[Federal Register Volume 66, Number 195 (Tuesday, October 9, 2001)]
[Proposed Rules]
[Pages 51340-51358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25229]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 66, No. 195 / Tuesday, October 9, 2001 / 
Proposed Rules  

[[Page 51340]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 330

[Docket No. 95-095-2]
RIN 0579-AA80


Plant Pest Regulations; Update of Current Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to revise our regulations regarding the 
movement of plant pests by adding risk-based criteria for determining 
the plant pest status of organisms, establishing a notification process 
that could be used as an alternative to the current permitting system, 
providing for the environmental release of organisms for the biological 
control of weeds, and updating the text of the subpart. These proposed 
changes would clarify the factors that would be considered when 
assessing the plant pest risks associated with certain organisms, 
facilitate the importation and interstate movement of regulated 
organisms, and address gaps in the current regulations.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by December 10, 2001.

ADDRESSES: Please send your comment and three copies to: Docket No. 95-
095-2, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 
4700 River Road Unit 118, Riverdale, MD 20737-1238.
    Please state that your comment refers to Docket No. 95-095-2.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS rules, are available on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Robert Flanders, Risk Assessment 
Branch Chief, or Ms. Deborah Knott, Permits Branch Chief, PPQ, APHIS, 
4700 River Road Unit 133, Riverdale, MD 20737-1236; phone 301-734-5930 
(Dr. Flanders) or 301-734-5055 (Ms. Knott).

SUPPLEMENTARY INFORMATION:

Background

    Under the Plant Protection Act (Title IV of Pub. L. 106-224, 
referred to below as the Act), the Secretary of Agriculture has broad 
authority to carry out operations or measures to detect, control, 
eradicate, suppress, prevent, or retard the spread of plant pests. 
Section 411(a) of the Act provides that ``no person shall import, 
enter, export, or move in interstate commerce any plant pest, unless 
the importation, entry, exportation, or movement is authorized under 
general or specific permit and is in accordance with such regulations 
as the Secretary may issue to prevent the introduction of plant pests 
into the United States or the dissemination of plant pests within the 
United States.'' The Act gives the United States Department of 
Agriculture (USDA) the flexibility to respond appropriately to a wide 
range of needs and circumstances to protect American agriculture 
against plant pests. The Act defines a plant pest as ``[A]ny living 
stage of any of the following that can directly or indirectly injure, 
cause damage to, or cause disease in any plant or plant product: (A) A 
protozoan. (B) A nonhuman animal. (C) A parasitic plant. (D) A 
bacterium. (E) A fungus. (F) A virus or viroid. (G) An infectious agent 
or other pathogen. (H) Any article similar to or allied with any of the 
articles specified in the preceding subparagraphs.''
    In addition, Sec. 412(a) of the Act provides that Secretary may 
prohibit or restrict the importation, entry, exportation, or movement 
in interstate commerce of, among other things, any biological control 
organism if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction into the United 
States or the dissemination of a plant pest or noxious weed within the 
United States. The Act defines a biological control organism as ``any 
enemy, antagonist, or competitor used to control a plant pest or 
noxious weed.''
    The purpose of the regulations in ``Subpart--Movement of Plant 
Pests'' (7 CFR 330.200 through 330.212) is to prevent the dissemination 
of plant pests into the United States, or interstate, by regulating the 
importation and interstate movement of plant pests. These regulations 
were issued by the Animal and Plant Health Inspection Service (APHIS) 
under the authority provided by, among other statutes, the Department 
of Agriculture Organic Act of 1944, as amended (7 U.S.C. 147a), and the 
Federal Plant Pest Act, as amended (7 U.S.C. 150aa through 150jj), both 
of which were superseded and repealed by the Plant Protection Act. The 
provisions of the Plant Protection Act that have a direct bearing on 
the proposed regulations in this document were derived from existing 
laws, including the Department of Agriculture Organic Act and the 
Federal Plant Pest Act, with little or no modification. Thus, the 
provisions of this proposed rule do not differ significantly from what 
we would have proposed under the authority of those applicable 
provisions of law that were repealed by the Plant Protection Act.

Advance Notice of Proposed Rulemaking

    On September 27, 1996 (61 FR 50767-50770, Docket No. 95-095-1), we 
published in the Federal Register an advance notice of proposed 
rulemaking (ANPR) to solicit public comment on several issues 
pertaining to our current regulations regarding the importation and 
interstate movement of plant pests. Specifically, we sought public 
comment on the criteria used to determine whether an organism is a 
plant pest; what types of direct and indirect injury or damage to 
plants and plant products should be regulated; how to facilitate the 
interstate movement and use of biological control organisms; and how to 
best evaluate the safety of proposed releases into the environment of 
organisms with plant pest

[[Page 51341]]

characteristics. In the ANPR, we stated that we would use the 
information we gathered as we considered the need for regulatory 
changes and weighed alternative methods of addressing plant pest risk 
as it pertains to the importation, interstate movement, and release 
into the environment of plant pests or potential plant pest organisms.
    We solicited comments concerning the ANPR for 90 days ending 
December 26, 1996. We received 52 comments by that date, including 3 
comments received at a public hearing held on November 7, 1996. They 
were from university researchers and students, Federal researchers, 
insect zoo owners and employees, insect dealers, State agricultural 
agencies, a crop science society, biological control practitioners, and 
associations representing biological control producers and researchers, 
phytopathologists, zoos, seed companies, organic farmers and suppliers, 
and repositories of biological specimens.
    The discussion contained in the ANPR and the questions it posed 
were, for the most part, well received by the majority of commenters. 
We considered the suggestions and criticisms offered in the comments 
during the drafting of this proposed rule. One aspect of the ANPR that 
was not well received was the suggestion that voluntary standards be 
considered for facilitating the interstate movement and release into 
the environment of organisms used in the biological control of plant 
pests. None of the commenters who addressed this subject recommended 
that we pursue this idea, most stating that such standards would be 
unenforceable and ill-advised.
    Many of the comments we received were from individuals or groups 
who are involved in biological control research or practice, so their 
comments were focused on the need for, and content of, regulations 
regarding the introduction of biological control organisms. We believe 
that it is important to make it clear that APHIS' regulation of 
biological control occurs in the larger context of the Agency's 
statutory authority, which requires us to focus on preventing the 
introduction and dissemination of plant pests. This means that the 
plant pest risk presented by an organism, rather than its intended use 
as a biological control agent, must be APHIS' primary consideration.
    This does not mean, however, that our proposed regulations would 
have no bearing on the study or practice of biological control. Indeed, 
most biological control endeavors begin with the importation of 
nonindigenous species that may exhibit some potential as biological 
control agents, and those importations frequently consist of field-
collected organisms of unknown or unconfirmed taxonomy, which precludes 
an adequate pre-import pest risk assessment. In addition, those 
organisms may be accompanied by plant material, foreign soil, or other 
organisms, all of which may pose a plant pest risk. Given these 
factors, the initial handling of organisms with potential biological 
control applications would not differ substantively from the handling 
of organisms imported for other purposes. Further, this proposed rule 
contains provisions regarding the release into the environment of 
agents for the biological control of weeds. This document represents 
our effort to address issues of concern to the biological control 
community in the context of our clear authority to take measures to 
prevent the introduction and dissemination of plant pests. The proposed 
regulations are discussed below.

Definitions

    In addition to our proposed revision of ``Subpart-- Movement of 
Plant Pests,'' we would also revise Sec. 330.100, ``Definitions,'' of 
``Subpart-- General Provisions,'' to incorporate the applicable new 
definitions provided by the Plant Protection Act and to update or 
eliminate some of the definitions currently provided in that section. 
The revised section is set out in its entirety in the rule portion of 
this document.
    From the Plant Protection Act, we would add definitions for the 
terms article, biological control organism, enter (entry), export 
(exportation), import (importation), noxious weed, plant, plant 
product, and State; we would also replace the current definitions of 
interstate, means of conveyance, move (moved and movement), permit, 
plant pest, and United States with the definitions provided for those 
terms in the Plant Protection Act. In addition, the revised section 
would include a definition of APHIS, as the Agency's acronym is used in 
our proposed revisions to ``Subpart--Movement of Plant Pests.''
    The definitions currently provided in Sec. 330.100 for the terms 
administrative instructions, Department, earth, garbage, owner, person, 
regulated garbage, shelf-stable, soil, and through the United States 
would remain the same. We would also retain, with minor, nonsubstantive 
editorial changes, that section's definitions of the terms 
Administrator, continental United States, Customs, Deputy 
Administrator, inspector, and Plant Protection and Quarantine Programs. 
The definitions provided in Sec. 330.100 for Plant Quarantine Act and 
the Federal Plant Pest Act would be removed, as those acts were 
repealed by the Plant Protection Act, and we would remove the 
definition provided for the term territories or possessions because 
territories or possessions are included within the Plant Protection 
Act's definition of the term State.

Titles of the Part and Subpart

    The title of part 330, ``Federal Plant Pest Regulations; General; 
Plant Pests; Soil, Stone, and Quarry Products; Garbage,'' reflects the 
titles of its four subparts. The subpart that is the subject of this 
proposed rule is titled ``Subpart--Movement of Plant Pests'' 
(Secs. 330.200 through 330.212). As explained below in our discussion 
of proposed Sec. 330.200 and elsewhere, the scope of the proposed 
regulations would not be limited to the movement of plant pests, so we 
are proposing to change the title of the subpart to ``Subpart--Movement 
and Release of Organisms Under the Plant Protection Act'' in order to 
more accurately reflect the content of the proposed regulations. This 
proposed change in the subpart's title would be reflected in the title 
of part 330, which we would change to ``Federal Plant Pest Regulations: 
General; Organisms; Soil, Stone, and Quarry Products; Garbage.''

What Organisms Are Regulated Under This Subpart? (Sec. 330.200)

    The proposed regulations would begin by identifying the categories 
of organisms that would be subject to the regulations in ``Subpart--
Movement and Release of Organisms Under the Plant Protection Act.'' As 
noted in the previous paragraph, the scope of the proposed regulations 
would not be limited to organisms commonly regarded as plant pests, but 
would include biological control agents when certain risk factors were 
present. We would introduce the term ``regulated organism'' in order to 
describe the variety of both harmful and beneficial organisms that 
would be subject to the regulations.
    As used in the proposed regulations, the term ``regulated 
organism'' would describe an organism that: (1) Meets the statutory 
definition of plant pest (i.e., it can directly or indirectly injure or 
cause disease or damage in plants, plant parts, or plant products) and 
(2) will be imported into the United States, moved interstate, or 
released into the environment. In addition, we would classify an 
organism that will be imported into the United States as a regulated 
organism if that organism was not adequately identified or if we had

[[Page 51342]]

reason to believe that the importation of the organism presents a plant 
pest risk due to the inclusion of plant pests, plant material, or soil 
in the container in which the organism is shipped. The risk criteria we 
would use to determine whether an organism should be designated as a 
regulated organism are discussed below. For the sake of clarity, we 
wish to emphasize that the proposed regulations would not cover 
genetically modified organisms, which are covered by our regulations in 
7 CFR part 340.
    It should be noted that the designation of any particular organism 
as a regulated organism would not result in an outright, open-ended 
prohibition on its importation or interstate movement. In almost every 
case, we believe that it would be possible to arrange adequate 
safeguards that would allow a regulated organism to be imported or 
moved interstate. Similarly, the designation of biological control 
agents of weeds as regulated organisms would not mean that we 
considered those organisms to present the same kinds of plant pest 
risks as, for example, a destructive fruit fly or pathogen. Rather, our 
proposed use of the term ``regulated organism,'' and the restrictions 
that such a designation would entail, is intended to provide us with a 
means of identifying and dealing with organisms that, at least 
initially, appear to require some degree of regulatory oversight in 
order to prevent the dissemination of plant pests in the United States 
and damage to this country's environment and ecosystems. It is our 
intention in promulgating these proposed regulations to achieve those 
goals within the scope of our existing statutory authority.
    Under proposed Sec. 330.200, regulated organisms would be divided 
into three categories: (1) Plant pests, (2) biological control 
organisms for the control of noxious weeds, and (3) imported biological 
control organisms for the control of plant pests and other imported 
organisms.
    The first category of regulated organisms, plant pests, would be 
addressed in paragraph (a) of proposed Sec. 330.200. That paragraph 
would provide that the importation, interstate movement, and, under 
certain limited circumstances, release into the environment of any 
plant pest would be subject to the restrictions of proposed 
Secs. 330.201, 330.202, and 330.203(a), which are explained later in 
this document. (It should be noted that not all plant pests would be 
eligible for release into the environment under the proposed 
regulations. An explanation of the circumstances under which a plant 
pest would be eligible for environmental release can be found later in 
the document in the discussion of proposed Sec. 330.203.)
    As an organism must be capable of directly or indirectly injuring, 
causing damage to, or causing disease in a plant or plant product to be 
considered a plant pest, proposed Sec. 330.200(a)(1) and (a)(2) would 
list the factors that we would consider when assessing the plant pest 
status of an organism.
    Under the criteria of proposed paragraph (a)(1), an organism would 
be determined to directly injure or cause disease or damage in plants, 
plant parts, or plant products when the organism:
     Reduces the yields, vigor, or viability of living plants 
by feeding on, infecting, parasitizing, or contaminating plants or 
plant parts or by vectoring agents of plant diseases; or
     Reduces the quality or marketability of plant products 
such as stored grain, stored fruit, or lumber by feeding on, infecting, 
or contaminating the plant products.
    In establishing these proposed criteria, we have attempted to 
incorporate a degree of flexibility that would allow us to take into 
account the fact that some organisms only incidentally feed on, develop 
on, or contaminate plants, plant parts, or plant products without 
causing an appreciable degree of damage. These proposed criteria would 
place an emphasis on organisms that present an identifiable risk, i.e. 
organisms that are capable of quantifiable reductions in the yields, 
vigor, or viability of living plants or the quality or marketability of 
plant products.
    Proposed paragraph (a)(2) would contain the criteria that would be 
considered in determining whether an organism presented a risk of 
indirectly injuring or causing disease or damage in plants, plant 
parts, or plant products. Under this paragraph, we would consider the 
risk of indirect injury, disease, or damage to be present when an 
organism adversely affects another organism that was beneficial to 
plants, and those adverse effects cause losses in yields of crops or 
forage plants or a reduction in the viability or vigor of ornamental or 
native plants. As with the proposed criteria regarding direct effects, 
these criteria would give us the flexibility to take into account the 
fact that some organisms only incidently attack or otherwise harm 
beneficial organisms and thus may present little actual risk.
    Because the organisms that can be considered to provide the most 
benefit to plants are those organisms that either control plant pests 
or pollinate plants, proposed Sec. 330.200(b) indicates the two types 
of organisms with indirect plant pest effects that would be of primary 
concern are organisms that are:
     Pathogens, predators, or parasites (except 
autoparasitoids) of important natural enemies of plant pests or weeds; 
or
     Pathogens, predators, or parasites of important or 
commercially available pollinators such as honeybees, bumble bees, and 
alkali bees.
    We have included the modifiers ``important'' and ``commercially 
available'' with regard to the natural enemies and pollinators that 
might be affected by a regulated organism to avoid lending undue weight 
to a regulated organism's effects on another organism that might play 
only a minor or occasional role in the pollination of plants or the 
suppression of plant pests or weeds. Our determination as to the 
``importance'' of a natural enemy or a pollinator would be based on our 
review of available information in the scientific literature regarding 
the role of those organisms in suppressing plant pest or weed 
populations or in the pollination of crops and native plants. Our 
determination as to whether pollinators are ``commercially available'' 
would take into account factors such as the inclusion of particular 
species in catalogs or their use by commercial pollination services. We 
acknowledge that these working definitions of ``important'' and 
``commercially available'' could be further refined to take into 
account additional factors that would increase their usefulness and 
clarity; therefore, we encourage the submission of any specific 
comments regarding these terms.
    The second category of regulated organisms, biological control 
organisms for the control of noxious weeds, would be addressed in 
paragraph (b) of proposed Sec. 330.200. Under proposed Sec. 330.200(b), 
the importation, interstate movement, and release into the environment 
of any biological control organism for the control of noxious weeds 
would be subject to the restrictions of proposed Secs. 330.201, 
330.202(a) and (b), and 330.203(b). Like plant pests with the direct 
effects on plants described above, biological control agents of weeds 
are capable of reducing the vigor or viability of living plants; 
however, those direct effects are actually the desired outcome when the 
plant in question is a noxious weed. Therefore, the regulations would 
provide that biological control agents of weeds may be eligible for 
release into the environment under the regulations.
    The third category of regulated organisms, imported biological 
control organisms for the control of plant pests

[[Page 51343]]

and other imported organisms, would be addressed in paragraph (c) of 
proposed Sec. 330.200. Under proposed Sec. 330.200(c)(1), an organism 
that was proposed for importation into the United States could be 
determined to present a risk of disseminating a plant pest when it was:
     A field-collected organism that, in natural conditions, is 
associated with plant pests and there is reason to believe that the 
plant pests could be shipped with the field-collected organisms; or
     A laboratory-reared organism that is provided with plant 
pests as host material during rearing or shipment; or
     An organism that will be shipped with plant material or 
soil; or
     An organism that has not been positively identified.
    In the first three criteria listed above, the plant pest risk is 
based on the risk that the shipment of organisms is contaminated by 
plant pests, either on the organism itself or in the material included 
in the shipment. We believe that our proposed use of these three 
criteria in the regulations is consistent with the approach APHIS takes 
to the importation of other articles, such as fruits and vegetables. 
While an orange, for example, is not a plant pest, the circumstances 
surrounding its production or shipment (e.g., the presence of plant 
pests in the growing area) could lead APHIS to conclude that certain 
regulatory measures would be necessary to prevent that orange from 
introducing plant pests into the United States. We would use the 
proposed criteria in the same way to ensure that the importation of 
organisms from another country did not result in the introduction of 
plant pests into the United States. The final criterion listed above 
would be included due to the fact that we would be unable to make any 
sort of a determination regarding an organism's plant pest status in 
the absence of a positive identification of the organism.
    After the organism had been imported into the United States, 
paragraph (c)(2) of proposed Sec. 330.200 would provide for the 
organism to be moved interstate without any further restriction under 
the regulations if, while being held under the conditions assigned to 
its importation, the organism was positively identified (if such 
identification had not been made prior to importation), was determined 
to not be a plant pest (i.e., once identified, the organism was found 
to not meet any of the criteria of proposed Sec. 300.200(a) or (b)), 
and was separated from any associated plant pests, plant material, 
soil, and other media. Satisfying these three requirements would 
address the contamination and identity risk factors listed in proposed 
Sec. 330.200(c)(1), thus making the subsequent movement of the organism 
possible without the risk of plant pest dissemination.
    It should be noted that although the Environmental Protection 
Agency (EPA) has exempted certain biological control agents from the 
requirements of its regulations issued under the authority of the 
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), other 
biological control agents (eukaryotic microorganisms, procaryotic 
microorganisms, and viruses) are still regulated by EPA as 
``substances'' under FIFRA. Such substances, unless otherwise exempt, 
would therefore need to be registered under FIFRA prior to their sale 
or distribution. Moreover, where residues of any biological control 
agents remain in or on food or feed, a tolerance or exemption from the 
requirement of a tolerance would be necessary under section 408 of the 
Federal Food, Drug and Cosmetic Act (FFDCA) before such food could 
legally be moved in interstate commerce. Therefore, while the 
provisions of proposed Sec. 330.200(c)(2) may allow some regulated 
organisms to be moved without further restriction under APHIS' 
regulations after satisfying certain requirements, those organisms may 
still be subject to EPA's requirements under FIFRA and FFDCA.

Movement of Regulated Organisms

    As described in the following sections, the regulations would 
provide for three ways to move a regulated organism:
     With a permit;
     Through post-movement notification if a compliance 
agreement is in place; and
     Without a permit (and without need of notification) if the 
regulated organism is on the list in proposed Sec. 330.202(c)(1) of 
negligible-risk, indigenous plant pest species that could be moved 
interstate within the continental United States if moved from 
populations located within the continental United States.
    Each of these three options is explained in greater detail below. 
In preparing this proposed rule, we also considered the possibility of 
including a fourth movement option that would be tailored specifically 
to low-risk organisms, i.e., those regulated organisms whose movement 
might not require the level of oversight and information processing 
that permitting and post-movement notification entail, but that for 
various reasons--most notably limited geographic distribution--would 
not qualify for inclusion on the ``no permit required'' list.
    While we believe that it might be possible to address the movement 
of these low-risk organisms through a pre-movement notification process 
that would not require the use of a compliance agreement, we identified 
two potential complicating factors with such an approach that led us to 
not include pre-movement notification in this proposed rule.
    First, it appears that it would be necessary to assemble a list of 
organisms eligible for movement through pre-movement notification, and 
we anticipate that it would be a time-consuming process to obtain 
consensus among the interested parties (e.g., public and private 
scientists, State and Federal regulators, etc.) as to the content of 
such a list. Further, the list would have to take into account the 
current distribution of each organism and identify the areas into which 
the organism could or could not be moved under pre-movement 
notification; this too would take some time to accomplish.
    The second consideration is determining how much information should 
be required of the person making the pre-movement notification. For a 
pre-movement notification process to offer benefits to its users, it 
would be necessary for us to pare down the number of data elements to 
be addressed in the notification (as compared to the questions 
contained in a permit application) without diminishing the ability of a 
reviewer to adequately consider the issues raised by the proposed 
movement. We believe that the resolution of the issues surrounding the 
list discussed in the previous paragraph would go far toward allowing 
us to construct a practical and useful pre-movement notification 
process.
    While these two factors led us to not pursue the idea of pre-
movement notification in this proposed rule, we have not abandoned that 
idea or, more generally, the idea of streamlining the process for 
moving low-risk organisms. With that in mind, we encourage anyone with 
an interest in these issues to provide comments and suggestions 
regarding pre-movement notification or any other approaches to 
simplifying the process for moving low-risk regulated organisms.

Requirements for the Importation of Regulated Organisms 
(Sec. 330.201)

    Proposed Sec. 330.201 would explain the options available to 
persons who wished to import a regulated organism into the United 
States. An importation

[[Page 51344]]

could be accomplished through notification or under permit when APHIS 
determines that the importation could be accomplished in a manner that 
would prevent the dissemination of plant pests. All imported organisms 
would have to be labeled in accordance with Sec. 330.211, which is 
discussed below.
    The introductory text of proposed Sec. 330.201 would also address 
the importation of preserved or dried biological specimens of plant 
pests. Such specimens could be imported without restriction under the 
proposed regulations, but would be subject to inspection upon arrival 
in the United States to confirm the nature of the material and its 
freedom from risk of plant pest dissemination. These proposed 
provisions are the same as those found in the final sentence of 
Sec. 330.200 in the existing regulations, with one exception: In order 
to address the potential that some dried specimens of fungi that are 
plant pests could be the source of viable spores, we would specify that 
a specimen would have to be nonviable. Thus, any viable specimens of 
fungi that are plant pests would be subject to the restrictions of the 
proposed regulations.
    Paragraph (a) of proposed Sec. 330.201 would explain that if a 
person has entered into a compliance agreement with APHIS and the State 
where the regulated organisms will be received, the importation of 
regulated organisms could be carried out under the notification 
provisions of proposed Sec. 330.204. The rationale for our proposed use 
of compliance agreements and notification, as well as the procedures 
that would apply to each, are explained later in this document in the 
discussion of proposed Sec. 330.204.
    Paragraph (b) of proposed Sec. 330.201 would explain that persons 
who do not wish to enter into a compliance agreement may apply for a 
permit for the importation of a regulated organism in accordance with 
proposed Sec. 330.205. APHIS would use the information provided in a 
permit application to identify the plant pest risks associated with the 
regulated organism and its importation, and to assign any additional 
conditions that APHIS determined were necessary to mitigate any 
identified risks. Explanations of the permit application and permit 
conditions can be found later in this document in the discussions of 
Secs. 330.205 and 330.208, respectively.

Requirements for the Interstate Movement of Regulated Organisms 
(Sec. 330.202)

    Proposed Sec. 330.202 would explain the options available to 
persons who wished to move a regulated organism from one State into or 
through another State. An interstate movement could be accomplished 
through notification or under permit or, under certain limited 
circumstances, without a permit, when APHIS determines that the 
interstate movement could be accomplished in a manner that would 
prevent the dissemination of plant pests within the United States.
    Paragraph (a) of proposed Sec. 330.202 would explain that if a 
person has entered into a compliance agreement with APHIS and the State 
where the regulated organisms will be received, the interstate movement 
of regulated organisms could be carried out under the notification 
provisions of proposed Sec. 330.204. As noted in the previous section 
regarding importation, the rationale for our proposed use of compliance 
agreements and notification, as well as the procedures that would apply 
to each, are explained later in this document in the discussion of 
proposed Sec. 330.204.
    Paragraph (b) of proposed Sec. 330.202 would explain that persons 
who do not wish to enter into a compliance agreement may apply for a 
permit for the interstate movement of a regulated organism in 
accordance with proposed Sec. 330.205. As would be the case with 
applications for a permit to import regulated organisms, APHIS would 
use the information provided in an application for an interstate 
movement permit to identify the plant pest risks associated with the 
regulated organism and its movement and assign any additional 
conditions that APHIS determined were necessary to mitigate any 
identified risks. Again, explanations of the permit application and 
permit conditions can be found later in this document in the 
discussions of Secs. 330.205 and 330.208, respectively.
    Paragraph (c)(1) of proposed Sec. 330.202 would contain a list of 
indigenous plant pest species that could be moved interstate within the 
continental United States without a permit if they were moved from 
populations located within the continental United States. In assembling 
the list, we identified organisms for inclusion based on their wide 
distribution and low plant pest risk; we do, however, welcome any 
comments on the adequacy of these criteria, whether we accurately 
applied the criteria in our selection of organisms, and whether there 
are additional considerations that should be taken into account. The 
organisms contained in the list are indigenous bacteria, insects, and 
viruses that are distributed throughout the continental United States 
and that are known to commonly accompany plants or plant products moved 
in interstate commerce. The proposed list of organisms is set out in 
the regulatory text at the end of this document under Sec. 330.202, 
``Requirements for the interstate movement of regulated organisms.'' 
Given the wide distribution of these organisms, we believe that their 
interstate movement within the continental United States is not likely 
to result in additional plant pest risks. The proposed list, which is 
provided for under Sec. 411(c) of the Plant Protection Act, is offered 
as a means of simplifying the movement of these ubiquitous organisms; 
we do not consider the list to be comprehensive and fully acknowledge 
that there may be additional organisms that could be appropriately 
included on the list. Therefore, we welcome any comments on the 
composition of the list and any suggestions for additions, deletions, 
or modifications to its contents. In that vein, we have included 
provisions in proposed paragraph (c)(2) of Sec. 330.202 for a person to 
petition APHIS for the addition of species to, or removal of species 
from, the list of organisms that could be moved within the continental 
United States without a permit. The petitioner would have to send APHIS 
detailed information regarding the organism's distribution and its 
biological, economic, and environmental significance. If, after 
reviewing the petition, we determined that it would be appropriate to 
allow the suggested organism to be moved within the continental United 
States without a permit, we would publish a proposed rule in the 
Federal Register to amend the list. Any such proposed rule would be 
supported by analyses documenting our review and consideration of the 
plant pest risks and potential environmental effects associated with 
the organism proposed for inclusion on the list.
    Just as Sec. 411(c) of the Plant Protection Act provides for the 
exceptions to the permit requirements for plant pests discussed in the 
previous paragraph, Sec. 412(g)(1) of that act provides that ``[i]n the 
case of biological control organisms, the Secretary may publish, by 
regulation, a list of organisms whose movement in interstate commerce 
is not prohibited or restricted. Any listing may take into account 
distinctions between organisms such as indigenous,

[[Page 51345]]

nonindigenous, newly introduced, or commercially raised.'' APHIS, with 
the cooperation of the other USDA agencies represented on the 
Department's Biological Control Coordinating Council (BCCC), is 
considering what options might be available to further streamline or 
even eliminate the regulatory requirements that would apply to the 
movement and environmental release of certain biological control 
agents. We intend to consult with the other members of the BCCC 
regarding the criteria that might be used to identify the specific 
biological control agents that could be considered for expedited 
approval or exemption from regulatory restrictions; however, we would 
also like to take this opportunity to solicit suggestions from 
interested persons regarding the criteria that should be considered in 
assembling a list of biological control organisms whose movement in 
interstate commerce is not prohibited or restricted. A suggested 
starting point for this list is the identification of biological 
control organisms that have a documented history of release in the 
United States and no known negative effects on nontarget organisms and 
the environment. We recognize, though, that additional considerations 
will likely need to be taken into account in assembling the list, so we 
encourage the submission of comments and suggestions on this subject.

Requirements for the Release Into the Environment of Regulated 
Organisms (Sec. 330.203)

    Although the Federal Plant Pest Act specifically addressed only the 
importation and interstate movement of plant pests, and not 
environmental release, the Plant Protection Act (Sec. 403) includes 
``to release into the environment'' in its definition of ``move and 
related terms.''
    Paragraph (a) of proposed Sec. 330.203 would address the 
environmental release of plant pests. In most cases, the factors that 
would lead to an organism being considered a plant pest also recommend 
against that organism being intentionally released into the 
environment. However, proposed Sec. 330.203(a) would recognize that 
there are limited circumstances under which a plant pest might be 
released into the environment. Specifically, proposed 
Sec. 330.203(a)(1) would provide that any of the plant pests listed in 
proposed Sec. 330.202(c)(1)--i.e., those ubiquitous, low-risk organisms 
that could be moved interstate without a permit under that proposed 
paragraph--may be released into the environment within the continental 
United States without a permit if the organism was collected from a 
population located within the continental United States. As we stated 
with regard to the interstate movement of those listed organisms, we 
believe that the wide distribution of these organisms throughout the 
continental United States makes it unlikely that their environmental 
release will result in any appreciable additional plant pest risks. 
Again, we encourage the submission of comments regarding the criteria 
used in assembling the list and the composition of the list itself. The 
provisions of proposed Sec. 330.203(a)(1) regarding the release of 
plant pests without a permit would apply only to those organisms listed 
in proposed Sec. 330.202(c)(1).
    We also recognize that there are circumstances under which the 
release of other plant pests might be a necessary element of a testing 
or research protocol. On example of such a situation would be the 
release of plant pests into a test plot as challenge organisms for a 
resistant plant variety under development. Therefore, proposed 
Sec. 330.203(a)(2) would provide that a plant pest not listed in 
proposed Sec. 330.202(c)(1) may be released into the environment only 
for research or testing purposes and only if the release is authorized 
by an APHIS permit and is conducted in accordance with any safeguards 
assigned as a condition of the permit.
    Paragraph (b)(1) of proposed Sec. 330.203 would begin by stating 
that an agent for the biological control of weeds could be released 
into the environment in the United States only if the release is 
authorized by an APHIS permit. The introductory text of proposed 
Sec. 330.203(b)(1) would also provide that the issuance of a permit 
would be based on our determination that the host range of the 
biological control agent is limited to the target weed or an acceptably 
narrow range of closely related species and upon our determination that 
the benefits that could be expected to accrue from the release were not 
outweighed by any significant negative environmental or ecological 
consequences resulting from the release. Those conclusions would be 
based on the reviews described below in the discussion of proposed 
Sec. 330.203(b)(2). The process leading up to the issuance of a permit 
would ensure that APHIS, in consultation with other Federal and State 
officials and the applicant, had the opportunity to review the plant 
pest, environmental, and ecological considerations associated with the 
proposed release.
    Paragraph (b)(1)(i) of proposed Sec. 330.203 would address 
applications for a permit to release a biological control agent of 
weeds that is not indigenous to the United States and that has not 
previously been released under an APHIS permit. Because the release of 
such organisms would not have previously been reviewed and approved by 
APHIS, the applicant would have to address all the data elements 
contained in proposed Secs. 330.205 and 330.206, which are explained 
later in this document.
    Paragraph (b)(1)(ii) of proposed Sec. 330.203 would address permits 
for the release into the environment of regulated organisms that are 
native to the United States or that have been introduced (i.e., 
released into an ecosystem where it did not exist previously) into the 
United States and have become established (i.e., have formed self-
perpetuating populations in the ecosystem into which they were 
introduced). APHIS' National Environmental Policy Act (NEPA) 
implementing procedures in 7 CFR part 372 provide for a categorical 
exclusion from the requirement for the preparation of an environmental 
assessment or environmental impact statement for the permitting of the 
release into a State's environment of pure cultures of organisms that 
are either native or established introductions. Therefore, proposed 
Sec. 330.203(b)(1)(ii) would provide that an applicant for a release 
permit would not have to address the data elements in proposed 
Sec. 330.206(h), ``Potential environmental impacts,'' if the candidate 
agent was native to, or established in, the State in which it would be 
released, and would further provide that the environmental assessment 
required by proposed Sec. 330.203(b)(2)(iv) would not have to be 
prepared. In addition, it may be that the native or established status 
of the organism would preclude the need for the applicant to address 
other specific elements contained in proposed Sec. 330.206 and would 
allow us to shorten or waive the remaining reviews required under 
proposed Sec. 330.203(b)(2). Proposed Sec. 330.203(b)(1)(ii) would, 
therefore, recommend that an applicant for a permit for the 
environmental release of pure cultures of regulated organisms that are 
either native or established introductions should consult with APHIS 
prior to preparing a permit application. This consultation would give 
APHIS and the applicant an opportunity to review the issues surrounding 
the proposed release and identify those aspects of the permitting 
process that could be omitted.
    Paragraph (b)(2) of proposed Sec. 330.203 would explain the reviews 
that would have to be conducted before APHIS

[[Page 51346]]

would issue a permit for the release into the environment of an agent 
for the biological control of weeds.
    First, APHIS would request that the interagency Technical Advisory 
Group for Biological Control Agents of Weeds (TAG) review the proposed 
release. TAG is an independent, voluntary committee that was first 
formed in 1957 to provide advice to researchers. In its current role, 
TAG members review petitions for biological control of weeds and 
provide an exchange of views, information, and advice to researchers 
and those in APHIS responsible for issuing permits for importation, 
testing, and field release of biological control agents of weeds. TAG's 
membership currently includes Federal representatives from five USDA 
agencies (APHIS, the Agricultural Research Service, the Forest Service, 
the Natural Resources Conservation Service, and the Cooperative State 
Research, Education, and Extension Service), five agencies of the U.S. 
Department of the Interior (the Bureau of Land Management, the Bureau 
of Reclamation, the U.S. Fish and Wildlife Service, the National Park 
Service, and the U.S. Geological Survey), the U.S. Environmental 
Protection Agency, and the U.S. Army Corps of Engineers, and State 
officials representing the National Plant Board and the Weed Science 
Society of America. The TAG review considers the safety of the agent 
being considered, the potential risks that might be involved in its 
release, and the long-term ecological consequences of a successful 
release.
    Second, APHIS would review the plant pest risk issues raised by the 
proposed release. TAG's conclusions regarding the host range of the 
candidate agent would figure prominently in our determination of 
whether or not the organism posed a risk of appreciably injuring or 
causing disease or damage in plants other than the target weed.
    Third, APHIS would consult with the U.S. Fish and Wildlife Service 
to consider the potential effects of the candidate biological control 
agent on threatened and endangered species.
    Finally, APHIS would prepare an environmental assessment of the 
proposed release as required by NEPA. The environmental assessment 
would allow us to reach a finding of no significant impact or would 
lead us to conclude that it was necessary to prepare an environmental 
impact statement or to deny the permit.
    In paragraph (b)(3) of proposed Sec. 330.203, we would encourage 
prospective permit applicants to contact the Fish and Wildlife Service 
at as early a stage as possible i.e., upon identification of the target 
weed in order to identify possible Endangered Species Act issues that 
might need to be considered with regard to any program for the control 
of the target weed. Similarly, we would encourage prospective 
applicants to contact APHIS for early consultation on complying with 
NEPA. Engaging in such early consultation prior to applying for a 
permit would help the applicant and the relevant agencies become 
familiar with the environmental and endangered species issues 
surrounding a planned weed control program and would help to avoid the 
delays that could occur in the event that unexpected issues arose 
during the permit application review process.

Compliance Agreements and Notification for Importation and 
Interstate Movement (Sec. 330.204)

    Proposed Sec. 330.204 would address the purpose of, and procedure 
for, entering into a compliance agreement, along with the notification 
process that may be used for the importation and interstate movement of 
regulated organisms by persons who are operating under a compliance 
agreement. An applicant could expect to receive a permit for 
importation or interstate movement anywhere from 15 to 60 days after 
submitting an application. Under the proposed notification system, a 
person or facility operating under a compliance agreement would simply 
have to notify APHIS within 3 days after receiving a shipment of 
regulated organisms. By providing a mechanism that would allow 
individuals or facilities to receive advance approval for the 
importation or interstate movement of specified types of regulated 
organisms, we anticipate that the proposed notification process would 
greatly facilitate the movement of regulated organisms. Persons who 
only occasionally have a need to request a permit for the importation 
or interstate movement of regulated organisms may find that the 
permitting process would continue to meet their needs. However, for 
those individuals or facilities that regularly receive organisms from 
foreign sources or other States, the time savings that could be 
realized by entering into a compliance agreement and using the 
notification process could be substantial.
    Paragraph (a)(1) of proposed Sec. 330.204 would explain the 
considerations discussed in the previous paragraph, i.e., that a person 
or facility that routinely receives regulated organisms under permit 
may wish to enter into a compliance agreement in order to facilitate 
the importation or interstate movement of those organisms. The 
paragraph would explain that compliance agreements would be signed by 
the applicant, APHIS, and the State into which the organisms would be 
moved, and that entering into a compliance agreement would allow the 
organisms to be moved under the notification process described in 
paragraph (b) of proposed Sec. 330.204 rather than under permit.
    Paragraph (a)(2) of proposed Sec. 330.204 would explain that a 
compliance agreement could be arranged by contacting a local office of 
APHIS Plant Protection and Quarantine (PPQ) or by contacting PPQ's 
central offices in Riverdale, MD. The terms of the compliance agreement 
would be prepared with the participation of all parties involved, and 
would be based on the plant pest risks presented by the specific types 
of regulated organisms that the applicant would be receiving, the 
intended use of those organisms, and any safeguarding issues such as 
the degree of physical and operational security needed to prevent the 
escape or dissemination of the regulated organisms. The compliance 
agreement would also spell out the specific requirements for the 
notification of APHIS when a shipment of regulated organisms was 
received, the disposition of host material and other media included in 
the shipment, the handling of regulated organisms while in the 
facility, and any recordkeeping requirements. Those elements are 
normally addressed through the assigning of permit conditions under the 
normal permit issuance process, but no similar opportunity for 
assigning conditions is practical under the notification process, so it 
would be necessary to address them in the compliance agreement.
    Paragraph (a)(3) of proposed Sec. 330.204 would provide that a 
person could terminate a compliance agreement at any time by informing 
APHIS, in writing, of their desire to do so. That paragraph would also 
provide that APHIS could cancel a compliance agreement if an inspector 
found that a person had failed to comply with the terms of the 
compliance agreement or with the regulations. A cancellation could be 
issued by APHIS either orally or in writing, with an oral cancellation 
being confirmed in writing as promptly as circumstances allowed. The 
written cancellation or confirmation would document the reasons for the 
cancellation. These cancellation provisions would be included to inform 
the person of the procedure for terminating a compliance agreement and 
to allow APHIS to terminate the agreement when it is determined that 
its

[[Page 51347]]

provisions, which would have been assigned to prevent the dissemination 
of plant pests, were not being observed.
    Paragraph (b) of proposed Sec. 330.204 would explain the 
notification process. Paragraph (b)(1) would reiterate who is eligible 
to use the notification process, i.e., persons who have entered into a 
compliance agreement with APHIS and their State, and paragraph (b)(2) 
would set out the requirements for notification. Specifically, APHIS 
would have to be notified within 3 business days after the regulated 
organisms were received in the facility, either by mail, fax, or 
electronic mail; APHIS would acknowledge the notification within 3 
business days of its receipt. The notification to APHIS would have to 
include:
     The recipient's name, organization, and compliance 
agreement number.
     The date the regulated organisms were received.
     The scientific name(s) of the regulated organisms.
     The life stage(s) of the regulated organisms.
     The total number of regulated organisms received.
     The origin of the regulated organisms.
    This information, when combined with the elements recorded in the 
compliance agreement, would provide APHIS with the same types of data 
concerning the regulated organisms and their movement as are provided 
through the standard permitting process provided for under the existing 
regulations and this proposed rule. While we believe that the amount of 
information that would be required is appropriate for the purposes of 
the proposed notification system, we welcome any comments regarding the 
number and scope of the proposed data elements, as well as any 
suggestions for alternative ways of implementing the notification 
process.

Applying for a Permit (Sec. 330.205)

    Proposed Sec. 330.205 would set out the information that would have 
to be provided by a person seeking a permit for the importation, 
interstate movement, or release into the environment of a regulated 
organism. The section would begin by stating that permit applicants 
must reside in the United States, as we believe that a permittee must 
be in a position to directly supervise the handling and use of any 
regulated organisms for which a permit was issued, and would state that 
the applicant must supply the information called for in paragraphs (a) 
through (w) of the section. The information that would have to be 
provided is the same as currently required by PPQ Form 526, which is 
the form that is used as a permit application under the existing 
regulations. These requirements are set out in the regulatory text at 
the end of this document under Sec. 330.205, ``Applying for a permit.'' 
The information requested on the PPQ Form 526 pertains to the regulated 
organism for which a permit is being sought, its origin and 
destination, its intended use, the facility in which it would be held, 
and the port or ports of entry through which the regulated organism 
would be imported into the United States. A footnote to the 
introductory text of proposed Sec. 330.205 provides the address to 
which the completed application must be sent and provides information 
as to how a person may obtain a PPQ Form 526.

Additional Application Data for Permits for the Environmental 
Release of Biological Control Agents of Weeds (Sec. 330.206)

    Proposed Sec. 330.206 would list the additional information (i.e., 
in addition to the information listed in proposed Sec. 330.205) that 
would have to be addressed by an applicant seeking a permit for the 
release into the environment of an agent for the biological control of 
weeds. This additional information would be necessary for APHIS to 
fully evaluate the plant pest risk considerations associated with the 
proposed release and would aid in the development of the documentation 
needed to address the environmental and endangered species 
considerations discussed in proposed Sec. 330.203(b)(2). Because, as 
noted in that section, the interagency Technical Advisory Group for 
Biological Control Agents of Weeds (TAG) would review the proposed 
release and its supporting documentation before APHIS would issue its 
final approval for the release, the information that would have to be 
provided under proposed Sec. 330.206 is the same as the information 
called for in the TAG's ``A Suggested Format for Field Release 
Petitions.'' Although the TAG's information requirements for release 
petitions are rather lengthy, we believe that reproducing those 
requirements in the regulations would in the end save applicants time 
by precluding the need to prepare two sets of documentation, i.e., one 
set to accompany their permit applications submitted under the proposed 
regulations and one set to satisfy the needs of the TAG reviewers. The 
information requested in the TAG petition includes both questions 
related to the target weed (identity, distribution, impacts, etc.) and 
questions regarding the candidate biological control agent (identity, 
distribution, biology, host specificity, etc.) This two-fold approach 
is consistent with the approach recommended by the Food and Agriculture 
Organization (FAO) of the United Nations (UN) in its publication ``Code 
of Conduct for the Import and Release of Exotic Biological Control 
Agents'' (Secretariat of the International Plant Protection Convention, 
FAO, UN, Publication No. 3, Rome, 1996). In addition, the TAG 
information requirements contain elements that will allow APHIS to 
consider the potential environmental effects of the proposed release 
and prepare the environmental assessment documentation required by 
NEPA. The consideration of potential environmental effects is also 
consistent with the approach recommended in the FAO code of conduct. 
The information requirements for release petitions are set out in the 
regulatory text at the end of this document under Sec. 330.206, 
``Additional application data for permits for the environmental release 
of biological control agents of weeds.''

APHIS Review of Permit Applications; Denial or Cancellation of 
Permits (Sec. 330.207)

    Paragraph (a) of proposed Sec. 330.207 would address the inspection 
of the premises where a regulated organism would be held. These 
proposed provisions are essentially the same as the existing 
regulations in Sec. 330.202(b), the difference being that proposed 
Sec. 330.207(a) would include a description of the three general areas 
that would be considered when APHIS inspected a facility. The current 
regulations provide that APHIS may inspect the facility where the 
regulated organisms would be received and handled to determine whether 
the facility will be adequate to prevent plant pest dissemination; 
those provisions would also be part of proposed Sec. 330.207(a). 
Because different regulated organisms will present differing degrees of 
risk, depending on factors such as their escape potential, biology, and 
the availability of a suitable habitat in the area surrounding the 
facility, we believe that it would be counterproductive to attempt to 
prepare a detailed list of prescriptive requirements for facilities 
i.e., a ``one size fits all'' design standard in the context of the 
proposed regulations. Rather, we have prepared a brief set of 
performance standards that we would consider to the degree to which 
they were appropriate to the plant pest risks presented by the 
particular regulated organism for which the applicant was seeking a 
permit. (We would, however, include a footnote

[[Page 51348]]

regarding the availability of guidelines that describe suggested 
physical and operational characteristics for facilities.) The 
performance standards that would be included in Sec. 330.207(a) are:
     Does the facility have entryways, windows, and other 
structures, including water, air, and waste handling systems, to 
contain the regulated organisms and prevent the entry of other 
organisms and unauthorized visitors? This standard would focus on 
whether the physical structure and features of the facility were 
sufficient to contain the regulated organism and prevent other 
organisms or unauthorized persons from gaining access to the regulated 
organisms, which could increase the risk of plant pest dissemination.
     Does the facility have operational and procedural 
safeguards in place to prevent the escape of the regulated organisms 
and to prevent the entry of other organisms and unauthorized visitors? 
This standard is similar to the first, although in this case the focus 
would be on the non-physical aspects that contribute to the biological 
security of the facility, i.e., the procedural and operational 
safeguards that are in place.
     Does the facility have a means of inactivating or 
sterilizing regulated organisms and any host material, containers, or 
other material? As explained below in the discussion of proposed 
Sec. 330.208(a), the standard conditions that apply to all permits 
require the destruction or sterilization of the container in which the 
regulated organisms were shipped and any accompanying material 
following the receipt of the organisms, as well as the destruction of 
the regulated organisms themselves upon completion of their intended 
use or the expiration of the permit. This standard would ensure that 
the facility had the means to fulfill those standard permit conditions.
    Paragraph (b) of proposed Sec. 330.207 would address the denial of 
permit applications. The paragraph would provide that APHIS will deny 
an application for a permit to move or release a regulated organism 
when we determine that the movement or release would involve a danger 
of the dissemination of a plant pest. These proposed provisions are the 
same as those contained in Sec. 330.204(a) of the current regulations, 
which state that the danger of plant pest dissemination could be deemed 
to exist under any one of the following circumstances:
     Existing safeguards against plant pest dissemination 
(e.g., the biosecurity offered by the facility in which the organisms 
would be held) are inadequate and no adequate safeguards can be 
arranged.
     The destructive potential of the regulated organism to 
plants, plant parts, or plant products, should it escape despite the 
proposed safeguards, outweighs the probable benefits that could be 
derived from the proposed movement and use of the regulated organism. 
It is likely that a permit would be denied on this basis in only a few 
extraordinary cases, such as when a particularly destructive pest was 
proposed for movement into an area that was ideally suited to 
sustaining populations of that pest.
     When the applicant, as a previous permittee, failed to 
maintain the safeguards or otherwise observe the conditions prescribed 
in a previous permit and has failed to demonstrate the ability or 
intent to observe them in the future. We must have at least a 
reasonable expectation that the permittee can and will observe the 
conditions of the permit; otherwise, the safeguards offered by those 
conditions would be rendered ineffective.
     The proposed movement of the regulated organism is adverse 
to the conduct of an eradication, suppression, control, or regulatory 
program of APHIS. It is likely that this basis for the denial of a 
permit would not be invoked in the absence of circumstances related to 
either of the first two bullets above, i.e., those regarding existing 
safeguards and the destructive potential of the organism.
    Paragraph (c) of proposed Sec. 330.207 would address the 
cancellation of permits that have already been issued. The paragraph 
would provide that APHIS could cancel a permit if, following its 
issuance, we received information of circumstances that would have led 
us to deny the application for that permit, i.e., those circumstances 
described in the previous paragraph. The paragraph would also provide 
that APHIS could cancel a permit if the permittee failed to maintain 
the safeguards or other conditions specified in the permit or in any 
applicable regulation. These provisions for the cancellation of 
permits, which are the same as those found in Sec. 330.204(b) of the 
current regulations, are necessary to mitigate the risk of plant pest 
dissemination when APHIS determines that our issuance of the permit was 
based on inaccurate or invalid information or that the permittee is 
failing to observe the conditions that have been deemed necessary to 
prevent the dissemination of plant pests.

Permit Conditions (Sec. 330.208)

    Proposed Sec. 330.208 would explain the standard conditions that 
would apply to all permits and provide for the inclusion of special 
permit conditions when circumstances warranted. This section would also 
address permits for the movement of regulated organisms through the 
United States (i.e., transit permits) and the length of time for which 
permits may be valid.
    Specifically, paragraph (a) of proposed Sec. 330.208 sets forth the 
standard conditions that would apply to all permits that are issued, 
and would provide that the permit may specify a particular port of 
entry for the regulated organism. These conditions, which are the same 
as those that now apply to permits issued under the current 
regulations, would be included in the regulations as a safeguarding 
measure to prevent the dissemination of plant pests into the United 
States or interstate. The standard conditions that would apply to all 
permits for importation and interstate movement call for:
     The sterilization or destruction of the shipping container 
and all packing material, media, substrate, and soil after the 
regulated organisms have been removed from the shipping container. This 
measure would ensure that the plant pest risks posed by the container 
and any other associated material is mitigated.
     The regulated organisms to be kept within the laboratory 
or other designated holding area of the receiving facility, with prior 
approval from APHIS being required for their removal. This would ensure 
that the regulated organisms remain in the facility that was approved 
to receive them or, if necessary, in a facility with comparable 
security. This measure is necessary because the security offered by the 
receiving facility would have been one of the factors on which APHIS 
based its decision to issue a permit.
     Allowing authorized APHIS and State regulatory officials 
to inspect, without prior notice and during reasonable hours, the 
conditions under which the regulated organisms are kept. Such 
inspections by APHIS or its State cooperators may be necessary to 
ensure that the regulated organisms are being kept under the conditions 
deemed necessary to mitigate the risk of plant pest dissemination.
     All regulated organisms kept under the permit to be 
destroyed at the completion of the intended use, and not later than the 
expiration date of the permit, unless an extension is granted by APHIS 
before the expiration of the permit. This measure would ensure that any 
plant pest risk posed by the regulated organisms is eliminated upon the 
completion of the research project or other activity in which they were 
being used.

[[Page 51349]]

     APHIS to be informed immediately, but no later that 24 
hours, after the escape of a regulated organism being detected. This 
measure reflects basic biosecurity considerations and would ensure that 
APHIS had the opportunity to take appropriate measures in a timely 
manner in response to the unintentional release or escape of the 
regulated organisms.
     Records to be maintained that identify the organisms being 
held in the facility under the permit, the person from whom they were 
received, the date the regulated organisms were received at the 
facility, and the disposition of the organisms. The records would have 
to be maintained for a period of 1 year following the final disposition 
of the organisms. During normal business hours, an APHIS inspector 
would have to be allowed to inspect and copy those records. This 
recordkeeping measure would be necessary to ensure that the facility 
operator and, if necessary, APHIS, could track and account for the 
regulated organisms moved into the facility from another State or 
country.
    Paragraph (b) of proposed Sec. 330.208 would provide that 
supplemental conditions may be included on the permit. The supplemental 
conditions, which would be specific to the biology of the organism, the 
types of activities involved with the movement, or the specific needs 
of a facility, would be included if APHIS determined that such 
additional conditions were necessary to mitigate the risk of plant pest 
dissemination.
    Paragraph (c) of proposed Sec. 330.208 would state that permits for 
the movement of organisms through the United States (i.e., permits for 
organisms that would transit the United States while moving from one 
foreign country to another foreign country) will include shipping 
instructions as to routing, labeling, and similar requirements. Those 
instructions, which would address any pest risk considerations 
associated with such a movement, would be included on the permit as 
supplemental conditions.
    Paragraph (d) of proposed Sec. 330.208 would state that the length 
of a permit's validity will be indicated on the permit, with 10 years 
being the maximum length of time for which a permit could be valid. We 
would consider the information supplied by the applicant--especially 
the information supplied regarding the intended use of the organisms--
in order to determine the appropriate length of time for which a permit 
would be valid. Having the flexibility to assign differing lengths of 
validity to permits would allow us to take into account the differing 
needs of various permit applicants and their projects.

Appealing the Denial or Cancellation of Permits and Compliance 
Agreements (Sec. 330.209)

    Proposed Sec. 330.209 would describe the process to be followed 
when appealing the denial or cancellation of permits and compliance 
agreements. The appeal process described in proposed Sec. 330.209 is 
the same as the appeal process that is provided elsewhere in APHIS' 
regulations for other programs. The current regulations in 
Sec. 330.204(c) provide only that a person may submit a written request 
for reconsideration and provide additional information to support the 
original application; proposed Sec. 330.209 would provide for an 
expanded appeals process.
    Under proposed Sec. 330.209, a person whose permit application was 
denied or whose permit or compliance agreement was canceled would be 
promptly informed, in writing, of the reasons for the denial or 
cancellation. The person would then be able to appeal the denial or 
cancellation by writing to the Administrator of APHIS. In the written 
appeal, the person would have the opportunity to provide all of the 
facts and reasons that he or she was relying upon to show that the 
permit application was wrongfully denied or the permit or compliance 
agreement was wrongfully canceled. The Administrator would respond to 
the appeal as promptly as circumstances allowed, either granting or 
denying the appeal, and would provide an explanation, in writing, of 
the reasons for his or her decision. If there was a conflict as to any 
fact that had a material bearing on the appeal, the person appealing 
the denial or withdrawal would be entitled to request a hearing to 
resolve the conflict. During that hearing, the person would have the 
opportunity to present information supporting the issuance or 
reinstatement of his or her permit or the reinstatement of his or her 
compliance agreement. The rules of practice for the hearing, which 
would be held before a hearing officer, would be adopted by the 
Administrator.

Packaging of Regulated Organisms (Sec. 330.210)

    The packaging provisions that are found in Secs. 330.210 and 
330.210a of the current regulations would be located in Sec. 330.210 of 
the revised subpart. Like the current regulations, proposed 
Sec. 330.210 would require that the regulated organisms be packed in a 
container or combination of containers that will prevent the escape of 
the organism, and that the outer container be clearly marked to 
indicate its contents. Proposed Sec. 330.210 would also restate the 
provisions of current Secs. 330.210 and 330.210a regarding the use of 
approved packing materials and the need to obtain advance APHIS 
approval for the inclusion of host material, soil, etc., in a package 
of regulated organisms. This advance approval continues to be necessary 
to ensure that APHIS has an opportunity to consider any risks that 
might be presented by the inclusion of such material in a package of 
regulated organisms.

Labeling of Regulated Organisms (Sec. 330.211)

    The labeling provisions that are found in Sec. 330.211 of the 
current regulations would be located in Sec. 330.211 of the revised 
subpart. The provisions of proposed Sec. 330.211 would be the same as 
the existing regulations with one exception, i.e., we would no longer 
issue labels for the interstate movement of organisms. The purpose of 
placing the APHIS-issued labels on packages is to clearly indicate that 
APHIS has issued a permit or otherwise approved the movement of the 
organisms into the United States, thus preventing delays in the 
clearance of the organisms by APHIS or U.S. Customs Service inspectors. 
Because packages of organisms being shipped interstate are not subject 
to the same APHIS and Customs Service inspection as packages arriving 
in the United States from outside the country, we do not believe that 
it is necessary to require their labeling.

Exportation of Organisms From the United States (Sec. 330.212)

    Proposed Sec. 330.212 would contain information regarding the 
exportation of organisms from the United States. Although the current 
regulations in Sec. 330.201(b) require a permit for the interstate 
movement of plant pests for export, we do not believe that it is 
necessary to include that requirement in the revised regulations. When 
we have issued such permits under the current regulations, the only 
condition of the permit has been that the organisms must be securely 
packaged in order to prevent their escape during movement to the port 
of export. We do not believe that a permit is necessary if it simply 
requires secure packaging; that information could be conveyed in the 
regulations, so we are proposing to include it in Sec. 330.212. 
Specifically, Sec. 330.212 would require that anyone shipping regulated 
organisms to places outside the United States must ensure that the 
organisms are packaged in

[[Page 51350]]

accordance with Sec. 330.210, ``Packaging and labeling of regulated 
organisms.''

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be significant for the purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.
    This proposed rule would revise the regulations regarding the 
movement of plant pests by adding risk-based criteria for determining 
the plant pest status of organisms, establishing a notification process 
that could be used as an alternative to the current permitting system, 
providing for the environmental release of organisms for the biological 
control of weeds, and updating the text of the subpart. These proposed 
changes are intended to clarify the factors that would be considered 
when assessing the plant pest risks associated with certain organisms, 
facilitate the importation and interstate movement of regulated 
organisms, and address gaps in the current regulations.
    This proposed rule would be beneficial from an efficiency 
standpoint, primarily because it would allow individuals and entities 
to expedite the movement of regulated organisms. Under the proposed 
notification process, persons would be allowed--once they entered into 
a compliance agreement--to move regulated organisms without prior 
approval from APHIS. Currently, those persons can move regulated 
organisms of a different species only after applying for and obtaining 
a permit from APHIS, a process that generally takes about 30 days. An 
expedited process for moving regulated organisms could prove especially 
beneficial to those in the scientific and research communities, whose 
work could be aided or accelerated by the elimination of the time spent 
waiting for the issuance of a permit. Furthermore, as discussed below, 
the switch from the current permitting system to the proposed 
notification process could be accomplished with little or no additional 
burden on any of the affected parties, i.e., the individuals and 
entities who move regulated organisms, APHIS, and State agricultural 
agencies.
    For the average affected entity, i.e., a research facility that 
applies for 20 permits and receives 100 shipments per year, the 
proposed notification process would pose about the same burden as the 
current permitting process. We estimate that it would take the average 
entity about 17 hours per year to perform the administrative tasks 
needed to comply with the proposed notification process, assuming one 
compliance agreement covers all 100 shipments. The 17 hours is 
comprised of the time spent preparing the compliance agreement itself, 
as well as the time spent notifying APHIS of each shipment and the time 
spent preparing labels for each shipment. By comparison, we estimate 
that it would take the same entity about 18 hours per year to comply 
with the current permitting process. The 18 hours is comprised of the 
time spent preparing the 20 permit applications (PPQ Form 526), as well 
as the time spent preparing an annual summary report of shipments 
received. (Under the current permitting system, APHIS, not the 
regulated entity, prepares the shipping labels.) The inspection and 
documentation requirements would be the same under the current process 
and the proposed notification process. Persons who move regulated 
organisms are not charged a fee for obtaining a permit, and they would 
not be charged a fee for entering into a compliance agreement.
    Currently, there are about 50 facilities in the United States that 
import regulated organisms or move regulated organisms interstate. Of 
that total, we estimate that about 35 facilities, or 70 percent, would 
choose to switch to the proposed notification process. The number of 
organisms moved by the remaining 15 facilities does not appear to be 
sufficiently high to warrant their interest in the proposed 
notification system. We estimate about 35 compliance agreements, 3,500 
shipment notifications, and 700 fewer permit applications per year if 
the proposed rule is adopted. Permit applications would decline from 
1,000 per year to 300 per year.
    We do not believe that an entity's decision to switch from the 
current permitting system to the proposed notification process would 
have a significant impact on APHIS and the State agricultural agencies. 
For the average entity with one compliance agreement covering 100 
shipments, we estimate that it would take APHIS and the affected State 
agency about 18 hours and 4 hours, respectively, per year to perform 
the administrative tasks needed to complete the compliance agreement 
and to process the subsequent notifications of individual shipments. By 
comparison, we estimate that it would take APHIS and the State agency 
about 18 hours and 3 hours, respectively, per year to perform their 
tasks under the current permitting process.
    This proposed rule would add provisions for the issuance of permits 
for the release into the environment of biological control agents of 
weeds. We do not expect that the addition of this permit category would 
have much of an impact, as the interagency Technical Advisory Group has 
reviewed environmental release petitions for several years. The 
proposed provisions would simply serve to standardize the process in 
that regard.
    Also, this proposed rule would revise the regulations by adding 
risk-based criteria for determining the plant pest status of organisms. 
This revision should have no cost or workload impact, since it merely 
serves to formalize what is already being done in practice.
    The Regulatory Flexibility Act requires that agencies consider the 
economic effects of their proposed regulatory changes on small entities 
(e.g., businesses, organizations, and governmental jurisdictions). The 
entities most likely to be affected by this proposed rule are research 
facilities that import and move regulated organisms interstate. These 
entities would likely benefit from the proposed notification system, as 
it would allow them to expedite the movement of regulated organisms. By 
using the proposed notification process, affected facilities would be 
able to move regulated organisms generally about 30 days sooner than 
they would under the current permitting process. Furthermore, the 
switch from the current permitting system to the proposed notification 
process could be accomplished with no additional burden on the affected 
facilities.
    However, this proposed rule is not expected to affect a substantial 
number of entities, large or small. We estimate that only about 35 
research facilities would choose to switch to the proposed notification 
process. The economic impact of the proposal is unknown, primarily 
because the impact of the expedited movement process on affected 
facilities is difficult to quantify in dollar terms.
    The decision by research facilities to use the proposed 
notification process should not have a significant impact on APHIS and 
the State agencies, either in terms of increasing their current costs 
or adding to their current workload. APHIS and the State agencies could 
not be considered ``small entities.''
    Under the U.S. Small Business Administration's (SBA) standards, 
firms primarily engaged in commercial physical and biological research 
(SIC 8731) are considered to be small if they have 500 or fewer 
employees. Even

[[Page 51351]]

though employment data is not available for each of the individuals and 
other entities that may be affected by this proposed rule, it is 
reasonable to assume that most are small by SBA standards. SBA data for 
1993 shows that of the 3,783 U.S. firms in SIC 8731, 92 percent had 
fewer than 100 employees.
    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 12988

    This proposed rule has been reviewed under Executive Order 12988, 
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

    We have determined that an environmental assessment is not 
necessary for these proposed regulations. The proposed regulations are 
procedural in nature and would not irrevocably commit the Agency to any 
decision concerning the movement or environmental release of any 
organisms. When considering an application for a permit to release an 
organism into the environment under the proposed regulations, an 
environmental assessment or environmental impact statement would be 
prepared as part of APHIS' decisionmaking process.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 95-095-2. 
Please send a copy of your comments to: (1) Docket No. 95-095-2, 
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River 
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, 
OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., 
Washington, DC 20250. A comment to OMB is best assured of having its 
full effect if OMB receives it within 30 days of publication of this 
proposed rule.
    Under our current regulations, any person who wishes to import, 
move interstate, or release into the environment an organism subject to 
APHIS' jurisdiction under the Plant Protection Act must apply for, and 
be issued, a permit authorizing such a movement or release. In this 
document, we are proposing to amend our regulations to allow those 
persons the alternative of entering into compliance agreements with 
APHIS and the State into which regulated organisms would be moved in 
order to be eligible to use a notification procedure in lieu of a 
permit to more easily effect the movement of regulated organisms. We 
are also proposing to provide specific provisions for the issuance of 
permits for the release into the environment of agents for the 
biological control of weeds.
    These proposed amendments would require the use of several 
information collection procedures, including permit applications, 
compliance agreements, notification, and environmental release 
petitions. We are asking OMB to approve our use of these information 
collections in connection with our efforts to ensure that the risks 
associated with the importation, interstate movement, and release into 
the environment of regulated organisms could be adequately reviewed and 
addressed.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.33769 hours per response.
    Respondents: Persons wishing to import regulated organisms into the 
United States, move regulated organisms interstate, or release agents 
for the biological control of weeds into the environment.
    Estimated annual number of respondents: 2,500.
    Estimated annual number of responses per respondent: 2.478.
    Estimated annual number of responses: 6,195.
    Estimated total annual burden on respondents: 2,092 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained by calling 
Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at 
(301) 734-7477.

List of Subjects in 7 CFR Part 330

    Customs duties and inspection, Imports, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

    Accordingly, we propose to amend 7 CFR part 330 as follows:

PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS; 
SOIL, STONE, AND QUARRY PRODUCTS; GARBAGE

    1. The authority citation for part 330 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 2260, 7711, 7712, 7714, 7718, 7731, 
7734, 7751, and 7754; 19 U.S.C. 1306; 21 U.S.C. 111, 114a, 136, and 
136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 
371.3.

    2. The title of part 330 would be amended by removing the words 
``PLANT PESTS;'' and adding the word ``ORGANISMS;'' in their place.
    3. In Subpart--General Provisions, Sec. 330.100 would be revised to 
read as follows:


Sec. 330.100  Definitions.

    The following definitions apply for the purposes of this part:
    Administrative instructions. Published documents relating to the 
enforcement of the regulations in this part, issued under authority of 
such regulations by the Administrator.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service, U.S. Department of Agriculture, or any employee of 
the U.S. Department of Agriculture delegated to act in his or her 
stead.
    APHIS. The Animal and Plant Health Inspection Service, U.S. 
Department of Agriculture.

[[Page 51352]]

    Article. Any material or tangible object that could harbor plant 
pests or noxious weeds.
    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
    Continental United States. The contiguous 48 States, Alaska, and 
the District of Columbia.
    Customs. The U.S. Customs Service of the U.S. Treasury Department, 
or, with reference to Guam, the Customs office of the Government of 
Guam.
    Department. The U.S. Department of Agriculture.
    Deputy Administrator. The Deputy Administrator of the Plant 
Protection and Quarantine Programs or any employee of the Plant 
Protection and Quarantine Programs delegated to act in his or her 
stead.
    Earth. The softer matter composing part of the surface of the 
globe, in distinction from the firm rock, and including the soil and 
subsoil, as well as finely divided rock and other soil formation 
materials down to the rock layer.
    Enter (entry). To move into, or the act of movement into, the 
commerce of the United States.
    Export (exportation). To move from, or the act of movement from, 
the United States to any place outside the United States.
    Garbage. That material designated as ``garbage'' in 
Sec. 330.400(b).
    Import (importation). To move into, or the act of movement into, 
the territorial limits of the United States.
    Inspector. A properly identified employee of the U.S. Department of 
Agriculture or other person authorized by the Department to enforce the 
provisions of the Plant Protection Act and related legislation, 
quarantines, and regulations.
    Interstate. From one State into or through any other State; or 
within the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Means of conveyance. Any personal property used for or intended for 
use for the movement of any other personal property.
    Move (moved and movement). To carry, enter, import, mail, ship, or 
transport; to aid, abet, cause, or induce the carrying, entering, 
importing, mailing, shipping, or transporting; to offer to carry, 
enter, import, mail, ship, or transport; to receive to carry, enter, 
import, mail, ship, or transport; to release into the environment; or 
to allow any of those activities.
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
    Owner. The owner, or his agent (including a carrier), having 
responsible custody of a plant pest, means of conveyance, product or 
article subject to the regulations in this part.
    Permit. A written or oral authorization, including by electronic 
methods, by the Administrator to move plants, plant products, 
biological control organisms, plant pests, noxious weeds, or articles 
under conditions prescribed by the Administrator.
    Person. Any individual, partnership, corporation, association, 
joint venture, or other legal entity.
    Plant. Any plant (including any plant part) for or capable of 
propagation, including a tree, a tissue culture, a plantlet culture, 
pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a 
root, and a seed.
    Plant pest. Any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: A protozoan, nonhuman animal, parasitic plant, 
bacterium, fungus, virus or viroid, infectious agent or other pathogen, 
or any article similar to or allied with any of those articles. (For 
the purposes of the regulations in Secs. 330.200 through 330.212 of 
this part, ``plant pest'' does not include any organism that has been 
genetically engineered as defined in Sec. 340.1 of this chapter.)
    Plant product. Any flower, fruit, vegetable, root, bulb, seed, or 
other plant part that is not included in the definition of plant; or 
any manufactured or processed plant or plant part.
    Plant Protection Act. Title IV of Public Law 106-224, 114 Stat. 
438, 7 U.S.C. 7701-7772, which was enacted June 20, 2000.
    Plant Protection and Quarantine Programs. The Plant Protection and 
Quarantine Programs of the Animal and Plant Inspection Health Service.
    Regulated garbage. That material designated as ``regulated 
garbage'' in Sec. 330.400(c) and Sec. 330.400(d).
    Shelf-stable. The condition achieved in a product, by application 
of heat, alone or in combination with other ingredients and/or other 
treatments, of being rendered free of microorganisms capable of growing 
in the product at nonrefrigerated conditions (over 50 deg. F. or 
10 deg. C.).
    Soil. The loose surface material of the earth in which plants grow, 
in most cases consisting of disintegrated rock with an admixture of 
organic material and soluble salts.
    State. Any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of 
Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the 
United States, or any other territory or possession of the United 
States.
    Through the United States. From and to places outside the United 
States.
    United States. All of the States.
    4. Subpart--Movement of Plant Pests, Secs. 330.200 through 330.212, 
including the title of the subpart, would be revised to read as 
follows:
Subpart Movement and Release of Organisms Under the Plant Protection 
Act
Sec.
330.200   What organisms are regulated under this subpart?
330.201   Requirements for the importation of regulated organisms.
330.202   Requirements for the interstate movement of regulated 
organisms.
330.203   Requirements for the release into the environment of 
regulated organisms.
330.204   Compliance agreements and notification for importation and 
interstate movement.
330.205   Applying for a permit.
330.206   Additional application data for permits for the 
environmental release of biological control organisms for the 
control of noxious weeds.
330.207   APHIS review of permit applications; denial or 
cancellation of permits.
330.208   Permit conditions.
330.209   Appealing the denial or cancellation of permits and 
compliance agreements.
330.210   Packaging of regulated organisms.
330.211   Labeling of regulated organisms.
330.212   Exportation of organisms from the United States.


Sec. 330.200  What organisms are regulated under this subpart?

    (a) Plant pests. The importation, interstate movement, and release 
into the environment of any plant pest will be subject to the 
restrictions of Secs. 330.201, 330.202, and 330.203(a). The following 
factors will be considered when assessing the plant pest status of an 
organism:
    (1) Direct effects. An organism directly injures or causes disease 
or damage in plants, plant parts, or plant products when it:
    (i) Reduces the yields, vigor, or viability of living plants by 
feeding on, infecting, parasitizing, or contaminating plants or plant 
parts or by vectoring agents of plant diseases; or
    (ii) Reduces the quality or marketability of plant products such as 
stored grain, stored fruit, or lumber by

[[Page 51353]]

feeding on, infecting, or contaminating the plant products.
    (2) Indirect effects. An organism indirectly injures or causes 
disease or damage in plants, plant parts, or plant products when the 
organism causes losses in yields of crops or forage plants or reduces 
the viability or vigor of ornamental or native plants by adversely 
affecting organisms that are beneficial to plants. Of primary concern 
are organisms that are:
    (i) Pathogens, predators, or parasites (except autoparasitoids) of 
important natural enemies of plant pests or weeds; or
    (ii) Pathogens, predators, or parasites of important or 
commercially available pollinators such as honeybees, bumble bees, and 
alkali bees.
    (b) Biological control organisms for the control of noxious weeds. 
The importation, interstate movement, and release into the environment 
of any biological control organism for the control of noxious weeds 
will be subject to the restrictions of Secs. 330.201, 330.203(b), and 
330.204.
    (c) Imported biological control organisms for the control of plant 
pests; other imported organisms. (1) The importation of any organism, 
including any biological control organism for the control of plant 
pests, that meets any of the following criteria will be subject to the 
restrictions of Sec. 330.201:
    (i) It is a field-collected organism that, in natural conditions, 
is associated with plant pests and there is reason to believe that the 
plant pests could be shipped with the field-collected organisms; or
    (ii) It is a laboratory-reared organism that is provided with plant 
pests as host material during rearing or shipment; or
    (iii) The organism will be shipped with plant material or soil; or
    (iv) The organism has not been positively identified.
    (2) If an organism that meets any of the criteria of paragraph 
(c)(1) of this section is imported in accordance with this subpart, the 
organism may be moved interstate without any further restriction under 
this subpart if it is positively identified, determined not to be a 
plant pest, and is separated from any associated plant pests, plant 
material, soil, and other media.


Sec. 330.201  Requirements for the importation of regulated organisms.

    You may import an organism regulated under this subpart into the 
United States if APHIS determines that the importation can be 
accomplished in a manner that will prevent the dissemination of plant 
pests that are new to or not widely distributed in the United States. 
An importation may be accomplished through notification (see paragraph 
(a) of this section) or under permit (see paragraph (b) of this 
section). All imported regulated organisms must be labeled in 
accordance with Sec. 330.211. Nonviable biological specimens of plant 
pests, in preservative or dried, may be imported without further 
restriction under this subpart, but will be subject to inspection upon 
arrival in the United States to confirm the nature of the material and 
its freedom from risk of plant pest dissemination.
    (a) Through notification. If you have entered into a compliance 
agreement with APHIS and the State where the regulated organisms will 
be received, you may import regulated organisms without a permit, 
provided that you notify APHIS upon receipt of the regulated organisms. 
The provisions of this subpart regarding compliance agreements and the 
requirements for notification are found in Sec. 330.204.
    (b) Under permit. If you wish to import regulated organisms without 
entering into a compliance agreement with APHIS and your State, you may 
apply for a permit to import a regulated organism. APHIS uses the 
information you provide in a permit application to identify the plant 
pest risks associated with the regulated organism and its importation. 
A permit issued for the importation of a regulated organisms may 
include requirements that APHIS determines are necessary to mitigate 
the identified risks. Instructions for applying for a permit are found 
in Sec. 330.205.


Sec. 330.202  Requirements for the interstate movement of regulated 
organisms.

    You may move an organism regulated under this subpart from one 
State into or through another State if APHIS determines that the 
interstate movement can be accomplished in a manner that will prevent 
the dissemination of plant pests that are new to or not widely 
distributed in the United States. An interstate movement may be 
accomplished through notification or under permit or, under certain 
limited circumstances, without a permit:
    (a) Through notification. If you have entered into a compliance 
agreement with APHIS and the State where the regulated organisms will 
be received, you may move regulated organisms interstate without a 
permit, provided that you notify APHIS upon receipt of the regulated 
organisms. The provisions of this subpart regarding compliance 
agreements and the requirements for notification are found in 
Sec. 330.204.
    (b) Under permit. If you wish to move regulated organisms 
interstate without entering into a compliance agreement with APHIS and 
your State, you may apply for a permit for the interstate movement of a 
regulated organism. APHIS uses the information you provide in a permit 
application to identify the plant pest risks associated with the 
regulated organism and its interstate movement. A permit issued for the 
interstate movement of a regulated organism may include requirements 
that APHIS determines are necessary to mitigate the identified risks. 
Instructions for applying for a permit are found in Sec. 330.205.
    (c) No permit necessary. (1) Certain indigenous plant pest species 
are distributed throughout the continental United States and are known 
to commonly accompany plants or plant products moved in interstate 
commerce. Given the wide distribution of these organisms, we have 
determined that their interstate movement within the continental United 
States is not likely to result in additional plant pest risks. 
Therefore, the following organisms may be moved within the continental 
United States without a permit if they are moved from populations 
located within the continental United States:

Bacteria

Agrobacterium radiobacter
Agrobacterium tumefaciens
Bacillus subtilis
Bradyrhizobium spp.
Erwinia amylovora
Erwinia carotovora subsp. atroseptica
Erwinia carotovora subsp. betavasculorum
Erwinia carotovora subsp. carotovora
Erwinia chrysanthemi
Pseudomonas syringae pv. glycinea
Pseudomonas syringae pv. morsprunorum
Pseudomonas syringae pv. phaseolicola
Pseudomonas syringae pv. syringae
Pseudomonas syringae pv. tomato
Rhizobium spp.
Xanthomonas campestris pv. glycines
Xanthomonas campestris pv. phaseoli
Xanthomonas campestris pv. vesicatoria

Insects

Acanthoscelides obtectus
Acheta domesticus
Actias luna
Antheraea polyphemus
Blatella germanica
Blatella vaga
Bombyx mori
Brachystola magna
Callosobruchus maculatus
Citheronia regalis
Eacles imperialis
Ephestia kuhniella
Gromphadorhina portentosa

[[Page 51354]]

Hyalophora cecropia
Hyalophora euryalus
Hyles lineata
Manduca sexta
Manduca quinquemaculata
Microcentrum retinerve
Microcentrum rhombifolium
Periplaneta americana 
Sitophilus granarius
Sitophilus oryzae
Sitotroga cerealella
Tenebrio molitor
Tenebrio obscurus
Trialeurodes vaporariorum
Trilobium castaneum
Trilobium confusum
Vanessa atalanta
Vanessa cardui
Vanessa virginiensis
Zoophobas morio

Viruses

Tobacco Mosaic Virus
    (2) You may petition APHIS to add species to, or remove species 
from, the list of organisms that may be moved within the continental 
United States without a permit. The petition must include detailed 
information as to the organism's distribution and its biological, 
economic, and environmental significance and must be submitted to 
Permits and Risk Assessment, PPQ, Vanessa virginiensis APHIS, 4700 
River Road Unit 133, Riverdale, MD 20737-1236.


Sec. 330.203  Requirements for the release into the environment of 
regulated organisms.

    (a) Environmental release of plant pests. The release into the 
environment of plant pests is prohibited except under the following 
circumstances:
    (1) A plant pest that is listed in Sec. 330.202(c)(1) may be 
released into the environment within the continental United States 
without a permit if the organism was collected from a population 
located within the continental United States.
    (2) A plant pest that is not listed in Sec. 330.202(c)(1) may be 
released into the environment in the United States only for research or 
testing purposes and only if the release is authorized by an APHIS 
permit and is conducted in accordance with any safeguards assigned as a 
condition of the permit. Instructions for applying for a permit are 
found in Sec. 330.205.
    (b) Environmental release of organisms for the biological control 
of weeds. (1) A biological control organism for the control of noxious 
weeds may be released into the environment in the United States only if 
the release is authorized by an APHIS permit. APHIS will issue a permit 
based on its determination that the host range of the biological 
control organism is limited to the target weed or an acceptably narrow 
range of closely related species, and upon our determination that the 
benefits that could be expected to accrue from the release were not 
outweighed by any significant negative environmental or ecological 
consequences resulting from the release.
    (i) Unprecedented releases of nonindigenous organisms for the 
biological control of weeds. If the organism you wish to release into 
the environment for the biological control of a weed is a nonindigenous 
organism that has not previously been released under an APHIS permit, 
you must address all the data elements contained in Secs. 330.205 and 
330.206.
    (ii) Releases of organisms that are native to the United States or 
that are established introductions. APHIS' National Environmental 
Policy Act Implementing Procedures in part 372 of this chapter provide 
for a categorical exclusion from the requirement for the preparation of 
an environmental assessment for the permitting of the release into a 
State's environment of pure cultures of organisms that are either 
native or established introductions. Therefore, if you are applying for 
a permit to release an agent for the biological control of weeds and 
that agent is native to, or established in, the State into which it 
will be released, it will not be necessary for you to address the data 
elements contained in Sec. 330.206(h), ``Potential environmental 
impacts,'' and the review required under paragraph (b)(2)(iv) of this 
section will be waived. In addition, the native or established status 
of the organism may preclude the need for you to address other specific 
elements contained in Sec. 330.206 and the reviews required under 
paragraph (b)(2)(i) through (b)(2)(iii) of this section may be 
abbreviated or waived. Therefore, we recommend that you consult with 
APHIS prior to preparing an application for a permit for the 
environmental release of biological control agents of weeds that are 
either native or established introductions.
    (2) Levels of review. A petition for a permit to release an agent 
for the biological control of weeds will be reviewed at four levels 
before a permit may be issued:
    (i) APHIS will request that the interagency Technical Advisory 
Group for Biological Control Agents of Weeds (TAG) review the proposed 
release. TAG review will consider the safety of the agent, the 
potential risks that might be involved in its release, and the long-
term ecological consequences of a successful release.
    (ii) APHIS will review the plant pest risk issues raised by the 
proposed release.
    (iii) APHIS will consult with the U.S. Fish and Wildlife Service in 
order to consider the potential effects of the agent on threatened and 
endangered species.
    (iv) APHIS will prepare an environmental assessment of the proposed 
release, if required.
    (3) Early consultation. With regard to the reviews described in 
paragraphs (b)(2)(iii) and (b)(2)(iv) of this section, we encourage you 
to contact the U.S. Fish and Wildlife Service as early a stage as 
possible--i.e., upon identification of the target weed--in order to 
identify possible Endangered Species Act issues that might need to be 
considered with regard to any program for the control of the target 
weed. Similarly, we encourage you to contact APHIS for early guidance 
on complying with the National Environmental Policy Act. Engaging in 
such early consultation prior to applying for a permit will help you 
and the relevant agencies become familiar with the environmental and 
endangered species issues surrounding a planned weed control program 
and may help to avoid the delays that could occur should unexpected 
issues arise during the review of your permit application.


Sec. 330.204  Compliance agreements and notification for importation 
and interstate movement.

    (a) Compliance agreements. (1) If you routinely receive regulated 
organisms under permit, you may wish to enter into a compliance 
agreement in order to facilitate the importation or interstate movement 
of those organisms. Entering into a compliance agreement, which will be 
signed by you, APHIS, and the State into which the regulated organisms 
are moved, will allow the organisms to be moved under the notification 
process described in paragraph (b) of this section rather than under 
permit.
    (2) Arranging a compliance agreement. You may request a compliance 
agreement by contacting a local office of APHIS Plant Protection and 
Quarantine (which are listed in local telephone directories) or by 
contacting Permits and Risk Assessment, PPQ, APHIS, 4700 River Road 
Unit 133, Riverdale, MD 20737-1236. The terms of the compliance 
agreement, which will be prepared with the participation of all parties 
involved,

[[Page 51355]]

will be based on the plant pest risks presented by the specific types 
of regulated organisms you wish to receive in your facility and the 
intended use of those organisms, and will address safeguarding issues 
such as the degree of physical and operational security needed to 
prevent the escape or dissemination of the regulated organisms. The 
compliance agreement will also include provisions for the notification 
of APHIS when you receive a shipment of regulated organisms, the 
disposition of host material and other media included in the shipment, 
the handling of regulated organisms while in your facility, and 
recordkeeping.
    (3) Cancellation of a compliance agreement. You may terminate your 
compliance agreement at any time by informing APHIS, in writing, of 
your desire to do so. APHIS may cancel your compliance agreement if an 
inspector finds that you have failed to comply with the terms of the 
compliance agreement or the regulations in this subpart. You may be 
notified of the cancellation either orally or in writing. An oral 
cancellation will be confirmed in writing as promptly as circumstances 
allow. The written cancellation or confirmation will document the 
reasons for the cancellation.
    (b) Notification for the importation and interstate movement of 
regulated organisms.
    (1) Eligibility. You may use the notification process described in 
this paragraph for the importation and interstate movement of regulated 
organisms only if you are operating under a valid compliance agreement 
with APHIS and your State as provided for under paragraph (a) of this 
section.
    (2) Notification process. (i) You must notify APHIS within 3 
business days after your receipt of a regulated organism. You must 
provide the notification to APHIS through one of the following means:
    (A) By mail to Permits and Risk Assessment, PPQ, APHIS, 4700 River 
Road Unit 133, Riverdale, MD 20737-1236; or
    (B) By facsimile at (301) 734-8700; or
    (C) By electronic mail to [email protected].
    (ii) In your notification, your must provide the following 
information:
    (A) Your name, organization, and compliance agreement number.
    (B) The date you received the regulated organisms.
    (C) The scientific name(s) of the regulated organisms.
    (D) The life stage(s) of the regulated organisms.
    (E) Total number of regulated organisms received.
    (F) Origin of the regulated organisms.
    (iii) APHIS will acknowledge your notification within 3 business 
days of its receipt.


Sec. 330.205  Applying for a permit.

    To apply for a permit, you must be a U.S. resident and you must 
supply, either on a completed PPQ Form 526 or in some other written 
form, the following information: \1\
---------------------------------------------------------------------------

    \1\ Mail your completed application to Permits and Risk 
Assessment, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 
20737-1236. A PPQ Form 526 may be obtained by writing to the same 
address, or by calling toll-free (877) 770-5990, or by faxing your 
request to (301) 734-8700.
---------------------------------------------------------------------------

    (a) Applicant information. Your name, title, organization, address, 
telephone number, facsimile number, and electronic mail address 
(provide all that are applicable).
    (b) Application type. New permit, permit renewal, or amendment to 
existing permit (if a renewal or amendment, provide the current permit 
number).
    (c) Type of movement. Importation, interstate movement, or 
environmental release. (See Sec. 330.206 for additional information 
that is required if your application is for a permit for the 
environmental release of a biological control organism for the control 
of noxious weeds.)
    (d) Scientific name of organism. Genus, species, and author (if 
known).
    (e) Type of organism. Invertebrate animal, parasitic plant, plant 
pathogen, entomopathogen, other (specify).
    (f) Taxonomic classification. Fungi--class. Insects, nematodes, and 
plants--family.
    Mites--order and family. Mollusks--order. Viruses--general group 
(e.g., geminivirus, baculovirus, potyvirus, etc.). Bacteria--not 
applicable.
    (g) Life stage(s). Invertebrate animals--eggs, juvenile, larvae, 
nymphs, pupae, adults. Fungi--spores, mycelia, fruiting bodies. 
Plants--seeds, whole plants, plant parts (specify parts, e.g., leaves, 
stems, fruits, etc.). Bacteria and viruses--not applicable.
    (h) Number of shipments.
    (i) Number of specimens or cultures per shipment.
    (j) Is the organism established in the United States?
    (k) Is the organism established in the destination State?
    (l) Major hosts(s) of the organism.
    (m) Media or species of host material accompanying the organism.
    (n) Source of organism (include any that apply, and list country or 
State of origin). Supplier (provide supplier's name and address and 
catalog number of organism), wild collected, reared under controlled 
conditions, or culture or seed collection.
    (o) Method of shipment. Air mail, air freight, express delivery 
(list company name), baggage, auto.
    (p) Port(s) of entry.
    (q) Approximate date(s) of initial import or movement.
    (r) Destination. Provide the address of the location where the 
organism will be received and maintained.
    (s) If you are applying for a permit for release into the 
environment, provide the name, address, telephone number, and 
affiliation of the species determiner.
    (t) Proposed date and method of environmental release or final 
disposal.
    (u) Intended use (include any that apply). Release into the 
environment, inoculation or propagation on plants, educational display, 
laboratory use, culture collection, greenhouse or growth chamber use, 
other (describe).
    (v) Has your facility been inspected by APHIS or by your State? If 
yes, list date(s) of approval. Is your facility approved for the 
species of organism for which you are seeking a permit?
    (w) Provide your signature and the date of your signature under the 
following certification: ``I certify that all statements and entries I 
have made on this document are true and accurate to the best of my 
knowledge and belief. I understand that any intentional false statement 
or misrepresentation made on this document is a violation of law and 
punishable by a fine of not more than $10,000, or imprisonment of not 
more than 5 years, or both. (18 U.S.C. 1001).''


Sec. 330.206  Additional application data for permits for the 
environmental release of biological control organisms for the control 
of noxious weeds.

    As stated in Sec. 330.203(b), when applying for a permit for the 
release into the environment of a biological control organism (agent) 
for the control of a noxious weed, you must submit a petition that will 
be reviewed by the interagency Technical Advisory Group for Biological 
Control Agents of Weeds (TAG). The information requested in this 
section is designed to gather information concerning the safety of the 
agent being considered, the potential risks that might be involved in 
its release, and the long-term ecological consequences of a successful 
release. It is recognized that for some situations, you will provide 
more information, while for others not all points will be addressed. 
(See Sec. 330.203(b)(3) for guidance regarding early consultation.)
    (a) Cover page. Prepare a cover page for the petition with the 
following information. This information provides TAG with a contact 
point for questions and with references for tracking.

[[Page 51356]]

    (1) Date of petition and mailing.
    (2) Name of petitioner with affiliation and a contact point within 
North America including an address, telephone number, fax, and e-mail 
address.
    (3) Nature of the petition: Proposed field release of a [identity 
of biological control agent] of a [identity of target weed(s)]. Include 
species, genus, family, order, author, and geographical origin.
    (4) Where have the studies been conducted?
    (5) If at least part of the study has been conducted in a U.S. 
quarantine facility, then list the location of the quarantine facility. 
Also list the quarantine facilities the candidate agents intend to pass 
through for initial releases. Note that different quarantines are 
required for insects and pathogens.
    (6) Identify the State(s) for the initial release.
    (7) Who will conduct the release and monitoring in the United 
States?
    (b) Petition introduction. (1) Nature of the problem. Give a brief 
summary (one to two paragraphs) of the problem caused by the weed. 
Topics to consider including in the summary are as follows:
    (i) History of introduction and/or spread of the target weed.
    (ii) The weed's present distribution in North America.
    (iii) Sectors affected and magnitude of program (e.g., 
agricultural, natural, rangeland).
    (iv) Pending issues about the taxonomy of the candidate agents or 
the target weeds, or about the agents, or about the location of the 
release.
    (2) Proposed action. Provide a statement of proposed action. For 
example, to introduce a [biological control agent] from [a foreign 
area] for field release in [a specific area] to control [target weed] 
in [State(s)].
    (3) Target weed information. (i) Taxonomy. (A) Full classification, 
synonymy, and common name including species, genus, family, and order.
    (B) Who identified the target weed including names, organizations, 
and locations.
    (C) Problems in identification or taxonomy of the group.
    (D) Origin and location of herbariums containing voucher specimens, 
and the date of depository. (The voucher specimens referred to here are 
the ones used as representative of the population that occurs in the 
area where the researcher has conducted the studies.)
    (ii) Description. Provide a general description of the target weed, 
complete enough that a person encountering it in the field could 
identify it.
    (iii) Distribution of the target weed. Describe the distribution of 
the target weed using maps, as appropriate. Include the following 
information:
    (A) Native range (map).
    (B) Areas of introduction throughout the world (map), pattern of 
movement, and apparent limits.
    (C) North American distribution (map).
    (D) Range areas of the present distribution and the potential 
spread in North America (a map is useful).
    (E) Genetic variability.
    (F) Habitats or ecosystems where this weed is found in North 
America.
    (iv) Taxonomically related plants. Identify economically and 
environmentally important plants that are closely related to the target 
weed. These are crops, ornamentals, and native plants including 
threatened and endangered species and those with cultural or aesthetic 
value. If possible, identify how closely these plants relate to the 
target weed.
    (v) Distribution of taxonomically related plants. Describe the 
distribution and habitats in North America of the closely related 
plants identified in paragraph (b)(3)(iv) of this section.
    (vi) Life history. Explain the life history and general biology of 
the target weed. Discuss the factors that are believed to contribute to 
the plant's weediness.
    (vii) Impacts. Indicate any and all impacts. Use the following list 
as a guide; not all areas listed below are applicable to all petitions:
    (A) Beneficial uses (honey bees, forage, ground cover, fruit, 
etc.).
    (B) Social and recreational uses (value as ornamentals).
    (C) Impact on threatened and endangered species.
    (D) Economic losses, including direct control costs.
    (E) Health (poisonous, allergenic, etc.).
    (F) Regulatory (noxious weed, restricts trade, etc.).
    (G) Effects on native plant and animal populations.
    (H) Impact of weed control on nontarget plants.
    (I) Effects on ecosystem functions and ecological relationships.
    (J) Other impacts (e.g., aesthetic).
    (viii) Alternative management options. Describe alternative options 
for managing the target weed.
    (A) Historical options (what has been done before and 
effectiveness).
    (B) Current options (biological, chemical, cultural, etc., and 
effectiveness).
    (C) Potential options (new herbicides or biological control agents 
used or released in other countries).
    (c) Biological control agent information. (1) Taxonomy. (i) Full 
classification (species, genus, family, and order), synonymy, and 
common name. (For pathogens, include strain, race, type.)
    (ii) Reason for choosing the agent and a general description of the 
agent including helpful morphology and general characteristics that 
could be used to identify it in the field.
    (iii) The taxonomist who identified the agent, including names and 
organizations with locations.
    (iv) For pathogens, description of the methods used to identify 
life stages.
    (v) Problems in identification or taxonomy of the genus.
    (vi) Origin and locations of voucher specimens for insects (or type 
cultures for pathogens) including date of depository, and how they are 
preserved.
    (2) Geographic range. (i) Origin (maps and literature citations 
describing the native range of the agent).
    (ii) If the agent is being used in other countries, give countries 
of introduction and present range and effects.
    (iii) Expected attainable range in North America (based on 
climatic, environmental, and vegetative parameters).
    (3) Known host range (specificity). (i) Literature records 
indicating what other plants have been attacked.
    (ii) Field collections and observations, including maps and data.
    (iii) Literature on the host range (specificity) of organisms 
closely related to the agent, no matter where the organism occurs.
    (4) Life history. (i) Biology, i.e., diapause, life cycle, 
dispersal capability, etc. from literature, field observations, and 
laboratory studies.
    (ii) Known mortality factors.
    (iii) Extent of damage or control of the target weed.
    (iv) Extent of damage or control of nontarget plants.
    (5) Population of the agent studied. (i) Geographical source, 
including maps and site description, if available. Be as accurate as 
possible so that the same population could be located, if needed.
    (ii) How pest-free populations of the agents were obtained and 
maintained in quarantine, if applicable.
    (iii) Site of field and lab studies (the location if in a foreign 
country, if available), or the location of U.S. quarantine facility 
used.
    (6) Experimental methodology and analysis. A test plant list shows 
the species of host plants on which the agent was tested to determine 
its potential feeding range. List the test plants and provide the 
rationale for selecting them. Include considerations

[[Page 51357]]

given to threatened and endangered plant species and economically 
important plants. A suggested format for test plant lists may be 
obtained by writing to Permits and Risk Assessment, PPQ, APHIS, 4700 
River Road Unit 133, Riverdale, MD 20737-1236 or by calling (301) 734-
8896.
    (i) Design of tests:
    (A) Part or stage of plants tested.
    (B) Source of population of plant (and weed) used in test.
    (C) Number of replicates.
    (D) Number of individual agents, target weeds, and test plants in 
each replicate. May be synonymous with number of replicates depending 
on test design (i.e., in no-choice tests, the number of individual 
plants of a species is the number of replicates).
    (E) Describe how results were measured, recorded, and evaluated.
    (F) If the weed has been targeted previously, compare this design 
with previous test designs including plant species tested.
    (ii) Positive controls. Were adequate positive controls used in all 
tests? For example, the target weed should be challenged with the agent 
during each testing procedure (except in no-choice testing for 
insects).
    (iii) Reason for decisions. Explain why you selected the test 
procedures and how they are appropriate for the biology of the agent 
being tested.
    (d) Summary of results. Provide a summary about the safety of this 
organism as a biological control agent and any risk associated with its 
release. Include literature, results of host specificity testing, and 
field observations. Present results in a manner that supports your 
conclusion (tables, graphs, narratives).
    (e) Protocol for releasing the agent. (1) Method to ensure pure 
cultures and correct identification of the agent to be released, 
including:
    (i) For insects: species, genus, family, and order (for pathogens: 
strain, race, type);
    (ii) Names and organizations with locations of identifier;
    (iii) Description of identification methods;
    (iv) Problems in identification; and
    (v) Date and place of depository containing voucher specimens.
    (2) General release protocol to ensure the absence of natural 
enemies and cryptic or sibling species.
    (3) Specific location of rearing or culturing facility.
    (4) Intended sites for initial release, timing of release, release 
methods to be used. For insects, number to be released, if known. For 
pathogens, method of preparing inoculum and inoculum concentration.
    (f) Post-release monitoring. Provide an explanation of the post-
release monitoring plan. Include the following information:
    (1) When the anticipated initial release of the agents will occur.
    (2) Groups to best perform monitoring.
    (3) Monitoring techniques to determine if the agents become 
established.
    (4) Monitoring techniques to determine the spread and impact on 
target and nontarget plants.
    (g) Benefits and risks. Offer your perspective about weighing the 
probable benefits of releasing the agent against the unknowns and 
possible negative impacts.
    (h) Potential environmental impacts. Discuss the potential 
ecological, economic, social, biological, health regulatory, and 
environmental impact. Present as clear a picture as possible of the 
long-term ecological consequences that could possibly result from the 
successful establishment of this agent in the North American 
environment. This information should go beyond the risk associated with 
attack on a few closely related species of plants, as indicated in the 
host testing results. This discussion should look at the overall 
potential impact of populations of this insect building up on the weed 
in a large variety of different habitats. This information will be 
critical in preparing an environmental assessment, which will be the 
next step in the approval process if the TAG recommends that this agent 
should be released in North America. (Note: The elements contained in 
this paragraph do not need to be addressed for the proposed release 
into a State's environment of pure cultures of organisms that are 
either native or established introductions. See 
Sec. 330.203(b)(1)(ii).) Impacts to be considered include:
    (1) Human impacts. Include positive and negative impacts to humans. 
For example, health, recreational, aesthetics, nuisance, poisonous, 
allergens. Discuss ways to overcome negative effects.
    (2) Potential economic impacts. Provide the potential gains and 
losses regarding the ecological, social, aesthetic, and biological 
impacts.
    (3) Plant impacts. Describe the direct and indirect impacts 
(positive and negative) of the organism on the local plant populations. 
Cover the intended effects on the target weed and on nontargets, 
including potential impacts on agricultural, horticultural, and 
threatened and endangered plants.
    (4) Non-plant impacts. Describe the indirect effects (positive and 
negative) on organisms (other than plants) that depend directly or 
indirectly on the target weed or affected nontarget plants based on 
test results.
    (5) Proposed methods for mitigation. Identify proposed methods 
(management and other alternatives) to mitigate potentially undesired 
effects.
    (6) Abiotic and edaphic effects. Identify the potential abiotic and 
edaphic effect, i.e., water, soil, air.
    (7) Outcome of no action. Provide a statement of the outcome if no 
release was made.
    (i) Petitioner's conclusion. Offer your conclusions on the 
potential risks and benefits regarding the consequences of the release 
of this agent and its successful establishment in the North American 
environment throughout the range of its target weed and susceptible 
nontarget hosts. Summarize all the results of your study of this agent, 
its host testing, and your evaluation of the potential environmental 
impact. Include a quantitative risk assessment, if available.


Sec. 330.207  APHIS review of permit applications; denial or 
cancellation of permits.

    (a) Inspection of premises. APHIS may inspect the facility where 
you are proposing to receive and handle regulated organisms to 
determine whether the facility will be adequate to prevent plant pest 
dissemination. When inspecting your facility, we will consider the 
following areas to the degree to which they are appropriate to the 
plant pest risks presented by the particular regulated organism for 
which you are seeking a permit:\2\
---------------------------------------------------------------------------

    \2\ Guidelines describing suggested physical and operational 
characteristics for facilities may be obtained by writing to Permits 
and Risk Assessment, PPQ, APHIS, 4700 River Road Unit 133, 
Riverdale, MD 20737-1236, or by calling (301) 734-8896, or by faxing 
your request to (301) 734-8700.
---------------------------------------------------------------------------

    (1) Does the facility have entryways, windows, and other 
structures, including water, air, and waste handling systems, to 
contain the regulated organisms and prevent the entry of other 
organisms and unauthorized visitors?
    (2) Does the facility have operational and procedural safeguards in 
place to prevent the escape of the regulated organisms and prevent the 
entry of other organisms and unauthorized visitors?
    (3) Does the facility have a means of inactivating or sterilizing 
regulated organisms and any host material, containers, or other 
material?
    (b) Denial of permits. APHIS will deny an application for a permit 
to move or release an organism regulated under this subpart when, in 
its opinion, such movement would involve a danger

[[Page 51358]]

of dissemination of a plant pest. Danger of plant pest dissemination 
may be deemed to exist when:
    (1) Existing safeguards against plant pest dissemination are 
inadequate and no adequate safeguards can be arranged; or
    (2) The destructive potential of the regulated organism to plants, 
plant parts, or plant products, should it escape despite the proposed 
safeguards, outweighs the probable benefits that could be derived from 
the proposed movement and use of the regulated organism; or
    (3) When you, as a previous permittee, failed to maintain the 
safeguards or otherwise observe the conditions prescribed in a previous 
permit and have failed to demonstrate your ability or intent to observe 
them in the future; or
    (4) The proposed movement of the regulated organism is adverse to 
the conduct of an eradication, suppression, control, or regulatory 
program of APHIS.
    (c) Cancellation of permits. APHIS may cancel any outstanding 
permit whenever:
    (1) We receive information subsequent to the issuance of the permit 
of circumstances that would constitute cause for the denial of an 
application for permit under paragraph (b) of this section; or
    (2) You, as the permittee, fail to maintain the safeguards or 
otherwise observe the conditions specified in the permit or in any 
applicable regulations.


Sec. 330.208  Permit conditions.

    (a) If your permit application is approved, APHIS will issue a 
permit that will include any requirements that are, in the opinion of 
APHIS, necessary to prevent the dissemination of plant pests into the 
United States or interstate. The permit may specify a particular port 
of entry through which the regulated organism must enter the United 
States. The following standard conditions will apply to all permits for 
importation and interstate movement:
    (1) After receiving the regulated organisms and removing them from 
their shipping container, you must immediately sterilize or destroy the 
shipping container and all packing material, media, substrate, and 
soil;
    (2) You must keep the regulated organisms within the laboratory or 
other designated holding area at your facility and may not remove them 
without prior approval from APHIS;
    (3) You must allow authorized APHIS and State regulatory officials 
to inspect, without prior notice and during reasonable hours, the 
conditions under which the regulated organisms are kept;
    (4) You must destroy all regulated organisms kept under the permit 
at the completion of the intended use, and not later than the 
expiration date of the permit, unless an extension is granted by APHIS 
before the expiration of the permit;
    (5) In the event of an escape of the regulated organisms, you must 
inform APHIS immediately, but no later than 24 hours after detecting 
the escape; and
    (6) During the time that the regulated organisms are held in your 
facility, you must maintain records that identify the organisms, the 
person from whom you received them, the date the regulated organisms 
were received at your facility, and the disposition of the organisms. 
You must maintain those records for a period of 1 year following the 
final disposition of the regulated organisms. During normal business 
hours, you must allow an APHIS inspector to inspect and copy those 
records.
    (b) Supplemental conditions may be included on the permit specific 
to the biology of the organism, the types of activities involved with 
the movement, or the specific needs of a facility.
    (c) Permits authorizing movement of organisms through the United 
States (i.e., transit movement) will include shipping instructions as 
to routing, labeling, and similar requirements. Those instructions will 
be included on the permit as supplemental conditions.
    (d) The length of a permit's validity will be indicated on the 
permit. Permits may be valid for a maximum duration of 10 years.


Sec. 330.209  Appealing the denial or cancellation of permits and 
compliance agreements.

    If your permit application has been denied or your permit or 
compliance agreement has been canceled, APHIS will promptly inform you, 
in writing, of the reasons for the denial or cancellation. You may 
appeal the decision by writing to the Administrator and providing all 
of the facts and reasons upon which you are relying to show that your 
permit application was wrongfully denied or your permit or compliance 
agreement was wrongfully canceled. 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, you may request a hearing to resolve the conflict. Rules 
of practice concerning the hearing will be adopted by the 
Administrator.


Sec. 330.210  Packaging of regulated organisms.

    (a) When moving a regulated organism, you must pack the organism in 
a container or combination of containers that will prevent the escape 
of the organism, and the outer container must be clearly marked to 
indicate its contents.
    (b) Only approved packing materials may be used in a shipment of 
regulated organisms.
    (1) The following materials are approved as packing materials: 
Absorbent cotton or processed cotton padding free of cottonseed; 
cellulose materials; excelsior; felt; ground peat (peat moss); paper or 
paper products; phenolic resin foam; sawdust; sponge rubber; thread 
waste, twine, or cord; and vermiculite.
    (2) Other materials, such as host material for the organism, soil, 
or other types of packing material, may be included in a container only 
with the advance approval of APHIS.


Sec. 330.211  Labeling of regulated organisms.

    If you are importing a regulated organism through the mail or 
through commercial express delivery, you must attach a special mailing 
label, which APHIS will provide with your permit or compliance 
agreement, to the container. The mailing label will indicate that the 
shipment of regulated organisms has been authorized by APHIS. If 
regulated organisms arrive in the mail without a mailing label, an 
APHIS inspector may refuse to allow the organisms to enter the United 
States.


Sec. 330.212  Exportation of organisms from the United States.

    If you are shipping regulated organisms to destinations outside the 
United States, the organisms must be packaged in accordance with 
Sec. 330.210 to prevent their escape during movement.

    Done in Washington, DC, this 1st day of October 2001.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 01-25229 Filed 10-5-01; 8:45 am]
BILLING CODE 3410-34-P