[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 6980-7005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00532]



[[Page 6979]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part V





Department of Agriculture





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Animal and Plant Health Inspection Service





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7 CFR Parts 318, 319, 330, et al.





Plant Pest Regulations; Update of Provisions; Proposed Rule

  Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 / 
Proposed Rules  

[[Page 6980]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 318, 319, 330, and 352

[Docket No. APHIS-2008-0076]
RIN 0579-AC98


Plant Pest Regulations; Update of Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal and reproposal.

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SUMMARY: We are proposing to revise our regulations regarding the 
movement of plant pests. We are proposing criteria regarding the 
movement and environmental release of biological control organisms, and 
are proposing to establish regulations to allow the importation and 
movement in interstate commerce of certain types of plant pests without 
restriction by granting exceptions from permitting requirements for 
those pests. We are also proposing to revise our regulations regarding 
the movement of soil. This proposed rule replaces a previously 
published proposed rule, which we are withdrawing as part of this 
document. This proposal would clarify the factors that would be 
considered when assessing the risks associated with the movement of 
certain organisms and facilitate the movement of regulated organisms 
and articles in a manner that also protects U.S. agriculture.

DATES: We will consider all comments that we receive on or before March 
20, 2017.

ADDRESSES: You may submit comments by either of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0076.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2008-0076, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2008-
0076 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Colin D. Stewart, Assistant 
Director; Pests, Pathogens, and Biocontrol Permits Branch, Plant Health 
Programs, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-
1236; (301) 851-2237.

SUPPLEMENTARY INFORMATION:

Background

    Under the Plant Protection Act (7 U.S.C. 7712 et seq., referred to 
below as the PPA or the Act), the Secretary of Agriculture has 
authority to carry out operations or measures to detect, control, 
eradicate, suppress, prevent, or retard the spread of plant pests. 
Section 7711(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 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 ``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) 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, section 412(a) of the Act provides that the 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) and ``Subpart--Movement of 
Soil, Stone, and Quarry Products'' (7 CFR 330.300 through 330.301) is 
to prevent the dissemination of plant pests into the United States, or 
interstate, by regulating the importation and interstate movement of 
plant pests, soil, stone, and quarry products.
    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 
PPA. Most of the provisions of the PPA regarding the importation and 
movement of plant pests were modeled on or directly derived from these 
two Acts; thus, the enactment of the PPA did not necessitate a major 
revision of the subpart. However, the PPA did contain provisions that 
clarified the authority in the earlier Acts regarding, among other 
things, our ability to regulate the importation and interstate movement 
of biological control organisms, as well as noxious weeds and 
associated articles.
    Accordingly, on October 9, 2001 (66 FR 51340-51358, Docket No. 95-
095-2), we published in the Federal Register a proposed rule which 
would have revised the plant pest regulations. Among other proposed 
provisions, it would have established a notification process that could 
be used as an alternative to the permitting system, provided for the 
environmental release of organisms for the biological control of weeds, 
and updated the text of the subpart to reflect the provisions of the 
PPA.
    We solicited comments for 60 days ending December 10, 2001. We 
received 1,332 comments by that date. They were from State Departments 
of Agriculture, a State fish and wildlife agency, universities, plant 
societies, biocontrol organizations, USDA's Forest Service and 
Agricultural Research Service, the U.S. Environmental Protection Agency 
(EPA), zoological associations, the World Trade Organization, 
pharmaceutical groups and biological supply companies, wildlife 
protection and conservation groups, trade organizations, butterfly 
breeders and associations, elementary schools, and private citizens.
    The majority of the comments that we received were from schools and 
students who requested that we continue to allow the environmental 
release of Monarch butterflies as part of a learning curriculum. Some 
of these commenters also requested that we continue to allow the 
environmental

[[Page 6981]]

release of Monarch butterflies for weddings and other ceremonies.\1\
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    \1\ Under this proposed rule, which withdraws our 2001 proposal, 
we would authorize the issuance of permits for the environmental 
release of Monarch butterflies in accordance with current practices. 
Under these practices, permits issued to permittees who reside east 
of the Rocky Mountains would authorize the environmental release of 
Monarch butterflies east of the Rockies, while those issued for 
permittees who reside west of the Rocky Mountains would authorize 
the environmental release of Monarch butterflies west of the 
Rockies. This is because there are two distinct ecological ranges 
for Monarchs in the United States, with each terminating at the 
Rocky Mountains.
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    We also received comments that addressed the proposed rule both 
generally and in regard to its specific provisions. Commenters often 
requested clarification regarding or suggested modification to several 
of the rule's provisions, but were, on the whole, generally supportive 
of the proposed rule. Accordingly, based on our evaluation of the 
comments that we received, we planned to issue a final rule.
    However, the events of September 11, 2001, led to a further 
evaluation of our proposal to determine whether the proposed provisions 
had sufficient safeguards governing our permitting process. 
Specifically, we evaluated whether an aspect of our proposal, which 
would have authorized the importation of regulated organisms without 
prior issuance of a permit, provided that the party receiving the 
organisms had entered into a compliance agreement with APHIS, could 
serve as a potential venue for bioterrorism. We also temporarily 
suspended issuance of new plant pest permits.
    In addition, on March 31, 2003, USDA's Office of the Inspector 
General (OIG) issued an audit of APHIS' permitting programs. Among 
other things, the audit examined APHIS' issuance of plant pest permits, 
and its administration of the permitting process. The audit suggested 
that we implement ePermits, a more thorough and technologically 
advanced permitting database than that used at the time, that we 
discontinue our practice at the time of issuing ``blanket'' permits to 
individuals or organizations to move plant pests and biological control 
organisms in favor of specific permits for each movement of a regulated 
organism, that we require more thorough documentation of an organism's 
intended use on each permit application, that we develop risk-based 
criteria for deciding whether or not to issue a permit for a particular 
movement, that we inspect the destinations listed on permit 
applications more regularly to evaluate their suitability for the 
organisms held onsite, and that we establish clear protocols, with an 
adequate degree of APHIS oversight, regarding the disposal of organisms 
once a permit expires. A 2007 followup OIG audit again encouraged us to 
fully implement ePermits, particularly at ports of entry into the 
United States.
    Although APHIS has not substantively revised the regulations in the 
subpart since the promulgation of the PPA and the release of the OIG 
audits, these audit reports have informed Agency decisions regarding 
our regulation of the movement of plant pests, biological control 
organisms, and associated articles.
    In this proposal, we are withdrawing our 2001 proposed rule and 
replacing it with an alternative proposal. This proposal retains 
several of the provisions of the 2001 proposal. For example, the 
conditions under which we would consider an organism a plant pest, and 
thus regulated by the subpart, remain similar to those of the 2001 
proposal. However, this proposal also removes or modifies other 
provisions of the 2001 proposal. For example, we have removed 
provisions that would have authorized the movement of regulated 
organisms through a process consisting of compliance agreements and 
notification of movement.
    Additionally, this proposal also incorporates new provisions that 
were not contained in the 2001 proposed rule but that would codify 
procedures that we have identified as best practices since that time 
but not yet added to the regulations.
    The most significant changes in this new proposal are:
     We are proposing to establish criteria for the movement 
and environmental release of both biological control organisms of 
noxious weeds and those of plant pests; and
     We are proposing to remove ``Subpart--Movement of Soil, 
Stone, and Quarry Products'' and would instead regulate these articles 
in a subpart titled ``Subpart--Movement of Plant Pests, Biological 
Control Organisms, and Associated Articles.''
    The full text of the proposed regulations appears in the rule 
portion of this document. Our discussion of the proposed provisions 
follows.

Definitions

    In addition to our proposed revision of ``Subpart--Movement Plant 
Pests'' and removal of ``Subpart--Movement of Soil, Stone, and Quarry 
Products,'' we would also revise Sec.  330.100, ``Definitions,'' of 
``Subpart--General Provisions,'' to incorporate the applicable new 
definitions provided by the PPA and to update or eliminate some of the 
definitions currently provided in that section.
    From the PPA, we would add definitions for the terms article, 
biological control organism, enter (entry), export (exportation), 
import (importation), noxious weed, plant, and plant product; and we 
would replace the current definitions of move (moved and movement), 
permit, person, plant pest, and State with the definitions provided for 
those terms in the PPA. However, regarding the definition of permit, 
although the PPA definition mentions the issuance of oral permits, our 
proposed definition does not. For the purposes of the plant pest 
regulations, oral permits would not provide a reliable means of 
verifying that a permittee was aware of the permit conditions at the 
time he or she was issued the permit, and would, we believe, adversely 
affect APHIS' ability to ensure appropriate compliance and enforcement 
of our regulatory requirements.
    We would also add definitions for Animal and Plant Health 
Inspection Service (APHIS), biocontainment facility, EPA, hand-carry, 
interstate movement, living, permittee, responsible individual, secure 
shipment, sterilization (sterile, sterilized), taxon (taxa), transit, 
and U.S. Customs and Border Protection (CBP). We will first discuss 
what we mean by the term taxon (taxa). We will then discuss, in 
alphabetical order, the definitions of the other new terms that we are 
proposing to add to the regulations.
    We would define taxon (taxa) as: ``Any recognized grouping or rank 
within the biological nomenclature of organisms, such as class, order, 
family, genus, species, subspecies, pathovar, biotype, race, forma 
specialis, or cultivar.'' This proposed definition is based on the 
International Plant Protection Convention's (IPPC's) Glossary of 
Phytosanitary Terms,\2\ which uses taxon, at various points, in 
reference to family, species, and subspecies.
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    \2\ International Standard for Phytosanitary Measures (ISPM) 
Number 5. To view this and other ISPMS, go to https://www.ippc.int/en/core-activities/standards-setting/ispms/#publications.
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    We would define the term Animal and Plant Health Inspection Service 
(APHIS) as: ``The Animal and Plant Health Inspection Service of the 
United States Department of Agriculture.''
    We would define the term biocontainment facility as: ``A physical 
structure, or portion thereof,

[[Page 6982]]

constructed and maintained in order to contain plant pests, biological 
control organisms, or associated articles.''
    We would define the term EPA as: ``The Environmental Protection 
Agency of the United States.''
    We would define the term hand-carry as: ``Importation of an 
organism that remains in one's personal possession and in close 
proximity to one's person.'' Our requirements governing the movement of 
plant pests by baggage, currently found in Sec.  330.212, are commonly 
referred to as the ``hand-carry'' regulations; we are proposing to 
revise these requirements.
    We would define the term interstate movement as: ``Movement from 
one State into or through any other State; or movement within the 
District of Columbia, Guam, the U.S. Virgin Islands, or any other 
territory or possession of the United States.''
    We would define the term living as: ``Viable or potentially 
viable.'' We are including ``potentially viable'' within our definition 
of living because most viruses and retroviruses of plants and plant 
products cannot grow or reproduce outside of a host cell; however, once 
inserted into the cell, they are capable of both growth and self-
replication, and, over time, exhibit pathogenic effects. Because of 
this potential for both growth and self-replication, it is generally 
our policy to consider such viruses living plant pests, and to require 
a permit for their importation, interstate movement, transit, or 
continued curation.
    We would define the term permittee as: ``The person to whom APHIS 
has issued a permit in accordance with this part and who must comply 
with the provisions of the permit and the regulations in this part.''
    We would define the term responsible individual as: ``The 
individual who a permittee designates to oversee and control the 
actions taken under a permit issued in accordance with this part for 
the movement or curation of a plant pest, biological control organism, 
or associated article. For the duration of the permit, the individual 
must be physically present during normal business hours at or near the 
location specified on the permit as the ultimate destination of the 
plant pest, biological control organism, or associated article, and 
must serve as a primary contact for communication with APHIS. The 
permittee may designate him or herself as the responsible individual. 
The responsible individual must be at least 18 years of age. In 
accordance with section 7734 of the PPA, the act, omission, or failure 
of any responsible individual will also be deemed the act, omission, or 
failure of a permittee.''
    Historically, we have only issued permits for the movement of plant 
pests, biological control organisms, and associated articles to 
individuals. However, as provided for in the definition of permittee, 
we would allow corporate entities to obtain permits under the revised 
regulations. This change will allow for better tracking and 
communication regarding a permit or permit application, and will also 
make it clear that the corporation as a whole is responsible for the 
permit. In such instances, we believe that it is of paramount 
importance that the permittee specifies a person whom APHIS may contact 
regarding the actions authorized under the permit who has first-hand 
knowledge of these actions. The responsible individual would fulfill 
this role.
    We anticipate that, if this rule is finalized, we would still issue 
a significant number of permits to individuals, rather than corporate 
entities. We expect that, for the majority of such permits, the 
permittee would wish to designate him or herself as the responsible 
individual; therefore, the definition of responsible individual would 
allow for such designation.
    Finally, Section 7734 of the PPA provides that a person will be 
held liable for the acts, omissions, and failures of an agent acting 
for that person, as long as the agent is acting within the scope of his 
or her office. Responsible individuals would be agents of the permittee 
pursuant to this section of the PPA.
    We would define the term secure shipment as: ``Shipment of a 
regulated plant pest, biological control organism, or associated 
article in a container or a means of conveyance of sufficient strength 
and integrity to prevent leakage of contents and to withstand shocks, 
pressure changes, and other conditions incident to ordinary handling in 
transportation.''
    We would define the term sterilization (sterile, sterilized) as: 
``A chemical or physical process that results in the death of all 
living organisms on or within the article subject to the process. 
Examples include, but are not limited to, autoclaving and 
incineration.''
    Note that, for the purposes of this subpart, the term sterilization 
does not refer to techniques that neutralize an organism by rendering 
it incapable of sexual reproduction. We recognize that this alternate 
meaning of the term ``sterilization'' might be more common within the 
regulated community, but believe that it is clear from the manner in 
which we would use the term in the revised subpart that it would have a 
different meaning within these regulations.
    We would define the term transit as: ``Movement from and to a 
foreign destination through the United States.'' This definition would 
replace a definition currently in the regulations, through the United 
States, which we define as: ``From and to places outside the United 
States.''
    We would define the term U.S. Customs and Border Protection (CBP) 
as: ``U.S. Customs and Border Protection within the Department of 
Homeland Security.'' This definition would replace the now outdated 
definition of Customs in the current regulations.
    In addition, we would substantively revise the definition of soil. 
We currently define soil as: ``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.'' We would 
redefine soil as: ``The unconsolidated material from the earth's 
surface that consists of rock and mineral particles and that supports 
or is capable of supporting biotic communities.'' This definition 
aligns with the current scientific understanding of soil, and would 
resolve ambiguities in the current definition that could be construed 
to suggest that soil includes consolidated or sterile matter that does 
not present a risk of harboring plant pests or noxious weeds. (For 
purposes of the regulations, it does not.) We would also remove the 
definition of 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,'' from the regulations.
    We would remove the definition of Plant Protection Act. The Act is 
cited in the authority citation for part 330, and we do not believe it 
is necessary to define it in the regulations.
    We would make nonsubstantive editorial changes to the definitions 
of administrative instructions, Administrator, Department, Deputy 
Administrator, inspector, means of conveyance, owner, and Plant 
Protection and Quarantine Programs.
    Finally, we would retain, without modification, the existing 
definitions of garbage, regulated garbage, and shelf-stable.

Titles of the Part and Subpart

    Currently, the title of part 330, ``Federal Plant Pest Regulations; 
General; Plant Pests; Soil, Stone, and Quarry Products; Garbage,'' 
reflects the

[[Page 6983]]

titles of its four subparts. As mentioned above, we are proposing to 
revise the second subpart, currently titled ``Subpart--Movement of 
Plant Pests,'' to clarify that it regulates the movement not only of 
plant pests, but also of biological control organisms and associated 
articles, including soil. Since we would now regulate soil within that 
subpart, we would remove and reserve the third subpart, ``Subpart--
Soil, Stone, and Quarry Products.''
    For this reason, we would also update the title of the second 
subpart. As amended, it would now be titled ``Subpart--Movement of 
Plant Pests, Biological Control Organisms, and Associated Articles.''
    As a result of these proposed revisions, we would also revise the 
title of the part. It would now be titled: ``Federal Plant Pest 
Regulations; General; Plant Pests, Biological Control Organisms, and 
Associated Articles; Garbage.''

Scope and General Restrictions (Sec.  330.200)

    The proposed regulations would begin by establishing the scope of 
the revised subpart. Paragraph (a) would state that no person shall 
import, move interstate, transit, or release into the environment plant 
pests, biological control organisms, or associated articles, unless the 
importation, interstate movement, transit, or release into the 
environment of the plant pests, biological control organisms, or 
associated articles is:
     Authorized under an import, interstate movement, or 
continued curation permit issued in accordance with proposed Sec.  
330.201;
     Authorized in accordance with other APHIS regulations in 7 
CFR chapter III;
     Explicitly granted an exception or exemption in the 
revised subpart from permitting requirements.
     Authorized under a general permit issued by the 
Administrator.
    By ``authorized in accordance with other APHIS regulations in 7 CFR 
chapter III,'' we mean that certain movements of plant pests or 
associated articles are regulated under other APHIS regulations in 
title 7. For example, the transit of a plant pest through the United 
States would require a permit issued in accordance with Sec.  352.5 of 
the plant quarantine safeguard regulations in 7 CFR part 352, and the 
interstate movement of regulated associated articles of domestic 
quarantine pests (e.g., host articles of pine shoot beetle or Asian 
citrus psyllid) normally require certificates or limited permits issued 
in accordance with their respective subparts in the domestic quarantine 
notice regulations of 7 CFR part 301.
    We discuss the exemptions from permitting requirements that we are 
proposing to grant for certain categories of biological control 
organisms in the discussion under the heading ``Biological control 
organisms (Sec.  330.202),'' and the exceptions from permitting 
requirements that we are proposing to grant for certain plant pests in 
the discussion under the heading ``Exceptions to permitting 
requirements for the importation or interstate movement of certain 
plant pests (Sec.  330.204).''
    Finally, to date, we have only issued specific permits, that is, 
permits issued to specific persons, for the interstate movement of 
plant pests. However, pursuant to section 7711 of the PPA, the 
Administrator may also issue general permits, that is, general 
authorizations, for the importation or interstate movement of plant 
pests.
    In recent years, we have contemplated issuing a general, Web-based 
permit for the interstate movement of certain plant pests that we 
regard to be low-risk unless they are moved into certain areas of the 
United States, rather than specific permits for the movement of these 
pests. If we finalize proposed paragraph (a) of Sec.  330.200 and 
decide to issue such a permit, we would announce the existence, 
location, and content of this general permit through a notice in the 
Federal Register.
    Paragraph (b) of Sec.  330.200 would specify the types of plant 
pests that we would regulate under the revised subpart. The paragraph 
would state that, for the purposes of the subpart, we would consider an 
organism to be a plant pest if the organism either directly or 
indirectly injures, causes damage to, or causes disease in a plant or 
plant product, or if the organism or part is an unknown risk to plants 
or plant products, but is similar to an organism known to directly or 
indirectly injure, cause damage to, or cause disease in a plant or 
plant product.
    This paragraph, which is not found in the current regulations, is 
similar to the criteria for designating an organism a plant pest that 
were contained in our 2001 proposal. We have, however, made two changes 
to those criteria.
    First, while our 2001 proposal would have designated certain 
organisms as plant pests if they directly or indirectly adversely 
affected plants, plant parts, or plant products, in this proposed rule, 
we would designate these organisms as plant pests if the organisms 
directly or indirectly injure, cause damage to, or cause disease in a 
plant or plant product. These latter criteria are based on the 
definition of plant pest found in the PPA, and have been our framework 
in recent years for determining whether an organism is a plant pest.
    We would also expand the scope of our 2001 proposal so that we may 
consider organisms of an unknown risk to plants or plant products to be 
plant pests, provided that the organisms are similar to an organism 
known to directly or indirectly injure, cause damage to, or cause 
disease in a plant or plant product.
    In our 2001 proposal, we did propose that organisms of an unknown 
risk to plants or plant products would require a permit, but we would 
have designated them regulated organisms rather than plant pests. We 
also stated that permitting conditions for such organisms would be 
aimed primarily at affording us an opportunity to identify and deal 
with the organisms with some initial degree of regulatory oversight, in 
order to prevent the dissemination of plant pests into or within the 
United States. We thus framed permitting requirements for such 
organisms as a necessary stopgap measure pending positive 
identification of the organism and an assessment of the organism's 
potential risk to plants and plant products.
    However, since 2001, there have been numerous occasions when 
applicants have requested authorization to import organisms that cannot 
readily be identified to the species level for a significant portion of 
their lifespans, but that may be plant pests. For example, we have 
issued several plant pest permits for the importation of larval 
scarabs. Before becoming mature, all scarabs are morphologically 
similar to one another and exhibit similar feeding patterns, but are 
not plant pests. However, once mature, certain scarab species are plant 
pests. In order to take this potential for future effects on plants, 
plant parts, and plant products into consideration, in issuing a permit 
for any scarab grub, we have considered it to be a plant pest, and 
tailored permitting and containment requirements accordingly.
    Paragraph (c) of Sec.  330.200 would specify the types of 
biological control organisms that we would regulate under the revised 
subpart. Although the PPA defines a biological control organism as 
``any enemy, antagonist, or competitor used to control a plant pest or 
noxious weed,'' practically speaking, we have only required permits for 
certain types

[[Page 6984]]

of biological control organisms since the PPA was promulgated.\3\ These 
are:
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    \3\ It is worth noting that, prior to the PPA, we issued permits 
for the movement and release of invertebrate herbivores used to 
control noxious weeds and microbial pathogens used to control 
noxious weeds pursuant to authority in the Federal Plant Pest Act 
(FPPA). The FPPA was superseded and repealed by the PPA.
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     Invertebrate predators and parasites (parasitoids) used to 
control invertebrate plant pests,
     Invertebrate competitors used to control invertebrate 
plant pests,
     Invertebrate herbivores used to control noxious weeds,
     Microbial pathogens used to control invertebrate plant 
pests,
     Microbial pathogens used to control noxious weeds, and
     Microbial parasites used to control plant pathogens.
    Regarding these types of biological control organisms, we recognize 
that biological control organisms used to control noxious weeds are 
also plant pests, insofar as they injure, cause damage to, or cause 
disease in plants. However, since this effect is desirable and 
ultimately beneficial to other plants, plant parts, and plant products, 
it has been our policy to draft permitting conditions for the movement 
and environmental release of these organisms in a manner that 
encourages these effects, unless we have reason to believe that the 
organisms may also have plant pest effects on non-target plants or 
plant products.
    As noted in the previous paragraphs, there are some types of 
biological control organisms for which we have not historically issued 
permits. However, there may be times when there would be a risk-based 
need to regulate the importation or interstate movement of an organism 
that falls within the PPA's definition of a biological control 
organism, but does not fall into any of the types of organisms listed 
above. For example, if a microbial parasite that has not previously 
been evaluated is put forth for the control of pathogenic fungi, it 
would not fall within the above categories, but could be an organism we 
would wish to regulate out of concern of the possibility of effects on 
non-target plants, such as fungi without phytopathogenic properties. To 
this end, paragraph (c) would also provide that other types of 
biological control organisms could be regulated under the revised 
subpart, as determined by APHIS. This determination would typically be 
on a case-by-case basis, and would be based on a permit application for 
movement of an organism which did not belong to any of the above types, 
but for which the Administrator determined it necessary to exercise a 
degree of regulatory oversight in order to prevent the introduction of 
a plant pest into the United States or the dissemination of a plant 
pest within the United States.
    Paragraph (d) would exempt biological control organism products 
that EPA has issued experimental use permits for or that EPA has 
registered as microbial pesticide products having outdoor uses from 
regulatory oversight under the revised subpart. Under the authority of 
the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 
seq., FIFRA), EPA regulates certain biological control organisms 
(eukaryotic microorganisms, prokaryotic microorganisms, and viruses) as 
``substances,'' and has established a registration process for their 
use as microbial pesticides. EPA issues experimental use permits (EUPs) 
to allow persons to release these organisms into the environment on a 
limited basis in order to obtain information necessary to apply to have 
the organisms registered as microbial pesticides. EPA also allows the 
transfer, sale, and/or distribution of unregistered pesticides under 
certain circumstances in accordance with its regulations in 40 CFR 
152.30. Because registered or permitted products are already subject to 
extensive regulation by EPA, we have entered into a memorandum of 
understanding with EPA stating that we consider the products to be 
exempt from our regulatory oversight, and paragraph (d) would largely 
codify the policy in this memorandum. It would also address EPA's 
provision for the transfer, sale, and/or distribution of unregistered 
pesticides under certain circumstances, and allow for the importation 
and interstate movement of such unregistered pesticides without APHIS' 
oversight, because of EPA's oversight.

Permit Requirements (Sec.  330.201)

    Section 330.201 would describe the types of permits that APHIS 
issues for plant pests, biological control organisms, and associated 
articles, the process for applying for a permit, and the manner in 
which APHIS acts on permit applications.
    Paragraph (a) of Sec.  330.201 would provide information regarding 
the types of permits that APHIS issues for plant pests, biological 
control organisms, and associated articles. It would state that we 
issue import permits, interstate movement permits, continued curation 
permits, and transit permits.
    Paragraph (a)(1) would provide information regarding import 
permits. It would state that APHIS issues import permits to persons for 
secure shipment from outside the United States into the territorial 
limits of the United States; that, when import permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States; and that, when import 
permits are issued to corporate persons, these persons must maintain an 
address or business office in the United States with a designated 
individual for service of process.\4\
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    \4\ Please note that other Federal agencies have separate 
regulatory authority related to the importation of secure shipments 
of plant pests, biological control organisms, and associated 
articles. For example, pursuant to their general regulatory 
authority, DHS requires formal entry for organisms and soil that are 
imported via hand-carry or express courier organizations.
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    Paragraph (a)(2) would provide information regarding interstate 
movement permits. It would state that interstate movement permits are 
issued to persons for secure shipment from any State into or through 
any other State; that, when interstate movement permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States; and that, when 
interstate movement permits are issued to corporate persons, these 
persons must maintain an address or business office in the United 
States with a designated individual for service of process.
    Both import and interstate movement permits may contain conditions 
regarding the manner in which an organism may be moved from the 
destination listed on the permit. Such conditions are necessary to 
ensure that the organism is moved in a manner that will prevent its 
escape and dissemination and to ensure that the new facility to which 
it will be moved is capable of providing the necessary level of 
containment.
    On a related matter, applicants for import and interstate movement 
permits should be aware that States and localities may have laws and 
regulations that restrict the movement or release of plant pests, 
biological control organisms, and associated articles for various 
reasons (for example, impact on the environment of the State or 
locality). We encourage applicants to consult with these authorities 
prior to applying for a permit.
    Paragraph (a)(3) would provide information regarding continued 
curation permits. It would state that continued curation permits are 
issued in conjunction with and prior to the expiration date for an 
import permit or interstate movement permit, in order for the permittee 
to continue the actions listed on the import permit or interstate

[[Page 6985]]

movement permit following the expiration of the original permit. It 
would also state that, when continued curation permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. It would further 
state that, when continued curation permits are issued to corporate 
persons, these persons must maintain an address or business office in 
the United States with a designated individual for service of process.
    Paragraph (a)(4) would provide information regarding transit 
permits. It would state that transit permits are issued for secure 
shipments through the United States, and that such permits are issued 
in accordance with 7 CFR part 352. As we mentioned above, Sec.  352.5 
of that part contains permitting requirements for transit permits.
    However, part 352 currently provides for the transit of plant 
pests, but does not provide for the transit of biological control 
organisms. Therefore, we would amend part 352 to include references to 
biological control organisms. (For this reason, we would also amend 
part 352 to add definitions for the terms biological control organism 
and noxious weed, and to revise the definitions for Deputy 
Administrator, person, plant pest, and soil. The revised definitions 
would be identical to the ones we are proposing for part 330.)
    Currently, part 330 contains provisions for the issuance of several 
additional types of permits: Permits for plant pest movement associated 
with national defense projects, permits for means of conveyance, and 
courtesy permits for organisms that are not subject to APHIS 
regulation. However, we no longer issue a special type of permit 
specifically for national defense projects; if such a permit 
application arises, we issue the appropriate type of movement permit, 
and specify as a permit condition that the use of the organism is for a 
national defense project. Similarly, we do not issue permits 
specifically for means of conveyance; if we have reason to believe the 
means of conveyance may be an associated article, we regulate it as 
such and issue the appropriate movement permit.
    Until 2009, we issued courtesy permits in order to facilitate the 
movement of organisms that were not regulated under 7 CFR part 330, but 
that were similar enough to a known plant pest or biological control 
organism that their movement might otherwise be impeded if they were 
not accompanied by some sort of documentation from APHIS during 
transit. However, courtesy permits historically generated much 
confusion in the public and especially in the research community. The 
application form for courtesy permits was identical to the application 
for other types of permits, and the courtesy permit itself looked like 
other permits. This periodically led to the misunderstanding by some 
researchers that courtesy permits were required for the movement of 
certain organisms that were, in actuality, not subject to APHIS 
regulation. For these reasons, in recent years, Plant Protection and 
Quarantine (PPQ) has discontinued its issuance of courtesy permits for 
organisms that are similar to plant pests or biological control 
organisms, and it would not be necessary to include courtesy permits in 
the revised subpart.
    In a related matter, Sec.  330.207 of the current regulations 
states that APHIS recognizes permits issued by other Federal Agencies 
for the movement of regulated organisms and will issue administrative 
instructions or engage in correspondence with a permittee to augment 
the provisions of these permits through further conditions, rather than 
issue a duplicative permit.
    We do not consider it necessary to retain those provisions in the 
revised subpart. First, we seldom engage in correspondence with the 
permittee for permits issued by another Federal agency, such as EUPs 
issued by EPA. Rather, if we believe that the actions authorized under 
the permit may place plants or plant products at risk, we discuss the 
matter with the issuing agency itself. Correspondingly, it is rare that 
we receive permit applications from applicants who have submitted a 
prior application to another regulatory agency. Therefore, the 
provisions do not reflect current Agency practices, and we believe that 
it is generally presupposed by the regulated community that we will 
recognize permits issued by other regulatory agencies for the movement 
of plant pests, biological control organisms, and associated articles.
    Finally, we have periodically received requests from individuals to 
issue permits certifying organisms and associated articles that are 
destined for export from the United States. We note that foreign 
countries, rather than APHIS, set the conditions under which they will 
allow the importation of plant pests, biological control organisms, and 
associated articles from the United States. To this end, we would 
include a footnote stating that persons contemplating the shipment of 
plant pests, biological control organisms, or associated articles to 
places outside the United States should make arrangements directly, or 
through the recipient, with the country of destination for the export 
of the plant pests, biological control organisms, or associated 
articles into that country.
    That being said, for certain high-risk plant pests, interstate 
movement permits may place conditions on the interstate movement of the 
organism for export purposes. This is not included in the current 
regulations, but reflects recent Agency policy. Such conditions are 
necessary to safeguard the movement of the organism to the port of 
export.
    Paragraph (b) of Sec.  330.201 would provide that permit 
applications must be submitted by the applicant in writing or 
electronically through one of the methods specified at http://www.aphis.usda.gov/plant_health/permits/index.shtml, and must be 
submitted in advance of the action(s) proposed on the permit 
application. That Web page would specify that persons may apply for a 
permit via the Internet through APHIS' secure site for online permit 
applications, and would provide a link to that portal. It would also 
provide that a person may submit a permit application by faxing the 
application to APHIS, and would specify the appropriate fax number. 
Additionally, it would state that an application may be obtained by 
calling PPQ at the number provided. Finally, it would provide that a 
person may submit a permit application by mailing it to APHIS at the 
address provided. We note that because of the need for additional 
administrative processing, permit applications that are submitted via 
fax or by mail may not be reviewed as expeditiously as those submitted 
through APHIS' online portal. We encourage applicants to submit their 
applications electronically.
    Paragraph (c) of Sec.  330.201 would provide that a permit 
application must be complete before we will evaluate it in order to 
determine whether to issue the permit requested. Guidance regarding how 
to complete a permit application, including guidance specific to 
various information blocks on the application, would be available at 
http://www.aphis.usda.gov/plant_health/permits/index.shtml. The 
guidance would also specify that, in order to facilitate timely 
issuance of a permit, an application should be submitted at least 90 
days before the actions proposed on the permit application are 
scheduled to take place, with additional time allotted for complex or 
novel applications, or applications for high-risk plant pests.
    Paragraph (d) of Sec.  330.301 would describe the actions APHIS 
takes on receiving a permit application. The introductory text to the 
paragraph

[[Page 6986]]

would state that APHIS reviews the information on the application to 
determine whether it is complete. In order to consider an application 
complete, APHIS may request additional information that we determine to 
be necessary in order to assess the risk to plants and plant products 
that may be posed by the actions proposed on the application. When it 
is determined that an application is complete, we commence review of 
the information provided.
    Paragraph (d)(1) would describe the first part of APHIS' formal 
review, consultation with States, Tribes, and other individuals. We 
share a copy of the permit application, and the proposed permit 
conditions, with the appropriate State or Tribal regulatory officials, 
and may share them with other persons or groups to provide comment. For 
instance, we may share the permit application with persons or groups 
other than State or Tribal regulatory officials when we lack technical 
expertise to evaluate certain aspects of a permit application and need 
to solicit the opinion of individuals or groups with such expertise.
    Paragraph (d)(2) would describe the second part of our review, our 
initial assessment of sites and facilities where the organism or 
article will be held or released that are listed on the permit 
application. Such sites and facilities may include private residences, 
biocontainment facilities, and field locations. Although we may not do 
an onsite inspection in some cases, all sites and facilities would be 
subject to inspection as part of the assessment. All facilities would 
have to be determined by APHIS to be constructed and maintained in a 
manner that prevents the dissemination or dispersal of plant pests, 
biological control organisms, or associated articles from the facility. 
Finally, the applicant would have to provide all information requested 
by APHIS regarding this assessment, and to allow all inspections 
requested by APHIS during normal business hours (8 a.m. to 4:30 p.m., 
Monday through Friday, excluding holidays). Failure to do so would 
constitute grounds for denial of the permit application.
    Paragraphs (d)(3) and (d)(4) would describe the two possible 
actions we would take upon concluding review of the permit application: 
Issuance or denial of the requested permit. Paragraph (d)(3) would 
discuss permit issuance. APHIS may issue a permit to an applicant if 
APHIS concludes that the actions allowed under the permit would be 
highly unlikely to result in the introduction or dissemination of a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that presents an unacceptable risk to plants 
and plant products.
    We would specify that the actions allowed under the permit must be 
highly unlikely to result in the introduction or dissemination of a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that presents an unacceptable risk to plants 
and plant products because we would allow the environmental release of 
certain plant pests and biological control organisms under the revised 
subpart. The considerations that lead us to determine whether to 
authorize the environmental release of such organisms are discussed 
later in this document.
    Paragraphs (d)(3)(i) through (d)(3)(iv) would describe the manner 
in which APHIS would issue a permit under the revised subpart. Prior to 
issuing the permit, APHIS would notify the applicant in writing or 
electronically of all proposed permit conditions. The applicant would 
have to agree in writing or electronically that he or she, and all his 
or her employees, agents, and/or officers, would comply with all permit 
conditions and all provisions of the regulations. If the organism or 
associated article will be contained in a private residence, the 
applicant would have to state in this agreement that he or she 
authorizes APHIS to conduct unscheduled assessments of the residence 
during normal business hours if a permit is issued.
    APHIS would issue the permit after it receives and reviews the 
applicant's agreement. The permit would be valid for no more than 3 
years. During that period, the permittee would have to abide by all 
permitting conditions,\5\ and use of the organism or article would have 
to conform to the intended use on the permit. Moreover, the use of 
organisms derived from a regulated parent organism during that period 
would have to conform to the intended use specified on the permit for 
the parent organism.
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    \5\ Permitting conditions may reference the regulations and 
policies of other Federal agencies. For example, an import permit 
may provide conditions that a permittee must abide by in order for 
customs entry of his or her shipment to occur pursuant to CBP's 
regulations in title 19 of the CFR.
---------------------------------------------------------------------------

    We would specify that the use of the organism or article under the 
permit must conform to the intended use on the permit, because, on 
occasion, laboratories have obtained a permit for the movement of a 
plant pest or biological control organism into biocontainment, and then 
used the organism for purposes that differed from those specified as 
the intended use on the permit. In such instances, APHIS was not 
afforded an opportunity to evaluate the uses and determine whether they 
present a risk to plants and plant products within the United States. 
There have also been instances when laboratories have claimed that 
subsequent generations derived from a parent organism during the time 
period specified on a permit are distinct organisms, and thus should 
not be subject to the conditions specified on the permit and may be 
used at the laboratory's discretion. Such unregulated use of subsequent 
generations or progeny could present a risk of dissemination of the 
pest. Hence, we would require that the use of organisms derived from a 
regulated parent organism must conform to the intended use specified on 
the permit application for the parent organism.
    All activities carried out under the permit would have to cease on 
or before the expiration date of the permit, unless, prior to that 
expiration date, the permittee has submitted a new permit application 
and a new permit has been issued to authorize continuation of the 
actions.
    Finally, at any point following issuance of a permit but prior to 
its expiration date, an inspector could conduct unscheduled assessments 
of the site or facility in which the organisms or associated articles 
are held, to determine whether they are constructed and are being 
maintained in a manner that prevents the dissemination of organisms or 
associated articles from the site or facility. As with inspections 
associated with our initial assessment of sites or facilities prior to 
permit issuance, the permittee would have to allow all such assessments 
that we request during normal business hours. Failure to allow such 
assessments would constitute grounds for revocation of the permit.
    Paragraph (d)(4) would set forth the conditions under which APHIS 
may deny an application for a permit. Currently, in Sec.  330.204 of 
the regulations, APHIS will deny a permit application when such 
movement would involve a danger of dissemination of the pest. Danger of 
plant pest dissemination may be deemed to exist when any of the 
following five conditions occurs:
     No acceptable safeguards adequate to prevent plant pest 
dissemination can be arranged.
     The destructive potential of the plant pest to plants, and 
parts and products thereof, should it escape despite proposed 
safeguards, outweighs the probable benefits to be derived from

[[Page 6987]]

the proposed movement and use of the pest.
     The applicant, as a previous permittee, failed to maintain 
the safeguards or otherwise observe the conditions prescribed in a 
previous permit and failed to demonstrate his ability or intent to 
observe them in the future.
     The movement is adverse to the conduct of an eradication, 
suppression, control, or regulatory program of APHIS.
     The movement is objected to in writing by an appropriate 
official of a State, Territory, or possession, or the District of 
Columbia, on the ground it will involve a danger of dissemination of 
the plant pest into the State, Territory or possession, or District.
    Although the current regulations set out criteria that will factor 
into APHIS' judgment of risk and may lead us to deny a permit 
application, certain of the considerations have been understood by 
regulated entities to be absolute, and may have dissuaded persons from 
submitting applications for which we would have likely issued a permit. 
For example, for several years, there was an erroneous but widespread 
interpretation that the last condition afforded States and territories 
the right to ``veto'' permit applications. From this perspective, the 
current criteria may appear too strict.
    Conversely, the current regulations do not mention circumstances 
that may arise during the application process that would call into 
question that person's ability to comply effectively with permitting 
conditions, such as an applicant refusing to allow APHIS to inspect a 
biocontainment facility listed on the application, and would thus make 
it unlikely that we would issue him or her a permit.
    Accordingly, we are proposing to revise the conditions under which 
the Administrator may deny a permit application. The revised conditions 
would be the following:
     APHIS concludes that the actions proposed in the permit 
application would present an unacceptable risk to plants and plant 
products because of the introduction or dissemination of a plant pest, 
biological control organism, or noxious weed within the United States.
    This condition is intended to replace the current first condition, 
which does not appear to allow for environmental release of a plant 
pest or biological control organism, and the second condition, 
sometimes referred to as the ``balancing'' condition, which can be 
construed to suggest that APHIS will issue a permit for a high-risk 
movement or use of a regulated organism, provided that the benefits 
potentially derived from that movement or use may be equally great or 
greater. However, it is APHIS policy to base its decisions regarding 
permit issuance for the movement or use of plant pests, biological 
control organisms, and associated articles solely on an assessment of 
potential risk to plants and plant products associated with that 
movement or use.
    We would retain the following two conditions drawn substantially 
from the current regulations:
     The actions proposed in the permit application would be 
adverse to the conduct of an APHIS eradication, suppression, control, 
or regulatory program.
     A State or Tribal executive official, or a State or Tribal 
plant protection official authorized to do so, objects to the movement 
in writing and provides specific, detailed information that there is a 
risk the movement will result in the dissemination of a plant pest or 
noxious weed into the State, APHIS evaluates the information and 
agrees, and APHIS determines that such plant pest or noxious weed risk 
cannot be adequately addressed or mitigated.
    We would add the following conditions:
     The applicant does not agree to observe all of the 
proposed permit conditions that APHIS has determined are necessary to 
mitigate identified risks.
     The applicant does not provide information requested by 
APHIS as part of an assessment of sites or facilities, or does not 
allow APHIS to inspect sites or facilities associated with the actions 
listed on the permit application.
     APHIS determines that the applicant has not followed prior 
permit conditions, or has not adequately demonstrated that they can 
meet the requirements for the current application.
    This last condition is intended to clarify the current third 
condition, which states that a permit application may be denied if the 
applicant, as a previous permittee, failed to maintain the safeguards 
or otherwise observe the conditions prescribed in a previous permit and 
failed to demonstrate his ability or intent to observe them in the 
future. Certain applicants have sought to interpret this current 
condition to suggest that actions taken under a previous permit cannot, 
on their own, serve as a basis for denying a future permit.
    This interpretation is incorrect. In deciding to issue a permit, 
APHIS often relies on the previous actions of an applicant to render a 
judgment regarding the likelihood that the applicant can comply with 
the permitting conditions. As a result, this last condition would also 
provide a list of factors that could lead us to a determination that 
the applicant cannot comply with the permit conditions:
     The applicant, or a partnership, firm, corporation, or 
other legal entity in which the applicant has a substantial interest, 
financial or otherwise, has not complied with any permit that was 
previously issued by APHIS.
     Issuing the permit would circumvent any order denying or 
revoking a previous permit issued by APHIS (for example, by issuing a 
permit to an immediate family member of a person with a lengthy record 
of non-compliance with previous permits issued.)
     The applicant has previously failed to comply with any 
APHIS regulation.
     The applicant has previously failed to comply with any 
other Federal, State, or local laws, regulations, or instructions 
pertaining to plant health.
     The applicant has previously failed to comply with the 
laws or regulations of a national plant protection organization or 
equivalent body, as these pertain to plant health.
     APHIS has determined that the applicant has made false or 
fraudulent statements or provided false or fraudulent records to APHIS.
     The applicant has been convicted or has pled nolo 
contendere to any crime involving fraud, bribery, extortion, or any 
other crime involving a lack of integrity.
    Proposed paragraph (d)(5) would discuss withdrawal of a permit 
application. Any permit application could be withdrawn; however, 
applicants who wish to withdraw a permit application would have to 
provide this request in writing to APHIS. APHIS would provide written 
notification to the applicant as promptly as circumstances allow 
regarding reception of the request and withdrawal of the application.
    Proposed paragraph (d)(6) of Sec.  330.201 would discuss 
cancellation of a permit. Any permit that has been issued could be 
canceled at the request of the permittee. If a permittee wishes a 
permit to be canceled, he or she would have to provide the request in 
writing to APHIS-PPQ. Whenever a permit is canceled, APHIS would notify 
the permittee in writing regarding such cancellation.
    Paragraph (d)(7) would discuss revocation of a permit. APHIS could 
revoke a permit for any of the following reasons:
     After issuing the permit, APHIS obtains information that 
would have

[[Page 6988]]

otherwise provided grounds for us to deny the permit application.
     APHIS determines that the actions undertaken under the 
permit have resulted in or are likely to result in the introduction 
into or dissemination within the United States of a plant pest or 
noxious weed in a manner that presents an unacceptable risk to plants 
or plant products.
     APHIS determines that the permittee, or any employee, 
agent, or officer of the permittee, has failed to comply with a 
provision of the permit or the regulations under which the permit was 
issued.\6\
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    \6\ Pursuant to section 424 of the PPA, such failure, whether on 
the part of the permittee or on that of his or her employees, 
agents, or officers, may result in the assessment of civil or 
criminal penalties.
---------------------------------------------------------------------------

    Paragraph (d)(8) would discuss amendment of permits. Amendments 
could occur at the request of the permittee, or may be initiated by 
APHIS. If a permittee determines that circumstances have changed since 
the permit was initially issued and wishes the permit to be amended 
accordingly, he or she would have to contact APHIS to request the 
amendment and may have to provide supporting information justifying the 
amendment.
    APHIS would review the request, and may amend the permit if only 
minor changes are necessary. Requests for more substantive changes 
could require a new permit application.
    Prior to issuance of an amended permit, depending on the nature of 
the amendments, the permittee may have to agree in writing that he or 
she, and his or her employees, agents, and/or officers, would comply 
with the amended permit and conditions.
    With regard to amendments initiated by APHIS, we could amend any 
permit and its conditions at any time, upon determining that the 
amendment is needed to address newly identified considerations 
concerning the risks presented by the organism or the activities being 
conducted under the permit. We would also be able to amend a permit at 
any time to ensure that the permit conditions are consistent with all 
of the requirements of the regulations; for example, if a subsequent 
rulemaking prohibits certain categories or types of organisms from 
being moved in certain means of conveyance, and the permit lacks these 
specific prohibitions.
    As soon as circumstances allow, APHIS would notify the permittee of 
the amendment to the permit and the reason(s) for it. Depending on the 
nature of the amendment, the permittee may have to agree in writing or 
electronically that he or she, and his or her employees, agents, and/or 
officers, will comply with the permit and conditions as amended before 
APHIS would issue the amended permit. If APHIS requests such an 
agreement, and the permittee does not agree in writing that he or she, 
and his or her employees, agents, and/or officers, will comply with the 
amended permit and conditions, the existing permit would be revoked.
    Paragraph (d)(9) would discuss suspension of actions authorized 
under a permit. It would state that we may suspend authorization of 
actions authorized under a permit if we identify new factors that cause 
us to reevaluate the risk associated with those actions. In such 
instances, we would notify the permittee in writing of this suspension 
and the reasons for it. This notification would also state the actions 
for which we are suspending authorization. Depending on the results of 
our evaluation, we would subsequently contact the permittee to remove 
the suspension, amend the permit, or revoke the permit.
    Paragraph (d)(10) would establish procedures in the event that a 
person whose application has been denied, whose permit has been revoked 
or amended, or whose authorization for actions authorized under a 
permit has been suspended, wishes to appeal the decision.

Biological Control Organisms (Sec.  330.202)

    The PPA defines a biological control organism as ``any enemy, 
antagonist, or competitor used to control a plant pest or noxious 
weed.''
    The PPA finds that ``biological control is often a desirable, low-
risk means of ridding crops and other plants of plant pests, and its 
use should be facilitated'' by APHIS and other agencies. In accordance 
with the PPA, APHIS authorizes the movement and environmental release 
of both biological control organisms through the issuance of permits.
    Since the PPA was enacted, we have published several documents in 
the Federal Register that have discussed codifying our permitting 
processes for biological control organisms. On each occasion, 
individuals who support the use of biological control have requested 
that we consider such organisms to be distinct from plant pests, and to 
regulate them in a manner that facilitates, rather than restricts, 
their movement and environmental release. Certain of these commenters 
have stated that APHIS should regulate biological control organisms 
only when their efficacy in controlling their target plant pest or 
noxious weed is not adequately established.
    We regulate biological control organisms pursuant to the PPA 
insofar as they may pose a plant pest risk. We consider it necessary to 
exercise a degree of regulatory oversight regarding the movement or 
environmental release of such biological control organisms, even when 
their efficacy is well established.
    It is worth noting, in that regard, that biological control 
organisms are usually moved for eventual environmental release. This is 
alluded to in the PPA's definition of biological control organism, 
which specifies that an organism must be used, that is, actively 
employed to control a plant pest or noxious weed in order for it to be 
considered a biological control organism. Because biological control 
organisms are almost always intended for eventual release into the 
environment, it is not sufficient for us only to consider their use in 
controlling their target plant pest or noxious weed. We must also take 
into consideration the plant pest effects that the organism may pose to 
non-target plants or plant products.
    If the organism is known to have non-target plant pest effects, it 
is consistent with APHIS' mission to prohibit or restrict its release. 
To the extent that we do not know these likely non-target plant pest 
effects, it is also prudent for us to place regulatory controls on its 
movement and release until these impacts and effects are better 
understood.
    Paragraph (a) of proposed Sec.  330.202 would provide, as a general 
condition for the importation, interstate movement, and environmental 
release of biological control organisms that are regulated under the 
proposed regulations, that no such biological control organism may be 
imported, moved interstate, or released into the environment unless a 
permit has been issued in accordance with proposed Sec.  330.201 
authorizing such importation, interstate movement, or environmental 
release, and the organism is moved or released in accordance with this 
permit and the proposed regulations.
    Because applications for the movement of biological control 
organisms often request that we authorize the release of the organism 
into the environment, several regulations issued pursuant to the 
National Environmental Policy Act of 1969, as amended (NEPA, 42 U.S.C. 
4321 et seq.) require certain procedural actions before APHIS may issue 
a permit: 40 CFR parts 1500-1508, which contains the regulations of the 
Council

[[Page 6989]]

on Environmental Quality for implementing the procedural provisions of 
NEPA; 7 CFR part 1b, which contains USDA's NEPA implementing 
regulations; and 7 CFR part 372, which contains APHIS' implementing 
regulations. In accordance with these regulations under NEPA, before 
issuing a permit, APHIS must assess whether the actions proposed on the 
applications, either individually or cumulatively, are likely to have 
significant impacts on the human environment.
    In order to make such an assessment, we often have to request 
additional information from applicants regarding the proposed release 
of the organism as part of our evaluation of the permit application. 
The end of paragraph (a) of Sec.  330.202 would alert interested 
parties to this fact, and direct them to our portal on the Internet for 
further information regarding the types of information that may be 
requested and the manner in which this information will be evaluated.
    The requirements in proposed paragraph (a) of Sec.  330.202 would 
apply to the importation, interstate movement, and environmental 
release of most biological control organisms. However, we are aware 
that certain taxa of biological control organisms have become 
established throughout their geographical or ecological range in the 
continental United States, such that the additional release of pure 
cultures derived from field populations of a taxon of these organisms 
into the environment of the continental United States will present no 
additional plant pest risk (direct or indirect) to plants or plant 
products. For such organisms, we do not consider there to be a 
sufficient basis in risk to require permits for their interstate 
movement or environmental release within the continental United States.
    To reflect this, paragraph (b) of Sec.  330.202 would state that 
APHIS has determined that certain biological control organisms have 
become established throughout their geographical or ecological range in 
the continental United States, such that the additional release of pure 
cultures derived from field populations of taxa of such organisms into 
the environment of the continental United States will present no 
additional plant pest risk (direct or indirect) to plants or plant 
products within the United States. The paragraph would direct persons 
to APHIS' online portal for permit applications for a list of all such 
organisms.
    Paragraph (b)(1) of Sec.  330.202 would provide that pure cultures 
of organisms on that list may be imported into or moved interstate 
within the continental United States without further restriction under 
the regulations, and paragraph (b)(2) of Sec.  330.202 would provide 
that pure cultures of organisms on the list may be released into the 
environment of the continental United States without further 
restriction under the regulations.
    We have made a draft list of such organisms available on 
Regulations.gov as a supporting document for this proposed rule (see 
ADDRESSES at the beginning of this proposed rule) and request public 
comment on the list. While we will consider comments received on the 
draft list to be distinct from those received on the proposed rule, the 
comments received on the draft list will inform our evaluation of the 
suitability of the exemptions from permitting requirements contained in 
proposed paragraph (b) of Sec.  330.202.
    Proposed paragraph (c) of Sec.  330.202 would establish a petition-
based process by which biological control organisms would be added to 
the list of organisms granted exceptions from permitting requirements 
for their importation or interstate movement. Any person would be able 
to request that APHIS add a biological control organism to the list 
referred to in paragraph (b) of Sec.  330.202 by submitting a petition 
to APHIS. We would specify that individuals should submit the petition 
via email to [email protected], or through any other means 
listed on APHIS' Web site at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    The petition would have to include the following information:
     Evidence indicating that the organism is indigenous to the 
continental United States throughout its geographical or ecological 
range, or evidence indicating that the organism has produced self-
replicating populations within the continental United States for an 
amount of time sufficient, based on the organism's taxon, to consider 
that taxon established throughout its geographical or ecological range 
in the continental United States.
     Results from a field study where data was collected from 
representative habitats occupied by the biological control organism. 
Studies would have to include sampling for any direct or indirect 
impacts on target and non-target hosts of the biological control 
organism in these habitats. Supporting scientific literature would have 
to be cited.
     Any other data, including published scientific reports, 
that suggest that that subsequent releases of the organism into the 
environment of the continental United States would present no 
additional plant pest risk (direct or indirect) to plants or plant 
products.
    APHIS would review the petition to determine whether it is 
complete. If the petition is complete, we would conduct an evaluation 
of the petition to determine whether there is sufficient evidence that 
the organism exists throughout its geographical or ecological range in 
the continental United States and that subsequent releases of pure 
cultures of field populations the organism into the environment of the 
continental United States will present no additional plant pest risk 
(direct or indirect) to plants or plant products.
    If we determine that there is sufficient evidence that that the 
organism exists throughout its geographical or ecological range in the 
continental United States and that subsequent releases of pure cultures 
of the organism into the environment of the continental United States 
will present no additional plant pest risk (direct or indirect) to 
plants or plant products, we would publish a notice in the Federal 
Register announcing the availability of the petition and requesting 
public comment on that document.
    If no comments are received on the notice, or if the comments 
received do not lead us to reconsider our determination, we would 
publish a subsequent notice in the Federal Register describing the 
comments received and stating that the organism has been added to the 
list referred to in proposed paragraph (b) of Sec.  330.202.
    If the comments received lead us to reconsider our determination, 
we would publish a subsequent notice in the Federal Register describing 
the comments received and stating our reasons for determining not to 
add the organism to the list referred to in proposed paragraph (b).
    Proposed paragraph (e) of Sec.  330.202 would provide that any 
biological control organism may be removed from the list referred to in 
paragraph (b) of the section if information emerges that would have 
otherwise led us to deny the petition to add the organism to the list. 
Whenever an organism is removed from the list, APHIS would publish a 
notice in the Federal Register announcing that action and the basis for 
it.

Soil (Sec.  330.203)

    The regulations governing the importation, interstate movement, and 
transit of soil and certain stone and quarry products under permit are 
currently found in ``Subpart--Movement of Soil, Stone, and Quarry

[[Page 6990]]

Products,'' Sec. Sec.  330.300 through 330.302. We are proposing to 
remove and reserve that subpart and integrate the regulations for soil 
into the revised ``Subpart--Plant Pests, Biological Control Organisms, 
Soil, and Associated Articles'' as Sec.  330.203. We are proposing to 
do so primarily in order to clarify that we regulate soil insofar as it 
is or may be an associated article. That is, we regulate soil insofar 
as it may harbor plant pests or noxious weeds: When a permit 
application for soil is submitted to APHIS, a soil specialist evaluates 
this likelihood of contamination with plant pests or noxious weeds and 
determines whether a permit should be issued.
    As part of our revision to the soil regulations, we would also 
update the regulations in light of the current scientific understanding 
of soil and the spread of soil-borne pathogens within Canada.
    Proposed paragraph (a) of Sec.  330.203 would state that the 
Administrator has determined that, unless it has been sterilized, soil 
is an associated article, and is thus subject to the permitting 
requirements of Sec.  330.201. It would also provide two conditions 
under which the movement of soil would not be subject to the permitting 
requirements of Sec.  330.201: If the movement is regulated pursuant to 
other APHIS regulations in 7 CFR chapter III (e.g., Sec.  301.86-5 
requires certificates for the interstate movement of soil from an area 
quarantined for pale cyst nematode), or if Sec.  330.203 states that 
the movement does not require such a permit. This second condition 
would apply to the importation of most soil from Canada, and most 
interstate movement of soil.
    Proposed paragraphs (b)(1) through (b)(3) of Sec.  330.203 would 
provide conditions governing the importation of soil. First, in a 
similar manner to our conditions for the importation of most biological 
control organisms, we would require an import permit to be issued in 
accordance with Sec.  330.201 for the importation of soil, and the soil 
to be imported under the conditions specified on the permit. We are 
requiring a permit so that we can evaluate the risks associated with 
any particular importation of soil and assign the appropriate 
mitigation measures.
    Currently, soil may be imported from Canada without a permit, 
unless the soil is from Newfoundland or the Land District of Central 
Saanich on Vancouver Island in the Province of British Columbia; these 
two areas are known to be infested with pale cyst nematodes (PCN). We 
are proposing to amend the regulations so that soil from any area of 
Canada regulated by the Canadian Food Inspection Agency (CFIA), the 
national plant protection organization of Canada, for a soil-borne 
plant pest would require a permit. We are doing this because there have 
been recent detections of soil-borne plant pests of quarantine 
significance in Canada (such as PCN in Quebec and potato wart disease 
on Prince Edward's Island) that are not reflected in the current 
regulations.
    We would also clarify that the proposed regulations do not pertain 
to soil used as a growing medium for plants for planting from Canada. 
Plants for planting that are intended to be imported into the United 
States and their growing media are regulated under 7 CFR part 319, 
``Subpart--Plants for Planting.''
    Plants for planting that can be inspected, treated, or handled to 
prevent them from spreading plant pests are designated in that subpart 
as restricted articles. Section 319.37-4 requires all restricted 
articles imported into the United States to be accompanied by a 
phytosanitary certificate of inspection, unless the section explicitly 
exempts the articles from this requirement. Paragraph (a)(1) of Sec.  
319.37-4 exempts greenhouse-grown plants from Canada imported in 
accordance with the provisions of a certification program administered 
by CFIA from this requirement; paragraph (c) of that section contains 
the provisions of CFIA's program.
    Section 319.37-8 addresses the growing media in which a restricted 
article may be imported. Currently, paragraph (a) of the section 
prohibits the use of soil as a growing medium for plants for planting 
from all countries other than Canada. Paragraph (b) allows a restricted 
article from Canada to be imported in any medium, with the restriction 
that articles from Newfoundland or a certain portion of the 
Municipality of Central Saanich in the Province of British Columbia 
must be accompanied by a phytosanitary certificate containing an 
additional declaration that the plants were grown in a manner to 
prevent infestation with potato cyst nematode. We are proposing to 
revise paragraph (b) of Sec.  319.37-8 so that articles from any area 
of Canada that is regulated by CFIA for a soil-borne plant pest would 
have to be accompanied by a phytosanitary certificate with an 
additional declaration that the plants were grown in a manner to 
prevent infestation with that soil-borne plant pest.
    Proposed paragraphs (b)(2) through (b)(4) of Sec.  330.203 would 
set forth additional conditions for certain types of importations of 
soil. Paragraph (b)(2) would provide additional conditions for the 
importation of soil via hand-carry. In addition to the requirements of 
proposed paragraph (b)(1), we would allow soil to be hand-carried into 
the United States only if the importation meets the conditions of Sec.  
330.205. That section, which is discussed later in this document, would 
contain our regulations governing the hand-carry of plant pests, 
biological control organisms, and soil.
    Proposed paragraph (b)(3) would provide additional conditions for 
the importation of soil intended for the extraction of plant pests. 
Since this soil is imported precisely because it is known to contain 
plant pests, with very few exceptions, it is not rerouted for 
sterilization upon arrival in the United States. Therefore, to mitigate 
the risk that such soil could present a pathway for the introduction or 
dissemination of plant pests within the United States, we would require 
all such soil to be imported directly to an approved biocontainment 
facility.
    On occasion, soil that presents a risk of harboring plant pests is 
imported into the United States for disposal; for example, this 
sometimes occurs when a natural disaster strikes an area quarantined 
for a soil-borne pathogen and emergency management personnel need to 
dispose of the resulting debris. Proposed paragraph (b)(4) would 
contain additional conditions for the importation of such soil. In 
addition to general conditions for the importation of soil, soil 
infested with plant pests and intended for disposal would have to be 
imported directly to an APHIS-approved disposal facility. Although all 
such facilities are subject to evaluation and approval by EPA, we would 
require independent APHIS approval of the facility because certain of 
these EPA-approved facilities are municipal landfills that may not 
provide adequate safeguards against plant pest dissemination.
    Currently, Sec.  330.301 restricts the importation into the United 
States of stone and quarry products from areas in Canada that are 
infested with gypsy moth. This section has at times led to confusion 
regarding the relationship between soil and stone and quarry products, 
as well as questions regarding the regulated status of articles, such 
as clay, that are similar to but fundamentally distinct from soil.
    Proposed paragraph (b)(5) of Sec.  330.203 would list certain 
articles that are not soil, and that, because of their composition or 
origin, present a negligible risk of serving as a medium for plant 
pests or noxious weeds, provided that they are free of organic 
material. The articles could be imported

[[Page 6991]]

into the United States without an import permit, unless the 
Administrator has issued an order stating that a particular article is 
an associated article. (Such orders would be maintained on PPQ's Web 
site, at http://www.aphis.usda.gov/plant_health/permits/organism/soil/index.shtml.) However, all such articles would be subject to inspection 
at the port of first arrival, subsequent reinspection at other 
locations, and other remedial measures deemed necessary by an inspector 
to remove any risk the items pose of disseminating plant pests or 
noxious weeds, and any other restrictions or prohibitions in 7 CFR 
chapter III. The articles would be:
     Consolidated material derived from any strata or substrata 
of the earth. Examples include clay (laterites, bentonite, china clay, 
attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel.
     Sediment, mud, or rock from saltwater bodies of water.
     Cosmetic mud and other commercial mud products.
     Stones, rocks, and quarry products.
    These provisions do not mean that we would no longer restrict the 
movement of stone and quarry products from areas in Canada that are 
infested with gypsy moth. Instead, we would amend ``Subpart--Gypsy Moth 
Host Material from Canada,'' Sec.  319.77-1 through Sec.  319.77-5, to 
incorporate those restrictions. Section 319.77-2 of that subpart 
contains a list of articles designated regulated articles; we would 
amend that section by adding a new paragraph (i) that would designate 
stone and quarry products as regulated articles. Section 319.77-4 
contains conditions for the importation of regulated articles; we would 
amend the section by adding a new paragraph (d) that would provide that 
stone and quarry products originating in a Canadian area known to be 
infested with gypsy moth may be imported into the United States only if 
they are destined for an infested area of the United States and will 
not be moved through any noninfested areas of the United States, and 
may be moved through the United States if they are moved only through 
infested areas. We consider this subpart a more appropriate location 
for the restrictions.
    Proposed paragraph (c) of Sec.  330.203 would provide general 
conditions governing the interstate movement of soil. Most soil could 
be moved interstate without prior issuance of an interstate movement 
permit in accordance with Sec.  330.201, or further restriction under 
the regulations. However, all soil moved interstate within the United 
States would still be subject to any movement restrictions and remedial 
measures specified for such movement in 7 CFR part 301.
    As we mentioned earlier in this document, part 301 contains our 
regulations that designate certain areas of the United States as 
quarantined areas for a particular plant pest, and that prohibit or 
restrict the movement in interstate commerce of certain host articles 
of that pest. The provisions currently in our regulations in Sec.  
330.302 mention certain sections of part 301 in which soil is 
considered a regulated article, such as our Japanese beetle and gypsy 
moth regulations, but omit others, such as our golden nematode and PCN 
regulations, and do not take into consideration the possibility that 
outbreaks of new plant pests within the United States may lead us to 
regulate the interstate movement of soil from areas quarantined for 
those or other pests.
    Proposed paragraph (c)(2) would provide conditions for the 
interstate movement within the continental United States of soil 
intended for the extraction of plant pests. Again, since such soil is 
moved precisely because it is known to contain plant pests, it is, by 
definition, an associated article, and therefore would require an 
interstate movement permit issued in accordance with Sec.  330.201 in 
order to be moved. Moreover, because of the intended use of the soil, 
in order to mitigate the risk of the dissemination of plant pests, the 
soil would have to be moved directly to an approved biocontainment 
facility, and in a secure manner that prevents its dissemination into 
the outside environment.
    Proposed paragraph (c)(3) would contain additional conditions for 
the interstate movement within the continental United States of soil 
infested with plant pests and intended for disposal. We would require 
issuance of an interstate movement permit prior to movement, and would 
require that all such soil to be moved directly to an APHIS-approved 
disposal facility, and in a secure manner that prevents its 
dissemination into the outside environment.
    Proposed paragraph (c)(4) would contain additional conditions for 
the interstate movement of soil samples from an area quarantined in 
accordance with 7 CFR part 301 for chemical or compositional testing or 
analysis. Such soil could be moved without prior issuance of an 
interstate movement permit in accordance with Sec.  330.201 or further 
restriction under 7 CFR chapter III, provided that the soil is moved to 
a laboratory that has entered into and is operating under a compliance 
agreement with APHIS, is abiding by all terms and conditions of the 
compliance agreement, and is approved by APHIS to test and/or analyze 
such samples.
    Proposed paragraph (c)(5) would contain additional conditions for 
the interstate movement of soil to, from, or between Hawaii, the 
territories, and the continental United States. In addition to all 
general conditions for interstate movement of soil, soil could be moved 
interstate to, from, or between Hawaii, the territories, and the 
continental United States only if an interstate movement permit has 
been issued for its movement in accordance with Sec.  330.201. This 
condition would apply to all soil moved to, from, or between Hawaii, 
the territories, and the continental United States. In addition to this 
provision, soil moved to, from, or between Hawaii, the territories, and 
the continental United States with the intent of extracting plant pests 
would still be subject to the conditions of proposed paragraph (c)(2) 
of the section, and would therefore have to be moved directly to an 
approved biocontainment facility. Similarly, soil infested with plant 
pests and intended for disposal would be subject to the conditions of 
proposed paragraph (c)(3) of the section, and would therefore have to 
be moved directly to an APHIS-approved disposal facility.
    Proposed paragraph (d) would contain conditions regarding the 
transit of soil. Such movement would require a transit permit issued in 
accordance with 7 CFR part 352.
    The regulations in Sec.  330.300 currently exempt movements of soil 
governed by Sec.  318.60 or Sec.  319.69 from permitting requirements. 
Section 318.60 currently prohibits the movement of sand (other than 
clean ocean sand), soil, or earth around the roots of plants from 
Hawaii, Puerto Rico, or the Virgin Islands into or through any other 
State, Territory, or District of the United States, unless the movement 
is in either direction between Puerto Rico and the Virgin Islands, or 
the soil is intended for experimental or scientific use by USDA. We 
would amend Sec.  318.60 to clarify that it pertains only to the 
movement of soil around the roots of plants, and that all other 
movement of soil from Hawaii, Puerto Rico, or the Virgin Islands, other 
than that soil around the roots of plants, is regulated under 7 CFR 
part 330. We consider this amendment necessary primarily so that we 
would not regulate the movement of such soil in two different subparts, 
and secondarily so that the section may not be used to circumvent the 
regulations in part 330.
    ``Subpart--Packing Materials,'' Sec.  319.69 through Sec.  319.69-
5, contains

[[Page 6992]]

our regulations regarding plants and plant products used as packing 
materials for imported commodities. Section 319.69 prohibits the use of 
soil containing an appreciable mixture of vegetable matter from being 
used as packing material, except for soil authorized as safe for 
packing by other rules and regulations in the subpart. Section 319.69-1 
specifies that soil containing an appreciable admixture of vegetable 
matter is covered by this prohibition because its decaying vegetation 
or plant remains carries a definite pest risk. Finally, Sec.  319.69-5 
states that the following soil may be used as packing material: Peat, 
peat moss, or osmunda fiber.
    After reviewing this section in light of the current scientific 
understanding of soil, as reflected in our proposed revision to the 
definition of soil in Sec.  330.100, we have determined that this 
section does not refer to soil, as it is currently understood, but to 
the organic decaying vegetative matter for which soil may serve as a 
medium, and of which peat, peat moss, and osmunda fiber are all 
examples. We have also determined that an instance may arise when the 
mitigation measures that we require in part 319 for the importation of 
a plant, plant part, or plant product may also address the risk 
associated with using organic decaying vegetative matter as a packing 
material for that commodity.
    Therefore, we would amend the existing prohibition in Sec.  319.69 
on the use of soil as a packing material so that it instead prohibits 
the use of organic decaying vegetative matter as a packing material. We 
would remove Sec.  319.69-1(b), which considers matter containing 
decaying vegetation or plant remains to be soil. We would establish an 
exemption for any organic decaying vegetative matter expressly 
authorized to be used as a packing material elsewhere in part 319. 
Finally, we would revise the heading of Sec.  319.69-5 to make it clear 
that it does not pertain to the use of soil as a packing material, but 
organic decaying vegetative matter.

Exceptions to Permitting Requirements for the Importation or Interstate 
Movement of Certain Plant Pests (Sec.  330.204)

    Section 7711 of the PPA provides that the Secretary of Agriculture 
may issue regulations to allow the importation and the movement in 
interstate commerce of plant pests without further restriction, if the 
Secretary finds that a permit for such movement is not necessary. The 
section further states that if the Secretary does issue such 
regulations, any person may petition him or her to add a plant pest or 
remove a plant pest from this list of pests. Finally, the section 
provides that if a petition is submitted, the Secretary will act on the 
petition and notify the petitioner of the action he or she will take on 
the petition.
    Section 330.204 would establish such regulations and petition 
process. The introductory paragraph would state that, pursuant to 
section 7711 of the PPA, the Administrator has determined that certain 
plant pests may be imported into or may move in interstate commerce 
within the continental United States without restriction. The list of 
all such plant pests would be on the PPQ Web site.
    Paragraph (a) of the section would describe the three categories of 
plant pests that comprise the list. In order to be included on the 
list, a plant pest would have to:
     Be from field populations or lab cultures derived from 
field populations of a taxon that is established throughout its entire 
geographical or ecological range within the continental United States; 
or
     Be sufficiently attenuated so that it no longer poses a 
risk to plants or plant products; or
     Be commercially available and raised under the regulatory 
purview of other Federal agencies.
    In our 2001 proposed rule, paragraph (c) of Sec.  330.202 would 
have established a ``no permit necessary'' list for certain indigenous 
plant pest species that were already distributed throughout the 
continental United States and are known to commonly accompany plants or 
plant products moved in commerce. The first category aligns with the 
criterion for that 2001 list. We would not require permits for plant 
pests from a field population or lab culture derived from a field 
population of a taxon that is established throughout its entire 
geographical or ecological range within the United States because such 
pests are ubiquitous within the continental United States.
    The second category reflects the fact that in vitro attenuation of 
plant pests such as phytopathogenic fungi, while rare, does occur. When 
a pest becomes attenuated, there is no longer a sufficient basis for us 
to presume that the pest presents a risk of directly or indirectly 
injuring, causing damage to, or causing disease in plants or plant 
products; in other words, an attenuated pest de facto no longer falls 
within the scope of the definition of plant pest under the PPA.
    (In order to avoid confusion and the possible unregulated movement 
of the virulent strains of the plant pest, the list would specify the 
strains of the plant pest that APHIS considers attenuated of their 
pathogenicity.)
    The third category of plant pests is intended to avoid duplicative 
or conflicting regulatory oversight of certain plant pests. For 
example, although it is a plant pest, Penicillium chrysogenum is 
regulated by the Food and Drug Administration (FDA).
    We have made a draft list of plant pests that may be imported or 
move in interstate commerce within the continental United States 
without restriction available on Regulations.gov as a supporting 
document for this proposed rule, and request public comment regarding 
that list. The list largely mirrors the list contained in the 2001 
proposed rule, but also contains certain plant pests that belong to the 
second and third categories.
    Paragraph (b) of Sec.  330.204 would contain a petition process to 
add a plant pest to the list. Any person would be able to petition to 
have an additional plant pest added to the list. To submit a petition, 
the person would have to provide, in writing, information supporting 
the placement of a particular pest in one of the categories listed in 
paragraph (a) of Sec.  330.204.
    Information that the plant pest belongs to a taxon that is 
established throughout its entire geographical or ecological range 
within the United States would have to include scientific literature, 
unpublished studies, or data regarding:
     The biology of the plant pest, including characteristics 
that allow it to be identified, known hosts, and virulence;
     The geographical or ecological range of the plant pest 
within the continental United States; and
     The areas of the continental United States within which 
the plant pest is established.
    The first category of information is intended to provide us with 
basic information regarding the plant pest for which unrestricted 
movement is sought. The second and third categories would aid our 
determination regarding whether the plant pest is established 
throughout its ecological or geographical range within the continental 
United States.
    Information that the plant pest has been attenuated of its 
pathogenicity would have to include experimental data, published 
references, or scientific information regarding such attenuation.
    Information that the plant pest is commercially available and 
raised under the regulatory purview of another Federal agency would 
have to include a citation to the relevant law, regulation,

[[Page 6993]]

or order under which the agency exercises such oversight. For example, 
Penicillium chrysogenum is regulated by FDA under the Kefauver-Harris 
drug amendments of 1962.
    APHIS would review the information contained in the petition to 
determine whether it is complete. In order to consider the petition 
complete, APHIS may require additional information to determine whether 
the plant pest belongs to one of the categories listed in paragraph (a) 
of Sec.  330.204. When it is determined that the information is 
complete, we would commence review of the petition.
    If, after review of the petition, we determine that there is 
insufficient evidence that the plant pest belongs to one of the three 
categories listed in paragraph (a) of Sec.  330.204--for example, the 
plant pest is known to exist throughout its entire geographical range 
in the continental United States, but population densities in certain 
areas are not sufficient to consider it established throughout its 
range--we would deny the petition, and notify the petitioner in writing 
regarding this denial.
    Conversely, if, after review of the petition, we determine that the 
plant pest belongs to one of the categories in paragraph (a), we would 
publish a notice in the Federal Register that announces the 
availability of the petition and any supporting documentation to the 
public, that states that we intend to add the plant pest to the list of 
plant pests that may be imported into or move in interstate commerce 
within the continental United States without restriction, and that 
requests public comment.
    If no comments are received on the notice, or if, based on the 
comments received, we determine that our conclusions regarding the 
petition have not been affected, we will publish in the Federal 
Register a subsequent notice stating that the plant pest has been added 
to the list.
    Under paragraph (c) of Sec.  330.204, any person could submit, in 
writing, a petition to have a plant pest removed from the list. The 
petition would have to contain independently verifiable information 
demonstrating that our initial determination that the plant pest 
belongs to one of the categories in paragraph (a) of the section should 
be changed, or that additional information is now available that would 
have caused us to change the initial decision.
    APHIS would review the information contained in the petition to 
determine whether it is complete. In order to consider the petition 
complete, we may require additional information supporting the 
petitioner's claim. When it is determined that the information is 
complete, we would commence review of the petition.
    If, after review of the petition, we determine that there is 
insufficient evidence to suggest that our initial determination should 
be changed, we would deny the petition, and notify the petitioner in 
writing regarding this denial.
    If, after review of the petition, we determine that there is a 
sufficient basis to suggest that our initial determination should be 
changed, we would publish a notice in the Federal Register that 
announces the availability of the petition, and that requests public 
comment regarding removing the plant pest from the list of plant pests 
that may be imported into or move in interstate commerce within the 
continental United States without restriction.
    If no comments are received on the notice, or if the comments 
received do not affect our conclusions regarding the petition, we would 
publish in the Federal Register a subsequent notice stating that the 
plant pest has been removed from the list.
    Paragraph (d) of Sec.  330.204 would provide for APHIS-initiated 
changes to the list. It would provide that APHIS may propose to add a 
plant pest to or remove a pest from the list without a petition, if we 
determine that there is sufficient evidence that the plant pest belongs 
to one of the categories listed in paragraph (a) of the section, or if 
evidence emerges that leads us to reconsider our initial determination 
that the plant pest was or was not in one of the categories listed in 
paragraph (a) of the section. We would publish a notice in the Federal 
Register announcing this proposed addition or removal, making available 
any supporting documentation that we prepare, and requesting public 
comment.
    If no comments are received on the notice, or if the comments 
received do not affect our conclusions, we will publish a subsequent 
notice in the Federal Register stating that the plant pest has been 
added to or removed from the list.

Hand-Carry of Plant Pests, Biological Control Organisms, and Soil 
(Sec.  330.205)

    Currently, we authorize the importation of plant pests in personal 
baggage (referred to as ``hand-carry'') under Sec.  330.212 of the 
regulations. The regulations provide that the person importing the 
plant pest must show the permit authorizing the importation to an 
inspector at the port of arrival where the baggage will be inspected, 
that the conditions specified on the permit must be observed, that an 
inspector will oversee the movement of the plant pest, that the owner 
of the plant pest will be responsible for all costs incidental to 
forwarding the plant pest prior to clearance, and that an inspector may 
specify and supervise the application of safeguards to prevent the 
dissemination of the pest until it is forwarded.
    The 2003 OIG audit referenced at the beginning of this document 
pointed out that the hand-carry process in place at the time did not 
provide guidance regarding what materials may be hand-carried or who 
may hand-carry, and that APHIS did not track hand-carried materials to 
ensure that they arrive at the point of destination listed on the 
permit. For these reasons, the audit strongly suggested that we issue 
regulations to prohibit hand-carry of regulated organisms into the 
United States, and to explicitly state that all organisms must be 
imported into the United States via a bonded commercial carrier.
    However, certain plant pests and biological control organisms are 
highly perishable, and may remain viable only if they are imported into 
the United States directly and without rerouting. We have also found 
that it is often useful, from a safeguarding perspective, to authorize 
hand-carry in order to have an expert regarding the organism or article 
exercise direct and continuous oversight of its importation.
    Therefore, we would include provisions for hand-carry in this 
proposed rule. These provisions, which would be contained in Sec.  
330.205, would reflect current Agency processes regarding hand-carry.
    The introductory text of Sec.  330.205 would state that plant 
pests, biological control organisms, and soil may be hand-carried into 
the United States only in accordance with the provisions of the 
section.
    Proposed paragraph (a) of Sec.  330.205 would discuss the first 
such provision, authorization to hand-carry. In order to obtain such 
authorization, a person would have to apply for an import permit for 
the plant pest, biological control organism, or soil, in accordance 
with Sec.  330.201, and specify hand-carry of the organism or article 
as the method of proposed movement.
    The application would also have to specify the individual or 
individuals who would hand-carry the plant pest, biological control 
organism, or soil into the United States. If we authorize this 
individual or these individuals to hand-carry, this authorization could 
not be transferred to, nor actions under it performed by, individuals 
other than those identified on the permit application.

[[Page 6994]]

    Under proposed paragraph (b) of Sec.  330.205, the permittee would 
have to notify APHIS through our online portal for permit applications 
or by fax after the permittee has obtained an import permit but no less 
than 20 days prior to movement and provide the following information in 
order to receive a hand-carry authorization:
     A copy of the face page of the passport for the individual 
or individuals who will hand-carry the plant pest, biological control 
organism, or soil.
     A description of the means of conveyance in which the 
individual or individuals will travel, including flight number and 
airline name for air travel, or vehicle license number or other 
identifying number for other modes of transportation.
     Expected date and time of first arrival.
     Expected port of first arrival.
     Travel itinerary from port of first arrival to final 
destination.
    We would require authorized identification, the description of the 
means of conveyance, and the expected date, time, and port of first 
arrival because, pursuant to the regulations in Sec.  330.105, hand-
carried organisms or soil, like all other imported articles, must be 
presented for inspection at the port of first arrival, and this 
information would help us ensure that the inspection takes place as 
expeditiously as possible. We would require the travel itinerary from 
the port of first arrival to the final destination in order to ensure 
that the individual does not intend to make prolonged stops en route 
that could result in breach of safeguarding and increase the risk of 
accidental dissemination of the organism or soil. The information also 
would help us respond promptly to accidental dissemination of the 
organism or soil en route to the final destination.
    Under proposed paragraph (c) of Sec.  330.205, the permittee or his 
or her designee would have to notify APHIS within 24 hours of arrival 
of the hand-carried plant pest, biological control organism, or soil at 
the biocontainment facility or other authorized point of destination. 
This notification would have to state that the plant pest, biological 
control organism, or soil has arrived at its destination and that the 
package in which it was hand-carried has remained sealed until arrival. 
Notification could be by fax or email, or via APHIS' permitting Web 
site.
    Proposed paragraph (d) of Sec.  330.205 would discuss denial, 
amendment, or cancellation of authorization to hand-carry. It would 
state that APHIS may deny a request to hand-carry, or amend or cancel 
any hand-carry authorization at any time, if we deem such action 
necessary to prevent the introduction or dissemination of plant pests 
or noxious weeds within the United States.
    In a similar manner, proposed paragraph (e) of Sec.  330.205 would 
state that any person whose request to hand-carry has been denied, or 
whose hand-carry authorization has been amended or canceled, would be 
able to appeal the decision in writing to APHIS.

Packaging Requirements (Sec.  330.206)

    We are proposing to revise the packaging requirements for the 
movement of plant pests, currently found in Sec.  330.210. The revised 
requirements would be contained in proposed Sec.  330.206.
    The introductory text of the section would state that shipments in 
which plant pests, biological control organisms, and associated 
articles are imported into, moved interstate, or transited through the 
United States must meet the general packaging requirements of the 
section, as well as all specific packaging requirements on the permit 
itself.
    Proposed paragraph (a) would contain general packaging 
requirements. All shipments would have to consist of an outer shipping 
container and at least two packages within the container. Both the 
container and the inner packages would have to be securely sealed to 
prevent the dissemination of the enclosed plant pests, biological 
control organisms, or associated articles.
    Paragraph (a)(1) would contain general requirements for the outer 
shipping container. The outer shipping container would have to be 
rigid, impenetrable, and durable enough to remain sealed and 
structurally intact in the event of dropping, lateral impact with other 
objects, and other shocks incidental to handling.
    Paragraph (a)(2) would contain requirements for inner packages. The 
innermost package or packages within the shipping container would have 
to contain all of the organisms or articles that will be moved. As a 
safeguard, the innermost package would have to be placed within 
another, larger package, for example, bagged and sealed petri samples 
placed within a sealed cooler. All packages within the shipping 
container would have to be constructed or safeguarded so that they will 
remain sealed and structurally intact throughout transit. The packages 
would also have to be able to withstand changes in pressure, 
temperature, and other climatic conditions incidental to shipment.
    Paragraph (b) would contain general requirements for packing 
material. It would specify that packing material must be free of plant 
pests, noxious weeds, or associated articles, and must be new, or must 
have been sterilized or disinfected prior to reuse. Packing material 
would also have to be suited for the enclosed organism or article, as 
well as any medium in which the organism or article will be maintained, 
and should not be capable of harboring or being a means of the 
dissemination of the organism or article.
    We would provide guidance regarding suitable outer shipping 
containers, inner packages, and packaging on the PPQ Web site.
    Paragraph (c) would provide that packing materials, including media 
and substrates, would have to be destroyed by incineration, be 
decontaminated using autoclaving or another approved method, or 
otherwise be disposed of in a manner specified in the permit itself. It 
would also provide that shipping containers could not be reused, except 
those that have been sterilized or disinfected prior to reuse.
    Proposed paragraph (d) would state that permittees who fail to meet 
the requirements of the section may be held responsible for all costs 
incident to inspection, rerouting, repackaging, subsequent movement, 
and any treatments.

Cost and Charges (Sec.  330.207)

    Proposed Sec.  330.207 would state that the inspection services of 
APHIS inspectors during regularly assigned hours of duty and at the 
usual places of duty would be furnished without cost. It would also 
state that APHIS would not be responsible for any costs or charges 
incidental to inspections or compliance with the provisions of this 
subpart, other than for the inspection services of the inspector.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
    This proposed 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.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order

[[Page 6995]]

13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility. 
The economic analysis also provides an initial regulatory flexibility 
analysis that examines the potential economic effects of this rule on 
small entities, as required by the Regulatory Flexibility Act. The 
economic analysis is summarized below. Copies of the full analysis are 
available by contacting the person listed under FOR FURTHER INFORMATION 
CONTACT or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    APHIS is proposing to revise its regulations regarding the 
importation, interstate movement, and environmental release of plant 
pests to incorporate provisions regarding biological control organisms 
(BCOs) and the movement of soils from which plant pests and BCOs are 
extracted. The proposed rule would revise and add definitions, 
streamline the permitting and compliance processes, and provide APHIS 
with increased flexibility in the regulation of plant pests. Parts 318, 
319, and 352 of 7 CFR chapter III would also be updated to reflect the 
proposed changes in part 330.
    A principal consequence of the proposed rule would be a 
streamlining of our permitting process and possible reduction in the 
number of permits issued under part 330, which numbered 6,538 in 2015. 
Approximately 33 percent of these permits (2,158) authorized the 
movement or environmental release of a plant pest or BCO that APHIS is 
proposing to exempt from permitting. While we do not expect the 
proposed rule would result in one-third fewer permits as one permit may 
list multiple BCOs or plant pests, we can say with confidence that the 
permitting burden would be reduced for applicants and that the 
permitting process could be expedited. We expect that affected entities 
would benefit from a 10 to 30 percent reduction in the overall time 
spent applying for and receiving permits under part 330. Assuming the 
time required to submit an application is 1 hour and assuming an 
average hourly wage of $45.50 per hour, then for the 6,538 permits 
issued in 2015, the time savings expected under the proposed rule would 
have totaled between 654 and 1,961 hours, which equates to a cost 
savings of between about $29,748 and $89,244.
    The proposed rule would codify existing practices by allowing 
entities requesting permits to apply electronically rather than by 
using the mail only. Expanded use of online permit applications through 
APHIS' portal would result in time and cost savings as compared to 
applying by mail using paper applications.
    Listing of exempted organisms on an APHIS-PPQ Web site, transparent 
procedures for petitioning for exceptions or exemptions to permitting, 
and provision for a notice-based process for adding and removing listed 
organisms would also combine to make an efficient, transparent, and 
user-responsive system that would facilitate the movement and 
environmental release of plant pests and BCOs.
    Regulated entities would continue to incur time costs associated 
with providing information during the permitting application process, 
and with meeting somewhat more robust recordkeeping (maintaining 
records) requirements in certain instances such as with soil imports 
and risk based permits. The time required overall for permitting would 
be reduced, however, because of the newly excepted organisms.
    The proposed revisions to 7 CFR part 330 would benefit entities, 
large and small, by increasing the efficiency of the permitting and 
compliance processes for plant pests, BCOs, and soils from which plant 
pests and BCOs are extracted, and by improving the general clarity and 
transparency of these regulations. The proposed rule also would 
facilitate the Agency's coordination with other Federal and State 
agencies in regulating the movement and environmental release of plant 
pests and BCOs. The majority of entities that would benefit from this 
rule are small entities, based on information obtained from the 
Economic Census.
National Environmental Policy Act
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
processes established by this proposed rule, we have prepared a draft 
environmental impact statement (EIS). The EIS was prepared in 
accordance with: (1) The National Environmental Policy Act of 1969 
(NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the 
Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations 
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    The draft EIS is available on Regulations.gov for review and 
comment, and may be accessed via the Internet address provided above 
under the heading ADDRESSES. Copies may also be obtained by contacting 
the individual listed below the section titled FOR FURTHER INFORMATION 
CONTACT.
    A notice of availability regarding the draft EIS will also be 
published by the Environmental Protection Agency in the Federal 
Register.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), some of the reporting, recordkeeping, 
and third party disclosure requirements included in this proposed rule 
are in the process of being reinstated under Office of Management and 
Budget (OMB) control number 0579-0054. The new reporting requirements 
included in this proposed rule have been submitted as a new information 
collection for approval to OMB.
    Please send comments on the information collection request to OMB's 
Office of Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for APHIS. Please 
state that your comments refer to Docket No. APHIS-2008-0076. Please 
send a copy of your comments to USDA, using one of the methods 
described under ADDRESSES at the beginning of this document.
    Under the PPA, the Secretary of Agriculture has authority to carry 
out operations or measures to detect, control, eradicate, suppress, 
prevent, or retard the spread of plant pests. Section 7711(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 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 
USDA the flexibility to respond appropriately to a wide range of needs 
and circumstances to protect American agriculture against plant pests.

[[Page 6996]]

    In addition, section 412(a) of the Act provides that the 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.''
    APHIS regulations implementing these aspects of the Plant 
Protection Act are contained (in part) in 7 CFR part 330.
    APHIS is proposing to revise: (1) Regulations regarding the 
movement of plant pests; (2) criteria regarding the movement and 
environmental release of biological control organisms, and proposing to 
establish regulations to allow the importation and movement in 
interstate commerce of certain types of plant pests without restriction 
by granting exceptions from permitting requirements for those pests; 
and (3) regulations regarding the movement of soil. This proposal would 
clarify the factors that would be considered when assessing the risks 
associated with the movement of certain organisms and facilitate the 
movement of regulated organisms and articles in a manner that also 
protects U.S. agriculture.
    This proposed rule replaces a previously published proposed rule, 
which APHIS is withdrawing as part of this document. This proposal 
would clarify the factors that would be considered when assessing the 
risks associated with the movement of certain organisms and facilitate 
the movement of regulated organisms and articles in a manner that also 
protects U.S. agriculture.
    Implementing this rule will require respondents to complete a new 
petition process to remove permitting requirements for the interstate 
movement of certain plant pests or biological control organisms.
    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 160 hours per response.
    Respondents: Importers and distributors of plants and plant 
products; importers, brokers, distributors, retailers, and exhibitors 
of biological control organisms and associated articles; and operators 
of biocontainment facilities.
    Estimated Annual Number of Respondents: 6.
    Estimated Annual Number of Responses per Respondent: 1.
    Estimated Annual Number of Responses: 6.
    Estimated Total Annual Burden on Respondents: 960 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.)
    A copy of the information collection may be viewed on the 
Regulations.gov Web site or in our reading room. (A link to 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) Copies can also be obtained from Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483. 
APHIS will respond to any information collection request-related 
comments in the final rule. All comments will also become a matter of 
public record.
E-Government Act Compliance
    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

Lists of Subjects

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and 
pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin 
Islands.

7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

7 CFR Part 330

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

7 CFR Part 352

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

    Accordingly, we propose to amend 7 CFR parts 318, 319, 330, and 352 
as follows:

PART 318--STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES

0
1. The authority citation for part 318 continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, 
and 371.3.


Sec.  318.60  [Amended]

0
2. In Sec.  318.60, paragraph (c) is amended by adding the words ``: 
And provided finally, that the prohibitions in this paragraph do not 
apply to the movement of soil from Hawaii, Puerto Rico, and the Virgin 
Islands, other than that soil around the roots of plants; movement of 
soil that is not around the roots of plants is regulated under part 330 
of this chapter'' after the words ``paragraphs (c)(1), (2), and (3) of 
this section''.

PART 319--FOREIGN QUARANTINE NOTICES

0
3. The authority citation for part 319 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

0
4. In Sec.  319.37-8, paragraph (b)(2) is revised to read as follows:


Sec.  319.37-8   Growing media.

* * * * *
    (b) * * *
    (2) A restricted article from an area of Canada regulated by the 
national plant

[[Page 6997]]

protection organization of Canada for a soil-borne plant pest may only 
be imported in an approved growing medium if the phytosanitary 
certificate accompanying it contains an additional declaration that the 
plant was grown in a manner to prevent infestation by that soil-borne 
plant pest.
* * * * *
0
5. Section 319.69 is amended as follows:
0
a. By revising paragraph (a)(8); and
0
b. By removing paragraph (b)(4).
    The revision to read as follows:


Sec.  319.69  Notice of quarantine.

    (a) * * *
    (8) Organic decaying vegetative matter from all countries, unless 
the matter is expressly authorized to be used as a packing material in 
this part. Exceptions to the above prohibitions may be authorized in 
the case of specific materials which has been so prepared, 
manufactured, or processed that in the judgment of the inspector no 
pest risk is involved in their entry.
* * * * *


Sec.  319.69-1   [Amended]

0
6. Section 319.69-1 is amended by removing paragraph (b), and 
redesignating paragraph (c) as paragraph (b).
0
7. Section 319.69-5 is amended by revising the section heading to read 
as follows:


Sec.  319.69-5  Types of organic decaying vegetative matter authorized 
for packing.

* * * * *
0
8. Section 319.77-2 is amended as follows:
0
a. In paragraph (g), by removing the word ``and'';
0
b. By revising paragraph (h); and
0
c. By adding paragraph (i).
    The addition and revision to read as follows:


Sec.  319.77-2  Regulated articles.

* * * * *
    (h) Mobile homes and their associated equipment; and
    (i) Stone and quarry products.
0
9. Section 319.77-4 is amended by adding paragraph (d) to read as 
follows:


Sec.  319.77-4  Conditions for the importation of regulated articles.

* * * * *
    (d) Stone and quarry products. Stone and quarry products 
originating in a Canadian infested area may be imported into the United 
States only if they are destined for an infested area of the United 
States and will not be moved through any noninfested areas of the 
United States, and may be moved through the United States if they are 
moved only through infested areas.
* * * * *

PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS, 
BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE

0
10. The authority citation for part 330 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

0
11. The heading of part 330 is revised to read as set forth above.
0
12. Section 330.100 is revised to read as follows:


Sec.  330.100  Definitions.

    The following terms, when used in this part, shall be construed, 
respectively, to mean:
    Administrative instructions. Published documents relating to the 
enforcement of this part, and issued under authority thereof by the 
Administrator.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS), United States Department of Agriculture, or 
any employee of APHIS to whom authority has been delegated to act in 
the Administrator's stead.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Article. Any material or tangible object, including a living 
organism, that could harbor living plant pests or noxious weeds.
    Biocontainment facility. A physical structure, or portion thereof, 
constructed and maintained in order to contain plant pests, biological 
control organisms, or associated articles.
    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.
    Department. The United States 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.
    Enter (entry). To move into, or the act of movement into, the 
commerce of the United States.
    EPA. The Environmental Protection Agency 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).
    Hand-carry. Importation of an organism that remains in one's 
personal possession and in close proximity to one's person.
    Import (importation). To move into, or the act of movement into, 
the territorial limits of the United States.
    Inspector. Any individual authorized by the Administrator of APHIS 
or the Commissioner of CBP to enforce the regulations in this part.
    Interstate movement. Movement from one State into or through any 
other State; or movement within the District of Columbia, Guam, the 
U.S. Virgin Islands, or any other territory or possession of the United 
States.
    Living. Viable or potentially viable.
    Means of conveyance. Any personal or public property used for or 
intended for use for the movement of any other property. This 
specifically includes, but is not limited to, automobiles, trucks, 
railway cars, aircraft, boats, freight containers, and other means of 
transportation.
    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 or her agent, having possession of a plant 
pest, biological control organism, associated article, or any other 
means of conveyance, products, or article subject to the regulations in 
this part.
    Permit. A written authorization, including by electronic methods, 
by the Administrator to move plant pests, biological control organisms, 
or associated articles under conditions prescribed by the 
Administrator.
    Permittee. The person to whom APHIS has issued a permit in 
accordance with this part and who must comply with the provisions of 
the permit and the regulations in this part.

[[Page 6998]]

    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 trees, tissue cultures, plantlet cultures, 
pollen, shrubs, vines, cuttings, grafts, scions, buds, bulbs, roots, 
and seeds.
    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 the foregoing.
    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 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).
    Responsible individual. The individual who a permittee designates 
to oversee and control the actions taken under a permit issued in 
accordance with this part for the movement or curation of a plant pest, 
biological control organism, or associated article. For the duration of 
the permit, the individual must be physically present during normal 
business hours at or near the location specified on the permit as the 
ultimate destination of the plant pest, biological control organism, or 
associated article, and must serve as a primary contact for 
communication with APHIS. The permittee may designate him or herself as 
the responsible individual. The responsible individual must be at least 
18 years of age. In accordance with section 7734 of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), the act, omission, or failure 
of any responsible individual will also be deemed the act, omission, or 
failure of a permittee.
    Secure shipment. Shipment of a regulated plant pest, biological 
control organism, or associated article in a container or a means of 
conveyance of sufficient strength and integrity to prevent leakage of 
contents and to withstand shocks, pressure changes, and other 
conditions incident to ordinary handling in transportation.
    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 unconsolidated material from the earth's surface that 
consists of rock and mineral particles and that supports or is capable 
of supporting biotic communities.
    State. Any of the States of the United States, the Commonwealth of 
the Northern Mariana Islands, the Commonwealth of Puerto Rico, the 
District of Columbia, Guam, the U.S. Virgin Islands, and all other 
territories or possessions of the United States.
    Sterilization (sterile, sterilized). A chemical or physical process 
that results in the death of all living organisms on or within the 
article subject to the process. Examples include, but are not limited 
to, autoclaving and incineration.
    Taxon (taxa). Any recognized grouping or rank within the biological 
nomenclature of organisms, such as class, order, family, genus, 
species, subspecies, pathovar, biotype, race, forma specialis, or 
cultivar.
    Transit. Movement from and to a foreign destination through the 
United States.
    United States. All of the States.
    U.S. Customs and Border Protection (CBP). U.S. Customs and Border 
Protection within the Department of Homeland Security.
0
13. Subpart--Movement of Plant Pests, Sec. Sec.  330.200 through 
330.212, is revised to read as follows:
Subpart--Movement of Plant Pests, Biological Control Organisms, and 
Associated Articles
Sec.
330.200 Scope and general restrictions.
330.201 Permit requirements.
330.202 Biological control organisms.
330.203 Soil.
330.204 Exceptions to permitting requirements for the importation or 
interstate movement of certain plant pests.
330.205 Hand-carry of plant pests, biological control organisms, and 
soil.
330.206 Packaging requirements.
330.207 Costs and charges.

Subpart--Movement of Plant Pests, Biological Control Organisms, and 
Associated Articles


Sec.  330.200  Scope and general restrictions.

    (a) No person shall import, move interstate, transit, or release 
into the environment plant pests, biological control organisms, or 
associated articles, unless the importation, interstate movement, 
transit, or release into the environment of the plant pests, biological 
control organisms, or plant pests is:
    (1) Authorized under an import, interstate movement, or continued 
curation permit issued in accordance with Sec.  330.201; or
    (2) Authorized in accordance with other APHIS regulations in this 
chapter; or
    (3) Explicitly granted an exception or exemption in this subpart 
from permitting requirements; or
    (4) Authorized under a general permit issued by the Administrator.
    (b) Plant pests regulated by this subpart. For the purposes of this 
subpart, APHIS will consider an organism to be a plant pest if the 
organism directly or indirectly injures, causes damage to, or causes 
disease in a plant or plant product, or if the organism is an unknown 
risk to plants or plant products, but is similar to an organism known 
to directly or indirectly injure, cause damage to, or cause disease in 
a plant or plant product.
    (c) Biological control organisms regulated by this subpart. For the 
purposes of this subpart, biological control organisms include:
    (1) Invertebrate predators and parasites (parasitoids) used to 
control invertebrate plant pests,
    (2) Invertebrate competitors used to control invertebrate plant 
pests,
    (3) Invertebrate herbivores used to control noxious weeds,
    (4) Microbial pathogens used to control invertebrate plant pests,
    (5) Microbial pathogens used to control noxious weeds,
    (6) Microbial parasites used to control plant pathogens, and
    (7) Any other types of biological control organisms, as determined 
by APHIS.
    (d) Biological control organisms not regulated by this subpart. The 
preceding paragraph notwithstanding, biological control organism-
containing products that are currently under an EPA outdoor 
experimental use permit or that are currently registered with EPA as a 
microbial pesticide product having outdoor uses are not regulated under 
this subpart. Additionally, biological control organisms that are 
pesticides that are not registered with EPA, but are being transferred, 
sold, or distributed in accordance with EPA's regulations in 40 CFR 
152.30, are not regulated under this subpart for their interstate 
movement or importation. However, an importer desiring to import a 
shipment of biological control organisms subject to the Federal 
Insecticide Fungicide and Rodenticide Act must submit to the EPA 
Administrator a Notice of Arrival of Pesticides and Devices as required 
by CBP regulations at 19 CFR 12.112. The Administrator will provide 
notification

[[Page 6999]]

to the importer indicating the disposition to be made of shipment upon 
its entry into the customs territory of the United States.


Sec.  330.201  Permit requirements.

    (a) Types of permits. APHIS issues import permits, interstate 
movement permits, continued curation permits, and transit permits for 
plant pests, biological control organisms, and associated articles.\1\
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    \1\ Persons contemplating the shipment of plant pests, 
biological control organisms, or associated articles to places 
outside the United States should make arrangements directly, or 
through the recipient, with the country of destination for the 
export of the plant pests, biological control organisms, or 
associated articles into that country.
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    (1) Import permit. Import permits are issued to persons for secure 
shipment from outside the United States into the territorial limits of 
the United States. When import permits are issued to individuals, these 
individuals must be 18 years of age or older and have a physical 
address within the United States. When import permits are issued to 
corporate persons, these persons must maintain an address or business 
office in the United States with a designated individual for service of 
process.
    (2) Interstate movement permit. Interstate movement permits are 
issued to persons for secure shipment from any State into or through 
any other State. When interstate movement permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. When interstate 
movement permits are issued to corporate persons, these persons must 
maintain an address or business office in the United States with a 
designated individual for service of process.
    (3) Continued curation permits. Continued curation permits are 
issued in conjunction with and prior to the expiration date for an 
import permit or interstate movement permit, in order for the permittee 
to continue the actions listed on the import permit or interstate 
movement permit. When continued curation permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. When continued 
curation permits are issued to corporate persons, these persons must 
maintain an address or business office in the United States with a 
designated individual for service of process.
    (4) Transit permits. Transit permits are issued for secure 
shipments through the United States. Transit permits are issued in 
accordance with part 352 of this chapter.
    (b) Applying for a permit. Permit applications must be submitted by 
the applicant in writing or electronically through one of the means 
listed at http://www.aphis.usda.gov/plant_health/permits/index.shtml in 
advance of the action(s) proposed on the permit application.
    (c) Completing a permit application. A permit application must be 
complete before APHIS will evaluate it in order to determine whether to 
issue the permit requested. Guidance regarding how to complete a permit 
application, including guidance specific to the various information 
blocks on the application, is available at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (d) APHIS action on permit applications. APHIS will review the 
information on the application to determine whether it is complete. In 
order to consider an application complete, APHIS may request additional 
information that it determines to be necessary in order to assess the 
risk to plants and plant products that may be posed by the actions 
proposed on the application. When it is determined that an application 
is complete, APHIS will commence review of the information provided.
    (1) State or Tribal consultation and comment; consultation with 
other individuals. APHIS will share a copy of the permit application, 
and the proposed permit conditions, with the appropriate State or 
Tribal regulatory officials, and may share the application and the 
proposed conditions with other persons or groups to provide comment.
    (2) Initial assessment of sites and facilities. Prior to issuance 
of a permit, APHIS will assess all sites and facilities that are listed 
on the permit application, including private residences, biocontainment 
facilities, and field locations where the organism or article will be 
held or released. As part of this assessment, all sites and facilities 
are subject to inspection. All facilities must be determined by APHIS 
to be constructed and maintained in a manner that prevents the 
dissemination or dispersal of plant pests, biological control 
organisms, or associated articles from the facility. The applicant must 
provide all information requested by APHIS regarding this assessment, 
and must allow all inspections requested by APHIS during normal 
business hours (8 a.m. to 4:30 p.m., Monday through Friday, excluding 
holidays). Failure to do so constitutes grounds for denial of the 
permit application.
    (3) Issuance of a permit. APHIS may issue a permit to an applicant 
if APHIS concludes that the actions allowed under the permit will be 
highly unlikely to result in the introduction or dissemination of a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that presents an unacceptable risk to plants 
and plant products. Issuance will occur as follows:
    (i) Prior to issuing the permit, APHIS will notify the applicant in 
writing or electronically of all proposed permit conditions. The 
applicant must agree in writing or electronically that he or she, and 
all his or her employees, agents, and/or officers, will comply with all 
permit conditions and all provisions of this subpart. If the organism 
or associated article will be contained in a private residence, the 
applicant must state in this agreement that he or she authorizes APHIS 
to conduct unscheduled assessments of the residence during normal 
business hours if a permit is issued.
    (ii) APHIS will issue the permit after it receives and reviews the 
applicant's agreement. The permit will be valid for no more than 3 
years. During that period, the permittee must abide by all permitting 
conditions, and the use of the organism or article must conform to the 
intended use on the permit. Moreover, the use of organisms derived from 
a regulated parent organism during that period must conform to the 
intended use specified on the permit for the parent organism.
    (iii) All activities carried out under the permit must cease on or 
before the expiration date for the permit, unless, prior to that 
expiration date, the permittee has submitted a new permit application 
and a new permit has been issued to authorize continuation of those 
actions.
    (iv) At any point following issuance of a permit but prior to its 
expiration date, an inspector may conduct unscheduled assessments of 
the site or facility in which the organisms or associated articles are 
held, to determine whether they are constructed and are being 
maintained in a manner that prevents the dissemination of organisms or 
associated articles from the site or facility. The permittee must allow 
all such assessments requested by APHIS during normal business hours. 
Failure to allow such assessments constitutes grounds for revocation of 
the permit.
    (4) Denial of a permit application. APHIS may deny an application 
for a permit if:
    (i) APHIS concludes that the actions proposed in the permit 
application would present an unacceptable risk to plants and plant 
products because of the introduction or dissemination of a plant

[[Page 7000]]

pest, biological control organism, or noxious weed within the United 
States; or
    (ii) The actions proposed in the permit application would be 
adverse to the conduct of an APHIS eradication, suppression, control, 
or regulatory program; or
    (iii) A State or Tribal executive official, or a State or Tribal 
plant protection official authorized to do so, objects to the movement 
in writing and provides specific, detailed information that there is a 
risk the movement will result in the dissemination of a plant pest or 
noxious weed into the State, APHIS evaluates the information and 
agrees, and APHIS determines that such plant pest or noxious weed risk 
cannot be adequately addressed or mitigated; or
    (iv) The applicant does not agree to observe all of the proposed 
permit conditions that APHIS has determined are necessary to mitigate 
identified risks; or
    (v) The applicant does not provide information requested by APHIS 
as part of an assessment of sites or facilities, or does not allow 
APHIS to inspect sites or facilities associated with the actions listed 
on the permit application; or
    (vi) APHIS determines that the applicant has not followed prior 
permit conditions, or has not adequately demonstrated that they can 
meet the requirements for the current application. Factors that may 
contribute to such a determination include, but are not limited to:
    (A) The applicant, or a partnership, firm, corporation, or other 
legal entity in which the applicant has a substantial interest, 
financial or otherwise, has not complied with any permit that was 
previously issued by APHIS.
    (B) Issuing the permit would circumvent any order denying or 
revoking a previous permit issued by APHIS.
    (C) The applicant has previously failed to comply with any APHIS 
regulation.
    (D) The applicant has previously failed to comply with any other 
Federal, State, or local laws, regulations, or instructions pertaining 
to plant health.
    (E) The applicant has previously failed to comply with the laws or 
regulations of a national plant protection organization or equivalent 
body, as these pertain to plant health.
    (F) APHIS has determined that the applicant has made false or 
fraudulent statements or provided false or fraudulent records to APHIS.
    (G) The applicant has been convicted or has pled nolo contendere to 
any crime involving fraud, bribery, extortion, or any other crime 
involving a lack of integrity.
    (5) Withdrawal of a permit application. Any permit application may 
be withdrawn at the request of the applicant. If the applicant wishes 
to withdraw a permit application, he or she must provide the request in 
writing to APHIS. APHIS will provide written notification to the 
applicant as promptly as circumstances allow regarding reception of the 
request and withdrawal of the application.
    (6) Cancellation of a permit. Any permit that has been issued may 
be canceled at the request of the permittee. If a permittee wishes a 
permit to be canceled, he or she must provide the request in writing to 
APHIS-PPQ. Whenever a permit is canceled, APHIS will notify the 
permittee in writing regarding such cancellation.
    (7) Revocation of a permit. APHIS may revoke a permit for any of 
the following reasons:
    (i) After issuing the permit, APHIS obtains information that would 
have otherwise provided grounds for it to deny the permit application; 
or
    (ii) APHIS determines that the actions undertaken under the permit 
have resulted in or are likely to result in the introduction into or 
dissemination within the United States of a plant pest or noxious weed 
in a manner that presents an unacceptable risk to plants or plant 
products; or
    (iii) APHIS determines that the permittee, or any employee, agent, 
or officer of the permittee, has failed to comply with a provision of 
the permit or the regulations under which the permit was issued.
    (8) Amendment of permits. (i) Amendment at permittee's request. If 
a permittee determines that circumstances have changed since the permit 
was initially issued and wishes the permit to be amended accordingly, 
he or she must request the amendment, either through APHIS' online 
portal for permit applications, or by contacting APHIS directly via 
phone or email. The permittee may have to provide supporting 
information justifying the amendment. APHIS will review the amendment 
request, and may amend the permit if only minor changes are necessary. 
Requests for more substantive changes may require a new permit 
application. Prior to issuance of an amended permit, the permittee may 
be required to agree in writing that he or she, and his or her 
employees, agents, and/or officers will comply with the amended permit 
and conditions.
    (ii) Amendment initiated by APHIS. APHIS may amend any permit and 
its conditions at any time, upon determining that the amendment is 
needed to address newly identified considerations concerning the risks 
presented by the organism or the activities being conducted under the 
permit. APHIS may also amend a permit at any time to ensure that the 
permit conditions are consistent with all of the requirements of this 
part. As soon as circumstances allow, APHIS will notify the permittee 
of the amendment to the permit and the reason(s) for it. Depending on 
the nature of the amendment, the permittee may have to agree in writing 
or electronically that he or she, and his or her employees, agents, 
and/or officers, will comply with the permit and conditions as amended 
before APHIS will issue the amended permit. If APHIS requests such an 
agreement, and the permittee does not agree in writing that he or she, 
and his or her employees, agents, and/or officers, will comply with the 
amended permit and conditions, the existing permit will be revoked.
    (9) Suspension of permitted actions. APHIS may suspend 
authorization of actions authorized under a permit if it identifies new 
factors that cause it to reevaluate the risk associated with those 
actions. APHIS will notify the permittee in writing of this suspension 
explaining the reasons for it and stating the actions for which APHIS 
is suspending authorization. Depending on the results of APHIS' 
evaluation, APHIS will subsequently contact the permittee to remove the 
suspension, amend the permit, or revoke the permit.
    (10) Appeals. Any person whose application has been denied, whose 
permit has been revoked or amended, or whose authorization for actions 
authorized under a permit has been suspended, may appeal the decision 
in writing to the Administrator within 10 business days after receiving 
the written notification of the denial, revocation, amendment, or 
suspension. The appeal shall state all of the facts and reasons upon 
which the person relies to show that the application was wrongfully 
denied, permit revoked or amended, or authorization for actions under a 
permit suspended. The Administrator shall grant or deny the appeal, 
stating the reasons for the decision as promptly as circumstances 
allow.


Sec.  330.202  Biological control organisms.

    (a) General conditions for importation, interstate movement, and 
environmental release of biological control organisms. Except as 
provided in paragraph (b) of this section, no biological control 
organism regulated under this subpart may be imported, moved 
interstate, or released into the

[[Page 7001]]

environment unless a permit has been issued in accordance with Sec.  
330.201 authorizing such importation, interstate movement, or 
environmental release, and the organism is moved or released in 
accordance with this permit and the regulations in this subpart. The 
regulations in 40 CFR parts 1500-1508, 7 CFR part 1b, and 7 CFR part 
372 may require APHIS to request additional information from an 
applicant regarding the proposed release of a biological control 
organism as part of its evaluation of a permit application. Further 
information regarding the types of information that may be requested, 
and the manner in which this information will be evaluated, is found at 
http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (b) Exceptions from permitting requirements for certain biological 
control organisms. APHIS has determined that certain biological control 
organisms have become established throughout their geographical or 
ecological range in the continental United States, such that the 
additional release of pure cultures derived from field populations of 
taxa of such organisms into the environment of the continental United 
States will present no additional plant pest risk (direct or indirect) 
to plants or plant products. A list of these organisms is maintained 
online, at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (1) Importation and interstate movement of listed organisms. Pure 
cultures of organisms on the list may be imported into or moved 
interstate within the continental United States without further 
restriction under this subpart.
    (2) Environmental release of listed organisms. Pure cultures of 
organisms on the list may be released into the environment of the 
continental United States without further restriction under this 
subpart.
    (c) Additions to the list of organisms granted exceptions from 
permitting requirements for their importation or interstate movement. 
Any person may request that APHIS add a biological control organism to 
the list referred to in paragraph (b) of this section by submitting a 
petition to APHIS via email to [email protected] or through 
any means listed at http://www.aphis.usda.gov/plant_health/permits/index.shtml. The petition must include the following information:
    (1) Evidence indicating that the organism is indigenous to the 
continental United States throughout its geographical or ecological 
range, or evidence indicating that the organism has produced self-
replicating populations within the continental United States for an 
amount of time sufficient, based on the organism's taxon, to consider 
that taxon established throughout its geographical or ecological range 
in the continental United States.
    (2) Results from a field study where data was collected from 
representative habitats occupied by the biological control organism. 
Studies must include sampling for any direct or indirect impacts on 
target and non-target hosts of the biological control organism in these 
habitats. Supporting scientific literature must be cited.
    (3) Any other data, including published scientific reports, that 
suggest that subsequent releases of the organism into the environment 
of the continental United States will present no additional plant pest 
risk (direct or indirect) to plants or plant products.
    (d) APHIS review of petitions. (1) APHIS will review the petition 
to determine whether it is complete. If APHIS determines that the 
petition is complete, it will conduct an evaluation of the petition to 
determine whether there is sufficient evidence that the organism exists 
throughout its geographical or ecological range in the continental 
United States and that subsequent releases of pure cultures of field 
populations of the organism into the environment of the continental 
United States will present no additional plant pest risk (direct or 
indirect) to plants or plant products.
    (2) Notice of availability of the petition. If APHIS determines 
that there is sufficient evidence that the organism exists throughout 
its geographical or ecological range in the continental United States 
and that subsequent releases of pure cultures of the organism into the 
environment of the continental United States will present no additional 
plant pest risk to plants or plant products, APHIS will publish a 
notice in the Federal Register announcing the availability of the 
petition and requesting public comment on that document.
    (3) Notice of determination. (i) If no comments are received, or if 
the comments received do not lead APHIS to reconsider its 
determination, APHIS will publish in the Federal Register a subsequent 
notice describing the comments received and stating that the organism 
has been added to the list referred to in paragraph (b) of this 
section.
    (ii) If the comments received lead APHIS to reconsider its 
determination, APHIS will publish in the Federal Register a subsequent 
notice describing the comments received and stating its reasons for 
determining not to add the organism to the list referred to in 
paragraph (b) of this section.
    (e) Removal of organisms from the list of exempt organisms. Any 
biological control organism may be removed from the list referred to in 
paragraph (b) of this section if information emerges that would have 
otherwise led APHIS to deny the petition to add the organism to the 
list. Whenever an organism is removed from the list, APHIS will publish 
a notice in the Federal Register announcing that action and the basis 
for it.


Sec.  330.203  Soil.

    (a) The Administrator has determined that, unless it has been 
sterilized, soil is an associated article, and is thus subject to the 
permitting requirements of Sec.  330.201, unless its movement:
    (1) Is regulated pursuant to other APHIS regulations in this 
chapter; or
    (2) Does not require such a permit under the provisions of 
paragraphs (b)(1) or (c)(1) of this section.
    (b) Conditions governing the importation of soil.
    (1) Permit. Except as provided in Sec.  319.37-8(b)(2) of this 
chapter and except for soil imported from areas of Canada other than 
those areas of Canada regulated by the national plant protection 
organization of Canada for a soil-borne plant pest, soil may only be 
imported into the United States if an import permit has been issued for 
its importation in accordance with Sec.  330.201, and the soil will be 
imported under the conditions specified on the permit.
    (2) Additional conditions for the importation of soil via hand-
carry. In addition to the condition of paragraph (b)(1) of this 
section, soil may be hand-carried into the United States only if the 
importation meets the conditions of Sec.  330.205.
    (3) Additional conditions for the importation of soil intended for 
the extraction of plant pests. In addition to the condition of 
paragraph (b)(1) of this section, soil may be imported into the United 
States for the extraction of plant pests if the soil will be imported 
directly to a biocontainment facility approved by APHIS.
    (4) Additional conditions for the importation of soil contaminated 
with plant pests and intended for disposal. In addition to the 
condition of paragraph (b)(1) of this section, soil may be imported 
into the United States for the disposal of plant pests if the soil will 
be imported directly to an APHIS-approved disposal facility.

[[Page 7002]]

    (5) Exemptions. The articles listed in this paragraph are not soil, 
provided that they are free of organic material. Therefore, they may be 
imported into the United States without an import permit issued in 
accordance with Sec.  330.201, unless the Administrator has issued an 
order stating that a particular article is an associated article. All 
such articles are, however, subject to inspection at the port of first 
arrival, subsequent reinspection at other locations, other remedial 
measures deemed necessary by an inspector to remove any risk the items 
pose of disseminating plant pests or noxious weeds, and any other 
restrictions of this chapter:
    (i) Consolidated material derived from any strata or substrata of 
the earth. Examples include clay (laterites, bentonite, china clay, 
attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel.
    (ii) Sediment, mud, or rock from saltwater bodies of water.
    (iii) Cosmetic mud and other commercial mud products.
    (iv) Stones, rocks, and quarry products.
    (c) Conditions governing the interstate movement of soil. (1) 
General conditions. Except for soil moved in accordance with paragraphs 
(c)(2) through (5) of this section, soil may be moved interstate within 
the United States without prior issuance of an interstate movement 
permit in accordance with Sec.  330.201 or further restriction under 
this subpart. However, all soil moved interstate is subject to any 
movement restrictions and remedial measures specified for such movement 
in part 301 of this chapter.
    (2) Conditions for the interstate movement within the continental 
United States of soil intended for the extraction of plant pests. Soil 
may be moved interstate within the continental United States with the 
intent of extracting plant pests, only if an interstate movement permit 
has been issued for its movement in accordance with Sec.  330.201, and 
the soil will be moved directly to a biocontainment facility approved 
by APHIS in a secure manner that prevents its dissemination into the 
outside environment.
    (3) Conditions for the interstate movement within the continental 
United States of soil infested with plant pests and intended for 
disposal. Soil may be moved interstate within the continental United 
States with the intent of disposing of plant pests, only if an 
interstate movement permit has been issued for its movement in 
accordance with Sec.  330.201, and the soil will be moved directly to 
an APHIS-approved disposal facility in a secure manner that prevents 
its dissemination into the outside environment.
    (4) Conditions for the interstate movement of soil samples from an 
area quarantined in accordance with part 301 of this chapter for 
chemical or compositional testing or analysis. Soil samples may be 
moved for chemical or compositional testing or analysis from an area 
that is quarantined in accordance with part 301 of this chapter without 
prior issuance of an interstate movement permit in accordance with 
Sec.  330.201 or further restriction under this chapter, provided that 
the soil is moved to a laboratory that has entered into and is 
operating under a compliance agreement with APHIS, is abiding by all 
terms and conditions of the compliance agreement, and is approved by 
APHIS to test and/or analyze such samples.
    (5) Additional conditions for interstate movement of soil to, from, 
or between Hawaii, the territories, and the continental United States. 
In addition to all general conditions for interstate movement of soil, 
soil may be moved interstate to, from, or between Hawaii, the 
territories, and the continental United States only if an interstate 
movement permit has been issued for its movement in accordance with 
Sec.  330.201. In addition, soil moved to, from, or between Hawaii, the 
territories, and the continental United States with the intent of 
extracting plant pests is subject to the conditions of paragraph (c)(2) 
of this section, while soil infested with plant pests and intended for 
disposal is subject to the conditions of paragraph (c)(3) of this 
section.
    (d) Conditions governing the transit of soil through the United 
States. Soil may transit through the United States only if a transit 
permit has been issued for its movement in accordance with part 352 of 
this chapter.


Sec.  330.204  Exceptions to permitting requirements for the 
importation or interstate movement of certain plant pests.

    Pursuant to section 7711 of the Plant Protection Act (7 U.S.C. 7701 
et seq.), the Administrator has determined that certain plant pests may 
be imported into or may move in interstate commerce within the 
continental United States without restriction. The list of all such 
plant pests is listed on the Internet at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (a) Categories. In order to be included on the list, a plant pest 
must:
    (1) Be from field populations or lab cultures derived from field 
populations of a taxon that established throughout its entire 
geographical or ecological range within the continental United States; 
or
    (2) Be sufficiently attenuated so that it no longer poses a risk to 
plants or plant products; or
    (3) Be commercially available and raised under the regulatory 
purview of other Federal agencies.
    (b) Petition process to add plant pests to the list. (1) Petition. 
Any person may petition APHIS to have an additional plant pest added to 
the list of plant pests that may be imported into or move in interstate 
commerce within the continental United States without restriction. To 
submit a petition, the person must provide, in writing, information 
supporting the placement of a particular pest in one of the categories 
listed in paragraph (a) of this section.
    (i) Information that the plant pest belongs to a taxon that is 
established throughout its entire geographical or ecological range 
within the United States must include scientific literature, 
unpublished studies, or data regarding:
    (A) The biology of the plant pest, including characteristics that 
allow it to be identified, known hosts, and virulence;
    (B) The geographical or ecological range of the plant pest within 
the continental United States; and
    (C) The areas of the continental United States within which the 
plant pest is established.
    (ii) Information that the plant pest has been attenuated of its 
pathogenicity must include experimental data, published references, or 
scientific information regarding such attenuation.
    (iii) Information that the plant pest is commercially available and 
raised under the regulatory purview of another Federal agency must 
include a citation to the relevant law, regulation, or order under 
which the agency exercises such oversight.
    (2) APHIS review. APHIS will review the information contained in 
the petition to determine whether it is complete. In order to consider 
the petition complete, APHIS may require additional information to 
determine whether the plant pest belongs to one of the categories 
listed in paragraph (a) of this section. When it is determined that the 
information is complete, APHIS will commence review of the petition.
    (3) Action on petitions to add pests. (i) If, after review of the 
petition, APHIS determines there is insufficient evidence that the 
plant pest belongs to one of the three categories listed in paragraph 
(a) of this section, APHIS will deny the petition, and notify the 
petitioner in writing regarding this denial.

[[Page 7003]]

    (ii) If, after review of the petition, APHIS determines that the 
plant pest belongs to one of the categories in paragraph (a) of this 
section, APHIS will publish a notice in the Federal Register that 
announces the availability of the petition and any supporting 
documentation to the public, that states that APHIS intends to add the 
plant pest to the list of plant pests that may be imported into or move 
in interstate commerce within the continental United States without 
restriction, and that requests public comment. If no comments are 
received on the notice, or if, based on the comments received, APHIS 
determines that its conclusions regarding the petition have not been 
affected, APHIS will publish in the Federal Register a subsequent 
notice stating that the plant pest has been added to the list.
    (c) Petition process to have plant pests removed from the list. (1) 
Petition. Any person may petition to have a plant pest removed from the 
list of plant pests that may be imported into or move in interstate 
commerce within the continental United States without restriction by 
writing to APHIS. The petition must contain independently verifiable 
information demonstrating that APHIS' initial determination that the 
plant pest belongs to one of the categories in paragraph (a) of the 
section should be changed, or that additional information is now 
available that would have caused us to change the initial decision.
    (2) APHIS review. APHIS will review the information contained in 
the petition to determine whether it is complete. In order to consider 
the petition complete, APHIS may require additional information 
supporting the petitioner's claim. When it is determined that the 
information is complete, APHIS will commence review of the petition.
    (3) APHIS action on petitions to remove pests. (i) If, after review 
of the petition, APHIS determines that there is insufficient evidence 
to suggest that its initial determination should be changed, APHIS will 
deny the petition, and notify the petitioner in writing regarding this 
denial.
    (ii) If, after review of the petition, APHIS determines that there 
is a sufficient basis to suggest that its initial determination should 
be changed, APHIS will publish a notice in the Federal Register that 
announces the availability of the petition, and that requests public 
comment regarding removing the plant pest from the list of plant pests 
that may be imported into or move in interstate commerce within the 
continental United States without restriction. If no comments are 
received on the notice, or if the comments received do not affect 
APHIS' conclusions regarding the petition, APHIS will publish a 
subsequent notice in the Federal Register stating that the plant pest 
has been removed from the list.
    (d) APHIS-initiated changes to the list. (1) APHIS may propose to 
add a plant pest to or remove a pest from the list of plant pests that 
may be imported into or move in interstate commerce within the 
continental United States without restriction without a petition, if it 
determines that there is sufficient evidence that the plant pest 
belongs to one of the categories listed in paragraph (a) of the 
section, or if evidence emerges that leads APHIS to reconsider its 
initial determination that the plant pest was or was not in one of the 
categories lists in paragraph (a) of this section. APHIS will publish a 
notice in the Federal Register announcing this proposed addition or 
removal, making available any supporting documentation that it 
prepares, and requesting public comment.
    (2) If no comments are received on the notice or if the comments 
received do not affect the conclusions of the notice, APHIS will 
publish a subsequent notice in the Federal Register stating that the 
plant pest has been added to or removed from the list.


Sec.  330.205  Hand-carry of plant pests, biological control organisms, 
and soil.

    Plant pests, biological control organisms, and soil may be hand-
carried into the United States only in accordance with the provisions 
of this section.
    (a) Authorization to hand-carry.
    (1) Application for a permit; specification of ``hand-carry'' as 
proposed method of movement. A person must apply for an import permit 
for the plant pest, biological control organism, or soil, in accordance 
with Sec.  330.201, and specify hand-carry of the organism or article 
as the method of proposed movement.
    (2) Specification of individual who will hand-carry. The 
application must also specify the individual or individuals who will 
hand-carry the plant pest, biological control organism, or soil into 
the United States. If APHIS authorizes this individual or these 
individuals to hand-carry, the authorization may not be transferred to, 
nor actions under it performed by, individuals other than those 
identified on the permit application.
    (b) Notification of intent to hand-carry. After the permittee has 
obtained an import permit but no less than 20 days prior to movement, 
the permittee must notify APHIS through APHIS' online portal for permit 
applications or by fax and provide the following information in order 
to receive a hand-carry shipping authorization:
    (1) A copy of the face page of the passport for the individual or 
individuals who will hand-carry the plant pest, biological control 
organism, or soil;
    (2) A description of the means of conveyance in which the 
individual or individuals will travel, including flight number and 
airline name for air travel, or vehicle license number or other 
identifying number for other modes of transportation;
    (3) Expected date and time of first arrival;
    (4) Expected port of first arrival; and
    (5) Travel itinerary from port of first arrival to final 
destination.
    (c) Notification of arrival at the facility or point of 
destination. The permittee or his or her designee must notify APHIS 
within 24 hours of arrival of the hand-carried plant pest, biological 
control organism, or soil at the biocontainment facility or other 
authorized point of destination. This notification must state that the 
plant pest, biological control organism, or soil has arrived at its 
destination and that the package in which it was hand-carried has 
remained sealed until arrival. Notification must be by fax or email, or 
via the Internet at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (d) Denial, amendment, or cancellation of authorization to hand-
carry. APHIS may deny a request to hand-carry, or amend or cancel any 
hand-carry authorization at any time, if it deems such action necessary 
to prevent the introduction or dissemination of plant pests or noxious 
weeds within the United States.
    (e) Appeal of denial, amendment, or cancellation. Any person whose 
request to hand-carry has been denied, or whose authorization to hand-
carry has been amended or canceled, may appeal the decision in writing 
to APHIS.


Sec.  330.206  Packaging requirements.

    Shipments in which plant pests, biological control organisms, and 
associated articles are imported into, moved interstate, or transited 
through the United States must meet the general packaging requirements 
of this section, as well as all specific packaging requirements on the 
permit itself.
    (a) Packaging requirements. All shipments must consist of an outer 
shipping container and at least two packages within the container. Both 
the

[[Page 7004]]

container and inner packages must be securely sealed to prevent the 
dissemination of the enclosed plant pests, biological control 
organisms, or associated articles.
    (1) Outer shipping container. The outer shipping container must be 
rigid, impenetrable and durable enough to remain closed and 
structurally intact in the event of dropping, lateral impact with other 
objects, and other shocks incidental to handling.
    (2) Inner packages. The innermost package or packages within the 
shipping container must contain all of the organisms or articles that 
will be moved. As a safeguard, the innermost package must be placed 
within another, larger package. All packages within the shipping 
container must be constructed or safeguarded so that they will remain 
sealed and structurally intact throughout transit. The packages must be 
able to withstand changes in pressure, temperature, and other climatic 
conditions incidental to shipment.
    (b) Packing material. Packing material must be free of plant pests, 
noxious weeds, or associated articles, and must be new, or must have 
been sterilized or disinfected prior to reuse. Packing material must be 
suited for the enclosed organism or article, as well as any medium in 
which the organism or article will be maintained, and should not be 
capable of harboring or being a means of the dissemination of the 
organism or article.\2\
---------------------------------------------------------------------------

    \2\ Guidance regarding suitable outer shipping containers, inner 
packages, and packaging is provided at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
---------------------------------------------------------------------------

    (c) Requirements following receipt of the shipment at the point of 
destination. (1) Packing material, including media and substrates, must 
be destroyed by incineration, be decontaminated using autoclaving or 
another approved method, or otherwise be disposed of in a manner 
specified in the permit itself.
    (2) Shipping containers may not be reused, except those that have 
been sterilized or disinfected prior to reuse.
    (d) Costs. Permittees who fail to meet the requirements of this 
section may be held responsible for all costs incident to inspection, 
rerouting, repackaging, subsequent movement, and any treatments.


Sec.  330.207  Cost and charges.

    The inspection services of APHIS inspectors during regularly 
assigned hours of duty and at the usual places of duty will be 
furnished without cost. APHIS will not be responsible for any costs or 
charges incidental to inspections or compliance with the provisions of 
this subpart, other than for the inspection services of the inspector.

Subpart--Movement of Soil, Stone, and Quarry Products [Removed and 
Reserved]

0
14. Subpart--Movement of Soil, Stone, and Quarry Products, Sec. Sec.  
330.300 through 330.302, is removed and reserved.

PART 352--PLANT QUARANTINE SAFEGUARD REGULATIONS

0
15. The authority citation continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

0
16. In Sec.  352.1, paragraph (b) is amended by adding, in alphabetical 
order, definitions for biological control organism and noxious weed, 
and by revising the definitions for Deputy Administrator, person, plant 
pest, and soil to read as follows:


Sec.  352.1  Definitions.

* * * * *
    (b) * * *
    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
* * * * *
    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.
* * * * *
    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.
* * * * *
    Person. Any individual, partnership, corporation, association, 
joint venture, society, or other legal entity.
    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 the above.
* * * * *
    Soil. The unconsolidated material from the earth's surface that 
consists of rock and mineral particles and that supports or is capable 
of supporting biotic communities.
* * * * *


Sec.  352.2  [Amended]

0
17. In Sec.  352.2, paragraph (a) introductory text, the first sentence 
is amended by removing the words ``plant pests, noxious weeds, soil,'' 
and adding the words ``plant pests, biological control organisms, 
noxious weeds, soil,'' in their place, and by removing the words 
``contain plant pests or noxious weeds'' and adding the words ``contain 
plant pests, biological control organisms, or noxious weeds'' in their 
place.


Sec.  352.3   [Amended]

0
18. In Sec.  352.3, paragraph (a) is amended by adding the words 
``biological control organisms,'' after the words ``plant pests,'' each 
time they occur.


Sec.  352.5   [Amended]

0
19. Section 352.5 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,'' each time they occur.


Sec.  352.6   [Amended]

0
20. Section 352.6 is amended as follows:
0
a. By removing footnote 2;
0
b. In paragraph (b), by removing the words ``as specified by'' and 
adding the words ``in accordance with'' in their place; and
0
c. In paragraph (c), by removing the citation ``Sec.  330.300(b)'' and 
adding the citation ``Sec.  330.203'' in its place.


Sec.  352.9  [Amended]

0
21. Section 352.9 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,''.


Sec.  352.10   [Amended]

0
22. Section 352.10 is amended as follows:
0
a. By redesignating footnote 3 as footnote 2;
0
b. By removing the words ``plant pest or noxious weed dissemination'' 
each time they occur and adding the words ``plant pest, noxious weed, 
or biological control organism dissemination'' in their place;
0
c. In paragraph (b)(1), by adding the words ``biological control 
organisms,'' after the words ``Prohibited or restricted plants, plant 
products, plant pests,'';
0
d. In paragraph (b)(2)(i), by adding the words ``or biological control 
organisms,'' after the words ``plant pests'';

[[Page 7005]]

0
e. In paragraph (b)(2)(ii), by adding the words ``biological control 
organisms,'' after the words ``plant pests,''; and
0
f. In paragraph (b)(2)(iv), by removing the words ``plant pest 
dispersal'' and adding the words ``plant pest or biological control 
organism dispersal'' in their place.


Sec.  352.11   [Amended]

0
23. In Sec.  352.11, paragraph (a)(1) is amended by adding the words 
``biological control organisms,'' after the words ``plant pests,''.


Sec.  352.13   [Amended]

0
24. Section 352.13 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,''.


Sec.  352.30   [Amended]

0
25. Section 352.30 is amended by redesignating footnotes 4 and 5 as 
footnotes 3 and 4, respectively.

    Done in Washington, DC, this 6th day of January 2017.
David Howard,
Acting Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2017-00532 Filed 1-18-17; 8:45 am]
 BILLING CODE 3410-34-P