[Federal Register Volume 60, Number 17 (Thursday, January 26, 1995)]
[Proposed Rules]
[Pages 5288-5307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1984]
[[Page 5287]]
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Part VI
Department of Agriculture
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Animal and Plant Health Inspection Service
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7 CFR Part 335
Plant Pests: Introduction of Nonindigenous Organisms: Proposed Rule
Federal Register / Vol. 60, No. 17 / Thursday, January 26, 1995 /
Proposed Rules
[[Page 5288]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 335
[Docket No. 93-026-1]
RIN 0579-AA61
Introduction of Nonindigenous Organisms
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule and notice of public hearings.
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SUMMARY: We are proposing to establish comprehensive regulations
governing the introduction (importation, interstate movement, and
release into the environment) of certain nonindigenous organisms. This
action appears to be necessary because the plant pest regulations under
which the movement of certain nonindigenous organisms are currently
regulated do not adequately address the introduction of nonindigenous
organisms that may potentially be plant pests. The proposed regulations
would provide a means of screening certain nonindigenous organisms
prior to their introduction to determine the potential plant pest risk
associated with a particular introduction.
DATES: Consideration will be given only to comments received on or
before March 27, 1995. We will also consider comments made at public
hearings to be held on March 6, 1995, in Kansas City, MO; March 7,
1995, in Sacramento, CA; and March 10, 1995, in Washington, DC. Each
public hearing will begin at 10 a.m. and is scheduled to end at 5:00
p.m.
ADDRESSES: Please send an original and three copies of your comments to
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, P.O.
Drawer 810, Riverdale, MD 20738. Please state that your comments refer
to Docket No. 93-026-1. Comments received may be inspected at USDA,
room 1141, South Building, 14th Street and Independence Avenue SW.,
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday,
except holidays. Persons wishing to inspect comments are requested to
call ahead on (202) 690-2817 to facilitate entry into the comment
reading room. The public hearings will be held at the following
locations:
1. Kansas City: Kansas City Airport Marriott, 775 Brasilia Avenue,
Kansas City, MO;
2. Sacramento: Holiday Inn Holidome, 5321 Date Avenue, Sacramento, CA;
3. Washington, DC: Jefferson Auditorium, U.S. Department of
Agriculture, South Building, 14th Street and Independence Avenue SW.,
Washington, DC.
FOR FURTHER INFORMATION CONTACT: Dr. Matthew H. Royer, Chief Operations
Officer, Biological Assessment and Taxonomic Support, Operational
Support, Plant Protection and Quarantine, APHIS, USDA, P.O. Drawer 810,
Riverdale, MD 20738. The telephone number for the agency contact will
change when agency offices in Hyattsville, MD, move to Riverdale, MD,
during February. Telephone: (301) 436-8896 (Hyattsville); (301) 734-
8896 (Riverdale).
SUPPLEMENTARY INFORMATION:
Public Hearings
Public hearings are scheduled to be held in Kansas City, MO, on
March 6, 1995; in Sacramento, CA, on March 7, 1995; and in Washington,
DC, on March 10, 1995.
A representative of the Animal and Plant Health Inspection Service
(APHIS), U.S. Department of Agriculture (USDA), will preside at each
public hearing. Any interested person may appear and may be heard in
person, by attorney, or by other representative. Written statements may
be submitted and will be made part of the meeting record. Persons who
wish to speak at a public hearing will be asked to provide their name
and organization. We ask that anyone who reads a statement provide two
copies to the presiding officer at the hearing.
Each public hearing will begin at 10 a.m. and is scheduled to end
at 5 p.m., local time. However, the hearing may be terminated at any
time after it begins if all persons desiring to speak have been heard.
If the number of speakers at the hearing warrants it, the presiding
officer may limit the time for each presentation so that everyone
wishing to speak has the opportunity.
The purpose of the hearings is to give interested persons an
opportunity for the oral presentation of data, views, and arguments.
Questions about the content of the proposed rule may be part of the
commenters' oral presentations. However, neither the presiding officer
nor any other representative of APHIS will respond to the comments at
the hearing, except to clarify or explain provisions of the proposed
rule.
Background
The Secretary of Agriculture has authority under the Federal Plant
Pest Act, as amended (7 U.S.C. 150aa through 150jj) and the Plant
Quarantine Act, as amended (7 U.S.C. 151 through 164a, 167) to regulate
the movement of articles to prevent the introduction and dissemination
into and within the United States of plant diseases, injurious insects,
and other plant pests, hereinafter referred to as plant pests. APHIS
has been delegated the authority to administer these and other related
statutes and has promulgated regulations implementing these statutes in
7 CFR chapter III.
Many of the regulations in 7 CFR chapter III are designed to
protect against the inadvertent dissemination of plant pests that may
be associated with certain plants, plant parts, or other articles. For
example, the foreign quarantine notices in 7 CFR part 319 contain
regulations that restrict the importation and entry of, among other
things, foreign cotton, sugarcane, fruits and vegetables, and coffee in
order to prevent the entry of plant pests.
The regulations in 7 CFR chapter III also provide for the issuance
of permits for the movement of plant pests into (importation) or
through (transit shipment) the United States, or interstate. A person
may apply to APHIS for a permit using the application process set forth
in the plant pest regulations in 7 CFR 330.200. Under those
regulations, APHIS will review an application and make a determination
as to whether the movement of the plant pest can be accomplished in a
manner that will prevent its dissemination. If adequate safeguards can
be put into place to prevent the dissemination of the plant pest, APHIS
may issue a permit for the movement into or through the United States,
or interstate, of the plant pest.
The scope of the plant pest regulations in 7 CFR 330.200 is limited
to the movement of known plant pests; the movement of nonindigenous
organisms not known to present a plant pest risk, as well as the
release of such organisms into the environment, are not addressed. A
report on nonindigenous species prepared by the U.S. Congress' Office
of Technology Assessment (OTA), ``Harmful Non-Indigenous Species in the
United States,'' (OTA-F-565, Washington, DC; U.S. Government Printing
Office, September 1993) (referred to below as the OTA report)
recommends that APHIS more closely examine any proposed introduction
(importation, interstate movement, or release into the environment)
into the United States of a nonindigenous organism. The OTA report
cited losses in the billions of dollars that can be attributed to the
negative effects of [[Page 5289]] certain nonindigenous organisms. As
U.S. agriculture's ``first line of defense,'' we believe that APHIS
must supplement its current regulations to prevent or minimize the
potential problems presented by the introduction of nonindigenous
organisms whose plant pest status is unknown. Therefore, we are
proposing to establish comprehensive regulations governing the
introduction of those nonindigenous organisms that we have reason to
believe may be plant pests or may result in the introduction or
dissemination of plant pests.
In our proposed regulations, a nonindigenous organism is defined as
any organism proposed for introduction into any area of the United
States beyond its established range. Therefore, an organism does not
have to be from another country to be considered nonindigenous; an
organism that has an established range only in one part of the United
States would be considered nonindigenous in another part of the United
States.
The proposed regulations would not eliminate the plant pest
regulations in 7 CFR 330.200. Those regulations would remain in place
to govern the importation and interstate movement of known plant pests,
both indigenous and nonindigenous. The proposed regulations would allow
APHIS to examine certain nonindigenous organisms proposed for
introduction to determine whether those nonindigenous organisms are
plant pests or constitute a risk of the introduction or dissemination
of plant pests. The proposed regulations would impose conditions on the
introduction of those nonindigenous organisms in order to prevent plant
pest dissemination. Under the proposed regulations, persons wishing to
import or move interstate a regulated nonindigenous organism would
first have to apply for a permit from APHIS. The proposed regulations
would also contain specific provisions regarding permits for the
release of certain nonindigenous organisms, such as pollinators or
biological control agents, into the environment.
It is the USDA's position that the provisions of the proposed rule
that would require a permit for the release of a nonindigenous organism
into the environment are consistent with the Federal Plant Pest Act and
the Plant Quarantine Act and are a reasonable construction of the
Secretary of Agriculture's statutory authority under those acts. The
Federal Plant Pest Act and the Plant Quarantine Act authorize the
Secretary of Agriculture to take certain actions to prevent the
introduction into and dissemination within the United States of plant
pests.
Scope
Our authority to regulate nonindigenous organisms is based on there
being reason to believe that such organisms may be plant pests or may
result in the introduction or dissemination of plant pests. Therefore,
any nonindigenous organisms that we propose to regulate would
necessarily have to fall within one of the categories of organisms
included in the definition of a plant pest or would have to present a
risk of introducing or disseminating a plant pest. The Federal Plant
Pest Act defines a plant pest as ``any living stage of: Any insects,
mites, nematodes, slugs, snails, protozoa, or other invertebrate
animals, bacteria, fungi, other parasitic plants or reproductive parts
thereof, viruses, or any organisms similar to or allied with any of the
foregoing, or any infectious substances, which can directly or
indirectly injure or cause disease or damage in any plants or parts
thereof, or any processed, manufactured, or other products of plants.''
Within the categories of organisms addressed above, there are
several nonindigenous organisms that are already regulated by APHIS
elsewhere in its regulations and would not, therefore, be included in
the scope of the proposed regulations. Those organisms are addressed
below in the discussion of proposed Sec. 335.2.
Proposed Regulations
The proposed regulations contain nine sections:
Sec. 335.1 Definitions.
Sec. 335.2 Regulated organisms.
Sec. 335.3 General restrictions on the introduction of regulated
organisms.
Sec. 335.4 Permits for the introduction of regulated organisms.
Sec. 335.5 Nonindigenous organisms exempted from regulation under this
part.
Sec. 335.6 Conditions for the introduction of regulated organisms.
Sec. 335.7 Facilities for the containment of regulated organisms.
Sec. 335.8 Container requirements for the movement of regulated
organisms.
Sec. 335.9 Costs and charges.
Each of these sections is discussed in detail below.
Definitions (Sec. 335.1)
In proposed Sec. 335.1, we define terms used in the regulations.
Several of these terms--Administrator, Animal and Plant Health
Inspection Service (APHIS), APHIS inspector, import, interstate,
introduce (introduction), move (moving, movement), permit, person, port
of first arrival, State, and United States--are terms used by APHIS
elsewhere in its regulations in 7 CFR chapter III and 9 CFR chapter I.
The remaining terms, as they apply to our proposed regulations, are
explained below.
We would define nonindigenous organism as ``any organism proposed
for introduction into any area of the United States beyond its
established range.'' This definition would place the primary focus on
whether the area into which an organism would be introduced is within
or outside of the organism's established range (which we would define
as ``the area in which a species maintains a self-sustaining, free-
living population'').
To identify the organisms covered by the proposed regulations, the
term regulated organism would be defined as ``any living stage of any
nonindigenous organism belonging to the taxa listed in Sec. 335.2(a)
that is not listed in Sec. 335.2(b) or exempt in accordance with
Sec. 335.5.'' The list in Sec. 335.2(a) is set forth later in this
proposed rule.
We would define environment as ``all land, air, and water; and all
living organisms in association with land, air, and water.'' As part of
our review of permit applications, we must consider a regulated
organism's effects on the environment within its established range and
its potential to affect the environment in the area into which its
introduction is proposed. The proposed definition, therefore, takes
into account those elements of what is commonly considered to be ``the
environment'' that could be affected by the introduction of a regulated
organism.
Established would be defined as ``the condition of a species that
has formed a self-sustaining, free-living population at a given
location.'' We are proposing to require that a person seeking a permit
furnish, as part of a permit application, information pertaining to a
regulated organism in its established range. This definition would help
to clarify the information to be included in an application.
Plant would be defined as ``any stage of any member of the plant
kingdom including, but not limited to, trees, plant tissue cultures,
plantlet cultures, pollen, shrubs, vines, cuttings, grafts, scions,
buds, roots, seeds, cells, tubers, and stems.'' Plant product would be
defined as ``any processed or manufactured plant or plant part.'' These
definitions are based on our statutory authority under the Federal
Plant Pest Act, as amended, and the Plant Quarantine Act, as amended.
We would use the definition provided for plant pest in the Federal
Plant Pest [[Page 5290]] Act: ``Any living stage of any insects, mites,
nematodes, slugs, snails, protozoa, or other invertebrate animals,
bacteria, fungi, other parasitic plants or reproductive parts of
parasitic plants, viruses, or any organisms similar to or allied with
any of the organisms previously identified in this definition, or any
infectious substances, which can directly or indirectly injure or cause
disease or damage in any plants or plant parts, or any processed,
manufactured, or other products of plants.''
We would define release into the environment as ``the use of a
regulated organism outside the constraints of physical confinement.''
Given the nature of many regulated organisms, we believe that it is
necessary to treat any use of a regulated organism outside of the
constraints of physical confinement, such as those found in a
laboratory or greenhouse, as a release into the environment.
Regulated Organisms (Sec. 335.2)
Paragraph (a)(1) of proposed Sec. 335.2 contains a list of
taxonomic groups that include known plant pest species. We have reason
to believe that other species within those taxonomic groups may also be
plant pests; therefore, we believe that nonindigenous organisms within
those taxonomic groups should be evaluated prior to their introduction
into the United States. The list was drawn from a similar list
contained in 7 CFR part 340 and was developed based on APHIS'
experience with issuing plant pest permits. (The list in proposed
Sec. 335.2(a)(1) differs from the list in 7 CFR part 340 in two
respects. First, parasitic weeds of the species Alectra are included on
the list in 7 CFR part 340 but have been omitted from the list in
proposed Sec. 335.2(a)(1) because Alectra spp. are listed noxious weeds
in 7 CFR 360.200. The second respect in which the two lists differ is
that the list in proposed Sec. 335.2(a)(1) contains additional
taxonomic groups under the class Insecta. These additional groups,
which are listed below, were included on the list in proposed
Sec. 335.5(a)(1) based on APHIS' experience with issuing plant pest
permits:
Family Aphelinidae
Family Braconidae
Genus Perilitus
Family Diapriidae
Genus Ismarus
Family Encyrtidae
Family Eulophidae
Family Ichneumonidae
Subfamily Cryptinae
Subfamily Diplazontinae
Subfamily Gelinae
Subfamily Mesochorinae
Subfamily Ephialtinae
Family Pteromalidae
Family Scelionidae
Genus Gryon
Genus Scelio
Family Signiphoridae
Family Trichogrammatidae
If the list in proposed Sec. 335.2(a)(1) is adopted and a person
believes that an
organism should be added to the list, that person could petition
APHIS for a change in the regulations under the Administrative
Procedure Act (5 U.S.C. 553(e)) and the USDA's regulations in 7 CFR
part 1.
The taxonomic scheme used in proposed Sec. 335.2(a)(1) is a five-
kingdom system, found in S.P. Parker's ``Synopsis and Classification of
Living Organisms'' (McGraw Hill, 1984). Within each taxon, all
nonindigenous species are regulated organisms, unless there are taxa of
lower rank specifically listed, in which case only those specifically
listed, lower-ranked taxa are regulated organisms. Other classified
organisms not listed are not regulated organisms.
We believe that organisms that are currently unclassified or whose
classification is unknown should be evaluated prior to their
introduction into the United States because of the possibility that the
organisms contain plant pests or are themselves plant pests; therefore,
such organisms would also be regulated organisms under
Sec. 335.2(a)(2).
As mentioned above, the proposed regulations would not supplant our
existing plant pest regulations in 7 CFR 330.200. Additionally, there
are other organisms covered elsewhere in existing regulations that
would also remain regulated under the existing regulations. To make
that clear, paragraph (b) of proposed Sec. 335.2 would specify that the
following categories of organisms would continue to be regulated under
their existing regulations: Live bees other than honeybees of the genus
Apis regulated under 7 CFR 319.76; plant pests regulated under 7 CFR
330.200; live honeybees of the genus Apis regulated under 7 CFR part
322; organisms genetically engineered through recombinant DNA
techniques regulated under 7 CFR part 340; noxious weeds regulated
under 7 CFR part 360; organisms and vectors that may introduce or
disseminate contagious animal diseases regulated under 9 CFR part 122;
and etiologic microorganisms that cause disease in humans (including
bacteria, bacterial toxins, viruses, fungi, rickettsia, protozoans,
arthropods, parasites, and the hosts and vectors that may carry these
etiological microorganisms) that are regulated by the Centers for
Disease Control and Prevention under 42 CFR part 71, unless the
microorganism, host, or vector could also be a plant pest.
General Restrictions on the Introduction of Regulated Organisms
(Sec. 335.3)
This section of the proposed regulations prohibits the introduction
of any regulated organism unless the regulated organism is introduced
in accordance with the proposed regulations. This means that a
regulated organism may not be imported, moved interstate, or released
into the environment unless APHIS has given its authorization to do so.
Under the proposed regulations, that authorization would entail the
issuance of a permit for the introduction in accordance with proposed
Sec. 335.4. The permit application process is discussed in detail
below.
Section 335.3 of the proposed regulations also provides that any
introduction of a regulated organism that is not in compliance with the
provisions of the proposed regulations makes that regulated organism
subject to destruction, disposal, or the remedial measures that the
Administrator determines to be necessary to prevent a plant pest from
being introduced into, or disseminated within, the United States.
We believe that these restrictions on the introduction of regulated
organisms are necessary to prevent the introduction and dissemination
within the United States of plant pests.
Permits for the Introduction of Regulated Organisms (Sec. 335.4)
Section 335.4 of the proposed regulations sets forth the proposed
process by which a person may obtain a permit from APHIS for the
introduction of a regulated organism. The section also sets forth the
procedure that would be followed by APHIS in response to the receipt of
a permit application and the appeal procedure that would be available
in the event of APHIS' denial of a permit application or revocation of
a permit.
Proposed paragraph (a) provides that an application for a permit
must be submitted to the Administrator in care of Biological Assessment
and Taxonomic Support (BATS), which is the staff within APHIS that
would be responsible for the processing of permit applications
submitted under the proposed regulations. The application would have to
state the type of permit being requested by the applicant (import,
interstate movement, or release into the environment). Although the
mailing address of BATS is provided in [[Page 5291]] proposed paragraph
(a), the proposed regulations would not necessarily require that an
application be submitted through the mail. By not specifically
requiring that an application be made in written form through the mail,
we are intentionally leaving open the possibility that a person could
submit an application using other means, such as via facsimile machine
or in an electronic medium compatible with APHIS equipment.
Proposed paragraph (a)(1) provides that a person may apply for a
permit for the importation or interstate movement of regulated
organisms within a taxon of a higher level than species (genus, family,
order, class, phylum). Because research is not always confined to a
single organism, or even to an identified group of organisms, the
issuance of such a permit would give researchers the ability to import
or move interstate a wide range of regulated organisms without having
to submit a permit application for each species or strain of regulated
organism. We believe that we could assure the prevention of plant pest
dissemination during the importation or interstate movement of even a
wide range of regulated organisms by assigning specific conditions that
would apply to the importation or interstate movement of all regulated
organisms covered by the permit. The conditions that would be assigned
to the permit would be designed to ensure that there is an appropriate
level of biosecurity, which would be determined by the biological
characteristics of the entire taxon. Because the range of organisms
that might be included in a permit could be quite broad, the assigned
safeguards may be more stringent than those that might be assigned to a
single organism within the same taxon.
Proposed paragraph (a)(2) contains provisions for the
identification of trade secret or confidential business information
(CBI). As set forth in the USDA's regulations regarding the handling of
information from private businesses (see 7 CFR 1.11), the USDA is
responsible for making the final determination with regard to the
disclosure of information designated CBI, but the policy of the USDA is
to obtain and consider the views of the submitter and to provide the
submitter the opportunity to object to the disclosure of CBI.
Under proposed paragraph (a)(2), if an application contained any
information deemed to be CBI, we would require that two copies of the
application be prepared. Each page of one copy would have to be marked
``CBI Copy'' and have all CBI designated as such. The second copy would
be required to have all designated CBI deleted and would be marked
``CBI Deleted'' on each page of the copy.
Proposed paragraph (a)(3) provides that an application for a permit
for the importation or interstate movement of a regulated organism must
be received by the Administrator at least 30 days prior to the date of
the proposed importation or interstate movement and that an application
for the release into the environment of a regulated organism must be
received by the Administrator at least 120 days prior to the date of
the proposed release. The 30- and 120-day time periods referred to in
proposed paragraph (a)(3) are necessary to ensure that APHIS has
adequate time to review applications for permits.
Proposed paragraph (a)(4) provides that, after receiving an
application, APHIS would conduct a review to determine whether the
application contains all of the information required by proposed
Sec. 335.4. This review would be completed within 15 days of our
receipt of an application for importation or interstate movement, and
within 30 days of receiving an application for release into the
environment. Upon completion of the review to determine whether the
application contains all of the information required by proposed
Sec. 335.4, we would inform the applicant of the date that the
application was received, which would be the date that the review
period had commenced, or, if the application is incomplete, what
additional information is needed. Once an application is complete,
APHIS would commence its review of the application. A copy of the
application marked ``CBI Deleted'' or ``No CBI'' would be forwarded to
the State department of agriculture in the State where the introduction
is planned so that the State would have an opportunity to review the
application and convey any comments to APHIS.
In addition to that State review, which, unless waived by an
individual State, would be conducted on all applications for the
importation, interstate movement, or release into the environment of a
regulated organism, there are several Federal agencies other than APHIS
that have authority over the release into the environment of certain
regulated organisms. (Within the USDA, there are the Agricultural
Marketing Service, the Agricultural Research Service, the Cooperative
State Research Service, the Forest Service, and the Extension Service;
outside the USDA are the Fish and Wildlife Service, the National
Oceanic and Atmospheric Administration, the Department of Defense, the
Environmental Protection Agency, the Centers for Disease Control and
Prevention, the Customs Service, the U.S. Coast Guard, the U.S. Army
Corps of Engineers, and the Drug Enforcement Agency.) These agencies
may be consulted as part of our 30-day review to determine whether the
application contains all of the information required by proposed
Sec. 335.4. There also may be instances when consultation with another
Federal agency would be required. For example, APHIS would have to
consult with the Fish and Wildlife Service if APHIS determined that a
regulated organism proposed for release into the environment may have
an effect on a threatened or endangered species. Because another agency
would be involved, APHIS would no longer have full control over the
review of an application and could not, therefore, be certain that the
review would be completed in the specified 120-day review period. In
such cases, the applicant would be notified, in writing, of the need
for consultation and informed that the review period may extend beyond
the specified 120 days.
When an application contains all the information required by
proposed Sec. 335.4 and outside consultation is not required, we
believe that the applicable 30- or 120-day review period is sufficient
for APHIS to thoroughly examine all aspects of a particular proposed
introduction of a regulated organism. Based on our past experience in
processing applications, we anticipate that, in many cases, action on a
permit application would be completed in less time. When sufficient
applicable data are available from previously issued permits, APHIS may
be able to complete its review of a permit application in appreciably
less time than the applicable 30- or 120-day review period.
Paragraphs (b) through (e) of proposed Sec. 335.4 contain the data
requirements that would have to be met for an application to be deemed
complete. Paragraph (b) contains data elements that would apply to all
permit applications; paragraphs (c), (d), and (e) contain specific
additional data elements that would be required for applications for
importation, interstate movement, and release into the environment,
respectively.
Except for those elements that are administrative in nature, the
proposed data elements would be a means by which we could assess the
plant pest and environmental risks involved in a proposed introduction.
A regulated organism of concern would fall into one of the following
categories: (1) An organism of foreign origin that is not
[[Page 5292]] present in the United States; (2) an organism of foreign
origin that is present in the United States but is capable of further
expansion beyond its present established range; and (3) an organism of
foreign origin that has reached its full range of potential
establishment in the United States but is sufficiently biologically
different from the organism that is present in the United States to
warrant concern. In each of these three categories, the regulated
organism may be also of concern if it can vector a foreign plant pest
that also falls into one of the three categories. The criteria we may
use to further determine whether a regulated organism in one of the
above categories warrants concern may be whether the organism causes an
increase in the population of a plant pest or whether the organism
causes injury or disease to plants.
We believe the information that would be required in a permit
application is necessary for APHIS to be able to gain a clear
understanding of the potential plant pest risk and environmental
effects of the introduction for which a person is seeking a permit. The
specific data requirements are discussed in detail below.
The first item that would be required under proposed paragraph (b)
for all permit applications would be the name, address, telephone
number, and facsimile number of the person seeking a permit. This
information is necessary because the permit will be issued to that
person, and we will likely need to contact that person during the
application review process.
We would then require several items that would serve to identify
the regulated organism and describe its biology. To that end, we would
require:
1. The scientific name, common name, and any other information that
serves to identify the regulated organism as specifically as possible
(including the subspecies, race, and strain of the regulated organism)
and a description of the methods used to establish the identity of the
regulated organism. The accurate identification of a regulated organism
is a necessary first step in APHIS' review of an application, and
knowing what methods were used, including consultation with experts, to
identify the regulated organism would enable APHIS to evaluate the
accuracy of the identification. If new techniques or information become
available that allow the regulated organism to be more accurately
identified, APHIS may need this information from the applicant in order
to fairly review the application and assess the plant pest and
environmental risks associated with the proposed introduction of the
regulated organism. This type of information would also help APHIS to
verify whether the application is complete by comparing information
provided in the application to that available in the literature and
other sources.
2. A description of the measures that have been taken to establish
that the regulated organism and any material associated with the
introduction of the regulated organism do not contain any organisms not
identified in the permit application. This information would be used by
APHIS to address the issue of purity as it applies not only to the
regulated organism itself, which may have hyperparasites or other
organisms, for example, but also as it applies to any material, such as
packaging or host material, associated with the introduction of the
regulated organism. By knowing what organisms will be associated with
the regulated organism, APHIS can more comprehensively determine the
plant pest risk associated with the regulated organisms and assign
appropriate conditions on the permit.
3. The intended use of the regulated organism. This information
would apprise APHIS of the materials, methods, or procedures to be used
in the intended experimental, commercial, or other uses of the
regulated organism. That knowledge would be used by APHIS to assess
plant pest risk, determine conditions necessary to mitigate the risk,
and come to a decision regarding the issuance or denial of a permit.
Additionally, pursuant to the provisions of the National Environmental
Policy Act of 1969 (42 U.S.C. 4321 et seq.) (NEPA), we will consider,
during our analysis, the potential beneficial or harmful effects that a
regulated organism could have on the environment, such as the effects
that a regulated organism used as a biological control agent could have
on its target and nontargets.
4. A description of the life cycle, biology, and ecology of the
regulated organism. Understanding a regulated organism's potential for
survival, establishment, and dispersal would enable APHIS to determine
the plant pest risk associated with the regulated organism. A
description of the biological characteristics of the organism would be
of use to APHIS during its review of the permit application, especially
if relatively little is known about the organism.
5. Whether the regulated organism has been genetically modified (if
so, include a description of the genetic modification). If the
regulated organism has been genetically modified through sexual
recombination and selection for traits not typical of the organism in
nature, through induced mutation and selection for special traits, or
through other classical techniques, APHIS would need a description of
the modification in order to assess the biology of the modified
regulated organism insofar as it differs from that of an unmodified
organism of the same species. If, on the other hand, recombinant DNA
techniques had been used to effect a modification, BATS would refer the
applicant to the Biotechnology Permits staff of Biotechnology,
Biologics, and Environmental Protection, which handles permits for
genetically engineered organisms.
6. The country and locality where the regulated organism was
originally collected from nature, and the countries and localities
where the regulated organism has been propagated and maintained since
its collection. When assessing plant pest risk, APHIS would consider
the conditions in the country or countries in which a regulated
organism was collected, propagated, and maintained. This information
would be used by APHIS to determine whether sufficient safeguards are
in place to prevent contamination of the regulated organism by other
organisms. In addition, an organism may genetically vary from area to
area, so this information may have bearing on APHIS' determination of
plant pest risk.
7. The established range of the regulated organism in the United
States. If the regulated organism is already established in one or more
areas of the United States, this information would be used to determine
the plant pest and environmental risks to areas of the United States in
which the organism does not already occur, and to identify
circumstances under which consultation with specific States and other
parties may be necessary before assigning conditions for the movement
or release of a regulated organism that is established within the
United States.
We would also require information relating to details of the
proposed introduction:
8. The number of specimens or units of the regulated organism to be
introduced. The scale of the introduction would be one factor
considered when assessing the possible plant pest risk associated with
a regulated organism. APHIS would consider whether the destination
facility listed on the application is equipped to handle any large
quantities of a regulated organism. The safeguards assigned as
conditions of a permit would have to be adequate to mitigate that risk.
[[Page 5293]]
9. A description of any host material, substrate, medium, or
organism that will accompany the regulated organism. There may be times
when the material accompanying a regulated organism is itself regulated
or restricted, such as a nonindigenous rust fungus on plants of the
genus Berberis. (The interstate movement of certain Berberis species is
restricted under 7 CFR 301.38.) An accurate description of the material
accompanying a regulated organism would enable APHIS to ascertain the
purity of the regulated organism and to decide whether the requirements
of other regulations needed to be met before a permit could be issued.
The final three data requirements of paragraph (b) direct the
person applying for a permit to answer the additional questions in
paragraph (c) if applying for a permit to import a regulated organism,
paragraph (d) if applying for a permit to move a regulated organism
interstate, and paragraph (e) if applying for a permit to release a
regulated organism into the environment.
A person applying for a permit to import a regulated organism would
have to provide the following seven data elements in proposed paragraph
(c) in addition to the data elements required by paragraph (b):
10. The country and locality from which the regulated organism will
be exported to the United States. When assessing plant pest risk, APHIS
would consider the conditions in the country and locality in which a
regulated organism was maintained. This information would be used by
APHIS to determine whether sufficient safeguards are in place to
prevent contamination of the regulated organism by other organisms.
11. The address, telephone number, and facsimile number of the
person in the exporting country from whom the regulated organism will
be received. This information would be used by APHIS to assess whether
sufficient safeguards are in place in the exporting country to prevent
contamination of the regulated organism by other organisms. APHIS would
need to know whether a regulated organism is coming from, for example,
some type of commercial or scientific establishment or directly from
nature in order to accurately assess all factors affecting the purity
of an organism.
12. The port of first arrival in the United States through which
the regulated organism is intended to be imported. Section 335.6 of the
proposed regulations would require that all regulated organisms
imported into the United States be imported through a port of first
arrival that has a plant inspection station. The answer to this
question would allow APHIS to ensure that the person importing a
regulated organism planned to use a plant inspection station and would
give APHIS the opportunity to give advance notice to personnel at the
port of first arrival as a means of facilitating handling of the
regulated organism.
13. The address (including the county), telephone number, and
facsimile number of the facility to which the regulated organism will
be delivered. Under Sec. 335.6 of the proposed regulations, all
regulated organisms imported into the United States could be moved only
to the destination listed on its permit. APHIS would need to know the
destination of the organism so that the facility could be inspected to
verify whether the conditions at the facility meet the requirements of
proposed Sec. 335.7.
14. A detailed description of the procedures, processes, and
safeguards that will be used in the destination facility to prevent the
escape and dissemination of the regulated organism and any material
accompanying the regulated organism. This information is necessary for
APHIS to assess whether the conditions at the facility in which the
regulated organism would be held meet the requirements of proposed
Sec. 335.7.
15. The means by which the regulated organism will be imported into
the United States (air mail, air freight, baggage, or motor vehicle).
This information would be provided to an APHIS inspector at the port of
first arrival to facilitate the entry of a regulated organism.
16. The planned date(s) of the importation of the regulated
organism. The planned dates of importation would be needed so APHIS
could verify that a regulated organism was received at its destination.
Also, there may be circumstances when APHIS would recommend or assign
dates of importation to help minimize the risk of spread in the event
of an escape of the regulated organism.
A person applying for a permit to move a regulated organism
interstate would have to provide the six data elements in paragraph (d)
in addition to the data elements required by paragraph (b). These six
data elements are:
17. The State and locality from which the regulated organism will
be moved interstate. When addressing plant pest risk, APHIS would
consider the conditions in the State and locality in which a regulated
organism was located. This information would be used by APHIS to
determine the plant pest risk posed by the regulated organism.
18. The address, telephone number, and facsimile number of the
person in the originating State from whom the regulated organism will
be received. For interstate movement, the proposed regulations in
Sec. 335.6 would require that a regulated organism be moved interstate
only to the destination listed on the permit. Knowledge of the location
from which the regulated organism is to be moved would help APHIS to
determine whether conditions at the facility in which the regulated
organism would be held after interstate movement meet the requirements
of proposed Sec. 335.7.
The remaining four data requirements for paragraph (d) are the same
as the final four data requirements in paragraph (c), and would serve
the same purpose in APHIS' review of the application.
A person applying for a permit to release a regulated organism into
the environment would have to address the data elements in proposed
paragraph (e) in addition to the data elements already required by
proposed paragraph (b). The effects of releasing a regulated organism
into the environment generally have the potential to be much more far-
reaching than those associated with importation and interstate
movement. When considering an application for an environmental release,
APHIS must consider the plant pest risk associated with the release and
the effects the release could have on the environment as a whole. This
means that the provisions of statutes such as the Endangered Species
Act and NEPA would have to be considered.
As discussed previously, there are several agencies other than
APHIS that may have an interest in the release into the environment of
regulated organisms and that may be consulted as part of our 30-day
review to determine whether the application for a permit to release a
regulated organism into the environment contains all the data required
by proposed Sec. 335.4. The additional requirements of paragraph (e)
would, therefore, be used to help determine what statutes might apply
to the proposed release into the environment and what agencies APHIS
might have to contact during its review of the application. We envision
that State regulatory officials will play a significant role in
providing environmental and ecological data regarding the location
where the regulated organism is to be released, and otherwise assist in
the enforcement of the Federal regulations on a cooperative basis.
[[Page 5294]]
The additional data requirements for applications to release a
regulated organism into the environment are:
19. The purpose of the release into the environment of the
regulated organism. This information would be used by APHIS during its
preparation of an environmental assessment.
20. The anticipated date(s) of the release into the environment of
the regulated organism. This information would be used to determine the
possible effects on nontarget species that may be particularly
susceptible or exposed to the regulated organism at the time of its
release into the environment.
21. A description, including methods of release and release
site(s), of the intended release into the environment of the regulated
organism. The method of release may impact the risk presented by the
regulated organism to the environment or plants, and APHIS may specify
conditions on a permit to mitigate that risk. The locations of planned
release sites would be needed to facilitate the evaluation of future
applications for releases of regulated organisms into the environment
at the same sites in the future.
22. A description of all testing and review that has been conducted
to assess the effects of the regulated organism on the environment.
This data element would be used to help APHIS evaluate whether
sufficient testing and review to determine the potential environmental
effects of a regulated organism had been conducted prior to issuing a
permit for release into the environment. If the regulated organism is
to be used as a biological control agent, any testing and review that
has been conducted to assess the effects of the biological control
agent on nontarget organisms must be described.
23. The effect of the regulated organism on the environment in its
established range. This information would be used to help APHIS
evaluate the anticipated effects, including potential effects on
threatened and endangered species, of releasing the regulated organism
into the environment. These effects may include destruction or
lessening of the aesthetic, recreational, or commercial value of the
environment, including threatened and endangered species. If APHIS
determined that there would be negative effects on the environment or
on threatened or endangered species, APHIS would report that
information to the proper Federal authorities.
24. The host specificity of the regulated organism under both
artificial and natural conditions. This information would help focus
APHIS' investigation of the nontarget effects of the regulated
organism. Of particular interest to APHIS would be the regulated
organism's potential effects on any biological control agents that
already might be in use in the area of the proposed release. This data
element, as well as those data elements dealing with the regulated
organism's effects on nontargets and the environment, would help APHIS
address that concern.
25. References to any published and unpublished documents that
support the information required by paragraphs (e)(4), (e)(5), and
(e)(6) of this section. If available to the applicant, copies of any
unpublished referenced documents must be attached to the application.
If the application contains information that is supported by available
literature, it would be useful for APHIS to review that literature to
assess plant pest risk and potential environmental effects. APHIS could
reasonably expect to have access to any published material cited in the
application, but the unpublished documents available to the applicant
must be attached to the application.
Facility and Release Site Inspection
Paragraph (f) of proposed Sec. 335.4 would provide that the
Administrator may inspect the facility into which a regulated organism
proposed for importation or interstate movement would be moved to
determine whether the procedures, processes, and safeguards at the
facility meet the requirements of proposed Sec. 335.7. Similarly, the
Administrator would be allowed to inspect the site where a regulated
organism would be released into the environment so that a determination
could be made as to the effects on the environment of the proposed
release of the regulated organism.
Administrative Action on Applications
Paragraph (g) of proposed Sec. 335.4 would provide that a permit
would be either issued or denied upon completion of APHIS' review of
the application.
If a permit is issued, it would be numbered and would specify the
conditions that would apply to the introduction of the regulated
organism. There may be considerations based on the particular
characteristics of a regulated organism that APHIS would take into
account when determining the length of time for which a permit would be
valid. Thus, to allow both APHIS and the permittee the greatest degree
of flexibility, all permits would not be valid for the same
predetermined length of time; rather, the length of a permit's validity
would be based on the circumstances of that particular introduction.
Therefore, we are proposing that a permit could be valid for as long as
10 years following the date of issuance, unless the permit was revoked
in accordance with proposed Sec. 335.4(h). The expiration date would be
specified on the permit.
Proposed paragraph (g)(2) states that if a permit is denied, the
applicant would be promptly informed, in writing, of the reasons the
permit was denied and given the opportunity to appeal the denial in
accordance with proposed Sec. 335.4(h).
A permit application would be denied to an applicant from whom a
permit had been revoked within the past 12 months due to the failure of
the applicant or the applicant's agents or employees to comply with the
proposed regulations or any condition specified on the permit, unless
the permit has been reinstated upon appeal. We believe that this
provision is necessary to ensure that applicants who have had a permit
revoked for cause are not able to immediately reapply for a new permit.
We believe this would discourage violations of the regulations and
would help advance the effectiveness of the permit system as a means of
excluding plant pests from the United States.
Proposed paragraph (g) would further provide that a permit would be
denied if an APHIS inspector is not allowed to inspect the facility
into which a regulated organism proposed for importation or interstate
movement would be moved or the site where a regulated organism is
proposed to be released into the environment. In order to prevent or
mitigate the potential plant pest risks that may be associated with an
introduction, we believe that it is essential that APHIS have the
opportunity to assess the conditions under which a regulated organism
would be held after movement or released into the environment.
A permit would also be denied if the Administrator determines,
based on a review of the available information, that the introduction
of the regulated organism would present a significant risk of plant
pest dissemination and that no adequate safeguards could be arranged to
mitigate the risk presented by the proposed introduction.
Denial or Revocation of Permit; Appeals
Proposed paragraph (h) would provide that APHIS may revoke a permit
that has already been issued if the conditions of the permit or any
part of the proposed regulations were violated by the person to whom
the permit was issued, or his or her agents or employees. We believe
that the proposed regulations are necessary to [[Page 5295]] ensure
that the introduction of regulated organisms would be conducted under
conditions that prevent the introduction and dissemination of plant
pests; that desired level of safety could not be reached if a regulated
organism was introduced contrary to the conditions of the permit or the
proposed regulations. If a person believed that a permit was wrongfully
revoked or a permit application was wrongfully denied, that person
could appeal to the Administrator, in writing. The appeal process is
set forth in paragraph (h) of proposed Sec. 335.4.
Paragraph (i) of proposed Sec. 335.4 would require the person to
whom a permit for the introduction of a regulated organism has been
issued to maintain records for 10 years that identify the regulated
organism as specifically as it can be determined, identify the
characteristics of the regulated organism, and state the disposition of
the regulated organism. Proposed paragraph (i) provides that an APHIS
inspector shall be allowed access to records required to be maintained
under the proposed paragraph for inspection and copying during normal
business hours. The proposed requirement that the records be kept for
10 years following the issuance of a permit is based on APHIS' belief
that most projects involving the introduction of a regulated organism
would have been completed by that time, or that substantial information
regarding the biology and potential effects on the environment of the
regulated organism would have been obtained within 10 years. This
information would provide APHIS with data regarding the nature of the
organism that may have a bearing on APHIS' review of subsequent
applications to introduce the same or similar organisms.
Nonindigenous Organisms Exempted From Regulation Under This Part
(Sec. 335.5)
The taxa listed in Sec. 335.2(a) include species that are known
plant pests, which gives us reason to believe that other species within
those taxa may be plant pests. However, some taxa may also include
species that present no significant plant pest risk and could safely be
introduced into the United States without restriction. Therefore,
Sec. 335.5 of the proposed regulations provides a process by which a
person could request that a taxon of nonindigenous organism be exempted
from regulation under proposed part 335.
Under proposed Sec. 335.5(a), exemptions could be obtained for the
introduction of a regulated organism into the entire United States, the
continental United States (the conterminous 48 States and Alaska),
Hawaii, Puerto Rico, the Northern Mariana Islands, or an individual
U.S. territory or possession, or a combination thereof.
Paragraph (b) of proposed Sec. 335.5 sets forth the information
that would have to be submitted to the Administrator with a person's
request to have a regulated organism exempted from regulation:
(1) The name, address, telephone number, and facsimile number of
the person submitting the request;
(2) The scientific name, common name, and any other information
that serves to identify the regulated organism as specifically as
possible (including the subspecies, race, and strain of the regulated
organism) that the person believes should be exempted from regulation
under this part and a description of the methods used to establish the
identity of the regulated organism;
(3) A description of the life cycle, biology, and ecology of the
regulated organism;
(4) Whether the regulated organism has been genetically modified
(if so, include a description of the genetic modification);
(5) The established range of the regulated organism in the United
States;
(6) Whether the regulated organism has been released into the
environment in the area or areas of the United States for which the
exemption is being requested and, if so, the location and date of the
release;
(7) A description of all testing and review that has been conducted
to assess the effects of the regulated organism on the environment;
(8) The effect of the regulated organism on the environment in its
established range;
(9) The host specificity of the regulated organism under both
artificial and natural conditions;
(10) References to any published and unpublished documents that
support the information required by paragraphs (b)(1)(ii) through
(b)(1)(ix) of this section. If available to the applicant, copies of
any unpublished referenced documents must be attached to the
application; and
(11) A list of at least three universities, museums, scientific
societies, or other organizations that maintain collections of
organisms to which specimens of the regulated organism have been
submitted, and the identification numbers assigned to the specimens.
Ten of these 11 data elements are similar to those found in
paragraphs (b) and (e) of proposed Sec. 335.4, which contain the data
elements that must be addressed in an application for a permit to
release a regulated organism into the environment. The eleventh
proposed element (a list of at least three universities, museums,
scientific societies, or other organizations that maintain collections
of organisms to which specimens of the regulated organism have been
submitted, and the identification numbers assigned to the specimens)
would provide a reference for APHIS and is also proposed as a permit
condition for the release of a regulated organism into the environment
in proposed Sec. 335.6(c). These 11 data elements are intended to
provide APHIS with information necessary to assess the environmental
and plant pest risks associated with exempting a nonindigenous organism
from regulation under proposed part 335.
Proposed Sec. 335.5(b)(2) provides that after receiving a request
for exemption, APHIS would conduct a review to determine whether the
request for an exemption contained all the information required by
proposed Sec. 335.5(b)(1). This review would be completed within 30
days of APHIS' receipt of the request for an exemption. Upon completion
of that review, we would inform the person requesting the exemption of
the date the request was received, which would be the date that the
review period had commenced (or, if the request was incomplete, what
additional information was needed). Once the request for exemption is
complete, APHIS would commence its review of the request. When the
request contains all the information required by proposed
Sec. 335.5(b)(1), we believe that a 120-day review period--which is
proposed in Sec. 335.5(b)(2)--would be sufficient for APHIS to
thoroughly examine all aspects of the request for an exemption.
If, based upon its review of the request, APHIS finds that
exempting the regulated organism from regulation would not present a
significant plant pest risk, APHIS would publish a notice of proposed
rulemaking in the Federal Register, proposing to add the organism to
the list of regulated organisms exempted from the regulations in
proposed part 335. If the public comments do not contain any
supportable information that indicate the organism should not be exempt
from regulation under proposed part 335, a final rule adding the
organism to the list of exempted nonindigenous organisms would be
published in the Federal Register. [[Page 5296]]
Conversely, if APHIS determines that the available information
could not support a finding that exempting the regulated organism from
regulation would not present a significant plant pest risk, the request
would be denied. The person requesting the exemption would be informed
of the denial in writing and given the opportunity to appeal. The
appeal process would be set forth in proposed Sec. 335.5(b). The denial
of an exemption request would not preclude the person who had requested
the exemption from applying for a permit for the introduction of the
same regulated organism.
There may be occasions where APHIS determines, without having
received a request from a member of the public, that a regulated
organism could be exempted from regulation under this proposed part
without presenting a significant plant pest risk. Therefore, proposed
Sec. 335.5(c) provides that in such cases, APHIS would publish a notice
of proposed rulemaking in the Federal Register, proposing to add the
organism to the list of exempted nonindigenous organisms in proposed
Sec. 335.5(d). If the public comment period did not produce any
supportable information that indicated the organism should not be
exempted from regulation, a final rule adding the organism to the list
of exempted nonindigenous organisms would be published in the Federal
Register.
In this proposed rule, the list of exempted nonindigenous organisms
in proposed Sec. 335.5(d) consists of 13 types of organisms that APHIS
believes should be exempted from regulation under proposed part 335.
The exemption would apply to the introduction of these organisms into
the entire United States. These organisms are:
----------------------------------------------------------------------------------------------------------------
Class Order Family Scientific or common name
----------------------------------------------------------------------------------------------------------------
Arachnida............... Scorpiones............. ....................... Scorpions.
Arachnida............... Pseudoscorpiones....... ....................... Pseudoscorpions.
Arachnida............... Solfugae............... ....................... Windscorpions.
Arachnida............... Amblypygi.............. ....................... Tailless whipscorpions.
Arachnida............... Opiliones.............. ....................... Daddy-longlegs/harvestmen.
Arachnida............... Aranae................. Theraphosidae.......... Tarantulas.
Insecta................. Blattodea.............. ....................... Cockroaches.
Insecta................. Diptera................ Culicidae.............. Mosquitoes.
Insecta................. Diptera................ Muscidae............... Musca domestica.
Insecta................. Diptera................ Drosophilidae.......... Drosophila melanogaster.
Chilopoda............... ....................... ....................... Centipedes.
Diploda................. ....................... ....................... Millipedes.
----------------------------------------------------------------------------------------------------------------
A permit would not be required under proposed part 335 to introduce
these organisms into the United States because, based on APHIS'
experience issuing plant pest permits, we do not believe that the above
types of organisms would need to be regulated under proposed part 335
in order to prevent the introduction of plant pests into the United
States.
Conditions for the Introduction of Regulated Organisms (Sec. 335.6)
This section of the proposed regulations contains conditions that
would apply to the introduction of regulated organisms. As mentioned
above in the discussion of proposed Sec. 335.4(g), any additional
conditions that would apply specifically to the introduction of a
particular regulated organism would be listed on the permit issued for
that introduction. These proposed conditions are designed to prevent
the introduction and dissemination of plant pests.
Paragraph (a) of proposed Sec. 335.6 contains the conditions that
would apply to the importation of regulated organisms. We would require
regulated organisms imported into the United States to be accompanied
by a permit and imported through a port of first arrival that has a
plant inspection station. Given the nature of some regulated organisms,
we believe it is necessary to route them through one of APHIS' plant
inspection stations, which have special inspection and treatment
facilities. In order to reduce the risk of the spread of plant pests,
and to help prevent a regulated organism's accidental release into the
environment, we would further require that imported regulated organisms
be moved from the port of first arrival only to the destination
specified on the permit. We would also require the regulated organism
to be enclosed in a container that meets the requirements of proposed
Sec. 335.8, and that the container remains unopened until the regulated
organism arrives at the destination specified on the permit. The
regulated organism could not be accompanied by an organism or article
not specified on the permit.
To facilitate the handling of the regulated organism at the port of
first arrival, we would require that the outside of the container bear
a label issued by APHIS; the label would identify the container so that
it would be handled by the APHIS inspector as quickly as possible. The
outside of the container in which the regulated organism is moved would
also have to accurately identify the regulated organism, the person to
whom the permit was issued, the destination of the regulated organism,
the return address of the sender of the regulated organism, and the
number of the permit authorizing the importation. By having this
information accompanying the regulated organism at the time of its
arrival at the port of first arrival, we could avoid unnecessary delays
that might result from inadequate identification of the container's
contents.
We would require the permittee to agree to notify the Administrator
immediately if there is an accidental or unauthorized release of the
regulated organism into the environment, or within 5 days if there are
any characteristics of the regulated organism that are substantially
different from those listed in the application for a permit.
In certain cases, APHIS may determine that a regulated organism
must be destroyed, disposed of, or subjected to other remedial measures
to prevent the spread of plant pests. Therefore, in situations where
the regulated organism presents a risk of disseminating plant pests,
the permittee would be required to present the regulated organism to
the Administrator for disposition.
Paragraph (b) of proposed Sec. 335.6 contains the proposed
conditions that would apply to the interstate movement of regulated
organisms. Regulated organisms moved interstate would have to meet,
with two exceptions, the same conditions as imported regulated
organisms under this section of the proposed regulations. Regulated
[[Page 5297]] organisms moved interstate would have to be accompanied
by a permit, moved only to the destination specified on the permit,
moved in a container that meets the requirements of proposed
Sec. 335.8, and moved without any other organism or article, except as
specified on the permit. Further, the container in which the regulated
organisms are moved would have to remain unopened until its arrival at
the destination specified on the permit. The outside of the container
would have to accurately identify the regulated organism, the person to
whom the permit was issued, the destination of the regulated organism,
the return address of the sender of the regulated organism, and the
number of the permit authorizing the interstate movement. The permittee
would also have to agree to notify the Administrator immediately if
there is an accidental or unauthorized release of the regulated
organism into the environment, or within 5 days if there are any
characteristics of the regulated organism that are substantially
different from those listed in the application for a permit. In
situations where the regulated organism presented a risk of
disseminating plant pests, the permittee would be required to present
the regulated organism to the Administrator for disposition.
For regulated organisms released into the environment, any specific
conditions would be determined by the nature of the individual release.
Therefore, the only conditions that would apply to the release of all
regulated organism into the environment would be: (1) That the release
be authorized by a permit and conducted in accordance with the
conditions of the permit; (2) that the permittee notify APHIS
immediately if there were an accidental or unauthorized release of the
regulated organism into the environment, or within 5 days if there were
any characteristics of the regulated organism that were substantially
different from those listed in the application for a permit; (3) that,
in situations where the regulated organism presented a risk of
disseminating plant pests, the permittee would present the regulated
organism to the Administrator for disposition; and (4) that specimens
of the regulated organism be submitted to the collections of at least
three universities, museums, scientific societies, or other
organizations that maintain collections of organisms. The
identification numbers assigned to the specimens would have to have
been provided to APHIS prior to the release to provide a reference for
APHIS.
Facilities for the Containment of Regulated Organisms (Sec. 335.7)
This section of the proposed regulations contains the requirements
that would apply to a facility into which a regulated organism would be
imported or moved interstate. Under the proposed regulations, the
Administrator would approve the use of a facility for the containment
of a regulated organism only if the facility met the requirements of
proposed Sec. 335.7.
We would require that the facility be constructed and operated in a
manner that would prevent the escape and dissemination of the regulated
organism. To that end, we would require that the facility's physical
structure possess adequate water, air, and waste handling systems, as
well as adequate entryways, windows, and facility structure to contain
the regulated organism and prevent the unauthorized entry of organisms
and people. In terms of its operation, we would require that the
facility have procedural safeguards and be operated in a manner that
would prevent the escape of a regulated organism and would prevent the
unauthorized entry of organisms and people.
We would require that the facility have a means of inactivating or
sterilizing the regulated organism and any host material, containers,
or other material used for the regulated organism. We believe this
requirement is necessary to ensure that, for example, unauthorized
material accompanying a regulated organism could be destroyed if it
constituted a plant pest risk. Additionally, there may be circumstances
under which the Administrator determines that the destruction or
disposal of a regulated organism is necessary to prevent the spread of
a plant pest.
Because there may be cases in which the circumstances of a
particular introduction dictate the need for additional safeguards, we
would further require that the facility and its operation meet any
other conditions the Administrator deemed necessary to prevent the
escape of a regulated organism and prevent the unauthorized entry of
organisms and people.
Finally, we would require that the operator of the facility
maintain certain records regarding the regulated organism during the
time the organism is held in the facility. The records would have to
identify the regulated organism, the person from whom the regulated
organism was received, the date the regulated organism was received at
the facility, and the disposition of the regulated organism. Those
records would be necessary for APHIS to determine whether a regulated
organism has been moved and held in accordance with the conditions of
the permit authorizing its introduction. Therefore, we propose to
require that an APHIS inspector be allowed to inspect and copy those
records during normal business hours.
Container Requirements for the Movement of Regulated Organism
(Sec. 335.8)
Proposed Sec. 335.8 specifies the container requirements for the
importation and interstate movement of a regulated organism and any
material moved with the regulated organism. A regulated organism must
be properly packaged to maximize its chances of survival and minimize
the possibility of an accidental release into the environment during
movement. For those reasons, we would prohibit the importation and
interstate movement of any regulated organism unless the regulated
organism is enclosed in a container that meets the requirements of this
section.
For the purposes of this section, a regulated organism and any
material moved with a regulated organism would be divided into five
categories: plants and plant parts, seeds, microorganisms, arthropods,
and other organisms. Each category is designed to provide safeguards
commensurate with the level of risk that would be presented by the
importation or interstate movement of an organism in that category.
Under proposed Sec. 335.8(b)(1), all plants or plant parts, except
seeds and cells, would have to be enclosed in a sealed plastic bag of
at least 0.1270 mm (5 mil) thickness or in an equivalent leakproof
container, and then enclosed in a sturdy, sealed, outer container
constructed of corrugated fiberboard, corrugated cardboard, wood, or
other material of equivalent strength. Under proposed Sec. 335.8(b)(2),
all seeds would have to be enclosed in a sealed plastic bag of at least
0.1270 mm (5 mil) thickness or in an equivalent leakproof container.
The sealed plastic bag or equivalent leakproof container would the have
to be enclosed within a second sealed plastic bag of at least 0.1270 mm
(5 mil) thickness or in an equivalent leakproof container. Each plastic
bag or equivalent leakproof container would have to be independently
capable of preventing the seeds from escaping the container. Each set
of containers would have to be enclosed in a sturdy outer container
constructed of corrugated fiberboard, corrugated cardboard, wood, or
other material of equivalent strength. [[Page 5298]]
All microorganisms, such as fungi, bacteria, nematodes, or cells,
would have to be enclosed in a container as specified in paragraph
(b)(3)(i) or (b)(3)(ii) of proposed Sec. 335.8. Microorganisms not
exceeding 50 mL in volume would have to be enclosed in a durable,
watertight primary container, which would have to be enclosed in a
second durable, watertight container (secondary container). Several
primary containers could be enclosed in a single secondary container if
the total volume of all the primary containers enclosed in a single
secondary container did not exceed 50 mL. The space at the top, bottom,
and sides between the primary and secondary containers would have to
contain sufficient nonparticulate absorbent material (e.g., paper
towel) to absorb the entire contents of the primary container(s). The
secondary container would then have to be enclosed in an outer
container constructed of corrugated fiberboard, corrugated cardboard,
wood, or other material of equivalent strength.
Microorganisms that exceeded a volume of 50 mL would have to comply
with the requirements described in the above paragraph. In addition, a
shock-absorbing material, in volume at least equal to that of the
absorbent material between the primary and secondary containers, would
have to be placed at the top, bottom, and sides between the secondary
container and the outer container. Single primary containers could not
contain more than 1,000 mL of material. However, two or more primary
containers whose combined volumes do not exceed 1,000 mL could be
enclosed in a single secondary container. The maximum amount of
microorganisms that could be enclosed within a single outer container
could not exceed 4,000 mL.
If dry ice was used as a refrigerant, it would have to be placed
between the secondary container and the outer container. The shock-
absorbing material would have to be placed so that the secondary
container would not become loose inside the outer container as the dry
ice sublimates.
Insects, mites, or other arthropods would have to be enclosed in a
container as specified for arthropods in paragraph (b)(4) of proposed
Sec. 335.8 or in a container specified for microorganisms described in
paragraph (b)(3) of proposed Sec. 335.8. Under proposed
Sec. 335.8(b)(4), arthropods (any life stage) would have to be enclosed
in a primary container (insulated vacuum container, metal, or plastic)
and the container would have to be sealed to prevent escape of the
arthropods. The primary container would have to be enclosed in a
secondary container of crushproof styrofoam or other material of
equivalent strength; one or more rigid ice packs could also be enclosed
in the secondary container; and sufficient packing material would have
to be added around the primary container to prevent movement of the
primary container within the secondary container. The secondary
container would have to be enclosed in an outer container constructed
of corrugated fiberboard, corrugated cardboard, wood, or other material
of equivalent strength.
Any organism not covered in paragraph (b)(1), (b)(2), or (b)(4) of
proposed Sec. 335.8 that did not require continuous access to
atmospheric oxygen would have to be enclosed in a container as
specified in paragraph (b)(3) or (b)(4) of this section. Any organism
that was not a plant and that required continuous access to atmospheric
oxygen would have to be enclosed in a primary container constructed
with a sturdy, crush-proof frame of wood, metal, or other material of
equivalent strength, surrounded by mesh or netting of a strength and
mesh size sufficient to prevent the escape of the smallest organism in
the container, with the edges and seams of the mesh or netting sealed
to prevent the escape of organisms. Each primary container would have
to be enclosed in a larger secondary container constructed of wood,
metal, or other material of equivalent strength. The primary and
secondary containers would have to be enclosed in an outer container
constructed of corrugated fiberboard, corrugated cardboard, wood, or
other material of equivalent strength, which outer container could have
air holes or spaces in the sides and/or ends of the container, provided
that the outer container would have to retain sufficient strength to
prevent crushing of the primary and secondary containers.
We believe that these proposed requirements would be sufficient to
prevent the accidental release of the regulated organism and any
material moved with the organism.
We understand that there may be unique circumstances, such as the
nature, volume, or life stage of a regulated organism, that could make
these proposed container requirements inappropriate for the importation
of interstate movement of a particular regulated organism. For that
reason, we would allow a person to request a variance from the
container requirements by submitting a written statement to APHIS
describing why the applicable container requirements are inappropriate
for the regulated organism that the person proposes to move, and what
container requirements the person would use in lieu of the applicable
container requirements. APHIS would make a decision regarding the
variance request and would inform the applicant of the decision prior
to the issuance of a permit. If APHIS granted the variance request, a
permit would be issued if APHIS had determined from its review of the
permit application that the regulated organism could be introduced
without risk of plant pest dissemination. If APHIS denied the variance
request, the applicant could submit an appeal to the Administrator by
following the procedure detailed in the proposed regulations; however,
no permit would be issued until such time as the appeal was resolved
and the applicant agreed to abide by APHIS' decision.
Costs and Charges (Sec. 335.9)
Proposed Sec. 335.9 relates to costs and charges that would apply
in connection with the services of an APHIS inspector. It is the policy
of APHIS that the services of an APHIS inspector during regularly
assigned hours of duty and at the usual places of duty be furnished
without cost to persons requiring inspection, unless a user fee is
payable under 7 CFR part 354. There are, however, no user fees
currently in place that would affect the permitting or inspection
activities that would be carried out under the proposed regulations.
Proposed Sec. 335.9 further provides that any costs or charges
incidental to inspection or to compliance with the provisions of this
part, other than an APHIS inspector's services, are not the
responsibility of the USDA.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been determined to be significant and was
reviewed by the Office of Management and Budget under Executive Order
12866.
We are proposing to establish comprehensive regulations governing
the introduction (importation, interstate movement, and release into
the environment) of certain regulated organisms. The proposed
regulations would clarify the permit application process and provide a
means of screening regulated organisms prior to their introduction to
determine the potential plant pest risk associated with a particular
introduction. According to the OTA report cited above, harmful
nonindigenous species have caused an economic loss of approximately $97
billion between 1906 and 1991. When weighed against that figure, the
costs of [[Page 5299]] implementing or complying with these proposed
regulations are insignificant.
The proposed regulations clearly set out the information that APHIS
would require to be able to make a decision concerning the plant pest
risk associated with a regulated organism, so prospective applicants
would not find themselves wasting scarce resources seeking
clarification or interpretation of the existing plant pest regulations.
These improvements are expected to encourage and facilitate research in
the area of nonindigenous organisms.
In 1992, APHIS issued 3,375 permits under 7 CFR part 330 for the
importation, interstate movement, or release into the environment of
organisms, nearly 3 times the 1982 total of 1,167 permits issued. The
average total cost (using the 1992 data) to APHIS to process an
application was approximately $139. No user fees have been charged to
the applicants.
Under the current system, the processing of an application can be a
lengthy process. It takes, on average, approximately 5 to 30 days to
issue a permit for importation or interstate movement of an organism,
while it may take as long as a year to process an application for the
release of an organism into the environment. This time variability is
partly a function of the level of risk assessment required, but the
adequacy of the initial information provided by the applicant plays an
important role. We anticipate that the permit application process set
forth in the proposed regulations would speed up the permit application
review process by ensuring that sufficient data are provided by
applicants from the start of APHIS' review of the application.
The applicants for permits to introduce nonindigenous organisms
have been researchers, scientists, private businesses, and agricultural
producers. Approximately two-thirds of all applicants have been
nonprofit entities. Most of the applicants are considered to be small
entities. Of the three types of permits that would be issued under
these proposed regulations--importation, interstate movement, and
release into the environment--we believe that an application for a
permit to release a regulated organism into the environment would take
the longest to prepare. We estimate that a Ph.D. researcher working
with clerical support for approximately 2 weeks to prepare an
application for a permit to release a regulated organism into the
environment would cost, based on their estimated salaries, less than
$5,000. We anticipate that the costs of preparing a permit application
for the majority of the regulated organisms covered by the proposed
regulations would not be significant because most, if not all, of the
data that would be required would already be known to the applicant,
thus minimizing the amount of time spent preparing a permit
application.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
National Environmental Policy Act
APHIS has determined that the preparation of an environmental
assessment was not necessary for the proposed regulations. The proposed
regulations are procedural in nature and would not irrevocably commit
APHIS to any decision concerning the issuance of any permit for the
release into the environment of a regulated organism. As a procedural
regulation, the proposed rule would advise persons of what data to
submit in a permit application so that APHIS would be able to decide
whether a permit could be granted. For an application for a permit to
release a regulated organism into the environment, the required data
would be used to prepare an environmental assessment as part of APHIS'
decision-making process. APHIS would retain the authority to grant,
deny, or revoke a permit on a case-by-case basis.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this proposed rule will be submitted for approval to the
Office of Management and Budget. Please send written comments to the
Office of Information and Regulatory Affairs, OMB, Attention: Desk
Officer for APHIS, Washington, DC 20503. Please send a copy of your
comments to: (1) Chief, Regulatory Analysis and Development, PPD,
APHIS, USDA, P.O. Drawer 810, Riverdale, MD 20738, and (2) Clearance
Officer, OIRM, USDA, room 404-W, 14th Street and Independence Avenue
SW., Washington, DC 20250.
List of Subjects in 7 CFR Part 335
Imports, Packaging and containers, Plant diseases and pests,
Reporting and recordkeeping requirements, Transportation.
Accordingly, 7 CFR part 335 would be added to read as follows:
PART 335--INTRODUCTION OF NONINDIGENOUS ORGANISMS
Sec.
335.1 Definitions.
335.2 Regulated organisms.
335.3 General restrictions on the introduction of regulated
organisms.
335.4 Permits for the introduction of regulated organisms.
335.5 Nonindigenous organisms exempted from regulation under this
part.
335.6 Conditions for the introduction of regulated organisms.
335.7 Facilities for the containment of regulated organisms.
335.8 Container requirements for the movement of regulated
organisms.
335.9 Costs and charges.
Authority: 7 U.S.C. 150aa-150jj, 151-164a, 167, and 1622(n); 31
U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.17, 2.51, and
371.2(c).
Sec. 335.1 Definitions.
Terms used in the singular form in this part shall be construed as
the plural, and vice versa, as the case may demand. The following
terms, when used in this part, shall be construed, respectively, to
mean:
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, U.S. Department of Agriculture, or any other
individual to whom the Administrator delegates authority to act in his
or her stead.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the U.S. Department of Agriculture.
APHIS inspector. Any employee of the Animal and Plant Health
Inspection Service or any other individual authorized by the
Administrator to enforce this part.
Environment. All land, air, and water; and all living organisms in
association with land, air, and water.
Established. The condition of a species that has formed a self-
sustaining, free-living population at a given location. [[Page 5300]]
Established range. The area in which a species maintains a self-
sustaining, free-living population.
Import. To bring into the territorial limits of the United States.
Interstate. From any State into or through any other State, or
within the District of Columbia, American Samoa, Guam, the Virgin
Islands of the United States, or any other territory or possession of
the United States.
Introduce (introduction). To move or to attempt to move into or
through the United States, to release or attempt to release into the
environment, or to move or attempt to move interstate.
Move (moving, movement). To ship, offer for shipment, enter, offer
for entry, import, offer for importation, receive for transportation,
carry, mail, or otherwise transport or allow to be transported into,
through, or within the United States.
Nonindigenous organism. Any organism proposed for introduction into
any area of the United States beyond its established range.
Permit. An authorization issued by the Administrator for the
introduction of a regulated organism.
Person. Any individual, partnership, corporation, company, society,
association, or other legal entity or organized group.
Plant. Any stage of any member of the plant kingdom including, but
not limited to, trees, plant tissue cultures, plantlet cultures,
pollen, shrubs, vines, cuttings, grafts, scions, buds, roots, seeds,
cells, tubers, and stems.
Plant pest. Any living stage of any insects, mites, nematodes,
slugs, snails, protozoa, or other invertebrate animals, bacteria,
fungi, other parasitic plants or reproductive parts of parasitic
plants, viruses, or any organisms similar to or allied with any of the
organisms previously identified in this definition, or any infectious
substances, which can directly or indirectly injure or cause disease or
damage in any plants or plant parts, or any processed, manufactured, or
other products of plants.
Plant product. Any processed or manufactured plant or plant part.
Port of first arrival. The land area (such as a seaport, airport,
or land border station) where a person, or a land, water, or air
vehicle, first arrives after entering the United States, and where
inspection of articles is carried out by APHIS inspectors.
Regulated organism. Any living stage of any nonindigenous organism
belonging to the taxa listed in Sec. 335.2(a) that is not listed in
Sec. 335.2(b) or exempt in accordance with Sec. 335.5.
Release into the environment. The use of a regulated organism
outside the constraints of physical confinement.
State. Any State, the District of Columbia, American Samoa, Guam,
the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the
United States, and any other territory or possession of the United
States.
United States. All of the States.
Sec. 335.2 Regulated organisms.
(a) The taxonomic groups listed in paragraph (a)(1) of this section
include organisms that are known plant pests. Therefore, there is
reason to believe that other organisms within the taxonomic groups
listed in paragraph (a)(1) of this section may be or may contain plant
pests and, except for those organisms listed in paragraph (b) of this
section or exempt in accordance with Sec. 335.5, are regulated
organisms. Within any taxonomic group included on the list in this
paragraph, the lowest unit of classification listed is the taxonomic
group that may contain regulated organisms. Organisms belonging to all
lower taxa contained within the groups listed in this paragraph are
included as organisms that may be or may contain plant pests.
(1) Group:
Viroids
Superkingdom Prokaryotae
Kingdom Virus
All members of groups containing plant viruses, and all other plant
and insect viruses.
Kingdom Monera
Division Bacteria
Family Pseudomonadaceae
Genus Pseudomonas
Genus Xanthomonas
Family Rhizobiaceae
Genus Rhizobium
Genus Bradyrhizobium
Genus Agrobacterium
Genus Phyllobacterium
Family Enterobacteriaceae
Genus Erwinia
Family Streptomycetaceae
Genus Streptomyces
Family Actinomycetacease
Genus Actinomyces
Coryneform group
Genus Clavibacter
Genus Arthrobacter
Genus Curtobacterium
Genus Corynebacteria
Gram-negative phloem-limited bacteria associated with plant diseases.
Gram-negative xylem-limited bacteria associated with plant diseases.
And all other bacteria associated with plant or insect diseases.
Rickettsiaceae
Rickettsial-like organisms associated with insect diseases.
Class Mollicutes
Order Mycoplasmatales
Family Spiroplasmataceae
Genus Spiroplasma
Mycoplasma-like organisms associated with plant diseases.
Mycoplasma-like organisms associated with insect diseases.
Superkingdom Eukaryotae
Kingdom Plantae
Subkingdom Thallobionta
Division Chlorophyta
Genus Cephaleuros
Genus Rhodochytrium
Genus Phyllosiphon
Division Myxomycota
Class Plasmodiophoromycetes
Division Eumycota
Class Chytridiomycetes
Order Chytridiales
Class Oomycetes
Order Lagenidiales
Family Lagenidiaceae
Family Olpidiopsidaceae
Order Peronosporales
Family Albuginaceae
Family Peronosporaceae
Family Pythiaceae
Order Saprolegniales
Family Saprolegniaceae
Family Leptolegniellaceae
Class Zygomycetes
Order Mucorales
Family Choanephoraceae
Family Mucoraceae
Family Entomophthoraceae
Class Hemiascomycetes
Family Protomycetaceae
Family Taphrinaceae
Class Loculoascomycetes
Order Myriangiales
Family Elsinoeaceae
Family Myriangiaceae
Order Asterinales
Order Dothideales
Order Chaetothyriales
Order Hysteriales
Family Parmulariaceae
Family Phillipsiellaceae
Family Hysteriaceae
Order Pleosporales
Order Melanommatales
Class Plectomycetes
Order Eurotiales
Family Ophiostomataceae
Order Ascophaerales
Class Pyrenomycetes
Order Erysiphales
Order Meliolales [[Page 5301]]
Order Xylariales
Order Diaporthales
Order Hypocreales
Order Clavicipitales
Class Discomycetes
Order Phacidiales
Order Helotiales
Family Ascocorticiceae
Family Hemiphacidiaceae
Family Dermataceae
Family Sclerotiniaceae
Order Cytarriales
Order Medeolariales
Order Pezziales
Family Sarcosomataceae
Family Sarcoscyphaceae
Class Teliomycetes
Class Phragmobasidiomycetes
Family Auriculariaceae
Family Ceratobasidiaceae
Class Hymenomycetes
Order Exobasidiales
Order Agaricales
Family Corticiaceae
Family Hymenochaetaceae
Family Echinodontiaceae
Family Fistulinaceae
Family Clavariaceae
Family Polyporaceae
Family Tricholomataceae
Class Hyphomycetes
Class Coelomycetes
And all other fungi associated with plant or insect diseases.
Subkingdom Embryobionta
Division Magnoliophyta
Family Balanophoraceae--parasitic species
Family Cuscutaceae--parasitic species
Family Hydnoraceae--parasitic species
Family Krameriaceae--parasitic species
Family Lauraceae--parasitic species
Genus Cassytha
Family Lennoaceae--parasitic species
Family Loranthaceae--parasitic species
Family Myzodendraceae--parasitic species
Family Olacaceae--parasitic species
Family Orobanchaceae--parasitic species
Family Rafflesiaceae--parasitic species
Family Santalaceae--parasitic species
Family Scrophulariaceae--parasitic species
Genus Bartsia
Genus Buchnera
Genus Buttonia
Genus Castilleja
Genus Centranthera
Genus Cordylanthus
Genus Dasistoma
Genus Euphrasia
Genus Gerardia
Genus Harveya
Genus Hyobanche
Genus Lathraea
Genus Melampyrum
Genus Melasma
Genus Orthantha
Genus Orthocarpus
Genus Pedicularis
Genus Rhamphicarpa
Genus Rhinanthus
Genus Schwalbea
Genus Seymeria
Genus Siphonostegia
Genus Sopubia
Genus Tozzia
Family Viscaceae--parasitic species
Kingdom Animalia
Subkingdom Protozoa
Genus Phytomonas
And all Protozoa associated with insect diseases.
Subkingdom Eumetazoa
Phylum Nemata
Class Secernentea
Order Tylenchida
Family Anguinidae
Family Belonolaimidae
Family Caloosiidae
Family Criconematidae
Family Dolichodoridae
Family Fergusobiidae
Family Hemicycliophoridae
Family Heteroderidae
Family Hoplolaimidae
Family Meloidogynidae
Family Nacobbidae
Family Neotylenchidae
Family Nothotylenchidae
Family Paratylenchidae
Family Pratylenchidae
Family Tylenchidae
Family Tylenchulidae
Order Aphelenchida
Family Aphelenchoididae
Class Adenophorea
Order Dorylaimida
Family Longidoridae
Family Trichodoridae
Phylum Mollusca
Class Gastropoda
Subclass Pulmonata
Order Basommatophora
Superfamily Planorbacea
Order Stylommatophora
Subfamily Strophocheilacea
Family Succineidae
Superfamily Achatinacae
Superfamily Arionacae
Superfamily Limacacea
Superfamily Helicacea
Order Systellommatophora
Superfamily Veronicellacea
Phylum Arthropoda
Class Arachnida
Order Parasitiformes
Suborder Mesostigmata
Superfamily Ascoidea
Superfamily Dermanyssoidea
Order Acariformes
Suborder Prostigmata
Superfamily Eriophyoidea
Superfamily Tetranychoidea
Superfamily Eupodoidea
Superfamily Tydeoidea
Superfamily Erythraenoidea
Superfamily Trombidioidea
Superfamily Hydryphantoidea
Superfamily Tarsonemoidea
Superfamily Pyemotoidea
Suborder Astigmata
Superfamily Hemisarcoptoidea
Superfamily Acaroidea
Class Diplopoda
Order Polydesmida
Class Insecta
Order Collembola
Family Sminthoridae
Order Isoptera
Order Thysanoptera
Order Orthoptera
Family Acrididae
Family Gryllidae
Family Gryllacrididae
Family Gryllotalpidae
Family Phasmatidae
Family Ronaleidae
Family Tettigoniidae
Family Tetrigidae
Order Hemiptera
Family Thaumastocoridae
Family Aradidae
Superfamily Piesmatoidea
Superfamily Lygaeoidea
Superfamily Idiostoloidea
Superfamily Coreoidea
Superfamily Pentatomoidea
Superfamily Pyrrhocoroidea
Superfamily Tingoidea
Superfamily Miroidea
Order Homoptera
Order Coleoptera
Family Anobiidae
Family Apionidae
Family Anthribidae
Family Bostrichidae
Family Brentidae
Family Bruchidae
Family Buprestidae
Family Byturidae
Family Cantharidae
Family Carabidae
Family Cerambycidae
Family Chrysomelidae
Family Coccinellidae
Subfamily Epilachninae
Family Curculionidae
Family Dermestidae
Family Elateridae
Family Hydrophilidae
Genus Helophorus
Family Lyctidae
Family Meloidae [[Page 5302]]
Family Mordellidae
Family Platypodidae
Family Scarabaeidae
Subfamily Melolonthinae
Subfamily Rutelinae
Subfamily Cetoniinae
Subfamily Dynastinae
Family Scolytidae
Family Selbytidae
Family Tenebrionidae
Order Lepidoptera
Order Diptera
Family Agromyzidae
Family Anthomyiidae
Family Cecidomyiidae
Family Chloropidae
Family Ephydridae
Family Lonchaeidae
Family Muscidae
Genus Atherigona
Family Otitidae
Genus Euxeta
Family Syrphidae
Family Tephritidae
Family Tipulidae
Order Hymenoptera
Family Apidae
Family Aphelinidae
Family Braconidae
Genus Perilitus
Family Caphidae
Family Chalcidae
Family Cynipidae
Family Diapriidae
Genus Ismarus
Family Encyrtidae
Family Eulophidae
Family Eurytomidae
Family Formicidae
Family Ichneumonidae
Subfamily Cryptinae
Subfamily Diplazontinae
Subfamily Gelinae
Subfamily Mesochorinae
Subfamily Ephialtinae
Family Psilidae
Family Pteromalidae
Family Scelionidae
Genus Gryon
Genus Scelio
Family Signiphoridae
Family Siricidae
Family Tenthredinidae
Family Torymidae
Family Trichogrammatidae
Family Xylocopidae
(2) Unclassified organisms and organisms whose classification is
unknown.
(b) An organism from a taxonomic group listed in paragraph (a) of
this section is not a regulated organism under this part if the
introduction of that organism is regulated under any of the following
regulations:
(1) Live bees other than honeybees of the genus Apis regulated
under Sec. 319.76 of this chapter;
(2) Plant pests regulated under Sec. 330.200 of this chapter;
(3) Live honeybees of the genus Apis regulated under part 322 of
this chapter;
(4) Organisms genetically engineered through recombinant DNA
techniques regulated under part 340 of this chapter;
(5) Noxious weeds regulated under part 360 of this chapter;
(6) Organisms and vectors that may introduce or disseminate
contagious animal diseases regulated under 9 CFR part 122; and
(7) Etiologic microorganisms that cause disease in humans
(including bacteria, bacterial toxins, viruses, fungi, rickettsia,
protozoans, arthropods, parasites, and the hosts and vectors that may
carry these etiological microorganisms) that are regulated under 42 CFR
part 71, unless the microorganism, host, or vector could also be a
plant pest.
Sec. 335.3 General restrictions on the introduction of regulated
organisms.
(a) No person shall introduce any regulated organism unless the
introduction is authorized by a permit issued in accordance with
Sec. 335.4 and is in conformity with this part.
(b) Any regulated organism that is introduced not in compliance
with this part shall be subject to destruction, disposal, or the
remedial measures that the Administrator determines are necessary to
prevent the dissemination into the United States, or dissemination
within the United States, of plant pests.
Sec. 335.4 Permits for the introduction of regulated organisms.
(a) Permit applications. An application for a permit to introduce a
regulated organism shall be submitted to the Animal and Plant Health
Inspection Service, Plant Protection and Quarantine, Biological
Assessment and Taxonomic Support, 4700 River Road Unit 133, Riverdale,
MD 20737-1236. The application shall state the type of permit being
sought by the applicant (import permit, interstate movement permit, or
permit for release into the environment).
(1) A person may apply for a permit for the importation or
interstate movement of regulated organisms within a taxon of a higher
level than species (genus, family, order, class, phylum) in lieu of
submitting an application for the importation or interstate movement of
each species of regulated organism. A permit issued for the importation
or interstate movement of regulated organisms within a taxon of a
higher level than species will be valid only for the importation or
interstate movement of those regulated organisms imported or moved
interstate between those locations specified on the permit. If a person
seeks to import or move interstate a regulated organism not specified
on the permit, or to import or move interstate a regulated organism
from or to a location not listed on the permit, a new application must
be submitted to the Administrator.
(2) If an application contains any information deemed to be trade
secret or confidential business information (CBI), each page of the
application must be marked ``CBI Copy'' and those portions of the
application that are deemed CBI must be so designated. In addition, a
second copy of the application shall be submitted that has all such CBI
deleted and is marked ``CBI Deleted'' on each page of the application
where CBI was deleted.
(3) An application for a permit for the importation or interstate
movement of a regulated organism must be received by the Administrator
at least 30 days prior to each importation or interstate movement. An
application for a permit for the release into the environment of a
regulated organism must be received by the Administrator at least 120
days prior to the release into the environment.
(4) The Animal and Plant Health Inspection Service (APHIS), within
15 days of the receipt of an application for a permit for the
importation or interstate movement of a regulated organism and within
30 days of the receipt of an application for a permit for the release
into the environment of a regulated organism, will review the
application for a permit to determine whether the application contains
all of the information required by this section. If the application
contains all of the information required by this section, APHIS will
notify the person applying for a permit of the date that the
application was received, which will be the commencement date of a 30-
day review period for applications for importation or interstate
movement or a 120-day review period for applications for release into
the environment. If the application does not contain all of the
information required by this section, APHIS will advise the person
applying for a permit of the additional information that must be
received by the Administrator to complete the application for a permit.
APHIS will commence the applicable review period upon receipt of the
additional information, if, with the addition of that information, the
application contains all of the information required by the section.
When APHIS determines that an application contains all the information
required by this section, [[Page 5303]] APHIS will submit a copy of the
application marked ``CBI Deleted'' or ``No CBI'' to the State
department of agriculture of the State where the introduction of the
regulated organism is planned for the State's review and comment.
(5) Statutory or regulatory mandates may require that APHIS consult
with other Federal agencies during its review of an application to
release a regulated organism into the environment. In such cases, APHIS
will notify the applicant, in writing, that APHIS is required to
consult with other Federal agencies and that the consultation may
result in the review period extending beyond the 120 days provided for
in paragraph (a)(4) of this section.
(b) Data requirements for all permit applications. All applications
for permits to introduce a regulated organism shall contain the
following information:
(1) The name, address, telephone number, and facsimile number of
the person applying for the permit;
(2) The scientific name, common name, and any other information
that serves to identify the regulated organism as specifically as
possible (including the subspecies, race, and strain of the regulated
organism) and a description of the methods used to establish the
identity of the regulated organism;
(3) A description of the measures that have been taken to establish
that the regulated organism and any material associated with the
introduction of the regulated organism do not contain any organisms not
identified in the permit application;
(4) The intended use of the regulated organism;
(5) A description of the life cycle, biology, and ecology of the
regulated organism;
(6) Whether the regulated organism has been genetically modified
(if so, include a description of the genetic modification);
(7) The country and locality where the regulated organism was
originally collected from nature, and the countries and localities
where the regulated organism has been propagated and maintained since
its collection;
(8) The established range of the regulated organism in the United
States;
(9) The number of specimens or units of the regulated organism to
be introduced;
(10) A description of any host material, substrate, medium, or
organism that will accompany the regulated organism;
(11) If the application is for a permit to import a regulated
organism, the additional information required by paragraph (c) of this
section;
(12) If the application is for a permit to move a regulated
organism interstate, the additional information required by paragraph
(d) of this section; and
(13) If the application is for a permit to release a regulated
organism into the environment, the additional information required by
paragraph (e) of this section.
(c) Import permits. In addition to the information required by
paragraph (b) of this section, an application for a permit to import a
regulated organism shall contain the following information:
(1) The country and locality from which the regulated organism will
be exported to the United States;
(2) The address, telephone number, and facsimile number of the
person in the exporting country from whom the regulated organism will
be received;
(3) The port of first arrival in the United States through which
the regulated organism is intended to be imported;
(4) The address (including the county), telephone number, and
facsimile number of the facility to which the regulated organism will
be delivered;
(5) A detailed description of the procedures, processes, and
safeguards that will be used in the destination facility to prevent the
escape and dissemination of the regulated organism and any material
accompanying the regulated organism;
(6) The means by which the regulated organism will be imported into
the United States (air mail, air freight, baggage, or motor vehicle);
and
(7) The planned date(s) of the importation of the regulated
organism.
(d) Interstate movement permits. In addition to the information
required by paragraph (b) of this section, an application for a permit
for the interstate movement of a regulated organism shall contain the
following information:
(1) The State and locality from which the regulated organism will
be moved interstate;
(2) The address, telephone number, and facsimile number of the
person in the originating State from whom the regulated organism will
be received;
(3) The address (including the county), telephone number, and
facsimile number of the facility to which the regulated organism will
be moved;
(4) A detailed description of the procedures, processes, and
safeguards that will be used at the destination facility to prevent the
escape and dissemination of the regulated organism and any material
accompanying the regulated organism;
(5) The means by which the regulated organism will be moved
interstate (air mail, air freight, baggage, or motor vehicle); and
(6) The planned date(s) of the interstate movement of the regulated
organism.
(e) Release permits. In addition to the information required by
paragraph (b) of this section, an application for a permit to release a
regulated organism into the environment shall contain the following
information:
(1) The purpose of the release into the environment of the
regulated organism;
(2) The anticipated date(s) of the release into the environment of
the regulated organism;
(3) A description, including methods of release and release
site(s), of the intended release into the environment of the regulated
organism;
(4) A description of all testing and review that has been conducted
to assess the effects of the regulated organism on the environment;
(5) The effect of the regulated organism on the environment in its
established range;
(6) The host specificity of the regulated organism under both
artificial and natural conditions; and
(7) References to any published and unpublished documents that
support the information required by paragraphs (e)(4), (e)(5), and
(e)(6) of this section. If available to the applicant, copies of any
unpublished referenced documents must be attached to the application.
(f) Facility and release site inspection. The Administrator may
inspect the facility into which a regulated organism proposed for
importation or interstate movement is intended to be moved to determine
whether the facility will meet the requirements of Sec. 335.7. The
Administrator may also inspect the site where a regulated organism is
proposed to be released into the environment to assess the conditions
described in the permit application.
(g) Administrative action on applications. After APHIS has reviewed
an application which contains all the information required by this
section, a permit for the introduction of the regulated organism will
be issued or denied.
(1) If a permit is issued, the permit will specify the applicable
conditions under this part for the introduction of the regulated
organism. Each permit issued will be numbered and, unless revoked
pursuant to paragraph (h) of this section, will be valid from the date
of issuance until the expiration date specified on the permit. The
expiration [[Page 5304]] date specified on the permit will be no more
than 10 years from the date of issuance of the permit.
(2) If a permit is denied, the applicant will be promptly informed,
in writing, of the reasons the permit was denied and given the
opportunity to appeal the denial in accordance with paragraph (h) of
this section. A permit application will be denied if:
(i) The applicant has had a permit revoked under paragraph (h) of
this section during the 12 months prior to APHIS' receipt of the
completed permit application, unless the revoked permit has been
reinstated upon appeal.
(ii) An APHIS inspector is not allowed to inspect the facility into
which a regulated organism proposed for importation or interstate
movement is to be moved, or the site where a regulated organism is
proposed to be released into the environment.
(iii) The Administrator determines, based on a review of the
available information, that the introduction of the regulated organism
would present a significant risk of plant pest dissemination and no
adequate safeguards could be arranged to mitigate that risk.
(h) Denial or revocation of permit; appeals. Any permit that has
been issued may be revoked, in writing, by an APHIS inspector or the
Administrator if the APHIS inspector or the Administrator determines
that the person to whom the permit was issued, or his or her agents or
employees, has not complied with any condition specified on the permit
or has violated any requirement of this part. Any person whose permit
has been revoked or any person who has been denied a permit may appeal
the decision in writing to the Administrator within 10 days after
receiving the written notification of the revocation or denial. The
appeal must state all of the facts and reasons upon which the person
relies to show that the permit was wrongfully revoked or denied. The
Administrator will grant or deny the appeal as promptly as
circumstances allow and will state, in writing, the reasons for the
decision. If there is a conflict as to any material fact and the person
whose permit application was denied or permit was revoked requests a
hearing, a hearing will be held to resolve the conflict. Rules of
practice concerning the hearing will be adopted by the Administrator.
(i) Recordkeeping. If a permit is issued for the introduction of a
regulated organism, the person to whom the permit is issued must
maintain records for 10 years that identify the regulated organism (as
specifically as can be determined), identify the characteristics of the
regulated organism, and state the disposition of the regulated
organism. An APHIS inspector shall, during normal business hours, be
allowed to inspect and copy the records required to be maintained in
accordance with this paragraph.
Sec. 335.5 Nonindigenous organisms exempted from regulation under this
part.
(a) In accordance with the procedures set forth in paragraphs (b)
and (c) of this section, a regulated organism may be exempted from
regulation under this part. A nonindigenous organism exempted from
regulation under this part may be introduced without restriction under
this part into one or more of the areas listed in this paragraph:
(1) The entire United States;
(2) The continental United States (the conterminous 48 States and
Alaska);
(3) Hawaii;
(4) Puerto Rico;
(5) The Northern Mariana Islands; or
(6) Any other U.S. territory or possession.
(b) Requests for exemption. (1) Any person who believes that a
regulated organism should be exempted from regulation under this part
shall submit a written request to the Animal and Plant Health
Inspection Service, Plant Protection and Quarantine, Biological
Assessment and Taxonomic Support, 4700 River Road Unit 133, Riverdale,
MD 20737-1236. The request for an exemption from regulation under this
part must include:
(i) The name, address, telephone number, and facsimile number of
the person submitting the request for the exemption;
(ii) The scientific name, common name, and any other information
that serves to identify the regulated organism as specifically as
possible (including the subspecies, race, and strain of the regulated
organism) that the person believes should be exempted from regulation
under this part and a description of the methods used to establish the
identity of the regulated organism;
(iii) A description of the life cycle, biology, and ecology of the
regulated organism;
(iv) Whether the regulated organism has been genetically modified
(if so, include a description of the genetic modification);
(v) The established range of the regulated organism in the United
States;
(vi) Whether the regulated organism has been released into the
environment in the area or areas of the United States for which the
exemption is being requested and, if so, the location and date of the
release;
(vii) A description of all testing and review that has been
conducted to assess the effects of the regulated organism on the
environment;
(viii) The effect of the regulated organism on the environment in
its established range;
(ix) The host specificity of the regulated organism under both
artificial and natural conditions;
(x) References to any published and unpublished documents that
support the information required by paragraphs (b)(1)(ii) through
(b)(1)(ix) of this section. If available to the applicant, copies of
any unpublished referenced documents must be attached to the
application; and
(xi) A list of at least three universities, museums, scientific
societies, or other organizations that maintain collections of
organisms to which specimens of the regulated organism have been
submitted, and the identification numbers assigned to the specimens.
(2) Within 30 days of receiving the request for exemption from
regulation under this part, APHIS will review the request to determine
whether the request contains all the information required by this
section. If the request contains all of the information required by
this section, APHIS will notify the person requesting the exemption of
the date that the request was received, which will be the commencement
date of a 120-day review period for requests for exemption. If the
request does not contain all of the information required by this
section, APHIS will advise the person submitting the request for an
exemption of the additional information that must be received by the
Administrator to complete the request for an exemption. APHIS will
commence the review period upon receipt of the additional information,
if, with the addition of that information, the request contains all of
the information required by the section.
(3) If, based upon its review of the request, APHIS concludes that
exempting the regulated organism from regulation under this part would
not present a significant plant pest risk, APHIS will prepare a notice
of proposed rulemaking for publication in the Federal Register
proposing to add the organism to the list in paragraph (d) of this
section of nonindigenous organisms exempt from regulation under this
part.
(4) If, based upon its review of the request, APHIS is unable to
conclude that exempting the regulated organism from regulation would
not present a significant plant pest risk, the request for an exemption
from regulation under [[Page 5305]] this part will be denied. The
person requesting the exemption will be informed, in writing, of the
denial and the reasons for APHIS' inability to find that exempting the
regulated organism from regulation under this part would not present a
significant plant pest risk. Any person whose request has been denied
may appeal the decision, in writing, to the Administrator within 10
days of receiving the written notification of the denial. The appeal
must state all of the facts and reasons upon which the person relies to
show that the request was wrongfully denied. The Administrator will
grant or deny the appeal, in writing, stating the reasons for the
denial as promptly as circumstances allow. If there is a conflict as to
any material fact and the person whose request was denied requests a
hearing, a hearing will be held to resolve the conflict. Rules of
practice concerning the hearing will be adopted by the Administrator.
(c) If, absent any request from the public, APHIS concludes that
exempting any nonindigenous organism from regulation would not present
a significant plant pest risk, APHIS will prepare a notice of proposed
rulemaking for publication in the Federal Register proposing to add the
organism to the list in paragraph (d) of this section of nonindigenous
organisms exempted from regulation under this part.
(d) Exempted nonindigenous organisms. The following nonindigenous
organisms may be introduced without restriction under this part into
the area or areas of the United States specified:
----------------------------------------------------------------------------------------------------------------
Scientific or common Where
Class Order Family name exempt\1\
----------------------------------------------------------------------------------------------------------------
Arachnida............... Scorpiones.............. ........................ scorpions.............. (1)
Arachnida............... Pseudoscor-piones....... ........................ pseudoscorpions........ (1)
Arachnida............... Solfugae................ ........................ windscorpions.......... (1)
Arachnida............... Amblypygi............... ........................ tailless whipscorpions. (1)
Arachnida............... Opiliones............... ........................ daddy-longlegs, (1)
harvestmen.
Arachnida............... Aranae.................. Theraphosidae........... tarantulas............. (1)
Insecta................. Blattodea............... ........................ cockroaches............ (1)
Insecta................. Diptera................. Culicidae............... mosquitoes............. (1)
Insecta................. Diptera................. Muscidae................ Musca domestica........ (1)
Insecta................. Diptera................. Drosophilidae........... Drosophila melanogaster (1)
Chilopoda............... ........................ ........................ centipedes............. (1)
Diploda................. ........................ ........................ millipedes............. (1)
----------------------------------------------------------------------------------------------------------------
\1\Areas of exemption are as follows: (1) The entire United States; (2) The continental United States (the
conterminous 48 States and Alaska); (3) Hawaii; (4) Puerto Rico; (5) The Northern Mariana Islands; (6) Any
other U.S. territory or possession.
Sec. 335.6 Conditions for the introduction of regulated organisms.
(a) Importation. A regulated organism may be imported into the
United States only if:
(1) The regulated organism is accompanied by a permit issued in
accordance with Sec. 335.4.
(2) The regulated organism is imported through a port of first
arrival designated by an asterisk in Sec. 319.37-14(b) of this chapter
or is mailed to APHIS at a port of first arrival designated by an
asterisk in Sec. 319.37-14(b) of this chapter;
(3) Following its arrival at the port of first arrival, the
regulated organism is not moved to any destination other than the
destination listed on the permit;
(4) The regulated organism is moved in a container that meets the
requirements of Sec. 335.8;
(5) The container in which the regulated organism is being moved
remains unopened until its arrival at the destination specified on the
permit;
(6) The regulated organism is not accompanied by any other organism
or article, except as specified on the permit;
(7) The outside of the container in which the regulated organism is
being imported bears a label issued by APHIS;
(8) The outside of the container in which the regulated organism is
being moved accurately identifies the regulated organism, the person to
whom the permit was issued, the destination of the regulated organism,
the return address of the sender of the regulated organism, and the
number of the permit authorizing the importation;
(9) The person to whom the permit has been issued agrees to notify
the Administrator of:
(i) The accidental or unauthorized release into the environment of
the regulated organism, immediately after the accidental or
unauthorized release into the environment occurs; and
(ii) Any characteristics of the regulated organism that are
substantially different from those listed in the application for a
permit, no later than 5 days after identifying the characteristics;
(10) The person to whom the permit has been issued agrees to
present the regulated organism or any material accompanying the
regulated organism to the Administrator for destruction, disposal, or
the remedial measures the Administrator determines necessary to prevent
the spread of plant pests, and to allow the Administrator to destroy,
dispose of, or apply remedial measures to the regulated organism or any
material accompanying the regulated organism if the Administrator
determines that such action is necessary to prevent the spread of plant
pests; and
(11) The regulated organism is imported in accordance with any
other conditions specified on the permit.
(b) Interstate movement. A regulated organism may be moved
interstate only if:
(1) The regulated organism is accompanied by a permit issued in
accordance with Sec. 335.4.
(2) The regulated organism is not moved to any destination other
than the destination specified on the permit;
(3) The regulated organism is moved in a container that meets the
requirements of Sec. 335.8;
(4) The container in which the regulated organism is being moved
remains unopened until its arrival at the destination specified on the
permit;
(5) The regulated organism is not accompanied by any other organism
or article, except as specified on the permit;
(6) The outside of the container in which the regulated organism is
being moved identifies the regulated organism, the person to whom the
permit was issued, the destination of the regulated organism, the
return address of the sender of the regulated organism, and the number
of the permit authorizing the interstate movement; and [[Page 5306]]
(7) The person to whom the permit has been issued agrees to notify
the Administrator of:
(i) The accidental or unauthorized release into the environment of
the regulated organism, immediately after the accidental or
unauthorized release into the environment occurs; and
(ii) Any characteristics of the regulated organism that are
substantially different from those listed in the application for a
permit, no later than 5 days after identifying the characteristics;
(8) The person to whom the permit has been issued agrees to present
the regulated organism or any material accompanying the regulated
organism to the Administrator for destruction, disposal, or the
remedial measures the Administrator determines necessary to prevent the
spread of plant pests, and to allow the Administrator to destroy,
dispose of, or apply remedial measures to the regulated organism or any
material accompanying the regulated organism if the Administrator
determines that such action is necessary to prevent the spread of plant
pests; and
(9) The regulated organism is moved interstate in accordance with
any other conditions specified on the permit.
(c) Release into the environment. A regulated organism may be
released into the environment only if:
(1) The release of the regulated organism into the environment is
authorized by a permit issued in accordance with Sec. 335.4;
(2) The person to whom the permit has been issued agrees to notify
the Administrator of:
(i) The accidental or unauthorized release into the environment of
the regulated organism, immediately after the accidental or
unauthorized release into the environment occurs; and
(ii) Any characteristics of the regulated organism that are
substantially different from those listed in the application for a
permit, no later than 5 days after identifying the characteristics;
(3) The person to whom the permit has been issued agrees to present
the regulated organism or any material accompanying the regulated
organism to the Administrator for destruction, disposal, or the
remedial measures the Administrator determines necessary to prevent the
spread of plant pests, and to allow the Administrator to destroy,
dispose of, or apply remedial measures to the regulated organism or any
material accompanying the regulated organism if the Administrator
determines that such action is necessary to prevent the spread of plant
pests;
(4) Specimens of the regulated organism have been submitted to, and
accepted into, the collections of at least three universities, museums,
scientific societies, or other organizations that maintain collections
of organisms, and the identification numbers assigned to the specimens
have been provided to APHIS; and
(5) The regulated organism is released into the environment in
accordance with the conditions specified on the permit.
Sec. 335.7 Facilities for the containment of regulated organisms.
(a) The Administrator will approve the use of a facility for the
containment of a regulated organism only if:
(1) The facility's physical structure possesses adequate water,
air, and waste handling systems, as well as adequate entryways,
windows, and facility structure to contain the regulated organism and
prevent the unauthorized entry of organisms and people;
(2) The facility has procedural safeguards and is operated in a
manner that will prevent the escape of a regulated organism and will
prevent the unauthorized entry of organisms and people;
(3) The facility has a means of inactivating or sterilizing the
regulated organism and any host material, containers, or other material
used for the regulated organism;
(4) The facility and its operation meet any other conditions the
Administrator deems necessary to prevent the escape of a regulated
organism and will prevent the unauthorized entry of organisms and
people;
(5) During the time that a regulated organism is held in the
facility, the operator of the facility maintains records that identify
the regulated organism, the person from whom the regulated organism was
received, the date the regulated organism was received at the facility,
and the disposition of the regulated organism; and
(6) During normal business hours, an APHIS inspector is allowed to
inspect and copy the records required by paragraph (a)(5) of this
section.
(b) [Reserved]
Sec. 335.8 Container requirements for the movement of regulated
organisms.
(a) General requirements. A regulated organism shall not be
imported or moved interstate unless the regulated organism and any
material accompanying the regulated organism are enclosed in a
container that complies with paragraph (b) of this section, unless a
variance has been granted in accordance with paragraph (c) of this
section.
(b) Container requirements. (1) Plants and plant parts. All plants
or plant parts, except seeds and cells, must be enclosed in a sealed
plastic bag of at least 0.1270 mm (5 mil) thickness or in an equivalent
leakproof container, and then enclosed in a sturdy, sealed, outer
container constructed of corrugated fiberboard, corrugated cardboard,
wood, or other material of equivalent strength.
(2) Seeds. All seeds must be enclosed in a sealed plastic bag of at
least 0.1270 mm (5 mil) thickness or in an equivalent leakproof
container. The sealed plastic bag or equivalent leakproof container
must then be enclosed within a second sealed plastic bag of at least
0.1270 mm (5 mil) thickness or in an equivalent leakproof container.
Each plastic bag or equivalent leakproof container must be
independently capable of preventing the seeds from escaping the
container. Each set of containers must be enclosed in a sturdy outer
container constructed of corrugated fiberboard, corrugated cardboard,
wood, or other material of equivalent strength.
(3) Microorganisms. All microorganisms, such as fungi, bacteria,
nematodes, or cells, must be enclosed in a container as specified in
paragraph (b)(3)(i) or (b)(3)(ii) of this section:
(i) Volume not exceeding 50 mL. Microorganisms not exceeding 50 mL
in volume must be enclosed in a durable, watertight primary container,
which must be enclosed in a second durable, watertight container
(secondary container). Several primary containers may be enclosed in a
single secondary container if the total volume of all the primary
containers enclosed in a single secondary container does not exceed 50
mL. The space at the top, bottom, and sides between the primary and
secondary containers must contain sufficient nonparticulate absorbent
material (e.g., paper towel) to absorb the entire contents of the
primary container(s). The secondary container must then be enclosed in
an outer container constructed of corrugated fiberboard, corrugated
cardboard, wood, or other material of equivalent strength.
(ii) Volume greater than 50 mL. Microorganisms that exceed a volume
of 50 mL must comply with requirements in paragraph (b)(3)(i) of this
section. In addition, a shock-absorbing material, in volume at least
equal to that of the absorbent material between the primary and
secondary containers, must be placed at the top, bottom, and sides
between the secondary container and the outer container. Single primary
containers may not contain more than 1,000 mL of material. However, two
or more primary containers whose combined volumes do not exceed 1,000
mL may be enclosed in a single secondary container. The maximum
[[Page 5307]] amount of microorganisms that may be enclosed within a
single outer container shall not exceed 4,000 mL.
(iii) Dry ice. If dry ice is used as a refrigerant, it must be
placed between the secondary container and the outer container. The
shock-absorbing material must be placed so that the secondary container
does not become loose inside the outer container as the dry ice
sublimates.
(4) Arthropods. Insects, mites, or other arthropods must be
enclosed in a container as specified in this paragraph or in paragraph
(b)(3) of this section. Arthropods (any life stage) must be enclosed in
a primary container (insulated vacuum container, metal, or plastic) and
the container must be sealed to prevent escape of the arthropods. The
primary container must be enclosed in a secondary container of
crushproof styrofoam or other material of equivalent strength; one or
more rigid ice packs may also be enclosed in the secondary container;
and sufficient packing material must be added around the primary
container to prevent movement of the primary container within the
secondary container. The secondary container must be enclosed in an
outer container constructed of corrugated fiberboard, corrugated
cardboard, wood, or other material of equivalent strength.
(5) Other organisms. Any organism not covered in paragraph (b)(1),
(b)(2), or (b)(4) of this section that does not require continuous
access to atmospheric oxygen must be enclosed in a container as
specified in paragraph (b)(3) or (b)(4) of this section. Any organism
that is not a plant and that requires continuous access to atmospheric
oxygen must be enclosed in a primary container constructed with a
sturdy, crush-proof frame of wood, metal, or other material of
equivalent strength, surrounded by mesh or netting of a strength and
mesh size sufficient to prevent the escape of the smallest organism in
the container, with the edges and seams of the mesh or netting sealed
to prevent the escape of organisms. Each primary container must be
enclosed in a larger secondary container constructed of wood, metal, or
other material of equivalent strength. The primary and secondary
containers must be enclosed in an outer container constructed of
corrugated fiberboard, corrugated cardboard, wood, or other material of
equivalent strength, which outer container may have air holes or spaces
in the sides and/or ends of the container, provided that the outer
container must retain sufficient strength to prevent crushing of the
primary and secondary containers.
(c) Request for a variance from container requirements. If the
person applying for a permit for the introduction of a regulated
organism believes that the container requirements in paragraph (b) of
this section are inappropriate for the importation or interstate
movement of a regulated organism due to unique circumstances (such as
the nature, volume, or life stage of the regulated organism), that
person may request a variance from the container requirements in
paragraph (b) of this section when applying for a permit. The request
for a variance under this section must consist of a written statement
describing why the applicable container requirements in paragraph (b)
of this section are inappropriate for the regulated organism that the
person proposes to move, and what container requirements the person
would use in lieu of the applicable container requirements of paragraph
(b) of this section. Prior to the issuance of a permit, APHIS will
advise the person as to the disposition of his or her request for a
variance from the container requirements in paragraph (b) of this
section. If APHIS has granted the variance request, a permit will be
issued if APHIS had determined from its review of the permit
application that the regulated organism can be introduced without risk
of plant pest dissemination. Any person who has been denied a variance
from the container requirements in paragraph (b) of this section may
appeal the decision in writing to the Administrator within 10 days
after receiving the written notification of the denial. The appeal must
state all of the facts and reasons upon which the person relies to show
that the variance was wrongfully denied. The Administrator will grant
or deny the appeal, in writing, stating the reasons for the decision as
promptly as circumstances allow. If there is a conflict as to any
material fact and the person denied a variance requests a hearing, a
hearing will be held to resolve the conflict. Rules of practice
concerning the hearing will be adopted by the Administrator. No permit
will be issued until such time as the appeal is resolved and the
applicant has agreed to abide by APHIS' decision.
Sec. 335.9 Costs and charges.
Unless a user fee is payable under Sec. 354.3 of this chapter, the
services of an APHIS inspector during regularly assigned hours of duty
and at the usual places of duty will be furnished without cost. The
U.S. Department of Agriculture's provisions relating to overtime
charges for an APHIS inspector's services are set forth in part 354 of
this chapter. The U.S. Department of Agriculture will not be
responsible for any costs or charges incident to inspections or
compliance with this part, other than for the services of the APHIS
inspector.
Done in Washington, DC, this 23rd day of January 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-1984 Filed 1-25-95; 8:45 am]
BILLING CODE 3410-34-P
