Plant Pest Regulations
| Citation | 84 FR 29938 |
| Record Number | 2019-13246 |
| Published date | 25 June 2019 |
| Section | Rules and Regulations |
| Court | Animal And Plant Health Inspection Service |
Federal Register, Volume 84 Issue 122 (Tuesday, June 25, 2019)
[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Rules and Regulations]
[Pages 29938-29967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13246]
[[Page 29937]]
Vol. 84
Tuesday,
No. 122
June 25, 2019
Part IIDepartment of Agriculture-----------------------------------------------------------------------Animal and Plant Health Inspection Service-----------------------------------------------------------------------7 CFR Parts 318, 319, 330, et al.Plant Pest Regulations; Final Rule
Federal Register / Vol. 84 , No. 122 / Tuesday, June 25, 2019 / Rules
and Regulations
[[Page 29938]]
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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
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are revising our regulations regarding the movement of
plant pests. We are also adding criteria to the regulations for the
importation, interstate movement, and release of biological control
organisms. This final rule also establishes regulations to allow the
interstate movement of certain plant pests and biological control
organisms without restriction by granting exceptions from permit
requirements for those pests and organisms. Finally, we are revising
our regulations regarding the importation and interstate movement of
soil. This rule clarifies the points that we will consider when
assessing the risks associated with the movement and release of certain
organisms and facilitates the movement of regulated organisms and
articles in a manner that protects U.S. agriculture.
DATES: Effective August 9, 2019.
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; [email protected]; (301) 851-2237.
SUPPLEMENTARY INFORMATION:
Background
Under the Plant Protection Act (7 U.S.C. 7701 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.\1\
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.
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\1\ 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.
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In addition, section 7712(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 B--Movement of Plant
Pests'' (7 CFR 330.200 through 330.212) and ``Subpart C--Movement of
Soil, Stone, and Quarry Products'' (7 CFR 330.300 through 330.302) is
to prevent the dissemination of plant pests into the United States, or
interstate, by regulating the importation and movement in interstate
commerce of plant pests, soil, stone, and quarry products.
On January 19, 2017, we published in the Federal Register (82 FR
6980-7005, Docket No. APHIS-2008-0076) a proposal \2\ to revise our
regulations regarding the movement of plant pests to include criteria
for the importation, movement in interstate commerce, and environmental
release of biological control organisms, and 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 also proposed to revise our
regulations regarding the importation and interstate movement of soil.
We solicited comments concerning our proposal for 60 days ending March
20, 2017.
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\2\ To view the proposed rule, supporting documents, the comment
extension notice, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0076.
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We extended the deadline for comments until April 19, 2017, in a
document published in the Federal Register on February 13, 2017 (82 FR
10444, Docket No. APHIS-2008-0076). We received 62 comments by that
date. The comments were from State departments of agriculture, nature
centers, research laboratories, professional associations,
universities, industry groups, manufacturers, law firms, and private
citizens. The comments are discussed below by topic.
Definitions (Sec. 330.100)
We received comments regarding our proposed changes to Sec.
330.100, ``Definitions,'' including requests to include additional
terms to the section.
Two commenters asked about the purposes for which continued
curation permits are issued.
In proposed Sec. 330.200(a)(3), we included requirements for such
permits but did not provide a definition that explains their use. To
address these commenters, we are adding a definition for continued
curation permit to read as set out in the regulatory text below.
We proposed to add the term import (importation) to the list of
definitions in Sec. 330.100.
A commenter asked if our proposed definition of import
(importation) means that the organism or article in question arrives in
and originates from outside the United States.
The commenter is correct. We define importation to mean ``to move
into, or the act of movement into, the territorial limits of the United
States.''
A commenter asked that we add the term ``plant health'' to Sec.
330.100 and allow industry stakeholders to provide a definition for it.
We are making no changes in response to the commenter's request.
``Plant health'' is not used in any specific or technical context in
the proposed or current part 330 regulations and we consider the
generally understood meaning of the term to be sufficient.
We proposed to add the term responsible individual to Sec. 330.100
to mean the individual designated by the permittee to oversee and
control the actions taken under a permit. We are requiring the
assignment of a responsible individual to serve as the primary point of
contact in order to improve communication between the Animal and Plant
Health Inspection Service (APHIS) and the permittee. If the permittee
is an individual, that individual can assign him or herself to the role
should they so choose. We included as a condition that ``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.''
Several commenters raised questions about our proposed definition
of responsible individual. One commenter stated that our proposed
definition of responsible individual does not allow for a designee to
substitute for the responsible individual when that individual cannot
be at or near the
[[Page 29939]]
specified location for the duration of the permit due to illness or
vacation. The commenter added that, if taken literally, the definition
would likely result in nearly every permitted entity being in violation
of permit requirements at some point. Similarly, another commenter
stated that designating a responsible individual in a field release
application is complicated by the fact that the applicant is often not
the same person in charge of a field experiment station. The commenter
added that a company may test microbial formulations at dozens of
sites, making it impossible for one person to enforce permit compliance
and be physically present during business hours at each location. The
commenter requested that corporate permittees be allowed to designate
more than one responsible individual on a permit.
As the commenters noted, many permit applications for regulated
articles do involve multiple field sites under the shared
responsibility of several persons. Under current policy, we allow
application requests to include more than one responsible individual,
and more than one site within a single State may be designated as the
permit location. This approach has ensured that permit actions are
undertaken safely while accommodating stakeholder needs for
flexibility. Our intention in proposing the definition was to emphasize
responsible oversight of actions taken under the permit without
literally requiring an individual's presence during business hours at
all locations specified on the permit. Accordingly, we are removing the
requirement that the responsible individual 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. We continue to require that
the responsible individual or individuals ensure compliance with permit
conditions during all phases of the activities being performed.
We proposed to define taxon (taxa) to mean 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.
Two commenters asked for clarification of our proposed definition
of taxon (taxa), with one commenter suggesting that taxon (taxa) be
defined by the biopesticide and biostimulant industries.
We defined taxon as any recognized grouping or rank within the
biological nomenclature of organisms. This definition is consistent
with the term as it is used in the International Plant Protection
Convention (IPPC's) Glossary of Phytosanitary Terms.\3\ Aligning our
definition of taxon in this way makes it easier to communicate and
trade with other IPPC signatory countries. We disagree with the
commenter that industry stakeholders should develop a separate
definition of taxon, as doing so could result in a less flexible
definition and potential conflicts with the internationally recognized
IPPC definition.
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\3\ International Standards for Phytosanitary Measures, ISPM 5,
``Glossary of Phytosanitary Terms (2015): https://www.ippc.int/static/media/files/publication/en/2015/05/ISPM_05_En_2015-05-29_CPM-10.pdf.
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A commenter asked APHIS to add the term ``yield enhancement'' to
Sec. 330.100 and to define it as ``the use of microorganisms whose
function when applied to plants or the rhizosphere is to stimulate
natural processes to benefit nutrient uptake, nutrient efficiency,
tolerance to abiotic stress, and crop quality.''
While some organisms we propose to regulate may stimulate natural
processes in plants, we have no plans to define ``yield enhancement''
as we make no reference in the regulations to the term or the processes
listed by the commenter. The ability of organisms or products to
enhance plant yields is not a criterion that APHIS uses when
determining whether to regulate an organism as a plant pest or a
biological control organism.
Scope and General Restrictions (Sec. 330.200)
We proposed revising the subpart ``Movement of Plant Pests'' to
regulate not only plant pests but biological control organisms and
associated articles such as soil and packaging material. In proposed
Sec. 330.200, we specified the types of plant pests and biological
control organisms that APHIS would regulate. We also established
restrictions on the importation and movement of biological control
organisms and plant pests.
General Permit
In Sec. 330.200(a), we proposed to include a general permit as one
means by which we may authorize the movement of plant pests, biological
control organisms, and associated articles that we regard to be of low
risk in certain areas of the United States. We indicated that we have
only issued specific permits, that is, permits issued to individual
persons, for each movement of plant pests interstate. We noted,
however, that section 7711 of the PPA gives APHIS the authority to
issue general permits for the importation or interstate movement of
plant pests. Such a permit would authorize organizations that
frequently move certain low-risk plant pests and organisms interstate
to do so without having to obtain an individual permit for each
movement. The general permit for the plant pest or organism would be
posted on the APHIS website with a list of permit requirements. Persons
would not be required to sign a permit or record movements of the plant
pest or organism.
Some commenters endorsed the issuance of general permits for the
importation and interstate movement of low-risk pests, while others
expressed concern about whether a general permit will ensure adequate
accountability, enforceability, and risk management. One commenter
asked how a corporation or university would be able to apply the
conditions of a general permit to every situation and added that
assigning responsibility for a permit at an organizational rather than
an individual level will dilute that responsibility.
We acknowledge the concerns raised by commenters regarding general
permits and questions about accountability and will therefore continue
issuing only specific permits in which one or more responsible
individuals are identified in the permit and agree to abide by its
requirements. However, for future needs we are retaining in the
regulations the language we proposed for issuing general permits and
reaffirming our authority under the PPA to issue such permits. We will
continue to evaluate the uses and purposes of general permits, and
whenever we begin issuing them we will announce in a Federal Register
notice the existence, location, and content of each such permit we
issue.
Types of Plant Pests Regulated
In proposed Sec. 330.200(b), we specified the types of plant pests
that we would regulate under the revised subpart. For the purposes of
the subpart, we stated that we consider an organism to be a plant pest
if the organism directly or indirectly injures, damages, or causes
disease in a plant or plant product, or if the organism is not known to
be a 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.
Several commenters commented on the criteria by which APHIS
considers an organism to be a plant pest.
[[Page 29940]]
One commenter stated that it would be helpful if the criteria for
plant pests could be limited to identifying only pests that cause
direct, actual damage to beneficial plants rather than indirect damage.
As an example of indirect damage, the commenter cited an organism that
has a negative impact on another organism that in turn has a beneficial
impact on a desired crop or plant.
We identify those organisms that indirectly harm or cause disease
to plants and plant products as plant pests because the consequences of
indirect harm can be as disruptive and costly as direct harm,
particularly if such organisms establish themselves in the environment
or harm organisms having a beneficial impact on crops, to cite the
commenter's example. Moreover, the PPA specifically states that causing
``direct or indirect injury to plants or plant products'' is one
attribute of a plant pest.
Another commenter stated that a plant pest's effect on plants or
plant products is either known or unknown and asked for clarification
of proposed Sec. 330.200(b).
If an organism poses an unknown risk to plants or plant products
but is similar to a plant pest or pathogen known to directly or
indirectly injure, cause damage to, or cause disease in a plant or
plant product, we will regulate that organism pending positive
identification and an evaluation of the organism's actual risk to
plants and plant products.
One commenter recommended that, for organisms that are not known to
be plant pests, APHIS should notify the applicant of the reason a
permit was required and explain how the organism is similar to one that
meets the definition of a plant pest, thereby giving the applicant
information needed to address the agency's concern for future
regulatory actions for the organism.
We do not consider the commenter's suggestion to be practicable for
every permit application involving an organism not known to be a plant
pest. However, if a permit applicant has specific questions regarding
why a permit is required for a particular organism, we recommend that
the applicant contact APHIS.\4\
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\4\ For questions about organism and soil permits, please call
(301) 851-2357 or (866) 524-5421 (toll free), or email
[email protected].
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Types of Biological Control Organisms Regulated
In proposed Sec. 330.200(c), we listed the biological control
organisms we would regulate under the subpart. We stated that these
organisms consist of invertebrate predators, competitors, herbivores,
microbial parasites, and microbial pathogens used to control
invertebrate plant pests, plant pathogens, and noxious weeds.
A commenter stated that there are approved weed biological control
organisms that attack exotic invasive plants not currently listed as
``noxious weeds'' by a regulatory authority. For this reason, the
commenter recommended that in proposed Sec. 330.200(c) we use the term
``exotic invasive plants'' instead of ``noxious weeds'' when referring
to exotic invasive plants not officially identified as ``noxious.''
An exotic invasive plant can be considered a noxious weed and
regulated as such without being listed as a Federal noxious weed as
long as it meets the PPA's definition of a noxious weed. Meeting this
definition are new incursions of plants that, like listed noxious
weeds, can directly or indirectly injure or cause damage to crops,
livestock, poultry, other interests of agriculture, or the environment.
While federally-recognized noxious weeds are covered under 7 CFR part
360, the use of invertebrate herbivores and microbial pathogens to
control such weeds is covered under part 330.
A commenter stated that, for any imported biological control
organism, host-specificity testing documentation and identification
verification are essential for protecting the resources of the United
States.
We agree with the commenter. We exercise considerable care to
ensure host specificity before approving an organism for release into
the environment. As necessary, we conduct host-specificity testing
documentation and identification verification as part of evaluating a
permit application. Persons with questions about applications and uses
of organisms and host-specificity testing can contact the person listed
above under the heading FOR FURTHER INFORMATION CONTACT.
EPA Oversight
In proposed Sec. 330.200(d), we exempted from this subpart
biological control organism products regulated by the Environmental
Protection Agency (EPA). This oversight exemption applies only to EPA
registered products, experimental use permits, Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) section 18 emergency exemptions,
the importation of pesticides being imported under a EPA Pesticide
Notice of arrival, as well as the interstate movement of pesticides
being moved in accordance with EPA's regulations in 40 CFR 152.30, If
EPA does not regulate an organism under APHIS jurisdiction, APHIS would
regulate it regardless of whether it is commercial (applied to more
than 10 acres) or experimental.
A commenter stated that while the regulatory status of microbial
pathogens regulated by EPA is clear, the proposed rule was ambiguous
regarding organisms that have been formulated into plant growth-
promoting products, also known as biostimulants. The commenter asked
what the framework is for regulating plant growth-promoting microbial
pathogens and organisms as commercial products excluded from
registration under FIFRA.
Although APHIS is not authorized under the PPA to regulate products
based on their biostimulant properties, the Act does allow APHIS to
regulate and impose restrictions on a product in order to prevent the
introduction or dissemination of plant pests within the United States.
APHIS will evaluate each product and its uses to assess their potential
plant pest risks and determine whether restrictions are warranted based
on plant pest risk. Manufacturers or producers of products that EPA
determines not to require registration should not assume that they
would not be subject to regulation by APHIS under part 330.
A commenter stated that the proposal to establish criteria for the
movement and release of unregistered microbial pesticides needs to be
clarified in the regulations, suggesting that the expanded ability to
import biological control organisms should also include the following:
Research samples containing organisms that were part of a fermentation
process destined to become an EPA registered bio-pesticide, material no
longer meeting EPA-established specifications (expired lots), partially
formulated bio-pesticides, experimental formulations, culture strains,
and quality control samples.
We will continue to observe EPA's jurisdiction over organisms
subject to their regulations as described in Sec. 330.200(d). Other
organisms falling outside EPA's jurisdiction but within the scope of
APHIS' authority under the PPA will be subject to the regulations under
part 330 as appropriate.
A commenter stated that having EPA-registered microbial pesticides
be exempt from current APHIS regulations is a positive benefit, but
that there needs to be clear, documented guidance to allow for
successful clearances at U.S. border facilities.
We noted in the proposed rule that biological control organisms
that are pesticides and not registered with EPA,
[[Page 29941]]
but that are transferred, sold, or distributed in accordance with EPA's
regulations in 40 CFR 152.30, would not be regulated under this subpart
for their importation or interstate movement. However, persons desiring
to import shipments of biological control organisms that are subject to
FIFRA will need to submit to EPA a Notice of Arrival by Pesticides and
Devices as required by U.S. Customs and Border Protection (CBP)
regulations. APHIS is working closely with CBP and EPA to ensure that
such guidance is available and sufficient for clearances at U.S. border
facilities.
One commenter asked if APHIS would issue general permits through
the process outlined in a Memorandum of Understanding (MOU) with EPA or
provide details of the process through APHIS guidance documents.
APHIS has no plans to continue issuing permits for the importation
of EPA-registered materials. These items will be imported under EPA's
regulatory oversight.
In addition to the MOU between EPA and APHIS, a commenter asked if
there would be ongoing coordination between the agencies for regulating
new products.
We intend to continue coordinating with EPA with respect to
coordinating regulation of new products not yet registered by EPA.
APHIS typically confirms EPA product registrations containing specific
strains and maintains its own permitting database to include these
strains.
A commenter asked if the APHIS regulatory oversight exemption for
EPA-regulated materials applies to registered Technical Grade Active
Ingredient, End Product, Active Ingredients, and Experimental Use
permit materials, as well as Section 18 requests.\5\ The commenter
added that according to the guidance available, no APHIS permit would
be required for any of these products.
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\5\ Permits issued under section 18 of FIFRA that allow State
and Federal agencies to permit the unregistered use of a pesticide
in a specific geographic area for a limited time if emergency pest
conditions exist.
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The commenter is incorrect. The exemption applies only to EPA
registered products and experimental use permits or pesticides being
imported under a EPA Pesticide Notice of Arrival.
A commenter stated that in order to prevent ``double regulating,''
APHIS should enter into an MOU with the U.S. Fish and Wildlife Service
(USFWS) as it has done with EPA. The commenter stated that USFWS
exempts arthropods from their oversight that are ``farm raised'' per
the definition in 50 CFR 14.4. The commenter added that many
commercially produced biological control arthropods have been farm
raised for decades and fall under the definition, nevertheless USFWS
requires permits at several ports of entry for organisms already
regulated by APHIS.
We acknowledge the commenter's concern to prevent double regulating
by APHIS and USFWS and will continue to work with affected entities and
the USFWS to identify and address instances of this occurring.
The same commenter recommended that APHIS establish a policy
concerning symbionts \6\ of pests, noting that while symbionts can
promote pest fitness, they can also exist in non-pest contexts, as when
a symbiont has multiple hosts. The commenter suggested that we define
``symbiont'' accordingly, as microbial taxa will inevitably occur on a
pest host as environmental contaminants. The commenter stated that if
detection on a pest host defines a symbiont organism, all environmental
taxa might fit the definition of ``symbiont'' because of ephemeral
encounters by pest hosts moving within their normal environments.
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\6\ Generally defined as organisms that live in symbiosis with
one another.
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We acknowledge the commenter's concern but have no plans to provide
a definition for ``symbiont.'' We do not use the term in the
regulations, and establishing a regulatory policy for all invertebrate
plant pests and biological control organisms under a single definition
of the term would by necessity be overly broad. Symbiont relationships
may be beneficial or detrimental to the organisms involved in
combinations and environmental contexts too varied to document.
Moreover, the available information regarding symbionts of any
particular organism is typically incomplete, with a knowledge base
frequently needing to be updated and revised. For these reasons, APHIS
will retain the authority under the regulations to regulate symbionts
as necessary on a case-by-case basis.
A few commenters stated that we did not define what we mean by
``similar'' in proposed Sec. 330.200(b), ``Plant pests regulated by
this Subpart,'' with respect to similarities existing between plant
pests having an unknown risk potential and those having a known risk
potential. One such commenter suggested that a definition of
``similar'' be defined through guidance instead of including it in the
regulations so that APHIS will have sufficient flexibility to define
the term based on evolving science. Another commenter noted that
regulating organisms based on similarities to other regulated organisms
could result in unintended consequences and suggested that such issues
may be mitigated in part by using tools such as molecular evaluation of
organisms.
We did not include a definition of ``similar'' in the proposed
regulations as it is an inherently relative term, and as a commenter
noted, scientific methods and genetic comparison techniques are
evolving rapidly and requiring APHIS to maintain a degree of regulatory
flexibility. A broad definition of ``similar'' that attempts to cover
every possible situation would require potentially arbitrary
restrictions on the characteristics used to compare organisms. If an
initial comparison of an organism reveals similarities with a known
plant pest or pathogen, we will undertake a closer evaluation of the
pest risk potential for that organism.
Permit Requirements (Sec. 330.201)
Under the proposed section ``Permit requirements,'' we listed the
types of permits that would be required for the importation, movement
in interstate commerce, and particular uses of plant pests, biological
control organisms, and associated articles. We also proposed
requirements for permit applicants as well as procedures for evaluating
and taking action on permit applications.
In proposed Sec. 330.201(a), we listed the types of permits that
APHIS would issue for plant pests, biological control organisms, and
associated articles. We also listed permit application requirements and
conditions under which APHIS would assess applications and issue, deny,
suspend, revoke, and amend permits.
One commenter stated that instead of requiring persons to apply
separately for permits for different plant pathogens, APHIS should
develop a list of conditions under which qualified persons can
transport pathogen cultures, infected plant material, and infected soil
under a blanket permit for organisms that will not be released or
organisms that are native to a State. The commenter added that having
to obtain new permits for every sample can be restrictive with respect
to sharing isolates.
The commenter appears to be describing the general permit that we
included in the proposal under Sec. 330.200(a). In the above
discussion of Sec. 330.200, we decided to defer issuing general
permits but are retaining the provision for issuing such permits for
[[Page 29942]]
future needs. However, we acknowledge the commenter's suggestion and
note that other options are available. Applicants meeting the
requirements in proposed Sec. 330.201 may include more than one type
of organism and its intended use in a permit application, especially
within a discipline such as plant pathology, but we often ask that
arthropods and plant pathogens appear on separate applications. This
lessens confusion for permit reviewers, permittees, and State and
Federal regulators. APHIS also maintains lists of plant pathogenic
fungi, bacteria, and viruses recognized as widely prevalent within
various States. Finally, we note that we are establishing a petition-
based process for listing certain biological control organisms and
plant pests (in Sec. Sec. 330.202 and 330.204, respectively) that may
be moved interstate within the continental United States without
restriction.
A commenter stated that the availability of a comprehensive list of
pathogens that APHIS considers to be high-risk plant pests would
alleviate the permit application process and reduce follow-up
questions. The commenter added that such a list would help to ensure
that sufficient evidence is provided to APHIS for scientific review.
We acknowledge the commenter's suggestion for improving the permit
application process. However, we do not consider it practical to
compile a comprehensive list of high-risk plant pests, as any criteria
we might develop to identify such pests is subject to many situational
variables that require case-by-case evaluation. We note that in 7 CFR
331.3 we maintain a list of high-risk biological agents and toxins that
have the potential to pose a severe threat to plant health or plant
products. Persons applying for a permit for what they believe may be a
high-risk organism are encouraged to contact APHIS with any questions
they have about preparing and submitting an application.
We proposed in Sec. 330.201(a)(1) that when import permits are
issued to a corporate entity, that entity will need to maintain an
address or business office in the United States with a designated
individual for service of process.
A commenter stated that APHIS should consider whether ``designated
individual for service of process'' should use the term in the plural
as a way to create more flexibility for the permittee.
``Service of process'' is the act of serving notice of legal action
against another party. The ``designated individual'' in proposed Sec.
330.201(a)(1) is a person located in the United States who receives
notice of legal action on behalf of the corporate entity. As a
corporate entity can designate more than one individual to act in this
role, we will change the wording to read ``one or more individuals.''
One commenter noted that many biological products companies conduct
research activities in U.S. territories and requested that corporate
permits be allowed to cover such activities in those areas.
U.S. territories, as well as the District of Columbia, fall within
the definition of State under the PPA and part 330, so interstate
movement permits for activities regulated under part 330 may be issued
for movement from those areas.
Curation Permits
In proposed Sec. 330.201(a)(3), we set forth provisions regarding
continued curation permits, which are issued in conjunction with either
an import permit or interstate movement permit prior to the expiration
date of the permit.
A commenter asked whether continued curation permits as proposed in
Sec. 330.201(a)(3) are also intended to cover research and diagnostic
activities.
Continued curation permits are issued prior to the expiration date
for an import or interstate movement permit in order for a permittee to
continue research or other actions listed on the import or interstate
movement permit. Before a continued curation permit can be issued, the
required laboratory conditions for safeguarding organisms received or
isolated for research under an import or interstate movement permit
must be reevaluated.
Two other commenters asked that we clarify the difference between a
continued curation permit and the renewal of an existing movement
permit authorizing diagnostic or research activities.
Continued curation permits do not allow acquisition of additional
organisms for research and other authorized activities and only address
retention of existing organisms for authorized uses. Continued curation
permits are intended for situations in which the permit applicant
wishes to retain live regulated organisms but does not request
permission for their continued or additional movement, which would
require a separate permit. The renewal of a permit would allow for such
movement, although it is not required that movement occur. Thus it is
usually more desirable to renew a permit authorizing movement in case
organisms need to be restored or additional organisms might need to be
received.
Application Process and Permit Issuance
In proposed Sec. 330.201(b), we provided that permit applications
would have to be submitted by the applicant in writing or
electronically via the internet.
A commenter requested that APHIS continue to modernize its
information technology systems to enable multistate listings on a
single permit application as allowed by APHIS for permits under its
biotechnology regulations in 7 CFR part 340.
We acknowledge the commenter's request. APHIS is modernizing its
information technology systems and is currently making only critical
technical improvements. However, we will consider including this
feature in future updates to the permit application page on the Plant
Protection and Quarantine (PPQ) website.
Another commenter stated that it would be useful for applicants to
track the progress of permit applications.
We note that a tracking feature exists in the current online
electronic permitting system.\7\
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\7\ To access an existing account or register for a new APHIS
ePermits account, visit ePermits at https://www.aphis.usda.gov/aphis/resources/permits.
---------------------------------------------------------------------------
One commenter suggested that it might be helpful to have affected
scientific societies and their members involved in designing the APHIS
permitting process.
APHIS typically solicits comments and feedback from scientific
societies and other stakeholders to continuously improve our permitting
process. In addition, APHIS received considerable input from other
Federal agencies, State regulatory officials, and industry prior to
developing the proposed rule.
In the preamble discussion of proposed Sec. 330.201(c), we noted
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. We intended this number of days to be a suggestion to
help ensure that permit decisions are made prior to the applicant's
proposed permit activity.
One commenter asked that we define ``novel'' within the scope of
APHIS' legal authority under the PPA as it relates to plant pests,
noxious weeds, and biocontrol organisms. The commenter stated that
``novel'' should
[[Page 29943]]
be defined solely within the scope of APHIS' legal authority under the
PPA and not in a general sense.
We disagree with the commenter that our use of the word ``novel''
is outside the scope of our authority under the PPA. The commenter is
referring to our use of the word ``novel'' in the proposed rule when
referring to permit applications, in which we state that additional
time should be allotted for submitting ``complex or novel applications,
or applications for high-risk plant pests.'' Such applications
typically include new or unusual processes, safeguards, designs, and
methods of organism destruction. As APHIS' primary purpose under the
PPA is to safeguard the United States against the introduction or
infestation of plant pests, noxious weeds, and biological control
organisms, novel applications require additional evaluation to ensure
that the intended activities do not harbor a new or unforeseen plant
pest risk.
Another commenter stated that the proposed rule does not indicate
whether the targeted 90 days for submission of a permit application
pertains to permits for imports, interstate movements, field releases,
or all of these, and asked for clarification.
The guidance regarding 90 days to allow for sufficient processing
was suggested for all permit applications.
Two other commenters asked that we provide timelines for permit-
related actions and decisions. One suggested that a consultation
timeline of 30 days and a permitting timeline of 60 days is reasonable.
As we indicate on the PPQ Plant Health website,\8\ permit
applications can be processed in as little as 30 days after they are
received, but the specific circumstances of many applications make it
difficult to publish accurate timelines for evaluating and making
decisions on them. These circumstances can include the need for a
facility inspection, the need to obtain additional equipment or
equipment certifications, or the need for additional information from
the applicant. Persons inquiring about the status of a permit
application can contact APHIS.\9\
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\8\ The website address is: https://www.aphis.usda.gov/planthealth/organism-soil-permits.
\9\ See footnote 4 for contact information.
---------------------------------------------------------------------------
As part of APHIS' action on permit applications, we noted in
proposed Sec. 330.201(d)(1) that we will share a copy of the
application and the proposed permit conditions with the appropriate
State or Tribal regulatory officials.
A commenter stated that APHIS should ensure that proper procedures
are in place whenever sensitive permit application information is
shared with States or Tribes. The commenter stated that many States and
other entities do not have procedures in place to protect sensitive
information to the extent that Federal agencies such as APHIS do,
adding that many of them are legally required to provide information in
their possession through ``Sunshine Acts'' and similar public
disclosure laws.
We acknowledge the commenter's concern regarding the protection of
sensitive and confidential information. Although APHIS may sometimes
request confidential business information as part of the permit
application process, as a matter of policy we do not share the
sensitive or confidential business information included in applications
with States or Tribes.
Another commenter asked if APHIS informs the permit applicant when
an application is shared with other persons or groups for analysis, and
if so, whether the applicant is informed of who those persons or groups
are. The commenter also asked how APHIS handles any objections arising
from sharing permit information with third parties.
APHIS typically does not inform permit applicants about details of
the evaluation process, of which deliberations with outside experts is
sometimes a part. However, if an applicant has questions or concerns
about the status of an application and how it is evaluated, he or she
can contact APHIS.\10\
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\10\ See footnote 4.
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We indicated in proposed Sec. 330.201(d)(3)(ii) that permits would
be valid for no more than 3 years. One commenter stated that a
timeframe of 5 years for a permit to be valid would be more desirable.
We acknowledge the commenter's view but are making no changes to
the proposal. Evolving developments in science, technology, and policy
necessitate a re-evaluation of permits every few years. Under a longer
timeframe, the original conditions of permitted activity could become
obsolete or be subject to new policy or regulatory changes.
One commenter said that the requirements for biocontrol agents as
currently administered are burdensome. The commenter noted that the
APHIS Level 2 user requirement is a significant hurdle to working with
many organizations because they are required to obtain this level
before they can apply for permits.
The commenter is referring to the requirement for obtaining a Level
2 user account from APHIS, which allows users to apply for permits
electronically through the APHIS ePermits system. The ePermits system
currently supports Level 2 users for all permit application types and
Level 1 users for selected permit application types. Level 2 access
differs from Level 1 in that it requires identity authentication either
through correctly answering online identity verification questions or
by presenting a Government-issued photo ID at a local U.S. Department
of Agriculture (USDA) office.\11\ APHIS considers the procedures for
obtaining a Level 2 user account to be necessary to maintaining
adequate security and we do not believe its requirements to be unduly
burdensome.
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\11\ See the website address in footnote 7 for more information
about obtaining an ePermits account.
---------------------------------------------------------------------------
In proposed Sec. 330.201(d)(3), we indicated that APHIS may issue
a permit to an applicant if APHIS concludes that the actions indicated
in the permit application are not likely to introduce or disseminate a
plant pest, biological control organism, or noxious weed within the
United States in a manner that exposes plants and plant products to
unacceptable risk.
A commenter stated that a purely risk-based approach on deciding
whether to issue permits does not consider benefits to U.S.
agriculture. The commenter said that the presence of a ``balancing
condition'' that considers both risks and benefits is most appropriate
for agriculture, and that the absence of such biological control
alternatives has resulted in the current standard of chemical control
with its associated risks. Another commenter similarly expressed
support for researchers who consider both the risks and the benefits of
imported biocontrol agents. The commenter noted that Australia has long
been a leader in the regulation of biocontrol agents and has included
in its analyses both the risks and benefits of importing biological
control organisms.
The primary mission of APHIS is to safeguard American agriculture
and the environment by applying and enforcing adequate protections to
prevent the introduction and spread of harmful organisms. Although we
are aware that both risks and benefits can be inherent in any
permitting decision, the PPA provides us with no directive to consider
benefits when issuing import or movement permits. While the PPA
indicates that APHIS should facilitate
[[Page 29944]]
the use of biological controls,\12\ no part of the Act directs us to
consider benefits other than safeguards to reduce risk.
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\12\ See PPA, section 7701(2), Findings.
---------------------------------------------------------------------------
On a practical level, the environmental risk or benefit occurring
from release of an organism is circumstantial and difficult to predict.
Conducting a risk/benefit analysis requires making assumptions and
analyzing hypothetical situations that may or may not occur. Moreover,
once a released organism establishes itself in the environment, there
may be no way to reverse the action if unexpected risks arise or
expected benefits never materialize.
A commenter asked if APHIS evaluates risk differently for different
activities when considering issuing a permit for the release of
biological control organisms, such as greenhouse releases versus field
releases, or for agricultural purposes versus recreational or
celebratory events such as weddings. The commenter suggested that APHIS
should consider relative risk when making release determinations.
We agree with the commenter. APHIS always evaluates movement or
release risk of organisms relative to the individual species and its
intended use.
A commenter noted that in proposed paragraphs (d)(3) and (4) of
Sec. 330.201, we explain the processes for permit application issuance
and denial but provide no details of the initial consultation. The
commenter referred to an initial consultation process presented by
APHIS-PPQ in September 2016 in which potential applicants consulted
with APHIS to determine whether an organism required a permit and, if
it did, to gain initial feedback on what data would need to be provided
in an application. The commenter asked that we include the consultation
process in the regulations to provide transparency and consistency for
the entire permitting process.
We do not plan to establish a formal consultation process in the
regulations, as the consultation process is specific to the
circumstances of each application. However, we will continue to use an
informal process of initial consultation for complex situations on a
case-by-case basis.
Two commenters raised concerns about the Letters of No Jurisdiction
(LONJ) that APHIS issues in response to permit applications for
organisms or products that do not fall under APHIS regulatory
authority. One commenter acknowledged that although LONJs are important
for clearing imported samples through customs, the letters sometimes
contain extraneous information that can be confusing to CBP agents. The
commenter cited as an example a LONJ stating that a sample can only
move from a certain country to a certain State even though APHIS has no
jurisdiction over the sample. The commenter asked that we not include
country, State, and address information in the LONJ and simply state
that the organism is not regulated by APHIS and can be imported and
moved without restriction. Another commenter similarly asked that APHIS
revise the LONJ to state specifically that all actions taken with the
organism or product, such as movement and release, are not under APHIS
jurisdiction.
We acknowledge the commenters' concerns and will consider revising
our LONJ templates accordingly. If APHIS issues a LONJ for an organism
or product, it means that APHIS has no jurisdiction over its movement
or release. However, we encourage persons to determine whether other
Federal or State agencies have jurisdiction over actions relating to
the organism or product.
A commenter requested that APHIS develop guidance to help permit
applicants provide the appropriate information to show that an organism
is not a plant pest. The commenter stated that if the applicant can
provide such information, APHIS should issue a LONJ to the previous
permit holder.
We are making no changes in response to the comment's request.
Guidance regarding the determination of jurisdiction is intended to be
specific to the taxonomic identity and biological properties of the
organism listed in the permit application and is not retroactive to
previous permit holders. APHIS will continue to work with applicants on
a case-by-case basis.
A commenter asked that we not issue Letters of No Permit Required
with an expiration date, as doing so results in additional
administrative activities for APHIS and the applicant to obtain the
same letter again following its expiration. The commenter acknowledged
that APHIS has the authority to rescind this letter if circumstances
change and the activities instead need to be conducted under a permit.
APHIS issues Letters of No Permit Required for organisms and
products over which APHIS has legal authority but has determined that
movement of the organism or product presents no appreciable risk.
However, as a condition of granting an exception from permit
requirements, the letter may base the exception narrowly on how the
organisms are used, their geographical location, or other
circumstances. Although most such letters issued by APHIS do not
include expiration dates, we reserve the right to include them when
warranted to maintain the flexibility needed to minimize risks to
plants and plant products.
One commenter stated that the proposed permitting requirements for
movement or importation of organisms are not consistent with how APHIS
administers the permitting process. According to the commenter, the
APHIS website states that a PPQ 526 permit typically is not required
for the interstate movement or release into the environment of
domestically isolated microorganisms that are not plant pests and that
are widely distributed in the continental United States. The commenter
stated that, despite what the website says, APHIS currently requires
permits for microorganisms that are not plant pests that are found and
collected in multiple locations in the continental United States.
We regulate microorganisms if they are known plant pests, act as
direct biological control organisms, or if their mode of action is
unknown. We are therefore obligated to require permits for their
interstate movement and importation regardless of how common they are
in the environment. We will review our website content and clarify any
requirements that may be unclear to readers.
In proposed Sec. 330.201(d)(5), we included provisions for the
withdrawal of a permit application. Applicants who wish to withdraw a
permit application are required to provide this request in writing to
APHIS, which in turn notifies the applicant regarding reception of the
request and withdrawal of the application.
A commenter representing a State government wanted to know if
withdrawals of applications by permit applicants could be posted on the
APHIS ePermit website, or if States could otherwise be notified of the
withdrawal. The commenter stated that knowledge of application
withdrawals helps the State maintain a better awareness of pest and
biocontrol-related activities of familiar and new applicants.
Permit applications withdrawn by APHIS at the request of the
applicant are recorded internally within the ePermit system. APHIS does
not plan to modify the system to share additional information with
States or stakeholders about applications that are not processed to a
permit decision. If we consider a permit withdrawal to materially
affect a State's agricultural or environmental welfare, we will share
[[Page 29945]]
this information with the State accordingly.
Biological Control Organisms (Sec. 330.202)
In proposed Sec. 330.202, we presented criteria for the
importation, interstate movement, and release of biological control
organisms. We noted that we regulate biological control organisms under
authority of the PPA insofar as they have the potential to pose a plant
pest or noxious weed risk.
In Sec. 330.202(a), we proposed general conditions for the
importation, interstate movement, and release of biological control
organisms. We proposed that, except as provided in proposed Sec.
330.202(b), no biological control organism regulated under the subpart
may be imported, moved in interstate commerce, or released into the
environment unless a permit has been issued in accordance with Sec.
[thinsp]330.201 authorizing such importation, interstate movement, or
release.
A commenter asked how APHIS will determine the pest risk to plants
and plant products when considering issuing a permit for a biological
control organism.
If APHIS determines the requested biological control organism is
not established in the continental United States and will be a first-
time release into the environment, we will undertake a more
comprehensive evaluation of the permit application. APHIS will conduct
a scientific risk review of the proposed release of the particular
organism.
Biological Control Organisms: Exceptions From Permitting
In the proposed rule, we established a notice-based process \13\ by
which persons could submit petitions for excepting certain biological
control organisms from permitting requirements for importation,
interstate movement, or environmental release. As part of this informal
adjudication process, we will evaluate each petition we receive to
determine whether the biological control organism is of a sufficiently
low risk. If we determine there is sufficient evidence that the
organism exists throughout its geographical or ecological range in the
continental United States and that subsequent releases of the organism
into the environment will present no additional plant pest risk, we
will announce the availability of the petition in a notice published in
the Federal Register and solicit public comment.
---------------------------------------------------------------------------
\13\ We also proposed establishing in Sec. 330.204 a parallel
process for excepting certain plant pests from permitting
requirements.
---------------------------------------------------------------------------
After we consider the comments we receive, we will announce our
final decision on whether to except the organism from permitting
requirements in a subsequent notice published in the Federal Register.
The final notice constitutes final agency action, which is subject to
being challenged in court under the Administrative Procedure Act.
We proposed the petition process for permit exceptions because we
determined that certain low-risk biological control organisms have
become established throughout their geographical or ecological range in
the continental United States. The additional release of pure cultures
derived from field populations of taxa of these organisms into the
environment presents no additional plant pest risk (direct or indirect)
to plants or plant products. We posted draft lists of these organisms
for comment online.\14\
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\14\ See footnote 2 for the draft lists, which include
``Invertebrate Organisms for the Biological Control of Weeds'' and
``Invertebrate Organisms for the Biological Control of Invertebrate
Plant Pests.'' These lists will be published and maintained on the
PPQ Permits and Certifications website: https://www.aphis.usda.gov/aphis/resources/permits.
---------------------------------------------------------------------------
Referring to the list of organisms excepted from permitting
requirements, a commenter asked APHIS to provide examples of items that
would be in the list.
We posted examples of invertebrate organisms excepted from permit
requirements for review and comment in an online list.\15\ Products
consisting of mixtures of biological control organisms may also be
eligible for exceptions from permitting provided that all organisms
included in the formulation appear on the list of exceptions.
---------------------------------------------------------------------------
\15\ See footnote 2.
---------------------------------------------------------------------------
With respect to a taxon's establishment throughout its geographical
or ecological range, a commenter asked what the taxon is and does it
have one strain or multiple strains.
As we noted in our proposed definition of the term, a taxon can be
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. A taxon can
contain one strain or multiple strains.
A commenter asked if taxon identification will be based on whole
genome sequencing.
APHIS will require identification using techniques appropriate for
the taxon and the particular circumstances of the permit request.
The same commenter also asked whether a permit will be required to
move an organism to a State outside its range if an organism is
established throughout its geographic or ecological range within the
United States.
If an organism is on the list of biological control organisms
excepted from permit requirements, that organism will not require a
permit for interstate movement within the continental United States.
Inclusion on the list indicates sufficient evidence that the species on
the list cannot persist outside of its recorded range and that the
species has already had ample opportunity to do so naturally.
The commenter also asked if APHIS will provide public access to the
information that we use to determine a taxon's geographical or
ecological distribution.
APHIS will provide access to the information referenced by the
commenter. If a person petitions for a species to be added to the list
of biological control organisms excepted from permit requirements, they
do so with the understanding that we will make publicly available any
information submitted by the petitioner with respect to determining the
distribution of that species.
A commenter representing a State expressed concern that allowing
certain biological control organisms to be moved interstate within the
continental United States without further restriction does not take
into account the organism's status in individual States and that any
such list would need to be subject to review by individual States where
agents will be used.
As we noted in proposed Sec. 330.201(d)(1), APHIS will share a
copy of the petition with the appropriate State or Tribal regulatory
officials. APHIS does not approve the use or distribution of biological
control organisms within the continental United States without first
considering the organism's status in individual States. We also note
that Sec. 330.202(e) indicates that any organism may be removed from
the list of organisms excepted from permitting requirements if
information emerges that would have otherwise led APHIS to deny the
petition to add an organism to the list.
In paragraph (b)(1) of Sec. 330.202, we proposed that pure
cultures of organisms excepted from permitting requirements may be
imported into or moved interstate within the continental United States
without further restriction under subpart B of part 330.
[[Page 29946]]
Citing pest risk concerns, several commenters recommended that all
imported biological control organisms be excluded from the draft list
of organisms excepted from permitting and that such imported organisms
not be eligible for the proposed permit exception process. One
commenter stated that biological control organisms could be imported
from unverified sources and result in the inadvertent introduction of
exotic parasitoids. The commenter added that the risk is high for weed
biocontrol agents and plant pests because herbivores from a different
geographic source than the originally introduced population often have
different host ranges or are discovered to be a different species.
Another stated that the proposed rule does not account for different or
new foreign sources that would be added to the list of pests and
organisms excepted from permit requirements, which may present varying
levels of risk in terms of the reliability of sources to ensure correct
identification, safe release practices, and freedom from contamination
by harmful species.
While we have confidence in our proposed petition-based process for
excepting organisms from permit requirements that pose a low risk to
plants or plant products, we acknowledge that the importation of
organisms from new sources and geographic locations could be a
potential source of new unapproved exotic species or parasites and
diseases of those species. An imported plant pest poses a potentially
higher risk level than the same domestic species moved interstate
because the former may be carrying unknown diseases or microbial
pathogens from the foreign source. Therefore, we will continue at
present to require permits for the importation of biological control
organisms and plant pests in order to continue the appropriate
safeguards with respect to foreign sources. As we envision that
stakeholders may wish in the future to import low risk species such as
Drosophila melanogaster, we will retain the petition process for
excepting biological control organisms and plant pests from permitting
requirements in Sec. Sec. 330.202 and 330.204, respectively. If we
receive petitions for importing certain organisms or pests without a
permit, we will review and consider making the petitions available for
public comment. Any organisms and pests that APHIS lists as being able
to be moved interstate without a permit will not be eligible to be
imported without a permit unless APHIS expressly indicates otherwise.
One commenter objected to any regulation of the interstate movement
of beneficial insects and mites because they are not plant pests. The
commenter stated that the proposed regulatory changes would place
beneficial insects and mites under the same movement restrictions
applied to plant pests unless they are included in the list ``Organisms
for the Biological Control of Invertebrate Plant Pests.'' The commenter
stated that this list should be used to determine whether organisms can
cross international boundaries unhindered but that no interstate
movement of beneficial insects and mites should be regulated. The
commenter also suggested that entire taxa containing no plant pests
should be included in the proposed list of excepted organisms, as
parasites and predators of plant pests except weed biocontrol agents
should be ``innocent until proven guilty.'' The commenter cited as an
example of such taxa the predatory mite family Phytoseiidae, which
according to the commenter contains no species known to cause harm to
plants.
We are making no changes with respect to our proposal to regulate
beneficial invertebrates as biological control organisms. In response
to previous documents published in the Federal Register in which we
discussed codifying requirements for biological control organisms, some
commenters stated that APHIS should regulate biological control
organisms only when their efficacy at controlling a target plant pest
or noxious weed is in question. However, the risk exists that
nonspecific and indiscriminant invertebrate parasites and predators
intended for beneficial purposes can also attack non-target
invertebrates that are themselves beneficial as pollinators or
biocontrol organisms. The draft list we posted for public review and
comment contains only those organisms for which there exists an
established record of observed information and that meet the criteria
for exception from permitting set forth in the regulations. We took
this approach to the list to minimize the potential direct or indirect
plant risk that adding entire taxa could pose absent an evaluation of
the risk potential of these taxa. As authorized under the PPA, APHIS is
required to evaluate the plant pest effects that organisms may pose to
non-target plants and plant targets and regulate them until we are
certain that such organisms can be safely released into the environment
without further restriction.
Pure Culture
A number of commenters asked us to define ``pure culture.'' One
commenter noted that many products containing biological control
organisms are typically formulated with carrier or host material, such
as insects as a food source for entomophagous mites, and asked if such
formulations can be considered as pure cultures. Another commenter
stated that the requirements for pure cultures need to be clearly
defined to ensure they consist of only specified biological control
organisms free of predators, parasites, and pathogens, and contain no
host material such as exotic invasive plant propagules. Another
commenter expressed concern about how identification or purity of
organisms could be assured prior to release into the environment,
particularly as the term ``pure culture'' does not appear to be defined
in law or policy.
We acknowledge that defining the term ``pure culture'' will provide
stakeholders with a clearer understanding of requirements under the
regulations and what constitutes a ``clean'' package of organisms
excepted from permitting requirements, especially for field collected
sources for weed biocontrol. Accordingly, we will define the term pure
culture as a single species of invertebrate originating only from an
identified/described population and free of disease and parasites,
cryptic species, soil and other biological material, except host
material and substrate as APHIS deems appropriate. Examples of
``identified/described population'' are those originating from a
specific laboratory colony or field collection from a specified
geographic area, such as an entire country, or States or provinces of a
country.
For the excepted biological control organisms listed on the PPQ
Permits and Certifications website (referenced in Sec. 330.202(b)), we
will also include the sources for each species excepted from permit.
For example, species of commercial entomophagous biological control
organisms will require verification that they are from domestic
laboratory colonies. Likewise, weed biological control organisms will
need to be field collected from within the continental United States or
derived from domestic colonies from those field sources.
Another commenter asked how ``pure culture'' will be defined if
organisms are harvested from the established geographical or ecological
range in the continental United States.
As we noted above, a pure culture consists of a single species of
invertebrate originating only from an identified/described population
and free of disease and parasites, cryptic species, soil and other
biological material except
[[Page 29947]]
host material and substrate. The source of the organism may originate
from the species' established geographical or ecological range within
the continental United States.
Another commenter asked whether the term ``pure culture'' also
includes ``pure populations'' in reference to invertebrates.
We cannot answer the commenter's question as we do not know what is
meant by ``pure populations'' and how it differs from ``pure culture.''
A commenter stated that ``pure culture'' can mean a single species
derived from a population in a defined geographical area, but added
that the biological control industry also considers the term to mean
the absence of contamination in commercial inbound shipments and
compliance with ``truth in labeling'' laws that require a package's
label to be identical to its content. The commenter stated that
packages are randomly checked by USDA inspectors for permitted
organisms and that clarification is needed on how to resolve purity
issues in organisms excepted from permitting requirements.
As we noted above, we will continue at present to require permits
for the importation of biological control organisms and plant pests but
will retain the petition process we proposed for excepting biological
control organisms and plant pests from permitting in Sec. Sec. 330.202
and 330.204, respectively. If we receive petitions to allow the
importation of certain organisms or pests without a permit, we will
review them and submit them for public comment.
A commenter asked what additional documentation or certificates may
be required to move organisms and products defined as pure cultures,
and what provisions will be implemented to ensure clarity with
inspectors when importing listed organisms.
Documents and certificates required to move organisms and products
are typically listed on the permit. APHIS provides guidance to CBP so
that inspectors are clear about importation requirements for biological
control organisms and products.
A commenter recommended that to ensure all redistribution efforts
for weed classical biological control organisms, APHIS should consider
the Code of Best Practices for Classical Biological Control of
Weeds.\16\
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\16\ Proceedings of the X International Symposium on Biological
Control of Weeds 435 4-14 July 1999, Montana State University,
Bozeman, Montana, USA; Neal R. Spencer [ed.]. p. 435 (2000). (http://bugwoodcloud.org/ibiocontrol/proceedings/pdf/10_435.pdf.)
---------------------------------------------------------------------------
APHIS is familiar with the document cited by the commenter and
agrees in principle with its best practices.
One commenter expressed concern that if all bacteria belonging to
the same genus as a plant pathogen are regulated, students isolating
antibiotic-producing Streptomyces bacteria in an introductory-level
microbiology lab exercise could inadvertently fall under APHIS purview.
The commenter stated that this could occur because students would not
typically move beyond morphologically classifying their isolates as
Streptomyces and this genus contains plant pathogens such as
Streptomyces scabies.
If persons have questions about lab or other specific activities
that may fall under APHIS' regulation of plant pathogens, they are
encouraged to contact APHIS for clarification.\17\
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\17\ See footnote 4 for contact information.
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The commenter also stated that it would be helpful to have access
to a comprehensive list of microbial pathogens of concern to APHIS so
that stakeholders can identify and deal with problematic taxa
appropriately.
APHIS has regulatory authority over all plant pests and biological
control organisms moved in interstate commerce and imported into the
United States. While we do not keep such a comprehensive list, an
extensive table of U.S. regulated plant pests is available on the
APHIS-PPQ website.\18\
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\18\ https://www.aphis.usda.gov/aphis/ourfocus/planthealth/import-information/rppl/rppl-table.
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Proposed Sec. [thinsp]330.202(c) lists the steps by which APHIS
accepts and evaluates petitions for adding biological control organisms
to the lists of those organisms granted exceptions from permit
requirements for their importation or interstate movement. We noted
that we drafted two lists of biological control organisms (one list for
control of invertebrate plant pests, one for control of weeds) for
which we would grant exceptions from the permit requirements, and made
the lists available for comment.\19\ Persons could request that an
organism be added to a list by submitting a petition to APHIS. A notice
of the petition would be published in the Federal Register for public
comment. We stated in proposed Sec. 330.202(c) that such petitions
must provide evidence that the organism is indigenous to the
continental United States throughout its range, or self-replicating for
a period of time sufficient to consider the organism to be established
in its range in the continental United States. The petition would also
have to provide results from a field study during which data was
collected from representative habitats occupied by the organism and
provide any data indicating that subsequent releases of the organism
into the continental United States will present no additional plant
pest risk.
---------------------------------------------------------------------------
\19\ See footnote 2.
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A commenter stated that, because the proposed rule addresses the
process for requesting that biological control organisms be added to
the lists of organisms excepted from permit requirements, APHIS needs
to make the current list readily available. Another commenter stated
that a clear description of how to access the lists is needed, and two
other commenters stated that a mechanism for updating the lists also
needs to be added to the regulations.
We made draft lists of biological control organisms excepted from
permitting available for review at the website address listed in
footnote 2.\20\ We noted in the proposed rule that while we will
consider comments received on the draft lists to be distinct from those
received on the proposed rule, the comments received on the draft lists
will inform our evaluation of the suitability of the exceptions from
permitting requirements contained in proposed Sec. 330.202(b). Once
the rule is finalized and a list of excepted organisms is established
on the APHIS website, persons can submit petitions according to the
provisions included in Sec. 330.202(c).
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\20\ Invertebrate Organisms for the Biological Control of Weeds;
Invertebrate Organisms for the Biological Control of Invertebrate
Plant Pests; and Native and Naturalized Plant Pests Permitted by
Regulation (Individual Permits not Required) for Their Interstate
Movement within the United States.
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One commenter supported a process for excepting certain biological
control organisms from permit requirements, but expressed concern that
publishing petition notices in the Federal Register and soliciting
public comment may make the process sufficiently onerous as to
effectively limit its use. Instead, the commenter suggested that we
establish a Technical Advisory Group (TAG) to expedite the listing
process for excepted biological control organisms.
APHIS is committed to ensuring transparency and public
participation with respect to reviewing petitions for permit
exceptions. For this reason, we intend to publish notices of petitions
we receive in the Federal Register and request public comment on them.
We may also use our Stakeholder Registry as another means of notifying
the public of proposed actions and requesting comment. Although we
maintain an active TAG, we disagree with the commenter and do not
consider it to be
[[Page 29948]]
as efficient or as transparent as the petition comment process. Under
Sec. 330.201(d)(1), APHIS will have the option of consulting with
technical experts on petitions as the need arises.
The same commenter opposed a blanket permit for interstate movement
of select organisms that appears to include fieldto-field collections
and releases without screening such organisms for unwanted
contaminants, but acknowledged that field-to-field movement can include
beneficial predators such as coccinellids (lady beetles). The commenter
stated that a blanket permit system may result in intentional or
unintentional mislabeling of shipments leading to accidental
introduction of a potentially serious pest.
The commenter seems to be referring to the general permit we
discuss above, which authorizes organizations that frequently move
certain low-risk plant pests and organisms interstate to do so without
having to obtain a separate permit for each movement. As we noted, we
have decided to defer issuing general permits until a later time. We
also note that APHIS does not approve the interstate movement and
release of any biological control organism without consideration of the
organism's status in individual States, and to that end solicits State
review. Moreover, the issue of contaminants is mitigated in two ways.
The majority of biocontrol releases are at present coordinated by
government-related programs or personnel, who have training and
experience in moving clean shipments. Likewise, commercial entities are
economically motivated to provide clean, quality shipments. State and
local plant regulatory personnel also have the opportunity and
authority to observe, report, and enforce regulations regarding the
movement and release of non-exempt, contaminant organisms in any
shipment.
One commenter stated that movement permits need to be specific to
each State, noting that transporting biological control organisms that
are effective in California may have consequences if the same agents
are used in another State. The commenter cited the potential danger of
walnut twig bark beetles on the West Coast spreading Thousand Cankers
disease to the Eastern United States. The commenter added that while
allowing permits for the transport of biological control organisms may
help problems such as this one, it should be the decision of States to
allow movement of certain agents across their borders.
The species listed by APHIS for exception from permitting
requirements are species that exist throughout their full ecological
range in the United States and therefore, from a State-by-State view,
are either already present in a given State or have been shown to be
unable to live in that State as a self-reproducing population. All
other petitions for biological control organisms would be subject to
APHIS permits for interstate movement and made available for review and
input from Tribal and State representatives as provided for in proposed
Sec. 330.201(d)(1).
One commenter observed that the regulatory status of
entomopathogenic nematodes is not addressed specifically in the
proposed rule.
Entomopathogenic nematodes meet the definition of biological
control organism we proposed in Sec. 330.100 and therefore we regulate
them accordingly. However, we have included seven such species on the
draft list of biological control organisms proposed to be excepted from
permit, which we posted for public comment.
One commenter stated that in classical biological control,
individual populations of a species have been identified as possible
importation sources into the United States, but even these need to be
quarantined for screening for contaminants. The commenter stated that
the list of excepted organisms maintained online should be reviewed in
light of the International Code of Best Practices for Biological
Control.
We note above that in this final rule we are not at present
allowing importation of biological control organisms without a permit
but will consider the commenter's suggestion should we begin to do so.
One commenter noted that the need for export certification on
biological control organisms is not addressed, and suggested that APHIS
should issue permits certifying the condition of organisms and
associated articles that are destined for export from the United
States. Another commenter stated that the need for export certification
on biological control organisms has been addressed in the North
American Plant Protection Organization (NAPPO) Regional Standards for
Phytosanitary Measures (RSPM) 26 and that the approved RSPM has been
waiting for the current proposed rule for appropriate action.
APHIS acknowledges that the proposed regulations do not include
provisions for certifying the export of regulated biological control
organisms. The IPPC has, however, published a set of guidelines \21\
that addresses the export of biological control organisms, and the
NAPPO standard \22\ addresses foreign export certification requirements
for biological control organisms being moved from the United States to
Canada or Mexico. As a signatory and participating member of these
organizations, APHIS observes internationally agreed upon standards for
the export of biological control organisms and products.
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\21\ ISPM 3, ``Guidelines for the export, shipment, import and
release of biological control agents and other beneficial
organisms,'' published 2016.
\22\ RSPM-26 ``Certification of commercial arthropod biological
control agents moving into NAPPO member countries,'' published 2015.
---------------------------------------------------------------------------
Another commenter stated that a generic permit or other indication
of status is needed for organisms listed as being excepted from permit
requirements and recommended that we explain how the list relates to
the biological control species approved in RSPM 26 Appendix II.\23\
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\23\ See footnote 22.
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The proposed list of biocontrol organisms to be excepted from PPQ
permit requirements includes all the species on the list of biological
control organisms approved in RSPM 26, Appendix II.
One commenter stated that RSPM 12, ``Guidelines for Petition for
First Release of Non-indigenous Entomophagous Biological Control
Agents,'' \24\ should be added to the rule with respect to the
petitioning process for excepted organisms. The commenter added that
the RSPM already outlines many of the proposed requirements.
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\24\ https://www.nappo.org/files/1814/4065/2949/RSPM12_30-07-2015-e.pdf.
---------------------------------------------------------------------------
We considered RSPM 12 guidelines when developing the proposed rule.
However, RSPM 12 is a tri-national agreement, is intended only as a
guideline, and is periodically revised. For these reasons, it would not
be practical or necessary to add RSPM 12 guidelines to the regulations.
One commenter proposed that a tiered, science-based approach be
adopted to determine permit requirements for microorganisms isolated
within the continental United States. The commenter suggested using the
following three categories: ``No permit required,'' if the microbe is
identified by its complete genome sequence and contains no proven plant
pathogenic sequences; ``fast track,'' if the microbe is a member of a
taxon not known to be a crop pathogen; and ``all other
microorganisms.'' The commenter added that guidelines to the identity
of these sequences should be developed by
[[Page 29949]]
the biopesticide industry and the research community.
We are making no changes in response to the commenter's proposal.
Our approach to determining the permit status and requirements for
microorganisms is done on a case-by-case basis. Our requirements for a
``no permit required'' determination include origin and distribution
information and intended use that we evaluate for each application. Due
to the evolving science, we do not identify specific microbial
identification techniques but we do use the best and most appropriate
methodology available to identify organisms.
A commenter stated that plant growth and plant health enhancing
consortia and biostimulants should be treated the same as biological
products making pesticidal claims, since the potential safety hazards
are the same for all these groups of novel microorganisms.
Under the PPA, APHIS has no authority to regulate products on the
basis of their plant health or growth enhancing attributes, but only on
the basis of pest risk potential.
One commenter suggested that a specific organism used to
manufacture an EPA-registered biopesticide should not require a plant
pest permit to move interstate as a pure culture or as part of a
formulation. The commenter added that if a beneficial organism can be
applied to crops as a registered biopesticide, a small-scale release
from an experimental formulation in a field trial should not pose a
risk to U.S. agriculture.
Typically, APHIS does not require a permit for the interstate
movement of a product that is regulated by EPA. However, other isolates
or non-registered uses may require a permit.
Two commenters addressed the topic of States regulating the
movement of plant pests and biological control organisms. One commenter
opposed allowing States to establish regulations for interstate
movement of organisms that are more restrictive than those established
by the Federal Government, while another stated that States have the
option of independently establishing more restrictive regulations.
Under the PPA, a State may not regulate the movement in interstate
commerce of any biological control organism, plant pest, or noxious
weed if the Secretary has issued a regulation or order to prevent its
dissemination within the United States. There are two exceptions listed
in the Act: A State may impose movement restrictions as long as they
are consistent with and do not exceed the regulations or orders issued
by the Secretary, and a State may impose movement restrictions that are
in addition to Federal restrictions as long as the State demonstrates a
clear need to do so based on science and pest risk. As we noted in the
proposed rule, 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), and we encourage
applicants to consult with these authorities when applying for a
permit.
One commenter stated that if the proposed regulations supersede
permits that were specifically issued for national defense projects,
means of conveyance, and organisms that are not subject to APHIS
regulation (i.e., courtesy permits), then this information needs to be
conveyed to regulatory personnel so that packages containing organisms
can be transported without inspection delays during the period of
transition to the new regulations.
The proposed regulations do not supersede or nullify the status of
current, valid permits.
A few commenters questioned whether notice of the petition and
public comment are necessary for excepting certain organisms from
permit requirements, with one commenter adding that APHIS could simply
respond to the petition by conducting the risk assessment and notifying
the petitioner of the decision, and that organisms either added or
removed from the list could be noted on the website.
APHIS embraces a transparent process and is committed to public
involvement during the petition process.
In Sec. 330.202, paragraph (c)(1) states that petitioners
proposing additions to the lists of organisms excepted from permitting
requirements must provide evidence indicating that the organism is
indigenous to the continental United States.
A commenter requested that APHIS provide guidance and examples that
would demonstrate that an organism is indigenous.
Guidance and examples for permit applicants are posted on the APHIS
Regulated Organism and Soil Permits website.\25\ Applicants may also
contact APHIS using the information in footnote 4.
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\25\ https://www.aphis.usda.gov/planthealth/organism-soil-permits.
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A commenter asked if the development of a new biocontrol product
involving previously unreleased organisms requires completion of a PPQ
526 Form (Application for Permit to Move Live Plant Pests or Noxious
Weeds) and an assessment of potential environmental effects.
Any new biological control organism or product that has not been
released into the environment requires completion of a PPQ 526 permit
application form and an environmental assessment.
Soil (Sec. 330.203)
As we noted in the proposed rule, we are integrating the soil
regulations into the revised ``Subpart B--Plant Pests, Biological
Control Organisms, Soil, and Associated Articles.'' We moved the
regulation of soil into the revised subpart B in order to highlight the
fact that soil, as an associated article, may harbor plant pests and
noxious weeds that can be spread within the United States through
importation or interstate movement. In proposed Sec. 330.203(a), we
established that, as an associated article, the importation or
interstate movement of soil is subject to the permitting requirements
in Sec. 330.201 unless otherwise indicated in the regulations.
Soil and Associated Articles From Canada
We proposed to amend the regulations in Sec. 330.203(b)(1) 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 noted that this
change is in response to recent detections of soil-borne plant pests of
quarantine significance in new areas of Canada. Previously, permits
were required for soil imports from a few small areas of Canada. These
areas, and areas with new detections of soil-borne plant pests, are now
regulated by the CFIA, and the risk of inadvertently introducing plant
pests into the United States is higher in soil imported from these
areas.
Two commenters disagreed with this proposed change. One of these
commenters asked us to identify the specific quarantined areas in
Canada from which importation of soil into the United States is not
allowed and requested that we define what information is required with
shipments of soil from Canada. The commenter stated that doing so would
provide a consistent process for applicants to demonstrate to
inspection officials at ports of entry that the soil is not from an
area regulated by the CFIA for soil-borne plant pests. Similarly,
another commenter asked us to indicate the procedure for proving to
U.S. inspectors that imported soil is not from a quarantined area in
Canada. The
[[Page 29950]]
commenter stated that there is nothing specified in the proposal on how
to prove the soil from Canada is not from a quarantined area.
Persons wishing to import soil into the United States from any area
of Canada not regulated by the CFIA for soil-borne plant pests are
responsible for verifying to inspectors that the soil is from such a
non-regulated area. CBP inspectors at U.S. ports of entry typically
require documentation provided by the CFIA to verify soil origin.
Inspectors can corroborate this documentation with other shipment
documentation, such as a bill of lading, to verify the origin of each
shipment. One option for persons for whom providing such documentation
is not practicable is to apply for a permit to move such soil. APHIS
will evaluate the request and, if no permit is necessary, issue a
Letter of No Permit Required on the basis that the soil originates from
an area not regulated by CFIA for a soil-borne plant pest.
In paragraphs (b)(2) through (4) of Sec. 330.203, we proposed
additional conditions for the importation of soil into the United
States.
A commenter asked if each of the purposes listed in those
paragraphs requires an import permit along with the other conditions
described.
An import permit with specific conditions is required for
importation of soil via hand-carry, importation of soil intended for
the extraction of plant pests, and importation of soil contaminated
with plant pests and intended for disposal.
Section 330.203(b)(3) provides additional conditions for the
importation of soil intended for the extraction of plant pests. To
mitigate the risk of introducing plant pests through the movement of
such soil, we will require the soil to be imported directly to an
approved biocontainment facility.
One commenter agreed with the conditions proposed in Sec.
330.203(b)(3) but wanted to know if the biocontainment facility will be
at the permittee's destination or at a central inspection center prior
to transport to the permittee's final destination. The commenter asked
that we specify in the regulations that the facility must be an APHIS-
approved biocontainment facility.
We would require such soil to be imported directly to the
permittee's APHIS-approved biocontainment facility. Maintaining a
biocontainment facility and having APHIS approve it for the extraction
of plant pests are prerequisites for this type of permit.
In Sec. 330.203(b)(5), we proposed to establish import permit
exemptions for a list of articles, including rocks, silt, clay, and
other quarry products, that are not soil. If the article being imported
is free of organic material, it will not require an import permit
unless the Administrator has issued an order stating that a particular
article is an associated article.
A commenter asked us to clarify how Sec. 330.203(b)(5) would apply
to the following materials: Products of non-soil stone or quarry
products combined with plant nutritive or soil conditioning materials
such as composts and manures; bone meal, feather meal, or blood meal;
fish, shellfish, or kelp materials; peat, coconut coir, humates, spores
or live mycorrhizae, as often used with potting mixes; animal and
insect repellent compounds like biological oils or neem oils, or
geranium extracts; animal derived or extract materials such as insect
pheromones; synthetic chemicals such as pesticides or fertilizers, and
recovered nutrients from sewage. The commenter added that many
beneficial plant growth products that include these materials are being
developed and marketed, and that preventing their interstate movement
could significantly inhibit the benefits they provide to agriculture.
To the extent that any of the articles listed by the commenter
contain organic material and are thus associated articles having the
potential to contain pests or plants and plant parts that pose a risk
to American agriculture and the environment, a permit would be required
to import such products or to move them interstate. Permit applicants
with questions about specific articles can contact APHIS using the
information in footnote 4.
The commenter also asked about interstate movement of plant growth
enhancers in relation to the permit exemptions in Sec. 330.203(b)(5),
which addresses the import of certain articles but makes no reference
to interstate movement.
APHIS considers permit requests for importation or interstate
movement of the materials listed on a case-by-case basis. To facilitate
our evaluation and permit decision process, we typically ask
prospective permittees wishing to import or move plant growth enhancers
to answer questions located on the APHIS plant growth enhancer
website.\26\ We note that some animal material, including bone, blood,
and feathers, are regulated under the jurisdiction of APHIS Veterinary
Services or other Federal agencies.
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\26\ https://www.aphis.usda.gov/planthealth/organism-soil-permits.
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The same commenter asked whether zeolite minerals, lignitic and
humate minerals, various cation-exchange capacity-enhancing clay
minerals, phosphate rock, limestone, dolomite, and green sands would be
exempt and considered non-soils under this proposed rule.
Articles eligible for exemption in proposed Sec. 330.203(b)(5)
must be free of all organic materials and considered to be non-soil.
The examples of exempted materials listed in paragraphs (b)(5)(i)
through (iv) are not intended to be exhaustive. If the materials cited
by the commenter are free of organic material and thus considered to be
non-soil, such material will be exempted from permitting requirements.
The commenter also asked if sterilization, heat treating, or other
methods of killing possible pathogens or organisms applied to the
products cited would allow for them to be exempt from regulation for
interstate movement.
If we determine that any of the materials indicated contain soil,
then restrictions for the interstate movement of soil will apply. Even
if the customer claims that sterilization, heat treatment, or other
methods of killing possible pathogens or organisms has been performed
on the material and its intended use is for release into the
environment, APHIS must first evaluate the material to determine a
regulatory action.
Finally, the commenter asked whether meeting the USDA organic
standards for composts, minimum heating times, and temperature regimes
allow for interstate movement without special permitting or regulation
under the proposed regulations.
The National Organic Program is administered by the USDA
Agricultural Marketing Service and develops national standards for
organically produced agricultural products. Those standards do not
address plant pest risks.
As we noted above, we proposed placing revised regulations for the
importation and interstate movement of soil under new ``Subpart B--
Movement of Plant Pests, Biological Control Organisms, and Associated
Articles,'' and removing and reserving current ``Subpart C--Movement of
Soil, Stone, and Quarry Products.'' As part of this change, we removed
current Sec. 330.301, which contains restrictions for the movement of
stone and quarry products from areas in Canada infested with gypsy
moth. We explained in the proposed rule that we would retain these
conditions but move them to 7 CFR 319.77-4 of ``Subpart R--Gypsy Moth
Host Material from Canada,'' as
[[Page 29951]]
we consider that subpart to be a more appropriate location for
regulating gypsy moth.
One commenter stated that open gravel pits and other disturbed
areas can harbor noxious weeds due to ground disturbances. The
commenter expressed concern that importation of stone and quarry
products from Canada without proper decontamination for noxious weeds
may increase the genetic diversity of the weed population in the United
States.
Under the soil regulations in Sec. 330.203(b)(5), we proposed to
exempt from regulation the importation and interstate movement of
stones, rocks, and other quarry products that are free of organic
material. If a shipment of gravel or other stone is found to contain
organic material, it will be considered to be an associated article and
be subject to the regulations under Sec. 330.203.
Another commenter asked us to revise proposed Sec.
330.203(b)(5)(ii), which includes a permit exemption for sediment, mud,
rock, and similar articles from saltwater bodies of water, to include
an exemption for similar articles taken from freshwater bodies of
water.
We already consider peat, cosmetic mud, and other mud products from
freshwater estuaries or the earth's upper surface, if processed to a
uniform consistency and free of plant parts and seeds, to be exempt
from our regulations. Rocks and other non-soil articles are already
exempt under Sec. 330.203(b)(5). However, plant pests can thrive in
freshwater bodies of water and therefore articles containing organic
material from freshwater bodies of water must be evaluated by APHIS to
determine their regulatory status.
In proposed Sec. 330.203(c), we established regulations governing
the interstate movement of soil, which includes general conditions for
moving soil interstate within the United States and conditions for
moving soil interstate for specific purposes. Except for soil moved in
accordance with Sec. 330.203(c)(2) through (5), soil may be moved
interstate within the United States without a permit or a compliance
agreement. We require, however, that all soil moved interstate is
subject to any restrictions and remedial measures specified for such
movement in our domestic quarantine regulations referenced in 7 CFR
part 301.
We proposed in Sec. 330.203(c)(2) that soil may be moved in
interstate commerce within the continental United States with the
intent of extracting plant pests only if an interstate movement permit
has been issued in accordance with Sec. 330.201 and the soil will be
moved directly to a biocontainment facility approved by APHIS.
A commenter asked if proposed Sec. 330.203(c)(2) would provide
additional conditions for the importation of soil intended for the
extraction of plant pests. To mitigate the risk that such soil could
present a pathway for the introduction or dissemination of plant pests
within the United States, the commenter stated that APHIS would need to
require all such soil to be imported directly to an approved
biocontainment facility.
As indicated in Sec. 330.203(b)(3), importation of soil into the
United States intended for the extraction of plant pests requires a
permit and the soil must be moved directly to a biocontainment facility
approved by APHIS. The shipment is subject to all conditions for
movement specified on the permit, including safeguarding requirements.
Proposed Sec. 330.203(c)(4) allows for the movement of soil
samples from an area quarantined in accordance with part 301 without
prior issuance of an interstate movement permit, provided that the soil
is moved to a laboratory that has entered into and is operating under a
compliance agreement with APHIS and is approved by APHIS to conduct
chemical/physical tests and analyses of such samples.
One commenter asked if no permit is required for movement of soil
under Sec. 330.203(c)(4) will there be another document required to
accompany the soil. The commenter also wanted to know if a permit
application needs to be submitted for such movement.
Proposed Sec. 330.203(c)(4) requires that the laboratory to which
the sample is destined to be moved enter into a compliance agreement
with APHIS. The movement can be made without prior issuance of an
interstate movement permit.
One commenter stated that the regulations for interstate movement
of restricted soil between approved laboratories should be expanded to
include foreign soil samples that are otherwise subject to the same
handling and disposal requirements. The commenter noted that currently
it is necessary to get USDA approval on a case-by-case basis to move
foreign samples between laboratories.
Imports of soil, unless otherwise exempted in the regulations, must
be accompanied by an import permit and sent directly to an APHIS-
approved biocontainment facility. If we authorize additional movements
of imported soil, the movements must also be to an APHIS-approved
biocontainment facility with the same safeguarding and containment
capacity as the original facility and must be moved under a permit as
well. As we consider imported soil to present a higher risk to U.S.
agriculture and the environment, we consider it necessary to track and
approve all foreign soil movements and disposition on a case-by-case
basis as part of our standard permit conditions.
Exceptions To Permitting Requirements for the Importation or Interstate
Movement of Certain Plant Pests (Sec. 330.204)
In accordance with the PPA, we proposed in Sec. 330.204 to
establish regulations allowing the importation and movement in
interstate commerce of plant pests without further restriction if we
determine that no permit is required. Specifically, we proposed a
notice-based petition process by which the public could petition to
have pests either added to or removed from the list of plant pests
excepted from permitting requirements for importation or interstate
movement. As part of this informal adjudication process, we will
evaluate the petition to determine whether the plant pest is of a
sufficiently low risk. If, after review of the petition, we determine
that the plant pest belongs to one of the categories in Sec.
330.204(a) that make it eligible for listing, we will publish a notice
in the Federal Register announcing the availability of the petition and
our intention to add it to the list of plant pests that may be imported
into or moved interstate within the continental United States without
restriction. We will also solicit public comment on the notice and
petition. If after we consider the comments 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 listed and excepted from permitting requirements.
This subsequent notice constitutes final agency action, which is
subject to being challenged in court under the Administrative Procedure
Act.
Several commenters expressed concern that importation of plant
pests excepted from permitting could result in new diseases and damage
to beneficial plants and plant products within the United States,
particularly plant pests imported from new sources and locations.
These comments raise concerns similar to those we received for
Sec. 330.202(b), in which we proposed allowing the exception from
permitting for the importation and interstate movement of certain
biological control
[[Page 29952]]
organisms. We acknowledge that the importation of plant pests from new
sources and locations could carry a risk for introducing new,
unapproved plant pest species or parasites and diseases of those
species. An imported plant pest poses a potentially higher risk level
than the same domestic species of that pest moved interstate because
the former may be carrying unknown diseases or microbial pathogens from
the foreign source. Therefore, we will continue at present to require
permits for the importation of plant pests. However, we will retain the
petition process for excepting plant pests from permit requirements in
Sec. 330.204. If APHIS receives a petition for allowing the
importation of low risk plant pests without a permit, we will review
it. Based on our review, we will either deny the petition or submit it
for public comment. Plant pests that APHIS lists as being able to be
moved interstate without a permit will not be eligible to be imported
without a permit unless APHIS expressly indicates otherwise.
Categories of Plant Pests Eligible for Exception From Permit
Requirements
In Sec. 330.204(a), we proposed three categories of plant pests
that would be eligible for exception from permitting requirements:
Pests from field populations or lab cultures derived from field
populations of a taxon established throughout its entire geographical
or ecological range within the continental United States; pests that
are sufficiently attenuated so that they no longer pose a risk to
plants or plant products; and pests that are commercially available and
raised under the regulatory purview of other Federal agencies.
We are making a change to Sec. 330.204 with respect to excepting
from permit requirements certain plant pests imported or moved
interstate. In Sec. 330.204(a)(2), we proposed excepting from permit
requirements the category of plant pests that are sufficiently
attenuated so that they no longer pose a risk to plants or plant
products. We noted in the proposed rule that when a pest becomes
attenuated, it loses its defining pest or biocontrol properties. For
this reason, there is no longer a sufficient basis to presume that the
pest presents a risk of injuring, damaging, 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. Accordingly, we will remove this category from the proposed
regulations. In the case of an attenuated pest, we will issue a LONJ to
a petitioner rather than a Letter of No Permit Required as the organism
is no longer considered to be a plant pest and therefore is not under
APHIS' jurisdiction.
A commenter stated that APHIS' guidance about permitting is
inconsistent with how we administer the permitting process. The
commenter noted that the APHIS website says a permit is typically not
required for the interstate movement or release into the environment of
domestically isolated microorganisms that are not plant pests and are
widely prevalent in the continental United States. The commenter noted
that, despite what the guidance says, APHIS currently requires permits
for microorganisms that are not plant pests that are found and
collected throughout the continental United States.
To address this inconsistency, the commenter requested that we
define several terms, including ``common,'' ``prevalent,'' and
``widespread,'' so that persons can determine whether they need a
permit for activities involving plant pests and biological control
organisms.
We are making no changes in response to the commenter's request as
we do not believe that defining these terms is necessary to determining
whether a permit is needed for interstate movement or release of a
given organism. Persons with questions about whether an activity
requires a permit under the regulations are encouraged to contact
APHIS.\27\
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\27\ See footnote 4 for contact information.
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A commenter representing the State of California noted that the
State is opposed to and does not participate in the Widely Prevalent
List program. The commenter noted that California is a large State with
many microclimates that could support new invasive pests, that
potential pathways for invasive species are numerous, and that the
introduction of unwanted parasites and pathogens that can accompany
such species would increase with a web-based permit system.
APHIS carefully evaluates the pest risk potential of organisms
before considering them to be widely prevalent and will not allow any
organisms posing a pest risk to be candidates for an exception to the
permit requirements.
The same commenter stated his opposition to having the Federal
Register be the only forum for contributing input regarding the list of
plant pests excepted from permit requirements.
In addition to accepting public comments on notices, petitions, and
proposed rules published in the Federal Register, we typically conduct
stakeholder outreach and invite stakeholders to contact APHIS if they
have questions or concerns.
A commenter asked whether the application process would exclude
those species already on the approved species list for no permit.
The commenter is correct. Species on the list have been determined
by APHIS to not require a permit.
A commenter recommended that APHIS clarify that the exempted
activities include release into the environment because the definition
of move includes that action.
We agree with the commenter. Movement without restriction implies
all uses, including release.
A commenter asked whether documentation supporting a petition to
add or remove organisms from the list of those excepted from permitting
requirements will also be made available for comment when the petition
is published in the Federal Register.
When APHIS issues a notice of petition in the Federal Register, we
will also make available for comment any documentation available that
supports the petition.
A commenter asked whether the omission of ``environmental release''
from the heading of Sec. 330.204(a) is intentional or accidental.
We did not consider it necessary to include the term
``environmental release'' in the heading ``Exceptions to permitting
requirements for the importation or interstate movement of certain
plant pests'' because the definition of move (moved and movement) we
proposed in Sec. 330.100 specifically includes releases into the
environment.
The commenter also asked if the term ``without restriction'' in
Sec. 330.204(a) means that no permit of any kind is needed, and
whether States are notified in such cases.
States will be notified of APHIS' decision to not require permits
for the importation or interstate movement of a given plant pest or
organism. States, however, have the authority to require permits for
the movement of these organisms into their boundaries. For example,
while no Federal permit is required for the interstate movement of the
Madagascar hissing cockroach, the State of Florida requires a permit to
move the cockroaches to Florida from another State.
One commenter noted that APHIS maintains a list of plant pests in
Sec. 340.2 and stated that, because the authority for APHIS-PPQ and
APHIS-Biotechnology Regulatory Services (BRS) to regulate plant pests
comes from the PPA, PPQ and BRS should work
[[Page 29953]]
together to ensure that the list in Sec. 340.2 and the proposed list
referenced in Sec. 330.204 are consistent.
The list cited by the commenter in Sec. 340.2(a) lists groups of
organisms which are or contain plant pests for the purpose of
determining what genetically produced or altered plant pests and
products are regulated under the regulations in part 340. The list
proposed for Sec. 330.204 will include plant pests that may be moved
interstate without a permit under the plant pest regulations in part
330. APHIS-PPQ and APHIS-BRS collaborate regularly to ensure that there
are no inconsistencies between their respective lists.
Referring to native and naturalized plant pests, a commenter asked
APHIS to clarify the meaning of ``permitted by regulation.''
The commenter is referring to the proposed list we made available
for review, titled ``USDA-APHIS-PPQ Native and Naturalized Plant Pests
Permitted by Regulation (Individual Permits Not Required) For Their
Interstate Movement within the United States.'' \28\ This refers to the
organisms proposed to be excepted from permit requirements under these
regulations.
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\28\ See footnote 2 for the location of the draft list.
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One commenter wanted to know the source of the proposed list we
provided for review and what its intended use would be.
Draft lists were developed by APHIS and reviewed by the National
Plant Board as well as by professional societies and Tribes. Many of
the individual species are of a lower risk and commonly requested in
applications processed by APHIS.
The same commenter, citing the categories in paragraphs (a)(2) and
(3) of Sec. 330.200, asked which of these categories applies to the
list of native and naturalized plant pests permitted by regulation.
Section 330.200(a)(3) refers to organisms under APHIS jurisdiction
explicitly granted an exception from permitting requirements in this
subpart. The term ``permit by regulation'' used by the commenter was
not used in the proposed rule. However, we have used the term in the
past in some APHIS documents and communications regarding these
proposed regulations to denote the organisms that would be excepted
from permitting requirements.
A commenter stated that APHIS should exempt dried herbarium
specimens from permitting because they are dried by heating and then
frozen. The commenter stated that no disease, pest, or invasive species
has escaped from a herbarium specimen.
This rulemaking only covers articles that fall under the plant pest
regulations, which includes herbarium specimens of parasitic plants not
classified as Federal noxious weeds and specimens collected as plant
disease samples. APHIS currently requires pest permits for the movement
of these plants because of the potential for the presence of viable
seeds in the case of parasitic plants, or of persistent resting stages
(e.g., sclerotia, chlamydospores) in the case of plant pathogens. As
there is some risk associated with the importation and interstate
movement of dried herbarium specimens, we acknowledge that the risk to
U.S. agriculture and the environment from these specimens is low as
long as risk protocols are observed.
A commenter noted that that tobacco mosaic virus (TMV) is on the
proposed list of plant pests excepted from permitting requirements and
suggested that tomato mosaic virus (ToMV) be added as well. The
commenter stated that while differentiated by serological reaction and
the amino acid sequences of the coat protein, these two Tobamoviruses
are nearly identical in their control by the tomato and pepper
resistance genes, mechanical and seed transmission, and host range.
We disagree with the commenter. Although we acknowledge that TMV
and ToMV are similar in morphology and serologically closely related,
the sequence information of the genome is distinct enough to
differentiate these viruses at a molecular level as different viral
species according to the International Committee of Taxonomy of
Viruses.\29\
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\29\ See https://talk.ictvonline.org/ictv-reports/ictv_online_report/positive-sense-rna-viruses/w/virgaviridae/672/genus-tobamovirus.
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Another commenter stated that the list of plant pests excepted from
permitting requirements should contain all plant pests that are widely
prevalent and thus present little additional plant pest risk due to
movement.
Under the amended regulations, persons will be able to petition
APHIS to add such plant pests to the list of plant pests excepted from
permitting requirements.
The commenter also recommended that Pantoea stewartii (Stewart's
wilt) be removed from the list of plant pests excepted from permitting
requirements for interstate movement, as it has not been observed in
the field for 8 years and testing for this pest costs the seed industry
millions of dollars to allow import of seed to other countries.
We agree with the commenter and will remove this species from the
list.
We are also changing the name Agrobacterium tumefaciens (crown
gall) to Rhizobium radiobacter on the list of plant pests excepted from
permitting requirements for interstate movement. We did this in order
to update the name of the organism.
Finally, during Tribal consultation, a Tribe raised concerns about
specific biological control organisms included on the draft list of
organisms excepted from permitting requirements for interstate
movement. Their concern was that the control organisms, which target
species of St. John's wort, could be released without a permit on
Tribal lands. As a result, we decided to continue to require permits
for biological control organisms that target these species.
Invertebrate Plant Pests
We received several comments requesting that certain animals be
excepted from the permit requirements as plant pests.
Arthropods
Several commenters requested exceptions from permitting
requirements for the importation and interstate movement of insects
that cannot establish themselves in parts of the continental United
States due to seasonal climate differences.
One commenter requested that we except certain ants from regulation
as they are already established throughout the United States. The
commenter added that several ant species cannot survive outside of
heated buildings and are only found living with humans. Similarly,
another commenter asked that we allow tropical species to move into the
continental United States for use as pets because they cannot become
established due to the cold seasonal climate in most of the country and
are not threats to agriculture as many do not eat living plants. A few
commenters asked that we relax restrictions on species that have been
wiped out of an area or tropical species that cannot survive in our
climate and that therefore pose no biological threat. Another commenter
stated that foreign rhinoceros and stag beetles should be allowed to be
imported without a permit because they cannot survive severe winters,
acknowledging that warm States such as Florida should require continued
monitoring. Another commenter asked that APHIS review, if not
eliminate, restrictions upon certain beetle species that are common in
zoos and the pet trade. As examples, the commenter cited Dynastes,
Megasoma, and Goliathus species.
[[Page 29954]]
We do not intend to relax restrictions on the importation and
interstate movement of arthropods with respect to seasonal climate
differences. The biological threat of arthropod plant pests can be
unseen, as unknown diseases and parasitoids may be transported
significant distances through the movement and distribution of live
specimens. We can, however, consider permit exceptions for arthropod
stock that has been isolated and evaluated for disease and parasites.
We note that this rulemaking establishes a petition process for persons
wishing to add organisms to the list of plant pests that are excepted
from permit requirements.
A commenter stated that the U.S. cricket pet food industry has been
devastated by epizootic Acheta domesticus densovirus outbreaks, and
that efforts to find an alternative, virus-resistant field cricket
species have led to the widespread U.S. distribution of a previously
unnamed Gryllus species despite Federal regulations to prevent such
movement. The commenter expressed concern that this taxon is likely to
become widely distributed throughout the United States and become an
established agricultural pest, and claimed that the USDA has taken no
action to prevent the movement and sales of Gryllus. The commenter
asked that all cultures of G. assimilis and G. locorojo be eliminated
from retail outlets in the United States.
We are evaluating our policies for the regulation of crickets and
other arthropods used both as feeder insects and fish bait. We intend
to address issues relating to the species noted by the commenter
through policy statements and the permitting process rather than
through rulemaking.
A commenter requested that APHIS use its authority under the PPA to
regulate the interstate movement of bumble bee adults, nests, and used
nest materials. The commenter also asked APHIS to promulgate rules
prohibiting movement of bumble bee adults, nests, and used nest
materials outside of their native ranges and to allow such articles to
be moved within their ranges only if the permit applicant shows that
all such articles are certified to be free of disease.
APHIS has initiated a scientific review and is collecting data
regarding the interstate movement of certain species of bumble bee
adults, nests, and related articles outside of their native ranges. If
we develop such regulations on the movement of bumble bees and related
materials, we will promulgate those regulations in 7 CFR part 322,
``Bees, Beekeeping Byproducts, and Beekeeping Equipment.''
A commenter stated that the permit process is onerous for acquiring
zebra swallowtail butterflies and other native species that do not harm
crops, and suggested that there are many species that are regulated for
no good reason.
Zebra swallowtail butterflies are regulated for several reasons.
The caterpillars feed on plants (in the genus Asimina) which makes them
plant pests, placing them under the authority of the PPA. Butterflies
are also important pollinators. Distributing zebra swallowtail
butterflies significant distances could result in the dissemination of
diseases or parasitoids to other lepidopteran species
A commenter stated that it should not be so difficult to obtain a
permit to import dead insects because they cause no harm to the
environment. The commenter added that just because Ornithoptera
alexandrae is in need of protection does not mean that all members of
the genus Ornithoptera, including dead specimens, should require
permits for importation.
APHIS does not require import permits for dead insects unless they
carry live plant pests or diseases in or on them. As indicated in part
322, we do have separate requirements for the importation of dead bees
in the superfamily Apoidea. Dead insects and those overseen by the
Convention on International Trade in Endangered Species, in particular,
are regulated by the USFWS.
Two commenters stated that some species of particular importance to
the research community should be included on the proposed list of plant
pests excepted from permitting requirements that we provided for
review. The species cited by the commenters are: Corn earworm,
Helicoverpa zea; tobacco budworm, Heliothis virescens; European corn
borer, Ostrinia nubilalis, and codling moth, Cydia pomonella. Two
commenters supported the inclusion of Helicoverpa zea, Heliothis
virescens, Ostrinia nubilalis, and Cydia pomonella to the proposed list
of insect species excepted from permit requirements.
APHIS will consider adding these species to the proposed list of
organisms for which no permit is required if we receive the supporting
information required as part of the petition process. Many more insect
species were initially considered for the list and have been removed at
the request of the National Association of State Departments of
Agriculture and other groups.
Snails
We also received a number of comments requesting that we exempt
certain snails from regulation as plant pests.
One commenter stated that the Federal government overregulates the
snail industry. The commenter acknowledged that certain States may need
to regulate and monitor movement of Helix aspersa movement but
disagreed that Federal regulation of the species is necessary. The
commenter noted that the need to regulate H. aspersa in Minnesota or
New York is not as great as it is in Florida, which has already banned
the species.
We are making no changes in response to the commenter. The brown
garden snail, Cornu aspersum (formerly H. aspersa, Cantareus aspersus,
and Cryptomphalus aspersus) is a serious plant pest causing significant
damage in areas where it has escaped cultivation. It feeds on a wide
range of plant hosts and can be readily transported in contaminated
nursery stock. More than 13 States have imposed quarantines against the
brown garden snail and several States have spent considerable time and
resources to eradicate infestations. We consider it necessary to
continue regulating this snail species to prevent new introductions and
limit its further spread.
Another commenter stated that certain snail species should be
allowed to be transported, raised, and processed for food because they
are not a threat to people or the environment. The commenter asked
APHIS to create rules allowing easier transport of captive gastropods
for pets and to remove the ban on giant African land snails, while
another commenter asked that non-plant pest snail species
(detritophages and epiphytic growth feeders) be exempted from
regulation.
Snail species that are not plant pests are not regulated by APHIS
under the regulations in part 330. We will consider adding species to
our list of plant pests excepted from permitting if we receive the
supporting information required as part of the petition process.
However, APHIS will continue to regulate species of snails that are
plant pests and cause significant damage in areas where they have
escaped cultivation.
Hand-Carry of Plant Pests, Biological Control Organisms, and Soil
(Sec. 330.205)
In proposed Sec. 330.205, we included provisions that allow for
plant pests, biological control organisms, and soil to be hand-carried
into the United States under permit.
A few commenters specifically voiced support for the continued
issuance of permits for hand-carrying plant pests, organisms, and soil
into the United
[[Page 29955]]
States. One commenter disagreed with the 2003 Office of the Inspector
General audit referenced in the proposed rule recommending that hand-
carry of samples be prohibited and noted that APHIS currently
authorizes the importation of plant pests in personal baggage under
Sec. 330.212 of the regulations. The commenter agreed with APHIS that
individual hand-carry is important from a safeguarding perspective, as
this option allows a responsible individual to exercise direct and
continuous oversight of an article's importation.
APHIS recognizes the importance of hand-carry and will continue to
authorize hand-carry events.
In Sec. 330.205(b), we proposed that hand-carry permittees be
required to provide APHIS with a copy of the first page of the passport
and other identifying information. In paragraph (c) of Sec. 330.205,
we requested that permittees notify APHIS about the dates and itinerary
of the permitted movement.
A commenter noted that APHIS makes no mention as to whether the
passport page copy is attached to their permit file, or how long APHIS
keeps this passport information. The commenter recommended that there
be more specific language to address how securely personal information
from permit applications will be stored and disseminated.
We have reevaluated the application requirements we proposed for
hand-carry permits and determined that making them available on the
APHIS website would allow more flexibility to adjust the requirements
as conditions warrant. As a result, we are revising Sec. 330.205(b) to
state that after the permittee has obtained an import permit but no
less than 20 days prior to movement, the permittee must provide APHIS,
through its online portal for permit applications or by fax, with the
names of the designated hand carrier, or carriers, assigned to that
movement. We will also note in paragraph (b) that additional conditions
for hand-carry are available on the APHIS website. Other conditions for
hand-carry that were contained in proposed paragraph (c) will also be
moved to the APHIS website.
The commenter also asked what the expected expiration date of the
import permit would be, adding that it is not clearly defined whether
the permittee must apply each time they travel but continue with the
same permit, or whether the permittee must apply online each time.
We consider each hand-carry trip to be a unique event. For this
reason, we require that the person wishing to hand-carry regulated
materials or organisms under a current permit to notify APHIS through
our online portal of the intention for a hand-carry event.
Packaging Requirements (Sec. 330.206)
We proposed in Sec. 330.206 to include general and specific
packaging requirements for the importation, interstate movement, or
transit of plant pests, biological control organisms, and associated
articles into or through the United States.
Regarding shipping of commercial biological control organisms, a
commenter stated that APHIS should cooperate with industry to establish
a process for shippers to expedite importation and movement of
commercial biological control organisms, and to develop an efficient
system for clearing shipments of commercial biological control
organisms with potentially affected governmental agencies and State
departments of agriculture. The commenter also stated that APHIS should
identify points of contact for resolving problems that often occur when
importing and transshipping commercial biological control organisms.
APHIS regularly works with industry to improve the efficiency and
timeliness for clearance of imported commercial biological control
organisms, including designating certain ports where clearance is a
priority and delays are minimal. We recognize, however, that these
specific designated ports (which is not the same as ``port of entry'')
may not be convenient for all importers and situations. APHIS will
continue to work with industry to seek additional solutions while
maintaining the safeguards needed for importation of live organisms.
A commenter wanted to know why we did not refer to RSPM 39 \30\ as
it relates to packaging.
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\30\ http://www.nappo.org/files/5714/3889/7020/RSPM39Rev-08-12-2014-e.pdf.
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We did not refer to the guidelines mentioned by the commenter
because we consider the proposed requirements for packaging to be
adequate. RSPM 39 provides packaging guidelines to facilitate the
movement of invertebrate biological control organisms into NAPPO member
countries. The provisions and recommendations of RSPM 39, as currently
written, exceed the packaging requirements of Sec. 330.206. Moreover,
RSPM guidelines are subject to change independent of the status of the
plant protection regulations of any member country.
The commenter also asked whether organisms attenuated and excepted
from permitting are also exempt from packaging requirements, as they do
not require a permit.
As we noted in the above discussion of Sec. 330.204, attenuated
organisms will no longer be considered as plant pests and therefore not
included on the exception list.
In proposed Sec. 330.206(a), we include packaging requirements for
the outer shipping container and inner packages. These include the
requirements that the outer shipping container must be rigid,
impenetrable, and durable enough to remain closed and structurally
intact, and that inner packages must be sealed.
A few commenters expressed concerns about the lack of flexibility
in the proposed packaging requirements, particularly as they relate to
the environmental needs of live organisms.
One commenter stated that some packaged cultures consume oxygen
quickly and generate carbon dioxide, creating conditions that kill
beneficial organisms if there are no air holes for oxygen exchange. As
an example, the commenter cited the current use of strong cardboard
boxes with 1 to 1.5-inch holes drilled in the sides for transporting
commercial packages of beneficial organisms, including predatory mites
and lady beetles. The commenter emphasized that the packaging described
in the proposed regulation would block all airflow vital for the
survival of beneficial organisms. For interstate travel of organisms
that are not plant pests, the commenter stated that containment in one
layer of packaging plus an outer breathable layer that keeps the inner
packages from impact should be sufficient. Another commenter
recommended establishing a performance-based standard for packaging
that would require the permittee to ship the organism or soil in a
secure manner and suggested that APHIS provide guidance and examples on
its website for meeting this standard.
We acknowledge the commenters' concerns about the packing
regulations and organism viability during shipment. We note that the
regulations allow for modifications as long as they are in keeping with
the proposed requirement that the packaging should not be capable of
harboring or being a means of dissemination of the organism or article.
For example, the requirement in Sec. 330.206(a) that inner packages
must be ``securely sealed'' does not equate to ``airtight'' unless it
is appropriate to the organisms being shipped. We agree that additional
guidance can be helpful, and accordingly APHIS will continue to
[[Page 29956]]
work with industry and other stakeholders to address their concerns.
In proposed paragraphs (b) and (c) of Sec. 330.206, we required
that packing material and shipping containers be new, sterilized, or
disinfected prior to reuse, or otherwise destroyed or disposed of at
the point of destination.
A commenter suggested that the provision prohibiting the reuse of
shipping containers, except for those sterilized or disinfected prior
to reuse, should not apply to most insect shipments. The commenter
stated that it is costly and time consuming to disinfect cardboard clad
foam shippers, and that using only new containers will generate
additional waste. Another commenter agreed that not all shipping
containers warrant sterilization and suggested revising proposed Sec.
330.206(c). As an illustration, the commenter cited the content of a
shipment containing all life stages of live insects within multiple
packages. The commenter stated that the removal of only the inner
containment packaging, which holds the insects, should suffice as
decontamination.
We agree with the commenters that shipping containers do not
warrant sterilization or disinfection for reuse as long as the inner
packaging sufficiently contains the organisms to prevent contamination
of the outer shipping container. We are revising Sec. 330.206(c)
accordingly.
Costs and Charges (Sec. 330.207)
In proposed Sec. 330.207, we stated that we would furnish
inspection services without cost during regularly assigned hours of
duty and usual places of duty. We also stated that APHIS would not be
responsible for any costs or charges incidental to inspections or
compliance with the provisions of this subpart other than the services
of the inspector.
A commenter asked if APHIS imposes charges for inspections and
compliance checks. Another commenter recommended that APHIS include
guidelines for charges associated with conducting inspections and
verifying compliance with the regulations.
As we note in Sec. 330.207, APHIS does not impose charges for
inspections and compliance checks carried out during regularly assigned
hours and usual places of duty. As we furnish inspection services under
these conditions without cost, we see no reason to include guidelines
for charging for such services.
Other Comments
Several persons submitted general comments that did not address
specific provisions included in the proposal.
One commenter noted that in a separate proposal to revise the
regulations to 7 CFR part 340, APHIS noted that a genetically
engineered plant pest organism meeting a proposed exemption from the
part 340 definition of genetic engineering would still be subject to
part 330 because an exemption, by its nature, is not considered an
``explicit authorization.'' The commenter asked that we wait to
promulgate any final rule under part 330 until we fully consider
comments received under the separate part 340 proposed rulemaking.
On November 7, 2017, APHIS published a document \31\ in the Federal
Register announcing withdrawal of the proposal referred to by the
commenter.
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\31\ https://www.federalregister.gov/documents/2017/11/07/2017-24202/importation-interstate-movement-and-environmental-release-of-certain-genetically-engineered.
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Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule with the
changes discussed in this document. Executive Orders 12866, 13563,
13771, and Regulatory Flexibility Act.
This final rule has been determined to be significant for the
purposes of Executive Order 12866 and, therefore, has been reviewed by
the Office of Management and Budget.
This final rule is considered an Executive Order 13771 deregulatory
action. Details on the estimated cost savings of this proposed rule can
be found in the rule's economic analysis.
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 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 a final 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 on the Regulations.gov
website (see footnote 2 in this document for a link to Regulations.gov)
or by contacting the person listed under FOR FURTHER INFORMATION
CONTACT.
This rule will amend regulations regarding the importation,
interstate movement, and environmental release of plant pests to
incorporate provisions regarding biological control organisms and the
movement of soils from which plant pests and biological control
organisms are extracted. The rule adds definitions, streamlines the
permitting and compliance processes, and provides APHIS with increased
flexibility in the regulation of plant pests. The regulations in 7 CFR
parts 318, 319, and 352 will be updated to reflect the changes in part
330. The rule will codify an existing process for electronically
requesting permits. Using the online permit process yields time and
cost savings as compared to mailing paper applications.
The rule will also reduce the number of permits issued under part
330, which numbered 6,538 in fiscal year (FY) 2015. About one-third of
these permits (2,158) were for the movement or environmental release of
plant pests or biological control organisms for which this rule will
authorize exemption from permitting requirements, based on plant health
risks. Their exemption from permitting requirements will reduce the
permitting burden for applicants. Because one permit may list multiple
biological control organisms or plant pests, we expect, overall, a 10
to 30 percent reduction in the time spent acquiring permits under part
330. Based on the 6,538 permits issued in FY 2015, and assuming the
time required to submit an application is one hour, the annual time
savings attributable to the rule will total between 654 and 1,961
hours. Given an average hourly wage of $44.50 per hour, the annual
total cost savings will be between about $29,100 and $87,300.
In accordance with guidance on complying with Executive Order
13771, the primary estimate of annualized cost savings attributable to
this rule is $54,950 (including consideration of the cost of
unscheduled assessments by APHIS of sites, facilities, and means of
conveyance). This value is the mid-point estimate of cost savings
annualized in perpetuity using a 7 percent discount rate.
Listing of exempted organisms on an APHIS-PPQ website, transparent
procedures for petitioning for exceptions or exemptions to permitting,
and provision for a notice-based process for adding and removing listed
organisms will also combine to make an efficient, transparent, and
user-responsive system that will facilitate the movement and
environmental release of plant pests and biological control organisms.
[[Page 29957]]
Certain regulated entities will continue to incur time costs
associated with providing information during the permitting application
process as was experienced before this rule was proposed. The time
required overall for permitting will be reduced, however, because of
the exempted organisms and the online, streamlined permitting system.
These revisions to part 330 will benefit entities, large and small,
by increasing the efficiency of the permitting and compliance processes
and by improving the clarity and transparency of these regulations. The
majority of entities that will benefit from this rule are small, based
on information obtained from the U.S. Economic Census. These entities
include: Academic, government, and commercial researchers; diagnostic
enterprises such as plant pathogen diagnostic laboratories; biological
supply enterprises that include suppliers of biology teaching kits and
suppliers of butterflies for release at special occasions; biological
control organism producers; educational display enterprises such as
butterfly houses, zoos, and museums; discovery companies that evaluate
living organisms for novel pharmaceuticals and pesticides; taxonomists
and systematists; educators; and hobbyists (see full economic
analysis). The rule will also facilitate the Agency's coordination with
other Federal and State agencies in regulating the movement and
environmental release of plant pests and biological control organisms.
In our final regulatory flexibility analysis, we have used the best
data available to examine potential impacts of the rule to achieve
desired policy goals. We have determined that the rule will result in
net cost savings for affected entities, nearly all of which are small.
We cannot certify that this rule will have no significant impacts on
small entities, but have found no evidence that it would have such
impacts. We did not receive information during the public comment
period on the proposed rule that would alter this assessment. Given the
expected net cost savings, we have not identified steps that would
minimize these impacts.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Executive Order 13175
In accordance with Executive Order 13175, APHIS has consulted with
Tribal Government officials. A Tribal summary impact statement has been
prepared that includes a summary of Tribal officials' concerns and of
how APHIS has attempted to address them. The Tribal summary impact
statement may be viewed on the Regulations.gov website.\32\
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\32\ See footnote 2.
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National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
processes in this final rule, we have prepared a final environmental
impact statement (EIS). The final EIS is based on a draft EIS, which we
drafted after soliciting public comment through a notice in the Federal
Register to help us delineate the scope of the issues and alternatives
to be analyzed. The final EIS responds to public comments, analyzes
each alternative and its environmental consequences, if any, and
provides APHIS' preferred alternative. 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).
Copies of the final EIS are available on the Regulations.gov
website (see footnote 2 in this document for a link to Regulations.gov)
or by contacting the person listed under FOR FURTHER INFORMATION
CONTACT.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this final rule, which were
filed under 0579-0187, have been submitted for approval to the Office
of Management and Budget (OMB). When OMB notifies us of its decision,
if approval is denied, we will publish a document in the Federal
Register providing notice of what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the EGovernment 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 rule, please contact Ms. Kimberly Hardy,
APHIS' Information Collection Coordinator, at (301) 851-2483.
List of Subjects
7 CFR Part 318
Cotton, Cottonseeds, Fruits, Guam, Plant diseases and pests, Puerto
Rico, Quarantine, Transportation, Vegetables, Virgin Islands.
7 CFR Part 319
Coffee, Cotton, Fruits, Honey, Imports, Plants for planting, Plant
diseases and pests, Plants, Quarantine, Reporting and recordkeeping
requirements, Rice, Sugar, Vegetables.
7 CFR Part 330
Customs duties and inspection, Plant diseases and pests,
Quarantine, Reporting and recordkeeping requirements, Transportation.
7 CFR Part 352
Customs duties and inspection, Plant diseases and pests,
Quarantine, Reporting and recordkeeping requirements, Transportation.
Accordingly, we are amending 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.
0
2. In Sec. 318.60, paragraph (c) introductory text is revised to read
as follows:
Sec. 318.60 Notice of quarantine.
* * * * *
(c) Sand (other than clean ocean sand), soil, or earth around the
roots of plants must not be shipped, offered for shipment to a common
carrier, received for transportation or transported by a common
carrier, or carried, transported, moved, or allowed to be moved by any
[[Page 29958]]
person from Hawaii, Puerto Rico, or the Virgin Islands of the United
States into or through any other State, Territory, or District of the
United States: Provided, That the prohibitions in this paragraph (c) 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: Provided further, That the prohibitions
of this section shall not apply to the movement of such products in
either direction between Puerto Rico and the Virgin Islands of the
United States: Provided further, That such prohibitions shall not
prohibit the movement of such products by the United States Department
of Agriculture for scientific or experimental purposes, nor prohibit
the movement of sand, soil, or earth around the roots of plants which
are carried, for ornamental purposes, on vessels into mainland ports of
the United States and which are not intended to be landed thereat, when
evidence is presented satisfactory to the inspector of the Plant
Protection and Quarantine Programs of the Department of Agriculture
that such sand, soil, or earth has been so processed or is of such
nature that no pest risk is involved, or that the plants with sand,
soil, or earth around them are maintained on board under such
safeguards as will preclude pest escape: And provided further, That
such prohibitions shall not prohibit the movement of plant cuttings or
plants that have been--
* * * * *
PART 319--FOREIGN QUARANTINE NOTICES
0
3. The authority citation for part 319 continues to read as follows:
Authority: 7 U.S.C. 1633, 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. 319.37-10, paragraph (b) is revised to read as follows:
Sec. 319.37-10 Growing media.
* * * * *
(b)(1) Plants for planting from Canada may be imported in any
growing medium, except as restricted in the Plants for Planting Manual.
Restrictions on growing media for specific types of plants for planting
imported from Canada will be added, changed, or removed in accordance
with Sec. 319.37-20.
(2) Plants for planting from an area of Canada regulated by the
national plant 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) introductory text;
0
b. By revising paragraph (a)(8);
0
c. By removing the undesignated paragraph after paragraph (a)(8); and
0
d. By removing paragraph (b)(4).
The revisions read as follows:
Sec. 319.69 Notice of quarantine.
(a) The following plants and plant products, when used as packing
materials, are prohibited entry into the United States from the
countries and localities named in this paragraph (a), exceptions to the
prohibitions may be authorized in the case of specific materials which
have been so prepared, manufactured, or processed that in the judgment
of the inspector no pest risk is involved in their entry:
* * * * *
(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 prohibitions in paragraphs (a)(1) through
(7) of this section 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 revised to read as follows:
Sec. 319.69-5 Types of organic decaying vegetative matter authorized
for packing.
The following types of organic decaying vegetative matter are
authorized as safe for packing:
(a) Peat;
(b) Peat moss; and
(c) Osmunda fiber.
0
8. Section 319.77-2 is amended as follows:
0
a. In paragraph (e), by removing the word ``and'';
0
b. By revising paragraph (f); and
0
c. By adding paragraph (g).
The revision and addition read as follows:
Sec. 319.77-2 Regulated articles.
* * * * *
(f) Mobile homes and their associated equipment; and
(g) 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. 1633, 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. The
term includes associated articles such as soil and packaging.
Biocontainment facility. A physical structure or portion thereof,
constructed and maintained in order to contain plant pests, biological
control organisms, or associated articles.
[[Page 29959]]
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.
Continued curation permit. A permit issued prior to the expiration
date for an import permit or interstate movement permit in order for a
permittee to continue research or other actions listed on the import or
interstate movement permit. Continued curation permits do not allow
acquisition of additional organisms for research and other authorized
activities and only address retention of existing organisms for
authorized uses.
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 U.S. Customs and Border Protection 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.
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.
Pure culture. A single species of invertebrate originating only
from an identified/described population and free of disease and
parasites, cryptic species, soil and other biological material except
host material and substrate as APHIS deems appropriate. Examples of
identified/described population are those originating from a specific
laboratory colony or field collection from a specified geographic area,
such as an entire country or States or provinces of a country.
Regulated garbage. That material designated as regulated garbage in
Sec. 330.400(c) and (d).
Responsible individual. One or more individuals who a permittee
designates to appropriately oversee and control the staff, facilities,
and/or site(s) at the location(s) specified on the permit as the
ultimate destination of the plant pest, biological control organism, or
associated article, to ensure compliance with the permit conditions
during all phases of the activities being performed with the regulated
articles authorized 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(s) must serve as a primary contact for communication with
APHIS. The permittee may designate him or herself as the responsible
individual. The responsible individual(s) must be at least 18 years of
age and to be able meet with and provide information to an APHIS
representative within a reasonable time frame. 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
[[Page 29960]]
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 and territories.
U.S. Customs and Border Protection (CBP). U.S. Customs and Border
Protection within the Department of Homeland Security.
Sec. 330.105 [Amended]
0
13. In Sec. 330.105, paragraph (a) is amended by removing the citation
``Sec. 330.300'' both times it appears and adding the words ``this
part'' in its place.
0
14. Subpart B is revised to read as follows:
Subpart B--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 B--Movement of Plant Pests, Biological Control Organisms,
and Associated Articles
Sec. 330.200 Scope and general restrictions.
(a) Restrictions. 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:
(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 from permitting requirements in
this subpart; 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.
Paragraph (c) of this section notwithstanding, biological control
organism-containing products that are currently under an EPA
experimental use permit, a Federal Insecticide Fungicide and
Rodenticide Act (FIFRA) section 18 emergency exemption, or that are
currently registered with EPA as a microbial pesticide product, 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 FIFRA
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 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 one or more designated individuals 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 one or
more designated individuals 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.
[[Page 29961]]
(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. To facilitate timely processing,
applications should be submitted as far in advance as possible of the
date of the proposed permit activity. 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 \2\ or associated
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.
---------------------------------------------------------------------------
\2\ Includes biological control organisms and plant pests.
---------------------------------------------------------------------------
(3) Issuance of a permit. APHIS may issue a permit to an applicant
if APHIS concludes that the actions indicated in the permit application
are not likely to introduce or disseminate a plant pest, biological
control organism, or noxious weed within the United States in a manner
that exposes plants and plant products to unacceptable risk. 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 associated 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 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.
[[Page 29962]]
(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.
(Approved by the Office of Management and Budget Under Control
Number 0579-0054)
Sec. 330.202 Biological control organisms.
(a) General conditions for importation, interstate movement, and
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 in interstate commerce, or
released into the environment unless a permit has been issued in
accordance with Sec. 330.201 authorizing such importation, interstate
movement, or 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 through 1508, part 1b of this title,
and part 372 of this chapter 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. Lists of biological control organisms for
invertebrate plant pests and for weeds are maintained on the PPQ
Permits and Certifications website at https://www.aphis.usda.gov/aphis/resources/permits.
(1) Importation and interstate movement of listed organisms. Pure
cultures of organisms excepted from permit requirements, unless
otherwise indicated, may be imported or moved interstate within the
continental United States without further restriction under this
subpart.
(2) 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, interstate movement, or
release. 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
[[Page 29963]]
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; or
(2) Evidence that the organism's geographical or ecological range
includes an extremely limited area of or none of the continental United
States based on its inability to maintain year to year self-replicating
populations despite repeated introductions over a sufficient range of
time; or
(3) The petition would include evidence that the organism cannot
establish anywhere in the continental United States; or
(4) Results from a field study where data were 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; or
(5) 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) Evaluation. 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.
(Approved by the Office of Management and Budget under control
number 0579-0187)
Sec. 330.203 Soil.
(a) Requirements. 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
paragraph (b)(1) or (c)(1) of this section.
(b) Conditions governing the importation of soil--(1) Permit.
Except as provided in Sec. 319.37-10 of this chapter and except for
soil imported from areas of Canada not regulated by the national plant
protection organization of Canada for a soil-borne plant pest, soil may
be imported into the United States if an import permit has been issued
in accordance with Sec. 330.201 and if the soil is 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 an APHIS-approved biocontainment facility.
(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.
(5) Exemptions. The articles listed in this paragraph (b) 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 otherwise. 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
referenced 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 in interstate commerce 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 if the soil will be
[[Page 29964]]
moved directly to an APHIS-approved biocontainment facility 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 in interstate commerce 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 in interstate commerce 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.
(Approved by the Office of Management and Budget Under Control
Number 0579-0054)
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 moved interstate within the continental United States without
restriction. The list of all such plant pests is on the PPQ Permits and
Certifications website at https://www.aphis.usda.gov/aphis/resources/permits. Plant pests listed as being excepted from permitting
requirements, unless otherwise indicated, may be moved interstate
within the continental United States without further restriction under
this subpart.
(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 is established throughout its entire
geographical or ecological range within the continental United States;
or
(2) 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 moved 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 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 categories listed in paragraph (a) of
this section, APHIS will deny the petition, and notify the petitioner
in writing regarding this denial.
(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
moved 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 moved interstate
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,
[[Page 29965]]
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, 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 listed 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.
(Approved by the Office of Management and Budget Under Control
Number 0579-0187)
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 provide APHIS through APHIS' online portal for
permit applications or by fax with the names of the designated hand
carrier, or carriers, assigned to that movement. Additional conditions
for hand-carry are available on the APHIS website.\3\
---------------------------------------------------------------------------
\3\ https://www.aphis.usda.gov/plant_health/permits/organism/downloads/HandCarryPolicy.pdf.
---------------------------------------------------------------------------
(c) 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.
(d) 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 in interstate commerce, 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 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 materials may be placed in the inner
packages or shipping container for such purposes as cushioning,
stabilizing, water absorption or retention, nourishment or substrate
for regulated articles, etc. Packing material for importation must be
free of plant pests, noxious weeds, biological control organisms not
listed on the permit or associated articles, and, as such, 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.
(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 be reused, provided that the container
has not been contaminated with plant pests, noxious weeds, biological
control organisms, or associated articles. Shipping containers that
have been in contact with or otherwise contaminated with any of these
items must be sufficiently sterilized or disinfected prior to reuse, or
otherwise disposed of.
(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.
[[Page 29966]]
Subpart C--[Removed and Reserved]
0
15. Subpart C, consisting of Sec. Sec. 330.300 through 330.302, is
removed and reserved.
PART 352--PLANT QUARANTINE SAFEGUARD REGULATIONS
0
16. The authority citation for part 352 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
17. In Sec. 352.1, paragraph (b) is amended as follows:
0
a. By adding, in alphabetical order, a definition for Biological
control organism;
0
b. By revising the definition for Deputy Administrator;
0
c. By adding, in alphabetical order, a definition for Noxious weed; and
0
d. By revising the definitions for Person, Plant pest, and Soil.
The additions and revisions 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 plant pests listed
in this definition.
* * * * *
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
18. 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 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
19. Section 352.3 is amended as follows:
0
a. In paragraphs (a) and (b), by adding the words ``biological control
organisms,'' after the words ``plant pests,'' each time they appear;
and
0
b. In paragraph (d), by removing the words ``plant pest or noxious weed
dissemination'' and adding the words ``plant pest, noxious weed, or
biological control organism dissemination'' in their place.
Sec. 352.5 [Amended]
0
20. Section 352.5 is amended by adding the words ``biological control
organisms,'' after the words ``plant pests,'' each time they appear.
Sec. 352.6 [Amended]
0
21. Section 352.6 is amended as follows:
0
a. In paragraph (b), by removing footnote 2 and removing the words ``as
specified by'' and adding the words ``in accordance with'' in their
place; and
0
b. In paragraph (c), by removing the reference to footnote 2 and
removing the citation ``Sec. 330.300(b)'' and adding the citation
``Sec. 330.203'' in its place.
0
c. In paragraph (e), by removing the words ``plant pest or noxious weed
dissemination'' both times they appear and adding the words ``plant
pest, noxious weed, or biological control organism dissemination'' in
their place.
Sec. 352.9 [Amended]
0
22. Section 352.9 is amended by adding the words ``biological control
organisms,'' after the words ``plant pests,''.
Sec. 352.10 [Amended]
0
23. Section 352.10 is amended as follows:
0
a. By redesignating footnote 3 as footnote 2;
0
b. In paragraph (b)(1), by removing the words ``plant pest or noxious
weed dissemination'' each time they appear and adding the words ``plant
pest, noxious weed, or biological control organism dissemination'' in
their place and adding the words ``biological control organisms,''
after the words ``Prohibited or restricted plants, plant products,
plant pests,'';
0
c. In paragraph (b)(2) introductory text, by removing the words ``plant
pest or noxious weed dissemination'' both times they appear and adding
the words ``plant pest, noxious weed, or biological control organism
dissemination'' in their place;
0
d. In paragraph (b)(2)(i), by adding the words ``or biological control
organisms'' after the words ``plant pests'';
0
e. In paragraph (b)(2)(ii), by adding the words ``biological control
organisms,'' after the words ``plant pests,'';
0
f. In paragraph (b)(2)(iii), by removing the words ``plant pest or
noxious weed dissemination'' and adding the words ``plant pest, noxious
weed, or biological control organism dissemination'' in their place;
0
g. 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; and
0
h. In paragraph (c)(1), by removing the words ``plant pest or noxious
weed dissemination'' and adding the words ``plant pest, noxious weed,
or biological control organism dissemination'' in their place.
Sec. 352.11 [Amended]
0
24. In Sec. 352.11, paragraph (a)(1) is amended by removing the words
``plant pests, noxious weeds, and soil'' and adding the words ``plant
pests, biological control organisms, noxious weeds, soil, or other
products or articles'' in their place.
[[Page 29967]]
Sec. 352.13 [Amended]
0
25. Section 352.13 is amended by removing the words ``plant pests,
noxious weeds, and soil'' and adding the words ``plant pests,
biological control organisms, noxious weeds, soil, or other products or
articles'' in their place and removing the word ``parts'' and adding
the word ``part'' in its place.
Sec. 352.15 [Amended]
0
26. Section 352.15 is amended by removing the words ``plant pest or
noxious weed dissemination'' and adding the words ``plant pest, noxious
weed, or biological control organism dissemination'' in their place.
Sec. 352.30 [Amended]
0
27. Section 352.30 is amended by redesignating footnotes 4 and 5 as
footnotes 3 and 4, respectively.
Done in Washington, DC, this 17th day of June 2019.
Lorren E.S. Walker,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2019-13246 Filed 6-21-19; 8:45 am]
BILLING CODE 3410-34-P
