Plant Pest Regulations; Update of Current Provisions
[Federal Register: October 9, 2001 (Volume 66, Number 195)]
[Proposed Rules]
[Page 51340-51358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc01-21]
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Proposed Rules
Federal Register
________________________________________________________________________
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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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 Notification@aphis.usda.gov.
(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
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