[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