Introduction of Nonindigenous Organisms

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