conservation efforts that U.S. breeders can carry out for
the species. The law allows for the issuance of permits authorizing
otherwise prohibited movement or imports for scientific or zoological
purposes, including non-commercial conservation breeding operations.
The Service has provided information online to help people apply for a
permit (see Permitting Difficulties below in this comment discussion
for additional details). Finally, as explained in the final rule, the
current prohibition on interstate transport in 18 U.S.C. 42(a) has been
clarified and does not apply to interstate transport between States
within the continental United States.
(38) Comment: When scientists collect tissues or specimens for lab
experiments, the animals are never released into the wild and therefore
pose no threat to the spread of Bsal or any other pathogen. The
Service's imposition of increased Federal permitting will inhibit
scientists who are studying the biology of regulated species and may
dissuade graduate students or other biologists from such work. This
type of regulatory change can hinder conservation efforts before their
need can even be evaluated.
Response: This listing should not adversely affect any valid
conservation efforts. In general, all wildlife species must be declared
at the time of importation (see 50 CFR part 14), but most do not
require special permits. Prior to this rule, only species of
salamanders listed under the Endangered Species Act (ESA) or CITES
required import permits under those wildlife laws implemented by the
Service. For injurious wildlife, permits are not needed for interstate
transport between the States within the continental United States
(except into or out of the District of Columbia), and permits to allow
import and transport between the enumerated jurisdictions in the
shipment clause of 18 U.S.C. 42(a) may be granted for bona fide
scientific purposes. This rule should have no significant effect on any
conservation efforts that are currently being or will be carried out.
(39) Comment: One commenter has never owned a pet frog or
salamander yet has educated more than 3,000,000 people about amphibians
via online and printed educational materials and through live
presentations and hikes to amphibian habitats to see local, native wild
amphibians. The commenter states that truly inspirational amphibian
experiences occur when humans come across wild amphibians, not captive
amphibians.
Response: The Service encourages visitors to the Service's national
wildlife refuges and other public lands to appreciate salamanders in
their natural environments. The purpose of listing these salamander
species as injurious wildlife is to prevent the introduction,
establishment, and spread of Bsal in the wild in the United States to
protect wildlife and wildlife resources, including native salamanders
in the wild.
(40) Comment: The rule prevents the ability of salamander owners to
further test their collections and, therefore, could unintentionally
increase the spread of this disease rather than decrease it, if it
arrives in this country. Another commenter noted that the current
prohibition, especially on interstate movement, will discourage
cooperation to get domestic collections tested for the disease.
Response: As explained in the final rule, the current prohibition
on interstate transport in 18 U.S.C. 42(a) has been clarified and does
not apply to interstate transport between States within the continental
United States. Treatment and testing that does not involve import into
the United States, transport between the enumerated jurisdictions in 18
U.S.C. 42(a) (also set forth at 50 CFR 16.3), or injurious wildlife
permits are not regulated by this rule.
(41) Comment: The rule does not list members of the Ambystoma
genus, so this omission may increase the chances of legal and illegal
collection of Ambystoma.
Response: Listing a species as injurious wildlife results in
prohibitions on import into the United States and shipment between the
enumerated jurisdictions in 18 U.S.C. 42(a), codified in Federal
regulations at 50 CFR 16.3. Neither listing a species as injurious nor
not listing it results in a prohibition on collection. It is the
responsibility of a person who may be engaged in salamander collection
to be aware of any Federal, State, Tribal, or territorial law or
regulation that applies to such activity. For example, some salamanders
are federally protected from take (including, but not limited to,
collection) under the Endangered Species Act, and other laws or
regulations may otherwise prohibit or regulate collection of other
salamanders in national wildlife refuges, national parks, or other
Federal lands, or in accordance with State or Tribal laws. While it is
possible that some people will switch to Ambystoma spp. in place of a
listed species if they want to keep salamanders, they may currently do
so in States where it is legal under State law. We are listing the
genus Ambystoma with the second interim rule as a way to prevent the
potential introduction of the fungus.
Permitting Difficulties
(42) Comment: Multiple commenters expressed concern that the
listing would complicate research efforts or breeding programs for
recovery efforts for some native salamanders due to extended permit-
application processing time and limited Federal resources to adequately
address an increased number of applications.
Response: As explained in the final rule, the current prohibition
on interstate transport in 18 U.S.C. 42(a) has been clarified and does
not apply to interstate transport between States within the continental
United States. Fewer permit requests will be required because
interstate transport between States within the continental States is
not prohibited.
(43) Comment: The Service should consider adopting a cooperative
agreement or memorandum of agreement to allow easier movement of
prohibited species for certain purposes.
Response: Several commenters suggested memoranda of understanding
(MOUs) or other mechanisms in lieu of
[[Page 2184]]
permits. Those arrangements cannot be used to authorize import or
transport between the enumerated jurisdictions in the shipment clause
of 18 U.S.C. 42 (the continental United States, the District of
Columbia, Hawaii, the Commonwealth of Puerto Rico, and any territory or
possession of the United States), which are codified in Federal
regulations at 50 CFR 16.3. Other interstate transport between States
within the continental United States is not prohibited by 18 U.S.C.
42(a). The text of 18 U.S.C. 42(a)(3) requires that exceptions to
otherwise prohibited activities with injurious wildlife be authorized
by permit, and only if there has been a proper showing of
responsibility and continued protection of the public interest and
health. The regulations at 50 CFR 16.22 specifically provide that the
Service may issue a permit authorizing the importation into or shipment
between the continental United States. Thus, MOUs cannot be utilized
for authorizing import or shipment between the enumerated
jurisdictions. We have provided information online that helps people
who are requesting a permit understand and navigate the process at
<a href="https://www.fws.gov/node/266100">https://www.fws.gov/node/266100</a>. The Service is committed to processing
permit applications as quickly as possible to minimize any delay or
disruption of legitimate activities. Permit applications can be found
here: <a href="https://fws.gov/service/3-200-42-import-acquisitiontransport-injurious-wildlife-under-lacey-act">https://fws.gov/service/3-200-42-import-acquisitiontransport-injurious-wildlife-under-lacey-act</a>.
(44) Comment: A commenter recommends that, to receive a permit to
transport potentially infectious (non-inactivated) material, be it live
or dead salamanders, parts of dead salamanders, or biological samples,
one of the requirements should be proving absence of infection with
Bsal. To acquire a permit, the sender or receiver or both would have to
quarantine the salamanders or other material (and demonstrate that the
quarantine measures are adequate to contain spread of the pathogen),
sample a percentage of the total number of animals or biologic
materials to be shipped, and submit those samples, such as skin swabs
from live or dead non-fixed salamanders, to a diagnostic laboratory for
PCR testing. Permit granting would depend upon confirmation of the
negative status of the animals or biologic materials.
Response: While testing of specimens and live animals before moving
them would be advisable, testing could not be a prerequisite for
receiving a permit at this time because the details of reliable testing
from all exporting countries have not been confirmed. And, as mentioned
in IV. Second Interim Rule below, interstate transport between States
within the continental United States is not prohibited under the
current prohibitions of 18 U.S.C. 42(a) for the listed salamanders,
making the requirement not necessary for many domestic shippers. We
recommend that salamander transporters conduct best practices to reduce
the risk of introducing, transporting, or spreading Bsal within the
United States.
(45) Comment: The 2016 interim rule should be amended to allow
accredited veterinary medical diagnostic laboratories to exchange,
receive, and accept live or dead specimens, including parts of the 201
listed species, without the requirement of first obtaining a Federal
permit. The first step in any Bsal response is to obtain an accurate
and confirmed diagnosis of Bsal. Requiring accredited labs to first
obtain a permit is an unnecessary burden that slows the diagnostic
process and any confirming diagnostic testing at different labs.
Response: We agree that the first step to any Bsal response is
obtaining accurate diagnosis of Bsal. However, a permit is no longer
necessary for shipment between States within the continental United
States, as explained below in the preamble to this final rule.
(46) Comment: The double-containment requirements for transport and
storage and uncertainties therein are concerning. More explicit
guidance is requested regarding the double-containment requirements for
transport, housing, or storage, or handling of animals, tissues, or
other samples. Specifically, how does this requirement apply to species
repatriation projects or State-approved releases of injurious listed
salamanders back into the wild? Many States conduct health testing (in
collaboration with diagnostic lab partners) and have established
standards that must be met before repatriation is conducted. Such
State-sponsored activities should be exempt. Another solution is to
permit exemptions for double containment of fixed tissues, where the
threat of Bsal transmission is removed by virtue of the fixative agent.
Response: The Service posted additional guidance on our website
that includes further discussion about the ``double escape-proof''
containment for live animals and samples (<a href="https://www.fws.gov/node/266100">https://www.fws.gov/node/266100</a>). It is possible, however, in situations where live animals have
been permitted and for which the ``double escape-proof'' containment
requirements would apply, that repatriation would run counter to that
requirement. This is the first time that native species that might be
part of repatriation or recovery efforts have been listed as injurious.
Because injurious wildlife must be carefully handled, all of the
containment requirements must be met when salamanders are in captivity.
However, the Service will work with people or institutions that are
involved in State-approved repatriation efforts to facilitate these
efforts. Finally, we clarify in A. Background in II. Final Rule to the
2016 Interim Rule that preserved tissues are not considered injurious.
Other Impacts
(47) Comment: Collection of fishes for shipment cannot totally
ensure that other species of ``free riders,'' such as non-marketed
amphibians, are not unintentionally included in the shipment process.
Unintentionally including a single regulated amphibian, regardless of
whether it is infected with Bsal, would subject the transporting farmer
to severe civil and even criminal penalties. Notably, actual interstate
transport of Bsal by some means not including a listed amphibian would
not violate the rule.
Response: As explained in the final rule, interstate transport
prohibitions have been clarified. We encourage anyone who transports
live fishes to use best management practices that include transporting
only the traded species and their uncontaminated media. Unintentional
importation or transport between the enumerated jurisdictions in the
shipment clause of 18 U.S.C. 42 (the continental United States, the
District of Columbia, Hawaii, the Commonwealth of Puerto Rico, and any
territory or possession of the United States), which are also set forth
at 50 CFR 16.3, through nursery stock or other pathways would also be a
violation of the prohibitions from listing.
Inaccurate or Incomplete Science
(48) Comment: The rule does not account for pressures that
amphibians are already facing, such as habitat loss, rising
temperatures, pesticide use, and siltation from agriculture. The
Service's focus should be on the systematic degradation of the
ecosystems in which the amphibians live and the capacity of the
salamanders to fight the fungus.
Response: The Service noted in the rule that salamanders may
demonstrate more severe clinical disease when infection is combined
with additional stressors in the wild. The comment does not provide any
evidence of how habitat loss, rising temperatures, pesticide use, and
siltation from agriculture diminishes the need for or benefits of the
rule that may prevent salamander
[[Page 2185]]
mortality. Native salamander species known to be negatively affected by
Bsal infection under experimental conditions may demonstrate more
severe clinical disease when infection is combined with additional
stressors in the wild, as has been found for other diseases. Besides
this rule, the Service is engaged in many other conservation measures
designed to help improve and protect salamander habitats across the
United States.
(49) Comment: Using a method of infecting a salamander from one
genus with Bsal in a laboratory setting and then extrapolating results
to all species within that genus is not in conformance with the
framework of the World Organisation for Animal Health code or the
National Aquatic Animal Health Plan (National Aquaculture Health Plan
and Standards) for the United States and is contrary to the credible
scientific findings of Martel et al. (2014). Therefore, the 2016
interim rule is arbitrary and capricious in violation of the APA. In
addition, other aquatic diseases have shown laboratory infection, but
the affected fish species are not included in regulatory lists.
Response: The WOAH has a different purpose than the injurious
wildlife listing provisions of the Lacey Act, and the standards the
WOAH uses are appropriate for their purposes. We followed the standards
in 18 U.S.C. 42 and the APA. The issue of fishes that may carry
diseases is beyond the scope of this rulemaking. Surrogate species are
used elsewhere in the 2016 interim rule, such as for Bd for where
information is lacking for Bsal and is common in scientific literature.
(50) Comment: The spread dynamics of Bd and Bsal are considerably
different. Given that Bd is endemic to the United States, the estimated
potential for Bsal distribution has been overestimated. This
overestimation is confirmed by salamander import data, the lack of
presence of Bsal in animals entering the United States, and its lack of
presence in wild populations.
Response: The commenter states that Bd originated in the United
States and is therefore endemic. We agree that Bd has occurred in the
United States for many years and is currently ubiquitous throughout
North America; however, we do not consider Bd endemic to the United
States. For reasons identified in the 2016 interim rule and this second
interim rule, we conclude that Bsal does pose a risk to native
salamander populations. We have updated the research cited and still
conclude that there is a risk of Bsal entering the country with
salamanders, and that risk is greatly reduced by listing the genera in
this rule.
(51) Comment: The 2016 interim rule reports that there is no
accurate way to test for or eliminate Bsal in captivity. PCR-based
testing has been well established for many years for the related Bd and
has been effectively demonstrated for Bsal. Effective measures for
clearing salamanders using heat alone or heat in conjunction with anti-
fungal medications have also been published. The authors of both of
those studies have reiterated in personal communication that the stated
Service position in the rule justification is contradictory to the
published data. Another comment noted that combined experience from
members of <a href="http://Caudata.org">Caudata.org</a> in the captive maintenance and breeding of the
species subject to this rule has shown that the temperatures required
by these treatments are safe and will not harm the majority of
salamanders of the Salamandridae, the family containing the bulk of the
regulated species.
Response: While the comments do not provide any information on how
the Service's finding is contradictory to the published data, the
second interim rule clarifies these issues. We have revised the rule to
note that testing and prophylactic treatments of imports of salamanders
to manage Bsal are available but have uncertain effectiveness when
applied as a nationwide regulatory tool by the Service.
(52) Comment: There is likely no Bsal in the United States, even
with the huge numbers of salamanders that have recently been imported,
because it gets too hot in the summer and too cold in the winter.
Response: As discussed under Bsal Risk Assessment, we found that
there is a significant risk that Bsal can establish and spread in the
United States. Some areas, such as south Florida, are likely to have
low consequences from Bsal introduction, in part due to temperatures
found in the region. The areas most likely to have consequences from
Bsal introduction are the Pacific Coast and Appalachian Mountains
(Richgels et al. 2016). Based on environmental suitability, areas of
the United States most suited to Bsal growth (Blooi et al. 2015a),
including the Southwest, Southeast (except south Florida as just
noted), and Pacific regions, are also the areas of highest salamander
diversity. The large land mass of the United States has a broad range
of climates, many of which are similar to the other continents where
Bsal is currently found.
(53) Comment: The Service did not publish the text of articles or
the risk assessment it used for the 2016 interim rule.
Response: The file for the references used, as well as other
supporting information used to develop the 2016 interim rule, was
posted under ``Supporting & Related Material'' in <a href="https://www.regulations.gov">https://www.regulations.gov</a> (Docket No. FWS-HQ-FAC-2015-0005), and is available
for public inspection as noted under ADDRESSES in the 2016 interim
rule. Comments and materials we received, as well as citations for
supporting documentation we used in preparing the interim rule, were
available for public inspection. The texts of publications are often
covered by copyright laws and those are therefore not posted.
(54) Comment: Species from the genera Ambystoma and Gyrinophilus
were not listed because they were tested and proved resistant to Bsal.
Why then were all Plethodon listed, since the one species tested (P.
glutinosus) was also demonstrated to be resistant?
Response: We did not believe that there was enough evidence to list
Ambystoma or Gyrinophilus at the time of the 2016 interim rule, but we
found evidence to support listing Plethodon. Three native salamander
species identified as resistant to Bsal infection included the spring
salamander (Gyrinophilus porphyriticus), marbled salamander (Ambystoma
opacum), and spotted salamander (A. maculatum) (Martel et al. 2014). At
the time the public-comment period closed, there was no evidence that
any species within these genera are carriers of Bsal. We discuss our
reasoning for listing all Plethodon species in the second interim rule
under Vulnerability and Carrier Status. In short, however, further
histological analysis of the slimy salamander revealed that Bsal could
invade the skin long enough to move or transmit the pathogen to other
salamanders. No such evidence existed then or now for any species in
the genus Gyrinophilus; therefore, we are not listing species from that
genus. As explained in the second interim rule under Vulnerability and
Carrier Status of Native Species, we have evidence now of carrier
capability for Ambystoma maculatum, A. mexicanum, and A. opacum and are
listing the genus.
(55) Comment: In Europe, where Bsal is believed to have been
introduced by Asian imports, Bsal was found in populations of
Salamandra and Alpine newts (Ichthyosaura alpestris) in the Netherlands
and in Belgium. It has also been found in captive Salamandra in the
United Kingdom and Germany, and
[[Page 2186]]
possibly in wild German populations. Martel et al. (2014) shows that
most lethally vulnerable species exposed to Bsal in the lab showed
signs of infection within 8 days and were dead within 3 to 4 weeks.
This means that non-resistant infected species in captive collections
would have died during the comment period on the 2016 interim rule.
Response: The comment suggests that there are no specimens carrying
Bsal at this time that might enter the United States and allow Bsal to
be introduced, establish, and spread, but does not provide evidence
that we can use in our analysis of the rule. Lethally vulnerable
specimens can still appear if the pathogen spreads, or if Bsal persists
in tolerant or susceptible populations or carcasses.
(56) Comment: The 2016 interim rule states that surveys of anglers
have indicated that they routinely release salamanders into the areas
where they fish, which includes areas that are not part of the
salamanders' native U.S. habitats, suggesting that animals are
routinely moved long distances. No similar survey data exists for pet
owners, so assuming the pet trade is the problem for releases is
unfounded and targeting the pet trade simply because it is an easy
target is unjust.
Response: Our statement relating to anglers was used to note that
this invasion expansion pathway has been attributed to the use and
subsequent release of salamanders used as fishing bait. Along with the
other evidence we documented, we found that there is the potential for
salamanders carrying Bsal to escape or be released into the wild where
they can transmit the pathogen to native species. We provided evidence
in the rule that we used to conclude that international trade is the
main pathway for the global spread of Bsal.
Additional Science Needed
(57) Comment: Several areas would benefit from further
investigation. For example, the origins of Bsal in wild salamanders
needs to be better understood. It is important to continue and expand
testing of salamanders in the wild and in trade in various locations.
Additional testing of species within the same genus would be beneficial
to guide field and collection surveillance.
Response: Since the 2016 interim rule was published, many studies
have been published that address the commenter's concerns and are
applicable to the rule, including a major surveillance of salamanders
in the wild by the USGS. We have reviewed the studies, and they support
our final and second interim rules. We agree that additional science
will help address issues related to better understanding of this
pathogen and preventing its introduction into the United States, but we
understand the need to take action now to list the species in the
genera in this rule to prevent the introduction, spread, and
establishment of Bsal.
Economic and Trade Data
(58) Comment: If the salamanders are already here, and Bsal is not,
then that means that any salamanders traveling across State lines pose
no risk. This law estimates that it will cause $3.8 million in damage
to the U.S. economy, mostly in the small business sector (``Regulatory
Flexibility Act,'' paragraph nine). Those numbers could be greatly
lessened if interstate travel were allowed.
Response: As explained above in III. Final Rule to the 2016 Interim
Rule in A. Background and D. Required Determinations, the current
prohibition on interstate transport in 18 U.S.C. 42(a) has been
clarified and does not apply to interstate transport between States
within the continental United States. Thus, the costs incurred are
expected to be less than originally estimated in the 2016 draft
economic analysis.
(59) Comment: <a href="http://Caudata.org">Caudata.org</a> conducted an online public survey from
February 1 to March 12, 2016, to gather additional data of U.S.
domestically bred animals. A total of 797 respondents to the survey
reported shipping 25,649 domestically bred caudates across State lines
in 1 year. Due to the low response rate relative to the number of U.S.
registered members on <a href="http://Caudata.org">Caudata.org</a> (8 percent) and the short duration of
the survey, this number likely represents a small fraction of the
actual trade. It can be safely extrapolated that the Service has
underestimated the trade in captive-bred newts and salamanders by at
least two orders of magnitude. <a href="http://Caudata.org">Caudata.org</a> is uniquely situated at the
interface of hobbyists, entrepreneurs, researchers, zoos, and
aquariums. A summary of that data and some important numbers are
presented here. Respondents to the survey possessed a total of 28,228
domestically bred salamanders or newts, the majority of which are
subject to the rule. Respondents shipped on average 25,649 salamanders
or newts over State lines per year. This number is nearly two orders of
magnitude greater than the ``338'' cited by the rule and represents
just a small fraction of our members. The total yearly salamander- and
newt-related revenue reported by our respondents was $207,528 for 2015.
The commenter further stated that <a href="http://Caudata.org">Caudata.org</a> has more than 10,000
unique registered U.S. members who have accessed their website in the
past 5 years. Their total number of unique U.S. visitors (people who
did not register for an account) in that time is orders of magnitude
greater than this number. The commenter stated that, apparently, the
Service did not perform due diligence in ascertaining the number of
private U.S. citizens affected by this rule.
Response: While we did obtain data from the Pet Industry Joint
Advisory Council (PIJAC; currently known as the Pet Advocacy Network)
for the 2016 interim rule, we appreciate <a href="http://Caudata.org">Caudata.org</a> for supplying
additional data. The survey does not indicate: (1) whether the
salamanders are domestically bred; (2) the net importation for each
State; or (3) what species they are. Since the survey data did not
include information on species or whether they are transported between
the listed jurisdictions, it is unknown if any of the revenue discussed
would be lost due to prohibitions under the rule. Consequently, the
data are not used in the final economic analysis for the 2016 interim
rule. Furthermore, unlike the 2016 interim rule, the final rule
clarifies that the current prohibition on interstate transport in 18
U.S.C. 42(a) does not apply to interstate transport between States
within the continental United States.
(60) Comment: The economic figures provided by the Service are a
gross understatement. <a href="http://Caudata.org">Caudata.org</a> has submitted the results of a survey
on the numbers of animals sold across State lines, and just from their
members, reported roughly $207,528 in income. Actual figures are
probably much higher, given that this amount likely represents just a
portion of the trade in the entire United States, and <a href="http://Caudata.org">Caudata.org</a>
pertains only to captive-bred animals. In addition to the money spent
purchasing animals, there's also food, lighting, enclosures, plants,
decorations, filters, shipping and packaging fees, and other costs
associated with keeping salamanders. To house a pair of salamanders can
cost $100 to $200 or more, with ongoing feeding costs. Overall, the
U.S. salamander hobby probably represents well over $5 million to $10
million in economic activity each year.
Response: Regarding the <a href="http://Caudata.org">Caudata.org</a> data, see also response to
Comment 59. The economic analysis addresses primary support services
(such as food and shipping) and secondary economic impacts in Sections
2.3.2 and 3.1.3, respectively.
[[Page 2187]]
(61) Comment: The 2016 interim rule states that ``a minimum of 338
domestically bred salamanders may be affected due to the interstate
transportation prohibition.'' As an individual, the commenter has
legally shipped 150-plus live specimens (eggs, larvae, and adults) in a
single year and knows that many more people legally ship more specimens
than that amount in the same period. The commenter has also received
dozens of animals in a single year and knows that this occurrence is
not unique. Many individuals will be affected by the listing.
Response: The minimum is based on available data from PIJAC and is
stated as a minimum due to the expectation of the actual number being
potentially larger. For this salamander breeding data, it is unclear
which species are shipped and whether these specimens are shipped
between listed jurisdictions. Unlike the 2016 interim rule, the final
rule clarifies that the current prohibition on interstate transport in
18 U.S.C. 42(a) does not apply to interstate transport between States
within the continental United States. Therefore, it is not incorporated
into the final economic analysis.
(62) Comment: Many small businesses have commented that the
prohibition on interstate transport will have a greater impact than the
Service anticipates. In the 2016 interim regulatory flexibility
analysis, the Service stated that it does not believe that the impact
of prohibiting interstate transport will be significant. However,
several small breeders and hobbyists involved in selling salamanders in
the United States have indicated a substantial domestic trade in
salamanders. The U.S. Small Business Administration Office of Advocacy
commented that a small business representative indicated that this
number could be as high as 1,500 specimens shipped in a year for
certain businesses. The difference between the limited information in
the analysis and the information provided by commenters indicates that
the analysis underestimates the effect of the prohibition of interstate
transport.
Response: As explained above in III. Final Rule to the 2016 Interim
Rule in A. Background, the current prohibition on interstate transport
in 18 U.S.C. 42(a) has been clarified and does not apply to interstate
transport between States within the continental United States.
Therefore, the interstate data provided are not incorporated into the
final economic analysis and final regulatory flexibility analysis. As
discussed in Comment 61, salamander breeding data that are submitted
without specific details regarding species type are too general to be
incorporated into the final economic analysis. It is possible that the
domestic market is more robust than estimated. However, it is unclear
whether any additional sales are related to species that are listed or
not listed under the rule.
(63) Comment: Many breeders who produce these animals as their main
source of income will lose significant income or go out of business
without the ability to sell across State lines. For example, last year,
a business owner produced more than 100 neotenic Ichthyosaura
alpestris, and this year [2016] they will have to cull those eggs in
light of the prohibition.
Response: The comment is incorrect that they will have to cull
eggs, because eggs of listed salamander species are not considered
injurious because they do not have the potential to serve as carriers
of Bsal. Furthermore, as explained above in III. Final Rule to the 2016
Interim Rule in A. Background, the current prohibition on interstate
transport in 18 U.S.C. 42(a) has been clarified and does not apply to
interstate transport between States within the continental United
States after April 7, 2017. Therefore, the interstate data provided are
not incorporated into the final economic analysis and final regulatory
flexibility analysis.
(64) Comment: Many States also prohibit or limit sale by biological
supply companies of certain native species, and the authority to
regulate nonnative species may be either with the State fish and
wildlife agency or the State's department of agriculture or shared in
some instances. For example, commercial production of native
salamanders is currently not legal in California, and the State's
department of agriculture does not regulate or track production or sale
of nonnative salamanders in the State. The only way to legally sell
native salamanders in California is as a biological supply house with a
permit to collect wild specimens for sale to scientific and educational
facilities. Only one business is currently in possession of this
permit, and it has not collected or sold salamanders.
Response: We appreciate the information.
(65) Comment: One commenter's company produces about 1,000
Neurergus kaiseri, 100 N. crocatus, 100 N. strauchii, and 200
Ichthyosaura alpestris a year.
Response: We appreciate the commenter supplying domestic breeding
data. It has been incorporated as appropriate into the appendix to the
final economic analysis.
(66) Comment: An international prohibition on trading gives small-
time breeders within the United States an economic boost to supply the
demand for these pets.
Response: We acknowledge that an international prohibition can have
an indirect effect of reducing competition for domestic breeders in
some markets. The rule was not implemented to provide an advantage to
domestic breeders but rather to prevent Bsal introduction,
establishment, and spread in the United States by salamander species
that are carriers of the pathogen.
(67) Comment: The Service estimates that, without the 2016 interim
rule, 217,000 salamanders would be imported each year. These imports
will be prohibited if the 20 genera are listed under the Lacey Act as
set forth in the 2016 interim rule. The Service further estimates that
338 domestically bred salamanders would be affected by the interstate
transportation prohibition per year, resulting in impacts to domestic
breeders of up to $23,000. These domestic production numbers do not
pass a straight-face test; for the estimate to be accurate, each
salamander would need to be worth an average of $68. In reality,
salamanders typically sell for between $10 and $50, depending on the
species. As several USARK members and others in the herpetoculture
industry have reported to the Service in written comments, including
trade numbers provided by <a href="http://Caudata.org">Caudata.org</a>, the actual number of
domestically bred salamanders shipped across State lines is far higher
than 338. The species listed in the 2016 interim rule comprise the
overwhelming majority of those in the pet trade, so the economic effect
of the listing will amount to nearly the full total of the industry's
value.
Response: The minimum number for domestic production (338) and the
corresponding prices for those salamanders were provided by PIJAC. The
detailed data they provided is in table A1-2. Furthermore, after the
2016 interim rule was issued, as explained above in A. Background in
III. Final Rule to the 2016 Interim Rule, the current prohibition on
interstate transport in 18 U.S.C. 42(a) has been clarified and does not
apply to interstate transport between States within the continental
United States.
Use of Categorical Exclusion
(68) Comment: The interim rule is not possible without the recently
implemented categorical exclusion that bypasses the requirement to
consider economic and social impacts under the National Environmental
Policy Act (NEPA). The decision to use the
[[Page 2188]]
categorical exclusion for the 2016 interim rule is flawed.
Response: We determined the categorical exclusion for injurious
wildlife listing, located in the Department of the Interior Manual at
516 DM 8.5 C(9), applies to the action in accordance with the
requirements of NEPA. The categorical exclusion does not bypass NEPA.
We reviewed the rule under NEPA requirements and prepared an
environmental action statement for the 2016 interim rule that was
available for review (see ``Supporting & Related Material'' at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under Docket Number FWS-HQ-FAC-2015-0005). Under
NEPA, the human environment is interpreted comprehensively to include
the natural and physical environment and the relationship of people
with that environment (40 CFR 1508.14), and the economic or social
effects are not intended by themselves to require preparation of an EIS
(40 CFR 1508.14). We prepared a draft economic analysis and regulatory
flexibility analysis separately as part of the required determinations
under the APA for the 2016 interim rule and made them available for
public comment. We determined that the regulations in that rule will
not individually or cumulatively have a significant effect on the human
environment.
Inaccurate Use of 18 U.S.C. 42(a)(1)
(69) Comment: The use of the Lacey Act in this manner opens the
door for similar regulations of other animals, such as dogs, cats,
fishes, horses, and chickens. The list of species is infinite, as would
be the economic impact they could have.
Response: Under the authorities provided under the injurious
wildlife provisions of the authorizing statute (18 U.S.C. 42), the
Service can list only wild mammals, wild birds, fishes, mollusks,
crustaceans, amphibians, and reptiles as injurious wildlife, meaning
the Service cannot list domesticated species, thus eliminating the
possibility to list domesticated dogs, domesticated cats, domesticated
horses, and domesticated chickens.
(70) Comment: Congress has never interpreted the Lacey Act to apply
to shipment between States within the continental United States.
Response: After the 2016 interim rule was issued, as explained
above in III. Final Rule to the 2016 Interim Rule, A. Background, the
current prohibition on interstate transport in 18 U.S.C. 42(a) has been
clarified and does not apply to interstate transport between States
within the continental United States. The final rule has been modified
consistent with the prohibition in the shipment clause of 18 U.S.C. 42,
which has been codified in Federal regulations at 50 CFR 16.3, for
transport between the enumerated jurisdictions (the continental United
States, the District of Columbia, Hawaii, the Commonwealth of Puerto
Rico, and any territory or possession of the United States).
(71) Comment: Although the pet trade is primarily regulated by USDA
agencies, including the Animal and Plant Health Inspection Service,
requirements for the movement of pets across State lines are generally
reserved to individual States. Furthermore, courts have often found
individual animals to be exempt from livestock regulations that would
otherwise apply when those animals are characterized as household pets.
Salamanders in the pet trade should similarly not be considered
``wildlife'' for purposes of Federal regulation of interstate
transport. Other commenters also stated that the Service should defer
this issue to another agency with additional resources for controlling
importation (such as the USDA) because the Service has stated that an
injurious listing under the Lacey Act is their only means of attempting
to control Bsal.
Response: The provisions of 18 U.S.C. 42 make no distinction
between pet salamanders and other salamanders. The purpose of listing
these salamander species as injurious wildlife is to prevent the
introduction, establishment, and spread of Bsal in the wild in the
United States to protect wildlife and wildlife resources. The authority
to take action to list species as injurious wildlife under 18 U.S.C. 42
lies solely with the U.S. Department of the Interior.
(72) Comment: The regulations promulgated in the 2016 interim rule
restrict not only international and interstate transport but any
movement whatsoever of the listed genera. The regulatory language
prohibits the importation, transportation, or acquisition of any live
or dead specimen, including parts, but not eggs or gametes, of the
genera. There is simply no authority in the Lacey Act to prohibit
acquisition. Because the Lacey Act does not forbid acquisition of a
listed animal, the interim regulation is beyond the law to the extent
it purports to prohibit the same. The Service must amend the 2016
interim rule to clarify that the prohibitions do not apply to
intrastate activities.
Response: Under the Lacey Act Amendments of 1981, 16 U.S.C.
3372(a)(1), it is unlawful among other things for any person to sell,
receive, acquire, or purchase any wildlife transported in violation of
any law of the United States. This includes acquiring any injurious
wildlife imported into the United States or transported between the
enumerated jurisdictions in violation of the shipment clause of 18
U.S.C. 42 (the continental United States, the District of Columbia,
Hawaii, the Commonwealth of Puerto Rico, and any territory or
possession of the United States), also set forth at 50 CFR 16.3. The
conditions of injurious wildlife permits may also place limitations on
subsequent sale or transfer of injurious wildlife under the permit
without prior authorization from the Service. Those activities are in
connection with transport of injurious wildlife between the listed
jurisdictions in the shipment clause or import into the United States
under 18 U.S.C. 42. It is the responsibility of a person who may be
engaged in salamander acquisition to be aware of any Federal, State,
Tribal, or territorial law or regulation that applies to that activity.
The rule adding injurious salamanders to the lists of species does
not change the scope of the prohibitions in 18 U.S.C. 42, 16 U.S.C.
3372, 50 CFR 16.3, or otherwise found in 50 CFR part 16. The regulatory
language referenced by the commenters (50 CFR 16.14) is identical to
longstanding, existing language that appears at 50 CFR 16.11, 16.12,
16.13, and 16.15. Revision of the general regulations found at 50 CFR
part 16 is beyond the scope of this rulemaking.
(73) Comment: The Lacey Act defines ``transport'' as ``to move,
convey, carry, or ship by any means, or to deliver or receive for the
purpose of movement, conveyance, carriage, or shipment.'' Even if the
law did authorize the Service to bar personal transport, which it does
not, this definition would reach solely intrastate activities. Although
the Service has agreed that States, not the Service, have the power to
regulate ownership and sales within their borders, the commenter is
concerned that the Service is laying the groundwork to involve itself
in Federal regulation of wholly intrastate activities.
Response: The definition quoted by the commenter applies to the law
codified at 16 U.S.C. 3371(j), also known as the Lacey Act Amendments
of 1981. Consistent with this definition, Service regulations also
provide a definition of transport found in 50 CFR 10.12. It is the
responsibility of a person who may be engaged in salamander
transportation to be aware of any Federal, State, Tribal, or
territorial law or regulation that applies to such activity. For
further information see also response to Comment 72.
[[Page 2189]]
Interim Rule Is a Regulatory Taking
(74) Comment: The Service evaluated the 2016 interim rule and
determined that it does not constitute taking. This conclusion is
facially false--a restriction on interstate travel with a family pet
not only is impermissible under the law, but most certainly denies the
pet owner enjoyment and companionship (amounting to use) of that pet.
Response: Import and transport of injurious wildlife between the
enumerated jurisdictions in the shipment clause of 18 U.S.C. 42 (and at
50 CFR 16.3) of any of the listed species is prohibited. The provisions
of 18 U.S.C. 42(a) do not prohibit any person who owns one of the
listed species at time of listing from continuing to possess the
species (such as listed salamanders) or engaging in transport and other
activities within the enumerated jurisdictions of the shipment clause,
as allowed under State, Tribal, or territorial law. Therefore, we
concluded that the 2016 interim rule and this final rule do not
constitute a regulatory taking. This action is consistent with all
previous injurious wildlife listings that have affected listed species
that members of the public might have owned at the time of listing. It
is the responsibility of a person who may be engaged in salamander
transportation to be aware of any Federal, State, Tribal, or
territorial law or regulation that applies to that activity.
Federalism Assessment Under Executive Order 13132
(75) Comment: Under Executive Order 13132, the 2016 interim rule
requires a federalism assessment as the rule's provisions have
significant federalism effects and will have several direct effects on
States, which have primary jurisdiction over native wild animals not in
captivity. The regulation of the movement of pets across State lines is
reserved to individual States. Under Executive Order 13132, this
interim rule does have sufficient federalism implications to warrant
the preparation of a federalism assessment.
Response: A federalism assessment is not required. Executive Order
13132 says that policies that have federalism implications refer to
regulations, legislative comments, or proposed legislation, and other
policy statements or actions that have substantial direct effects on
the States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. This rule does not limit the policymaking
discretion of the States or preempt State law. The States are not
restricted from also regulating the transport of listed salamanders or
other activities related to such species within their State boundaries,
such as sale or possession. The commenter did not provide evidence
showing how the rule would be a substantial direct action impacting the
States.
Law Enforcement Issues
(76) Comment: Salamanders will be smuggled into the country or sold
through the black market once they are prohibited, as all contraband
inevitably is, with no regard for fungal safety or often the health of
the animals. One commenter noted that they have received messages from
overseas asking them to illegally ship animals, with instructions for
how to package and ship animals to demonstrate how easy it is to do so.
The rule will not prevent Bsal from entering the United States.
Response: The injurious wildlife provisions of 18 U.S.C. 42 serve
an important role in protecting humans, the interests of agriculture,
horticulture, and forestry, and the wildlife or wildlife resources of
the United States from injurious wildlife. The rule is intended to
reduce opportunities for Bsal to spread disease to native species in
the wild. As previously explained, the listing of salamander species
that may be carriers of Bsal results in prohibitions on import and
transport between the enumerated jurisdictions in the shipment clause,
and violations of these prohibitions are subject to strict liability,
18 U.S.C. 42(b) (Whoever violates this section, or any regulation
issued pursuant thereto, shall be fined under this title or imprisoned
not more than six months, or both.). Additionally, pursuant to 18
U.S.C. 42(a)(1), all prohibited injurious wildlife imported or
transported in violation of the Lacey Act ``shall be promptly exported
or destroyed at the expense of the importer or consignee.'' Where
applicable, penalties may also be assessed under the Lacey Act
Amendments of 1981, 16 U.S.C. 3371 et seq. Although we acknowledge that
some unscrupulous dealers may take advantage of people or engage in
illegal trade, the regulatory provisions we are promulgating play an
important role in deterring and, as necessary, penalizing and remedying
unlawful activity, in order to protect the interests under the Act. We
strongly encourage compliance with the law, and we may take appropriate
enforcement action against violations that may occur. However, our
experience is that pet owners prefer to be responsible, law-abiding
citizens and would make informed decisions not to engage in import or
transport contrary to the Lacey Act and thereby reduce the risk of
spreading Bsal.
(77) Comment: The final rule will subject exhibitors, nature
centers, wildlife rehabilitators, private citizen hobbyists, and
commercial breeders to Federal prosecution and penalties from felonies
under the Lacey Act.
Response: The interstate transport language in 18 U.S.C. 42 is
clarified in A. Background in III. Final Rule to the 2016 Interim Rule.
Prohibitions remain for importation and transportation between the
enumerated jurisdictions of 18 U.S.C. 42, also listed in 50 CFR 16.3.
Violations of the injurious wildlife listing prohibitions are a
misdemeanor, not a felony.
(78) Comment: For salamander species not listed as injurious, the
final rule should incorporate authority for the Service to collect Bsal
samples from any shipment where dead animals are present upon
importation. This is a noninvasive procedure, and these data are needed
to help modify this rule in the future if additional Bsal carrier
species are discovered. The presence of dead salamanders upon
importation can be a smoking gun for the presence of Bsal (and other
harmful pathogens).
Response: The recommended action is outside the scope of this final
rule relating to the listing of injurious wildlife under 18 U.S.C.
42(a).
(79) Comment: A Federal ban on interstate movement of salamanders
is unenforceable given the Service's resource limitations. Many of the
exotic caudate species listed as injurious are already widely
distributed in private collections in virtually every State. There is
no system in existence (or resources to create a system) to register or
effectively monitor their numbers or locations.
Response: The Federal ban was lifted in 2017 as the result of a
Federal court decision regarding the interpretation of the statute 18
U.S.C. 42(a). This final rule has been amended to address interstate
transport as explained above in III. Final Rule to the 2016 Interim
Rule in A. Background and D. Required Determinations. Whether a Federal
ban on interstate movement is enforceable is beyond the scope of this
rule.
(80) Comment: Regulation alone will not put a halt to the
international and interstate traffic in species listed as injurious
under the Lacey Act or under various State regulations. Accordingly,
adequate law enforcement, especially at ports of entry, is critical to
manage the ongoing, and possibly increased, volume of underground
traffic in regulated wildlife. The commenter
[[Page 2190]]
encourages building cooperative partnerships between State and Federal
enforcement agencies to increase capacity and to capitalize on the
specific expertise that the respective programs can bring to bear on
this problem.
Response: We agree. The Service's Law Enforcement Office has a
longstanding relationship with Customs and Border Protection and USDA
inspectors regarding cooperation for enforcement on the borders. The
Service's law enforcement officers at ports have and will continue to
maintain strong working relationships with their State counterparts.
(81) Comment: The trade in species not listed by the rule needs to
be monitored. The rule's prohibitions of the vast majority of commonly
traded species may inadvertently create a new legal market for species
not previously in demand by the salamander trade community. Those newly
traded species could be carriers of Bsal.
Response: The Service collects information on all imported
salamanders, listed or otherwise. This situation will not change with
the listing of the species in this rule as injurious wildlife. This
rule does not preclude the ability to take additional regulatory
actions if new information emerges.
(82) Comment: There was a push to acquire species before the
prohibition could go into effect after it was announced. Prior to the
ban, some people would have only purchased captive-bred or long-time-
in-captivity amphibians. Due to the prohibition, they stepped out of
their comfort zone and purchased wild-caught salamanders.
Response: The comment supports the Service's decision to implement
an effective date of 15 days after the date of publication for the 2016
interim rule and again for the second interim rule. We wanted to give
shipments in transit or pending transit the time needed to complete the
travel for the welfare of the live animals, but we did not want to
encourage a rush to import over a longer period. Purchasing a wild-
caught salamander listed under this rule is not prohibited under 18
U.S.C. 42, provided transport of the specimen occurs only within an
enumerated jurisdiction of 18 U.S.C. 42 (also listed at 50 CFR 16.3)
and complies with any permit condition for a specimen traded under an
injurious wildlife permit. It is the responsibility of a person who may
be engaged in salamander acquisition to be aware of any Federal, State,
Tribal, or territorial law or regulation that applies to that activity.
Alternatives to the 2016 Interim Rule
(83) Comment: Numerous commenters recommended health certification
as an alternative to the injurious wildlife listing. For example, a
commenter urged the Service to reconsider the listing of the 201
salamander species, and instead to employ models proven effective by
USDA's Animal and Plant Health Inspection Service, such as utilization
of certificates of veterinary inspection, pre- or post-import
quarantine and treatment, import permits, and import restrictions based
on risk assessments for given countries of origin. Another commenter
urged the Service and other relevant agencies to work with its members
to develop immediate measures to allow for preventive treatment and
certification, without causing undue personal impacts.
Response: While we do work collaboratively with the USDA and
nongovernmental organizations on many invasive-species issues, the
authority to list species as injurious wildlife under 18 U.S.C. 42 lies
with the U.S. Department of the Interior. Although some countries may
have the necessary skills to prepare a health certificate that
salamanders are free of Bsal, not all exporting nations may have the
necessary skills or resources. Scientists and diagnostic laboratories
are also working to standardize laboratory protocols. Please see
heading in the second interim rule on Ability To Prevent or Control the
Spread of Pathogens or Parasites for more explanation. The Service will
continue to seek opportunities to work with partners to ensure
salamander conservation consistent with its mission but cannot commit
to specific actions that do not fall under the scope of this
rulemaking.
(84) Comment: Related to other comments about establishing a
certification system, the Service should consider establishing a permit
from which the proceeds would help manage certification, testing, and
conservation efforts and, therefore, could both help fund the program
and make it more scientifically accurate.
Response: While we are not establishing a certification system at
this time under this rule, we acknowledge that the general statutory
authority to charge fees for processing applications for permits and
certificates is found in 31 U.S.C. 9701, which states that services
provided by Federal agencies are to be ``self-sustaining to the extent
possible.'' Federal user-fee policy, as stated in Office of Management
and Budget (OMB) Circular No. A-25 Revised, requires Federal agencies
to recoup the costs of Federal activities that provide ``special
benefits'' to identifiable recipients. Permits are special services,
authorizing identifiable recipients to engage in activities not
otherwise authorized for the general public. Please also see our
response to Comment PR31.
(85) Comment: Chain pet stores should be prohibited from selling
salamanders because it is too hard to regulate them. Only specialty pet
places and breeders that have a permit should be allowed to sell
salamanders.
Response: Regardless of the business size or type, as explained in
the final rule, all import and transport of injurious wildlife between
the enumerated jurisdictions in the shipment clause of 18 U.S.C. 42,
codified in Federal regulations at 50 CFR 16.3, are prohibited for
salamander species listed by this rule except by permit for authorized
purposes. Otherwise regulating the sale of salamanders is not within
the scope of this rulemaking. It is the responsibility of a person who
may be engaged in salamander sales to be aware of any Federal, State,
Tribal, or territorial law or regulation that applies to that activity.
(86) Comment: A mandatory holding period for salamanders should be
considered for transport across State lines. Studies show that if an
animal is infected, it will die within a very short period. Only
animals that test negative for Bsal should be allowed to be shipped.
All animals in quarantine should also be treated to prevent infection
and spread of Bsal, once reliable protocols are developed, as they have
been for Bd (Pessier and Mendelson 2010). Quarantine efforts would
facilitate both prevention of introduction and compliance.
Response: Only lethally vulnerable species are expected to die in
response to Bsal infection. Other species listed by this rule are also
capable of carrying Bsal without lethal consequences and transmitting
the fungus to native species. For these and other reasons discussed in
this rule regarding certification and testing options, while research
is ongoing, it is currently not feasible to establish such a system.
The interstate prohibition has also been clarified as discussed in the
second interim rule.
(87) Comment: Consider instead a CITES import ban of all species of
salamanders and newts, under the notion that CITES exists to protect
endangered species. There are 35 species of amphibians that would be at
risk of being wiped out entirely if Bsal
[[Page 2191]]
becomes introduced into the United States.
Response: CITES exists for a different purpose from the injurious
wildlife provisions of the Lacey Act, and the purpose and use of CITES
is beyond the scope of this rulemaking.
(88) Comment: The Service has not acknowledged nonregulatory
approaches. The pet industry has taken voluntary action to halt the
import of known carriers. For example, PIJAC called for an immediate,
temporary moratorium of Oriental fire-bellied newt and paddle-tailed
newts on November 20, 2015.
Response: One of our alternatives (Alternative 1) involved taking
no action on the Service's part. This is our status quo. We would not
list any species of salamanders as injurious under this alternative. We
did not select this option because of the significant risk that Bsal
poses to native species and other wildlife resources in the United
States. We expect that significantly greater financial and natural
resources losses will be incurred by us and our partners in having to
manage and respond to Bsal if the fungus establishes and spreads in the
United States than by taking action now to prevent its introduction.
While we appreciate and support voluntary conservation efforts, we
concluded that regulatory action was necessary to ensure compliance and
protect native species. For example, the voluntary moratorium called
for by PIJAC affected only two not-listed species, even though more
have been identified as carriers (Martel et al. 2014). The species with
the highest number of imports into the United States from 2004 to 2014
was the Oriental fire-bellied newt. This species comprised 54 percent
of the total number of imported salamanders (USFWS OLE 2015). A review
of LEMIS (Law Enforcement Management Information System) data in August
2016 shows that there were no shipments after November 20, 2015, for
Oriental fire-bellied newts declared to the Service, except for 6
shipments totaling 539 live animals that occurred since the inception
of the voluntary moratorium (all but 39 were before the rule took
effect). This situation suggests that the rule is necessary because
some importers, even if only a few, did not follow the voluntary
moratorium and imported hundreds of specimens. However, since the 2016
interim rule took effect and as of the end of 2020, no Pachytriton spp.
salamanders (not listed) have been imported, and we recognize and
appreciate the role that the PIJAC moratorium likely played.
(89) Comment: Although Alternative 3 of the draft economic
analysis, which declares 201 salamander species as injurious, is deemed
most effective, the commenter suggests that Alternative 4, which
declares all species of salamander as injurious, is necessary to fully
prevent the spread of Bsal in the United States. Furthermore, the
economic loss associated with Alternative 3 is estimated to be $10
million, while the economic loss associated with Alternative 4 is $10.7
million. The benefit of almost certainly preventing the spread of the
fungus into the United States as provided by Alternative 4 far
outweighs the marginal cost as compared to Alternative 3.
Response: The expected increase in cost from Alternative 3 to
Alternative 4 was not considered in our determination about the
injuriousness of the species. The Service determined that there was
unknown risk from genera where no species have yet been tested for Bsal
and, therefore, could not list those genera at this time.
(90) Comment: We need more citizen scientists to help with
salamander conservation. Many knowledgeable hobbyists are available to
assist if asked.
Response: We recognize that the public can play a critical role in
conservation; however, this comment is outside the scope of this
rulemaking.
(91) Comment: Put more funding into Bsal research to find a cure,
treatments, and other ways of reducing the risk.
Response: We recognize the important contributions made by Bsal
research; however, this comment is outside the scope of this
rulemaking.
(92) Comment: As new evidence becomes available and while Bsal
remains undetected in the United States, the commenter would like to
see a proposed rule with a comment period for native U.S. species,
rather than an interim final rule, before these new listings go into
effect. For nonnative species, however, we would support other interim
final rules to further reduce the chances of introduction via the
importation pathway.
Response: This second interim rule is adding new nonnative and
native species to the injurious list. See above in III. Final Rule to
the 2016 Interim Rule in A. Background. Also, several native species
are raised outside the United States and then imported into the
country; this supports the Service's decision to implement a nearly
immediate effective date of 15 days for all species listed under the
rule. See also response to Comment 24.
(93) Comment: The costs to State fish and wildlife agencies to deal
with pet salamanders that cannot be transported across State lines when
the owner moves do not appear to have been evaluated and could place a
significant burden on State agency staff that would be tasked with
informing the public about the rules, working with rescues and zoos to
provide rehoming opportunities, and law enforcement. The commenter
would like to see a Service-administered education and outreach program
that provides explicit instructions, and assistance, for pet owners to
properly rehome or dispose of their salamanders. One commenter
mentioned that the State of Florida has an Exotic Pet Amnesty Program
in place that allows the public to surrender their regulated or
unwanted exotic pets without penalty or cost. The commenter encourages
continued Federal support of this program as an integral part of
managing risks of nonnative introductions.
Response: The interstate prohibition was clarified by a court
decision in 2017 as explained in the final rule, so the costs for
transporting across State lines between States within the continental
United States is not an issue now, unless regulated by other State or
Federal laws. We share concerns about the irresponsible re-homing and
disposal of pet salamanders into the wild and are working with
partners, including the industry, to help ensure that release does not
occur. The Service has been a partner with the State of Florida's
Exotic Pet Amnesty Program and will continue to work with other
partners to help encourage the public not to release animals that they
own into the wild. The Service does not have the funds necessary to
implement a national amnesty and rehoming program.
(94) Comment: In the past, increased restrictions on species
already in widespread possession (personal and commercial) have been
accompanied by additional releases (such as walking catfishes,
snakeheads). The commenter recommends consideration of regulatory
approaches with the flexibility to accommodate existing ownership.
Further Federal restrictions, without this ``grandfathering'' approach
for current pet owners, may lead to an increase in the rates of
release.
Response: The commenter offers no proof that releases have been
caused by the new Federal regulation. The injurious wildlife provisions
of the Lacey Act do not prohibit continued ownership of injurious
wildlife that members of the public own at the time of listing. Under
the injurious wildlife provisions of the Lacey Act, the Service is not
authorized to grandfather in existing salamander owners as exempt
[[Page 2192]]
from subsequent activities that are prohibited with injurious wildlife,
including import or transport between the enumerated jurisdictions.
(95) Comment: Prohibit the use of amphibians as fishing bait. It
has been shown that using animals, such as tiger salamanders, as
fishing bait has led to species introductions (posing a major threat to
California tiger salamanders) and the spread of disease, particularly
Bd and ranaviruses. If Bsal ever enters the United States, it is far
more likely to be spread through bait shops and fishermen than from
hobbyists shipping to one another. Even if studies have shown tiger
salamanders are unlikely to carry Bsal, the practice has already been
shown to have spread other diseases, and other, more susceptible
species may be used.
Response: The request is beyond the scope of this rulemaking. The
Service, under the injurious wildlife provisions of 18 U.S.C. 42, is
not authorized to prohibit amphibians for use as fishing bait, unless
they are imported, transported between the enumerated jurisdictions, or
subject to injurious wildlife permits. We also note that the Service's
State partners regulate fishing activities within their States and can,
and often do, regulate use of amphibians for fishing bait.
(96) Comment: Include a clause that if a North American species is
determined to be a carrier or lethally infected, it will immediately be
included in the prohibition, and any species screened and determined to
be insensitive and not capable of carrying Bsal will be removed from
the list in a timely manner.
Response: The Service does not have authority to include or remove
species on the injurious wildlife list without evidence regarding
whether the wildlife is injurious to the interests protected under the
Lacey Act. The determination of injuriousness is based on defensible
scientific evidence. This rule does not preclude the ability to take
additional regulatory actions if new information emerges. If a species
is found to be incapable of carrying Bsal under all conditions, we may
consider its removal from the injurious list by conducting an
evaluation and promulgating a rule. Likewise, if a species is found to
be a carrier of Bsal, we may consider its addition or the addition of
its genus to the injurious list through this same regulatory process.
(97) Comment: Continue exploring a clean-trade program for future
emerging infectious diseases. As indicated in previous correspondence
with the Service, the commenter has consistently supported the concept
of a clean-trade program for salamanders imported into the United
States rather than restricting interstate movement of salamanders at
this point. The commenter appreciates that the current situation makes
executing such a program difficult, if not impossible; however, the
commenter hopes that the Service will continue exploring options for
such a program in the future for other emerging infectious diseases
that are likely to impact U.S. wildlife species.
Response: The interstate prohibition has been clarified as
explained in the final rule. Please also see heading in the second
interim rule on Ability To Prevent or Control the Spread of Pathogens
or Parasites. The Service will consider other options as opportunities
arise.
(98) Comment: The Service cites inadequate agency resources to
conduct inspections and expenses associated with testing as additional
reasons supporting its finding that there are not less restrictive
means to prevent Bsal than those selected for the 2016 interim rule. To
the extent that those expenses and hardships fall upon the owners of
salamanders, a commenter would like to work with the Federal Government
in developing safe, practical procedures. To the extent that those
burdens fall upon the agency, the Service must not discriminate between
regulation of salamanders in the pet trade and other species for which
it has dedicated resources to developing satisfactory testing
protocols.
Response: The Service welcomes and encourages engagement by a
myriad of entities that can develop the science and help better manage
wildlife pathogens entering, becoming established in, and spreading in
the United States. No safe, effective alternatives have yet been
presented to us. The fungus that affects the salamanders was discovered
in 2013, much more recently than the pathogens infecting salmonids for
which the Service has testing protocols. Much research needs to be done
on the tremendous diversity of salamanders and their in situ
environmental conditions to find an equitable, reliable, economical
test as well as testing facilities in other countries.
Other Issues
(99) Comment: The Wildlife Society recommends the development of
new comprehensive legislation to address the complexities of emerging
wildlife diseases that encourages investment, increases professional
capacity, focuses on collaborative prevention, and uses a
multidisciplinary approach to better understand the interaction and
transmission mechanisms of wildlife pathogens.
Response: The comment is outside the scope of this rulemaking.
(100) Comment: Since no method of pathogen control is likely to
reduce risk of invasion by 100 percent, it is equally important to
invest in proactive monitoring for Bsal emergence within the United
States. In August 2015, the commenter launched a citizen science
project on iNaturalist for people to report sightings of dead or
diseased salamanders. The commenter would be happy to work together
with the Service more quickly to identify and respond to potential
sites of Bsal emergence. More information about the project ``Saving
Salamanders with Citizen Science'' can be found at: <a href="http://www.inaturalist.org/projects/saving-salamanders-with-citizen-science">http://www.inaturalist.org/projects/saving-salamanders-with-citizen-science</a>.
Response: We shared this feedback with our National Wildlife Refuge
System's Inventory and Monitoring Program. The Service is also helping
the National Bsal Task Force and PARC to develop the protocols to
monitor for Bsal's introduction and to allow for rapid response if it
is identified in the United States.
(101) Comment: The commenter requests increased communication and
education efforts around the Bsal rule. There is still a significant
amount of confusion around the reasoning behind the scope of the action
taken in the rule, including, but not limited to, why certain species
were chosen and why interstate commerce was included. Addressing these
concerns through a coordinated education and communication initiative
would likely help garner further support for the implementation of the
rule. Many groups, such as caudata.org, the National Bsal Task Force,
and Partners in Amphibian and Reptile Conservation (PARC) would likely
be able to play a role in helping to disseminate this information.
Response: The interstate prohibition has been clarified as
explained in the final rule. The Service is a partner in PARC and a
member of the Bsal Task Force and appreciates the need to better
address the communication needs associated with the rule. We have also
been providing additional information through our website to assist
stakeholders in understanding the need for the rule and clarifying the
permit process.
(102) Comment: The rule is being exploited by animal rights
organizations who do not represent the majority of views of U.S.
citizens. This rule was formulated in part due to a petition by the
``Save the Frogs'' organization.
[[Page 2193]]
Response: The Service received the petition from the Center for
Biological Diversity and Save the Frogs! in mid-May 2015. However, we
began discussions on what action to take in October 2014 and had
already begun the regulatory process several months before we received
the petition. Letters to the Service Director from such agencies as
AFWA urged the Service to take action to prevent the fungus from
entering the United States, and we took action as soon as we were able
to make a determination based on defensible scientific evidence and
comply with applicable rulemaking requirements to promulgate injurious
wildlife listings under the Lacey Act within our available resources.
C. Affirmation of the 2016 Interim Rule
After careful consideration of the comments received and
information presented, we are affirming our 2016 listing of the 20
genera of salamanders that the 2016 interim rule added to the lists of
injurious wildlife in 50 CFR part 16 (81 FR 1534, January 13, 2016).
All species in the 20 genera continue to be listed as injurious
wildlife. The defensible scientific evidence continues to indicate that
the importation of these genera poses significant risks of introducing
Bsal into the United States, and none of the inputs received in
response to the 2016 interim rule have changed this determination.
Therefore, with this document, we affirm the addition of the following
genera to 50 CFR 16.14: Chioglossa, Cynops, Euproctus, Hydromantes,
Hynobius, Ichthyosaura, Lissotriton, Neurergus, Notophthalmus,
Onychodactylus, Paramesotriton, Plethodon, Pleurodeles, Salamandra,
Salamandrella, Salamandrina, Siren, Taricha, Triturus, and
Tylototriton. Because we consider rulemaking on the 2016 interim rule
to end with the publication of this document affirming the 2016 interim
rule, we are not soliciting comments regarding the genera listed in
this final rule.
D. Required Determinations
We hereby affirm our responses to the following determinations
required of the Federal rulemaking process as published in the January
13, 2016, interim rule (81 FR 1534):
<bullet> Executive Orders 12630, 12866, 12988, 13132, 13175, 13211,
and 13563;
<bullet> Regulatory Flexibility Act and Congressional Review Act (5
U.S.C. 601 et seq. and 804(2)) (except a decrease in the economic
effect on U.S. industries has occurred due to the clarification of the
interstate transport prohibition);
<bullet> Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.);
<bullet> Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.);
<bullet> National Environmental Policy Act (42 U.S.C. 4321 et
seq.); and
<bullet> Government-to-Government Relations with Native American
Tribal Governments (59 FR 22951 and 512 DM 2).
IV. Second Interim Rule
Summary of Changes to the 2016 Interim Rule
For the injurious wildlife evaluation in this second interim rule,
in addition to information used for the 2016 interim rule, we
considered: (1) comments and new information from the public comment
period for the 2016 interim rule, (2) comments on the 2016 interim rule
from three peer reviewers, and (3) new information acquired by the
Service after the 2016 interim rule published. This new information was
used to update the science about Bsal and determine if any additional
genera of salamanders should be added to the list according to the
criteria laid out in the 2016 interim rule.
This second interim rule incorporates into 50 CFR 16.14 the
clarifications and changes to the 2016 interim rule based on comments
we received that are discussed above in the final rule under B. Summary
of Comments Received on the 2016 Interim Rule. This is because only one
revision of 50 CFR 16.14 will be made from both rules and will include
the clarifications from the final rule and the new genera and
clarifications from this second interim rule.
We are clarifying, in response to public and peer-review comments,
what is and is not injurious on a cellular or molecular level based
upon chemical preservation or other methods that will kill the fungus.
Unpreserved swabs are injurious; however, preserving swabs, such as by
using 70 percent (or higher) ethanol for at least 1 minute (Van Rooij
et al. 2017), renders the fungus unviable and, therefore, preserved
swabs are not injurious and are excluded from the prohibitions. In
addition, purified extracted genetic material of salamanders
(salamander DNA or RNA) is unable to cause pathogen transmission;
therefore, it is not injurious. Swabs collected for molecular biology
applications should be preserved by using a higher ethanol
concentration (95-99 percent), which is adequate for both the molecular
preservation of DNA for testing and denaturing the proteins on the
surface of fungi, rendering them unviable and thus not injurious
(Marquina et al. 2021).
We provide evidence here that specimens that are chemically
preserved to deactivate any live Bsal and purified extracted genetic
material are not considered injurious. The Service has concluded that
there is a low risk of transmission of Bsal to native species from eggs
and gametes, preserved specimens, and purified extracted genetic
material, which is consistent with the intent of what is not injurious
in the 2016 interim rule. However, all other parts, such as unpreserved
salamander tissues, fluids, and cells carried on swabs and on or in
other media, will continue to be regulated under the listing. Specimens
that are frozen are also included in the listing.
The Service reviewed research that has published since the 2016
interim rule took effect and is adding 16 genera of salamanders to the
20 already listed in 50 CFR 16.14. This action adds approximately 164
species in this second interim rule to the previously listed 201
species. The genera are added under the same criteria that were used
for the original 20 genera in the 2016 interim rule. However, the
scientific community has made changes to salamander taxonomy within the
20 genera in the 2016 interim rule. Thus, the number of species that we
identified in those genera increased from 201 to 262 species as of May
1, 2023. The combined total is 36 genera with approximately 426
species. We note that taxonomic changes within each genus may occur at
any time for such reasons as new species discovered, subspecies
elevated to full species, species split into two species, and other
modifications resulting from genomic testing. All species subsequently
scientifically added to the genera that we are listing are also
heretofore considered listed species. For this reason, we are not
enumerating all of the known salamander species in each of the 36
listed genera in 50 CFR 16.14.
The statute (18 U.S.C. 42(a)(1)) refers to ``the offspring or eggs
of any of the foregoing'' as being injurious. Therefore, we are
clarifying that hybrids of species in any listed genus, including
offspring from a listed and a nonlisted parent, are injurious.
In response to the D.C. Circuit Court of Appeals Decision in United
States Association of Reptile Keepers, Inc. v. Zinke, 852 F.3d 1131
(D.C. Cir. 2017), the prohibition on interstate transport in the 2016
interim rule has been modified. The D.C. Circuit Court of Appeals held
that 18 U.S.C. 42(a) does not prohibit transport of injurious wildlife
between States within the
[[Page 2194]]
continental United States. Therefore, this interim rule clarifies that
50 CFR 16.3 does not prohibit interstate transport between States
within the continental United States. This means that transportation of
injurious wildlife between the 49 States within the continental United
States (the contiguous 48 States and Alaska, provided no international
borders are crossed) is not prohibited by the statute or injurious
wildlife regulations, unless that movement of the wildlife is
restricted due to conditions associated with issued injurious wildlife
permits. This change took effect as of April 7, 2017. However, import
of injurious wildlife into the United States remains prohibited. In
addition, transport of injurious wildlife between the listed
jurisdictions in the shipment clause (the continental United States,
the District of Columbia, Hawaii, the Commonwealth of Puerto Rico, and
any territory or possession of the United States) remains prohibited.
As before, injurious species may not transit into or out of the
District of Columbia. Also, injurious wildlife permits under 50 CFR
16.22 continue to be required to import injurious wildlife and to
transport injurious wildlife between the listed jurisdictions for
zoological, educational, medical, and scientific purposes; movements
within the continental United States may be subject to conditions from
an injurious wildlife permit.
Additionally, injurious wildlife unlawfully imported into the
United States or transported between the enumerated jurisdictions is
still unlawful to transport, including within the continental United
States. Under the Lacey Act Amendments of 1981, 16 U.S.C. 3372(a)(1),
it is unlawful for any person to import, export, transport, sell,
receive, acquire, or purchase any wildlife transported in violation of
any law of the United States. This includes transport of any injurious
wildlife imported into the United States or transported between the
enumerated jurisdictions in violation of 18 U.S.C. 42(a).
Need for an Interim Rule
Rulemaking under 18 U.S.C. 42 is governed by the Administrative
Procedure Act (APA) (5 U.S.C. 551 et seq.). The process of issuing a
proposed rule, providing the opportunity for public comment, and
completing a final rule can take a significant amount of time to
complete. During that time, the species proposed for listing are still
allowed to be imported and transported, offering increased
opportunities for introduction, establishment, and harm. Under section
553(b)(3)(B) of the APA, however, a proposed rule is not required when
the agency for good cause finds (and incorporates the finding and a
brief statement of reasons therefor in the rules issued) that notice
and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest. There is good cause to forgo notice
and public comment on a proposed rule in this case and instead take
immediate action in the form of an interim rule to help prevent the
Bsal fungus from being introduced, established, or spread in the United
States. Providing notice and public comment prior to implementing the
injurious wildlife prohibitions would be contrary to the public
interest because of the need to take immediate action due to the
significant risk from Bsal. Not only could the fungus cause the
devastation of some populations of native salamanders critical to
ecosystem health, but it could also cause mortality if it spreads in
the salamander pet trade. For these reasons, we find good cause in
accordance with 5 U.S.C. 553(d)(3) to make the second interim rule
effective 15 days after the date of publication in the Federal
Register.
This second interim rule is the result of peer-reviewed, scientific
information published since the publication of the 2016 interim rule.
At the time the 2016 interim rule published, there was very little
information on the newly described chytrid fungus species affecting
salamanders (discovered in 2013). We used defensible scientific
evidence to quickly stop the importation of the host species
(salamanders) of the fungus. However, after the 2016 interim rule
published, many research institutions realized the need for more
research, both on the novel fungus and on the effect on and variety of
host amphibians, to assess the validity of previous studies and
determine other potential carriers. That body of research, done
primarily in the United States, Europe, and Asia, has taken years to
develop and put through the peer-review and journal-publication
processes.
We have now compiled a more comprehensive picture of the fungus,
including 16 more genera that we determined are injurious (using the
same criteria as in the 2016 interim rule). We still have the
opportunity to prevent the contagious lethal fungus from being
introduced into the United States on salamanders in trade, hence the
need for the second interim rule with the new high-risk species. Some
of the new species are in the pet trade, and a proposed rule would give
the public the counterproductive opportunity to rush to import the
proposed species prior to the regulation. We note that a shipment of 24
live fire salamanders (Salamandra salamandra) was imported into Los
Angeles on January 26, 2016, which was 2 days before the listing took
effect (USFWS OLE 2021), although we do not know that the shipment was
intentionally shipped to preemptively avoid the 2016 interim rule's
effective date. Fire salamanders are the species that brought this
lethal fungus to the attention of scientists, and the shipment was
exported from Germany, where the fungus had been detected in 2015
(Schultz et al. 2020), making the potential for Bsal introduction from
this shipment a genuine threat. Fortunately, there is no evidence that
those imported salamanders carried Bsal.
Purpose of Listing as Injurious
The purpose of listing the live specimens, dead specimens, hybrids,
and parts (but not eggs, gametes, preserved specimens or parts
(including tissue), and purified extracted genetic material) of 16
genera of salamanders as injurious wildlife is to prevent the
accidental or intentional introduction of salamanders that are expected
to serve as carriers of Batrachochytrium salamandrivorans (hereafter,
Bsal), a fungus that poses a risk to native species of salamanders,
into the United States. The genera are all from the order Caudata and
are commonly referred to as salamanders and newts (hereafter,
salamanders). If Bsal is introduced into wild populations of native
salamanders, we expect it to cause significant harm to wildlife and the
wildlife resources of the United States.
Under 18 U.S.C. 42(a), the Service, through the Secretary of the
Interior, may prescribe by regulation any wild mammals, wild birds,
fishes, mollusks, crustaceans, amphibians, reptiles, or the offspring
or eggs of any of the foregoing found to be injurious to human beings,
to the interests of agriculture, horticulture, forestry, or to wildlife
or the wildlife resources of the United States. Salamanders are
amphibians, and the Service has the authority to list amphibians when
we find that they are injurious to one or more of the statutory
interests. We may list species before they are introduced into the
United States and have the opportunity to harm interests of the United
States as enumerated under 18 U.S.C. 42.
We have determined that salamanders that potentially carry Bsal are
injurious to wildlife and wildlife resources of the United States. With
this second interim rule, we are attempting to prevent the introduction
and subsequent establishment and spread of the salamander chytrid
fungus, Bsal, which
[[Page 2195]]
is a pathogen capable of causing significant harm to native salamander
species and their ecosystems. As described below under Role of
Salamanders in the Ecosystem, the benefits that these native salamander
species provide to ecosystems in ensuring ecosystem health and
stability, and, in turn, the ecosystem services that benefit people,
are significant.
As of the publication of the 2016 interim rule, Martel et al.
(2014) and Cunningham et al. (2015) identified some of the salamander
species that can carry Bsal and are at risk from infection. The
researchers tested a limited number of the approximately 689 (currently
804) known species of salamanders that exist worldwide and found that
not every species was negatively affected by the fungus, as determined
by standard detection methods. However, the results clearly indicated a
severe threat for many species of salamanders that will be negatively
affected by this pathogen and others that could carry the fungus to the
vulnerable species. Research showed that some tested species that are
native to the United States were found to be lethally vulnerable to the
fungus. Such an emerging infectious disease of fungal origin can cause
a significant loss in biodiversity and ecosystem services (Fisher et
al. 2012). Bsal research results and concerns about emerging infectious
disease, as described by Spitzen-van der Sluijs et al. (2013), Martel
et al. (2013), and Martel et al. (2014), generated a strong response
from academia, industry groups, and conservation and other
organizations who wrote to the Service seeking quick and decisive
action to ensure that Bsal does not have a similar impact on salamander
populations that Batrachochytrium dendrobatidis (Bd) has had on frogs
(see the 2016 interim rule). In early November 2014, the Service
initiated a review to determine whether salamanders capable of carrying
Bsal should be listed as injurious.
Martel et al. (2014, and others later) used several methods to
determine vulnerability to Bsal-caused disease of some salamander
species but do not have a category for the status as a carrier. While
the vulnerability of native species is of great concern to the Service,
the 2016 interim rule was primarily concerned with the ability of
viable Bsal spores to remain on salamander species or their parts, thus
introducing and spreading the fungus to the United States, causing
chytridiomycosis disease outbreaks in native salamander populations. We
reviewed the literature and based our criteria for determining carrier
status of genera on whether a species was found, as determined by
microscopic analysis of preserved tissue specimens (histology), qPCR
(quantitative polymerase chain reaction), or other confirmatory
approach to harbor viable spores.
We also looked at challenge studies, where a salamander that is
free of Bsal as determined by initial pathogen-specific qPCR, is then
inoculated with Bsal spores. A follow-up swab for qPCR is done at a
specified period of days later to see if the spores caused disease
according to field observations or histology or did not cause disease
but was able to invade the skin of that species long enough to move or
transmit the fungus to other salamanders, as confirmed by histology. We
also looked at surveillance studies of swabs of wild and captive
salamanders, where presence or absence of Bsal was determined by qPCR;
negative results were not evidence for being classified as noncarrier
whereas positive results were classified as carriers.
Regardless of the vulnerability of a species or the ability to
manifest disease, if the species is a carrier, we consider that genus
to be listable as injurious. However, if there is conclusive
countervailing evidence that at least one species in that genus is not
a carrier, as shown by histology, then we do not list the genus. Case
definition and diagnostic criteria are described in White et al.
(2016).
The 2016 interim rule effectively reduced import volume of targeted
species, but new research on species susceptibility suggests the list
of regulated species was incomplete regarding Bsal reservoir species
(Grear et al. 2021). Since the publication of the 2016 interim rule,
additional research has provided additional evidence of the diversity
of species and genera affected by Bsal or determined to be carriers
(for example, Yuan et al. 2018, Carter et al. 2020, Barnhart et al.
2020, Gray et al. 2023). Based on the Service's genus-level carrier
extrapolation from data obtained from the aforementioned publications,
and because Bsal has not been found in natural environments in the
United States (Waddle et al. 2020), the opportunity still exists to
prevent the introduction of Bsal by adding new genera of salamanders to
the injurious list. In 2017, following the 2016 interim rule and
Canada's temporary import ban of all living or dead salamanders, eggs,
sperm, tissue cultures, and embryos (made permanent in 2018;
Environment and Climate Change (ECCC) 2018), we received a letter from
the American Society of Ichthyologists and Herpetologists (ASIH 2017)
requesting the Service prohibit all salamander imports into the United
States. For reasons explained herein, we are not listing all
salamanders, but we are adding more genera, which we suggested in the
2016 interim rule was a possibility. We specifically solicited comment
on whether there is there any evidence suggesting that additional
species are carriers of Bsal and should be listed by this rule, and if
so, what species.
We reviewed Bsal risk in conjunction with those salamander species
known or suspected to carry the fungus utilizing injurious wildlife
evaluation criteria, described in more detail as part of this interim
rule in G. Factors That Contribute to Injuriousness of Salamanders.
These criteria were previously developed by the Service to evaluate
whether a species qualifies as injurious under 18 U.S.C. 42. The
resulting analyses form the basis for the Service's regulatory
decisions regarding injurious wildlife-species listings. This rule
finds that Bsal is a significant threat to the wildlife and wildlife
resources of the United States and lists 16 genera of salamanders that
we have determined to be injurious because they are likely carriers of
Bsal.
Multiple factors confirm that Bsal can be introduced, become
established, and spread, thereby causing substantial damage and harm in
the United States (Spitzen-van der Sluijs et al. 2013; Martel et al.
2014; Cunningham et al. 2015; Chytridcrisis 2015b). Specifically, these
factors include: (1) the discovery of the newly emerging fungus Bsal in
the Netherlands and the associated deleterious effects to native
salamanders (ibid.); (2) its subsequent spread in the wild to Germany
and Belgium (Spitzen-van der Sluijs et al. 2016) and Spain (Lastra
Gonz[aacute]laz et al. 2019; Martel et al. 2020); (3) the appearance in
captive collections in the United Kingdom, Germany, and Spain (Spitzen-
van der Sluijs et al. 2016; Thumsova et al. 2021); and (4) laboratory
research (numerous papers cited in this rule). The United States leads
all other countries in the number of native salamander species; 9 of
the 10 families of salamanders worldwide are found in the United States
(AmphibiaWeb 2023a). Based on scientific evidence as of publication of
the 2016 interim rule, we knew that the fungus is lethal to at least
two salamander species native to the United States (eastern newt
Notophthalmus viridescens in the Eastern States and rough-skinned newt
Taricha granulosa along the Pacific coast).
Of the 221 native U.S. species known as of the preparation of this
second interim rule (AmphibiaWeb 2023a), and including both rules in
this document,
[[Page 2196]]
we have determined that 13 genera with 164 species may be carriers, and
9 species are lethally vulnerable. Most of the remaining 10 genera
(with 57 species) have not been scientifically tested, with a few that
have had testing that was not conclusive; these may also be found to be
carriers eventually. While the Service's greatest concerns are for
species that are likely to die from Bsal, salamander species known to
be tolerant of, or susceptible to, Bsal infection under experimental
conditions may also develop clinical disease or experience increased
severity of disease in the wild. These species may be Bsal carriers and
are concerning because their long lifespans increase their likelihood
of spreading the fungal spores and serving as Bsal reservoirs (Gray et
al. 2023). A disease reservoir may be defined as ``a passive host or
carrier that harbors pathogenic organisms without injury to itself and
serves as a source from which other individuals can be infected'' (in
Laking et al. 2017). Nonlethal infection in salamanders may have other
negative effects, such as slowing their growth (Barnhart et al. 2020).
Bsal infections have been found to increase in severity as animals are
exposed to additional stressors in the wild, including other amphibian
diseases (Wobeser 2007; Kerby et al. 2011; Kiesecker 2011; Longo et al.
2019; McDonald et al. 2020).
Experience with the introduction of Bsal into the Netherlands and
associated deleterious effects to native salamanders, along with
laboratory research, confirm that Bsal can be introduced, become
established, spread, and cause substantial and immediate harm in the
United States (Spitzen-van der Sluijs et al. 2013; Martel et al. 2014;
Cunningham et al. 2015; Chytridcrisis 2015b). The United States leads
all other countries in salamander diversity (PARC 2014). Based on
scientific evidence, we know that the fungus is lethal to at least nine
salamander species native to the United States. While the Service's
greatest concern will be for species that are lethally vulnerable to
Bsal, salamander species known to be tolerant of or susceptible to Bsal
infection under experimental condit
[…truncated; see source link]Indexed from Federal Register on January 10, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.