Controlled Import Permits, 65976-65985 [2011-27580]
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65976
Proposed Rules
Federal Register
Vol. 76, No. 206
Tuesday, October 25, 2011
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Part 319
[Docket No. APHIS–2008–0055]
RIN 0579–AD53
Controlled Import Permits
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
We are proposing to amend
the regulations concerning the
importation of plants and plant
products by establishing the controlled
import permit as a single type of
authorization for the importation into
the United States of otherwise
prohibited or restricted plant material
for experimental, therapeutic, or
developmental purposes. Currently,
some sections of the regulations provide
for those articles to be imported under
a departmental permit, while other
sections provide for their importation
under administrative instructions or
conditions specified by the
Administrator or Deputy Administrator.
This action would consolidate and
harmonize the conditions for obtaining
authorization for the importation of
otherwise prohibited or restricted plant
material for scientific or certain other
purposes.
SUMMARY:
We will consider all comments
that we receive on or before December
27, 2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2008-00550001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2008–0055, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
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Supporting documents and any
comments we receive on this docket
may be viewed at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2008-0055 or
in our reading room, which is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue,
SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 690–2817
before coming.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
William Aley, Senior Import Specialist,
Plant Health Programs, PPQ, APHIS,
4700 River Road, Unit 133, Riverdale,
MD 20737–1231; (301) 734–5057.
SUPPLEMENTARY INFORMATION:
Background
The regulations contained in 7 CFR
part 319, Foreign Quarantine Notices,
prohibit or restrict the importation into
the United States of certain plants and
plant products to prevent plant pests
and noxious weeds from being
introduced into and spread within the
United States.
These regulations are administered
and enforced by the Plant Protection
and Quarantine program (PPQ) of the
Animal and Plant Health Inspection
Service (APHIS) under the authority of
the Plant Protection Act (7 U.S.C. 7701
et seq.). The regulations in part 319
designate specific articles as prohibited
or restricted, and assign conditions to
their movement, if allowed, into the
United States according to the risks
posed by each article to agriculture in
the United States.
The current regulations contain
provisions for several different means of
authorizing the importation of plants
and plant products. These means of
authorization have been used to allow
restricted articles to be imported under
conditions that differ from the generally
applicable provisions of the particular
subpart; other types have been used to
authorize the importation of articles that
would otherwise be prohibited under
the regulations.
The means of authorizing these types
of movements that is most commonly
found in the regulations is the
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departmental permit. In § 319.40–1, we
define a departmental permit as ‘‘a
document issued by the Administrator
authorizing the importation of a
regulated article for experimental,
scientific, or educational purposes.’’
The departmental permit has been used
to allow researchers and scientists
affiliated with the United States
Department of Agriculture (USDA) to
import prohibited or restricted articles
for scientific, analytical, experimental,
or research purposes. It is currently
available under several subparts of the
regulations. In other areas of the
regulations, we have referred to the
departmental permit when we have
stated that a regulated article may be
allowed to be imported ‘‘by the U.S.
Department of Agriculture for
experimental or scientific purposes.’’ In
still other areas of the regulations, the
regulations state that, under certain
circumstances, regulated articles may be
imported under conditions ‘‘modified to
be less stringent’’ than those contained
in the regulations.
In recent years, the number of
requests to import, for research
purposes, articles that are otherwise
prohibited or restricted has increased as
the number and types of possible uses
for such articles in the United States has
expanded. Also, entities requesting to
import these articles now include
private scientific and academic
laboratories and researchers, and
commercial and other nongovernmental
organizations.
We recognize that research and
investigations concerning restricted or
prohibited plant material may benefit
agricultural interests in the United
States in several ways. Such benefits
may include the introduction of plants
or varieties or cultivars of plants
adaptable to certain environments or
resistant to domestic plant pests in the
United States, suitable to consumers in
the United States, or with value to
certain markets. Other benefits may
include the establishment of new
markets, the introduction of new plant
varieties, or trade opportunities.
We are committed to making our
permit procedures found in the various
subparts of the regulations consistent
according to the plant pest risks
associated with the plant material and
its intended use. We are also committed
to making our regulations more
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transparent and easier to use and
implement.
Therefore, we are proposing to amend
the regulations in part 319 to
standardize the type of authorization
used to permit the importation of plants
and plant products for experimental,
therapeutic, or developmental purposes.
We would also amend these portions of
the regulations that contain outdated
language or that refer to procedures for
importation that we believe pose
unnecessary risks to agriculture in the
United States.
We are proposing to establish the
controlled import permit (CIP) as the
permit that would be used in place of
departmental permits and the other
types of authorizations discussed
previously that we have used to allow
the importation of otherwise prohibited
articles or of articles under different
conditions than those found in the
regulations. We are also proposing to
use the CIP as the form of permit
required for the importation of plant
materials for postentry quarantine.
We propose to define controlled
import permit as ‘‘a written or
electronically transmitted authorization
issued by APHIS for the importation
into the United States of otherwise
prohibited or restricted plant material
for experimental, therapeutic, or
developmental purposes, under
controlled conditions as prescribed by
the Administrator in accordance with
§ 319.6.’’
The CIP would be issued based on
consideration of the plant pest risks of
the imported plant material, whether
such risks can be mitigated sufficiently,
the intended use of the plant material,
and the plant pest risks associated with
such use. We would also consider the
taxon of the plant material and country
of origin. The CIP would be available to
all entities in the United States and no
longer limited to researchers and
scientists affiliated with the USDA.
The CIP would be issued only for
articles subject to the regulations in part
319; we would not provide for the
issuance of a CIP for the movement of
plant pests regulated under 7 CFR part
330, genetically engineered plant
material regulated under 7 CFR part
340, noxious weeds regulated under 7
CFR part 360, or seeds regulated under
7 CFR part 361. We believe that the
restrictions imposed on the movement
of these articles by the regulations in
parts 330, 340, 360, and 361 are
effective in preventing the introduction
and dissemination of plant pests or
noxious weeds into or within the United
States.
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General Requirements for a Controlled
Import Permit
We would add a new ‘‘Subpart—
Controlled Import Permits’’ (§ 319.6)
that would contain the general
requirements regarding the proposed
CIP.
In paragraph (a) of § 319.6, we would
define the terms Administrator,
developmental purposes, experimental
purposes, and therapeutic purposes, the
latter three being the purposes for which
the CIP may be issued. We would define
Administrator as the Administrator of
the Animal and Plant Health Inspection
Service, United States Department of
Agriculture, or any employee of the
United States Department of Agriculture
delegated to act in his or her stead.
Developmental purposes would be
defined as the evaluation, monitoring,
or verification of plant material for plant
health risks and/or the adaptability of
the material for certain uses or
environments. Experimental purposes
would be defined as scientific testing of
plant material which utilizes collected
data and employs analytical processes
under controlled conditions to create
qualitative or quantitative results. We
would define therapeutic purposes as
the application of specific scientific
processes designed to eliminate, isolate,
or remove potential plant pests or
diseases.
An application for a CIP could be
obtained through any of the means
currently available for applying for
other types of permits to import
regulated plant material, i.e., through
the Internet using the APHIS ePermits
Web site or using applications obtained
from APHIS headquarters or from local
offices of PPQ; paper applications could
be submitted by fax or by mail. The
regulations in § 319.6(c) would provide
the necessary mailing address, fax
number, and the address of the APHIS
ePermits Web site. An application
would have to be submitted at least 60
days prior to the proposed arrival of the
article at the port of entry.
The application for a CIP would have
to contain the following information:
• Name, address in the United States,
and contact information of the
applicant;
• Identity (common and botanical
[genus and species] names) of the plant
material to be imported; country of
origin and country shipped from;
• Intended experimental, therapeutic,
or developmental purpose for the
importation; and
• Intended ports of departure and
entry; quantity of importation; means of
conveyance; estimated date of arrival.
This information would allow us to
evaluate the risks associated with the
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proposed importation. A CIP would be
issued only if APHIS determines that
the plant pest risks associated with the
plant material and the intended
experimental, therapeutic, or
developmental use of the plant material
can be effectively mitigated. The CIP
would contain the applicable conditions
for importation and subsequent
handling of the plant material if it is
deemed eligible for importation into the
United States.
With limited exceptions, plant
material to be offered for importation
under a CIP would have to be selected
from apparently disease-free and pestfree sources, and be free of foreign
matter or debris, other prohibited
plants, noxious weed seeds, soil, living
organisms such as parasitic plants,
pathogens, insects, snails and mites, and
other prohibited matter. The plant
material would also have to be free of
fungicide, insecticide, pesticide,
coating, dipping, spraying, or other
applied treatments that would make the
consignment difficult or hazardous to
inspect. Similarly, plant materials could
not be wrapped or otherwise packaged
in a manner that impedes or prevents
adequate inspection or treatment at the
port of entry.
Although we would generally require
all material imported under a CIP to be
apparently disease-free and pest-free,
under certain circumstances and for
specific purposes, we may permit plant
material to be imported under a CIP for
scientifically approved treatment
therapies. For example, we may permit
the importation under a CIP of plant
material not considered free of plant
pests to an approved facility capable of
applying approved scientific techniques
to eliminate plant pests and verifying
freedom from plant pests.
All plant material offered for
importation under a CIP would have to
be moved in an enclosed container or
one completely enclosed by a covering
adequate to prevent the possible escape
or introduction of plant pests during
shipment. Any packing material used in
the consignment would have to meet the
requirements of § 319.37–9, and wood
packing material used in the
consignment would have to meet the
requirements of § 319.40–3(b) and (c).
The CIP would identify the manner in
which the consignment is to be shipped
(e.g., as cargo, by mail, as air freight).
Under certain circumstances, we may
allow the plant material to be handcarried.
The plant material would have to be
offered for importation at the port of
entry or plant inspection station
specified in the CIP. A copy of the CIP
and an invoice or packing list indicating
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the contents of the consignment would
have to accompany each consignment.
All consignments would be required to
be labeled as specified in the permit,
and to bear a tag provided with the CIP.
Depending on the intended purpose
of the plant material presented for
importation and the risks associated
with such importation, we may require
that the plant material be transported
from the plant inspection station for
release only to preapproved facilities.
We would assess a facility prior to
issuing a permit to ensure that it has the
infrastructure and equipment identified
by APHIS as being necessary to manage
the risks associated with the imported
plant material.
At the approved facility, the plant
material imported under a CIP would
have to be identified and labeled as
quarantined material to be used only in
accordance with a valid CIP. Such plant
material would have to be maintained in
a secure place and be under the
supervision and control of the permit
holder, and could not be moved or
distributed without prior written
permission. During regular business
hours, properly identified officials,
either Federal or State, would have to be
allowed to inspect the plant material
and the facility in which the plant
material is maintained.
The permit holder would be required
to keep the permit valid for the duration
of the authorized experimental,
therapeutic, or developmental activity.
A CIP would be valid for a period of 1
year and could be renewed if we
believed the additional time was
necessary to complete the experimental,
therapeutic, or developmental purpose
for which the permit was issued.
In the event the permit holder leaves
the institution in which the plant
material is kept, another person would
be required to assume responsibility for
the continued maintenance of the plant
material and obtain a new CIP for the
material or it would have to be
destroyed.
Any conditions of the CIP or assigned
safeguarding or mitigation measures
would be clearly explained in the CIP.
Failure to comply with all of the
conditions specified in the CIP or any
applicable regulations or administrative
instructions, or forging, counterfeiting
or defacing permits or shipping labels,
may result in immediate revocation of
the permit, denial of future permits, and
civil or criminal penalties for the permit
holder.
Proposed paragraph (g) of § 319.6
would address the circumstances under
which an application for a CIP may be
denied or a CIP may be revoked after
issuance. Under these provisions, the
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Administrator would deny an
application for a CIP permit when the
Administrator determines that:
• No safeguards adequate or
appropriate to prevent the
dissemination of a plant pest or plant
disease can be implemented;
• The applicant, as a previous
permittee, failed to maintain the
safeguards or otherwise comply with all
the conditions prescribed in a previous
permit and failed to demonstrate the
ability or intent to observe them in the
future;
• The application for a permit is
found to be false or deceptive in any
material particular;
• Such an importation would involve
the potential dissemination of a plant
pest or plant disease which outweighs
the probable benefit that could be
derived from the proposed importation
and use of the regulated plant material;
• The importation is adverse to the
conduct of an APHIS eradication,
suppression, control, or regulatory
program; or
• The government of the State or
Territory into which the plant material
would be imported objects to the
proposed importation and provides a
written explanation of its concerns
based on plant pest risks.
The Administrator would revoke any
outstanding CIP when the Administrator
determines that information is received
subsequent to the issuance of the CIP of
circumstances that would constitute
cause for the denial of an application
described above, or the permittee fails to
maintain the safeguards or otherwise
observe the conditions specified in the
CIP or in any applicable regulations or
administrative instructions.
All denials of an application for a
permit, or revocation of an existing
permit, would be provided to the
applicant or permittee in writing. The
reasons for the denial or revocation
would be stated in writing as promptly
as circumstances permit.
We would require that, upon
revocation of a permit, the permittee
must either:
• Surrender all regulated plant
material covered by the revoked CIP to
an APHIS inspector;
• Destroy all regulated plant material
covered by the revoked CIP under the
supervision of an APHIS inspector; or
• Remove all regulated plant material
covered by the revoked CIP from the
United States.
We would provide for the appeal of
the denial or revocation of a CIP. Any
person whose application for a permit
has been denied or whose permit has
been revoked may appeal the decision
in writing to the Administrator within
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10 days after receiving written
notification of the denial or revocation.
The appeal would have to state all facts
and reasons upon which the person was
relying to show that the CIP was
wrongfully denied or revoked. The
Administrator would grant or deny the
appeal, in writing, as promptly as
circumstances permit, and would state
in writing the reason for the decision. If
there is a conflict as to any material fact,
a hearing would be held to resolve such
conflict. Rules of practice concerning
such a hearing would be adopted by the
Administrator. The permit denial or
revocation would remain in effect
during the resolution of the appeal.
Regulations That Would Include
References to the CIP
We are proposing to use the CIP to
authorize the importation of certain
prohibited or restricted plant material
for experimental, therapeutic, or
developmental purposes in the current
regulations in part 319. In doing so, we
would replace the current provisions for
importations for these purposes.
In the paragraphs that follow, we
discuss the changes we are proposing
and cite the specific areas of the
regulations we are proposing to change.
• Foreign cotton and covers regulated
under §§ 319.8 through 319.8–26. In
§ 319.8, which establishes a notice of
quarantine for parts or products of
plants of the genus Gossypium, we
would replace the current text, which is
dated and difficult to follow, with a
clear statement that the importation of
the plants and plant products listed in
the section is prohibited unless they are
imported in accordance with the
regulations of the subpart or imported
for experimental, therapeutic, or
developmental purposes under the
provisions of a CIP. We would remove
and reserve §§ 319.8–19 and 319.8–20,
as provisions for the importation of
plant material regulated by the subpart
for experimental or scientific purposes
would be covered in the revised § 319.8.
• Sugarcane regulated under
§ 319.15. In § 319.15(a), we would
remove the provision that sugarcane and
its related products may be imported for
scientific or experimental purposes
under a departmental permit only by the
USDA, and provide that these articles
may be moved under the conditions
specified in a CIP.
• Citrus fruit and nursery stock
regulated under §§ 319.19 and 319.28.
In §§ 319.19(b) and 319.28(d) we would
remove the provision that plants or
plant parts of the botanical family
Rutaceae may be imported for scientific
or experimental purposes under
conditions as prescribed by the APHIS
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Administrator or the PPQ Deputy
Administrator, and instead provide that
these articles may be moved under the
conditions specified in a CIP. We would
also remove the statement that the
paragraph’s provisions apply only to
importations by the USDA.
• Indian corn or maize and related
plants and their seeds regulated under
§§ 319.24 through 319.24–5 (the corn
diseases subpart), and §§ 319.41
through 319.41–6 (the Indian corn or
maize, broomcorn, and related plants
subpart). In § 319.24(b) we would
remove the provision that portions of
Indian corn or maize and related plants
may be imported into Guam under
conditions less stringent than those of
the subpart as prescribed by the Deputy
Administrator, and the statement that
the paragraph’s provisions apply only to
USDA importers and instead provide
that these articles may be moved under
the conditions specified in a CIP.
Paragraph (c) of § 319.41 has an
identical provision regarding
importations into Guam which we
would also remove and instead provide
that the articles may be moved under
the conditions specified in a CIP.
• Nursery stock, plants, roots, bulbs,
seeds, and other plant products
regulated under §§ 319.37 through
319.37–14. In § 319.37–1 we would
remove the definition of Deputy
Administrator and add definitions of
Administrator and controlled import
permit for use in the subpart. In
§ 319.37–2(c)(1), we would add that
importations for experimental,
therapeutic, or developmental purposes
may be allowed under the conditions of
a CIP, and remove the statement that the
paragraph’s provisions apply only to
importations by the USDA. In
paragraphs (c)(3) through (c)(5) we
would replace references to a
departmental permit with references to
the CIP. In § 319.37–3, we would add a
new paragraph (g) requiring that the
importation of restricted articles into the
United States for experimental,
therapeutic, or developmental purposes
would require application for a CIP in
accordance with § 319.6, and add a new
paragraph (h) indicating that restricted
articles imported into the United States
that are required to be grown under
postentry quarantine provisions must be
accompanied by a CIP obtained in
accordance with § 319.6.
Section 319.37–7 contains provisions
governing postentry quarantine
activities. Postentry quarantine is
required for an established length of
time following importation of certain
restricted plants so they may be
investigated and monitored for freedom
from plant pests of foreign origin.
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Current paragraphs (a)(2) and (d) of this
section require that an importer of the
listed restricted articles from the
designated regions complete and submit
to PPQ a postentry quarantine growing
agreement and an application for a
written permit for the importation of the
article in accordance with § 319.37–3.
Section 319.37–3 designates articles
whose importation requires a permit
and indicates the information a permit
application must contain, how a permit
is issued, and under which
circumstances a permit may be
withdrawn.
We are proposing to amend § 319.37–
7(a)(2) and (d) to state that the CIP is the
form of permit required to accompany a
postentry quarantine growing
agreement. We believe that the
information required in the application
for a CIP will allow us to make a more
informed decision about the specific
article submitted for the postentry
quarantine program, and allow us to
provide more specific conditions for the
issuance of the permit. It will also allow
us more control over the plant material
selected for the postentry quarantine
program.
As noted above, current § 319.37–
7(a)(2) and (d) require that the
application for the written permit be
made in accordance with § 319.37–3.
We would add a new paragraph (h) to
§ 319.37–3, which would require that
the importation of restricted articles into
the United States to be grown under the
postentry quarantine provisions of
§ 319.37–7 must be authorized by a CIP
obtained in accordance with § 319.6.
Since we are proposing to change the
type of permit required by § 319.37–
7(a)(2) and (d) to accompany a postentry
quarantine growing agreement to the
CIP, we would amend those provisions
to require that a CIP, as provided for in
the newly added § 319.37–3(h), be
obtained.
• Logs, lumber, and other
unmanufactured wood articles
regulated under §§ 319.40–1 through
319.40–11. In § 319.40–1 we would add
a definition of controlled import permit
for use in the subpart, and remove that
of departmental permit. In § 319.40–
2(d)(1), we would add that importations
for experimental, therapeutic, or
developmental purposes may be
allowed under the conditions of a CIP,
and we would remove the statement
that the paragraph’s provisions apply
only to importations by the USDA. In
paragraphs (d)(2) and (d)(3), we would
replace the references to a Departmental
permit with references to a CIP.
• Rice regulated under §§ 319.55
through 319.55–7. In § 319.55(c), we
would remove the provision that all
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seed or paddy rice, rice straw, and rice
hulls may be imported, when public
interests will permit, into Guam under
conditions less stringent than those of
the subpart as prescribed by the Deputy
Administrator, and in its place provide
that the articles may be moved under
the conditions specified in a CIP.
• Plant material subject to wheat
diseases regulated under §§ 319.59–1
through 319.59–4. In § 319.59–1 we
would add a definition for the
controlled import permit for use in the
subpart. In paragraph (b) of § 319.59–2
we would remove the statement that the
paragraph’s provisions apply only to
importations by the USDA and in its
place provide that the articles may be
moved under the conditions specified in
a CIP. We would replace the references
to a departmental permit with
references to a CIP in paragraphs (b)(2),
(b)(3), and (b)(4).
• Packing materials regulated under
§§ 319.69 through 319.69–5. Section
319.69 prohibits certain plants and
plant products and restricts certain
others for use as packing materials. In
paragraph (c) we would replace
outdated language with the statement
that the importation of those prohibited
or restricted plant products may be
imported for experimental, therapeutic,
or developmental purposes under the
provisions of a CIP.
• Cut flowers regulated under
§§ 319.74–1 through 319.74–4. In
§ 319.74–1 we would add a definition
for the controlled import permit for use
in the subpart. We would remove the
provision that regulated articles may be
imported for experimental or scientific
purposes if moved under conditions
prescribed by the Deputy Administrator
in § 319.74–3 and instead provide that
the articles may be moved under the
conditions specified in a CIP.
• Articles restricted in order to
prevent the entry of khapra beetle under
§§ 319.75 through 319.75–9. In
§ 319.75(c), we would remove the
statement that the paragraph’s
provisions apply only to importations
by the USDA and would replace
references to a departmental permit
with references to a CIP.
We believe that these proposed
changes would consolidate and
harmonize requirements for obtaining a
permit for the importation of plant
material imported for scientific or
certain other purposes, and therefore
make the requirements of part 319
clearer and easier to use and implement.
In addition to these specific proposed
changes regarding the CIP, we are also
proposing to update the subparts
discussed above by replacing references
to ‘‘Deputy Administrator’’ wherever
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they still appear with references to the
Administrator. In some subparts, this
would include removing a definition of
Deputy Administrator and adding one
for Administrator. Most APHIS
regulations refer to the Agency’s
Administrator rather than the Deputy
Administrators of specific programs like
PPQ. This proposed change would make
the regulations in part 319 consistent
with other APHIS regulations.
Executive Order 12866 and Regulatory
Flexibility Act
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866 and,
therefore, has not been reviewed by the
Office of Management and Budget.
We have prepared an economic
analysis for this proposed rule, which is
set out below. The analysis provides a
basis for our determination that this
action would not have a significant
economic impact on a substantial
number of small entities.
For the purpose of this analysis and
following the Small Business
Administration (SBA) guidelines, we
note that a major segment of entities
potentially affected by the proposed
changes are classified within the
following industries: Nursery and Tree
Production (NAICS 111421), and
Floriculture Production (NAICS
111422). The nursery and floriculture
industries are representative of other
agricultural and nonagricultural
industries in terms of being comprised
largely of small entities. According to
the Census of Agriculture, these two
categories included 52,845 farms in
2007, and represented 3 percent of all
farms in the United States. These
entities are considered small by SBA
standards if their annual sales are
$750,000 or less. Over 93 percent of the
farms in these industries had annual
sales of less than $500,000.
Research and development
establishments within Physical,
Engineering, and Life Sciences (NAICS
541711) that provide professional,
scientific, and technical services may
also be affected by this proposed rule.
These entities are considered small by
SBA standards if they employ not more
than 500 persons. According to the 2002
Economic Census, 82 percent of these
establishments are small.
The CIP would replace the
departmental permit and other forms of
authorizations that have been in use.
Because this is an administrative
change, we do not anticipate that the
replacement would have any significant
economic impact on the concerned
entities. From January 1, 2007, to
December 31, 2009, a total of 108
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postentry quarantine permits and 1,012
departmental permits were issued. The
proposed rule is not expected to affect
the number of permits issued.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action would not
have a significant economic impact on
a substantial number of small entities.
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) All State and local laws and
regulations that are inconsistent with
this rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) administrative proceedings
will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or recordkeeping
requirements included in this proposed
rule have been submitted for approval to
the Office of Management and Budget
(OMB). Please send written comments
to the Office of Information and
Regulatory Affairs, OMB, Attention:
Desk Officer for APHIS, Washington, DC
20503. Please state that your comments
refer to Docket No. APHIS–2008–0055.
Please send a copy of your comments to:
(1) APHIS–2008–0055, Regulatory
Analysis and Development, PPD,
APHIS, Station 3A–03.8, 4700 River
Road, Unit 118, Riverdale, MD 20737–
1238, and (2) Clearance Officer, OCIO,
USDA, Room 404–W, 14th Street and
Independence Avenue, SW.,
Washington, DC 20250. A comment to
OMB is best assured of having its full
effect if OMB receives it within 30 days
of publication of this proposed rule.
APHIS is proposing to amend the
regulations concerning the importation
of plants and plant products by
establishing the controlled import
permit as a single type of authorization
for the importation into the United
States of otherwise prohibited or
restricted plant material for
experimental, therapeutic, or
developmental purposes. Currently,
some sections of the regulations provide
for those articles to be imported under
a departmental permit, while other
sections provide for their importation
under administrative instructions or
conditions specified by the
Administrator or Deputy Administrator.
This action would consolidate and
harmonize the conditions for obtaining
authorization for the importation of
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otherwise prohibited or restricted plant
material for scientific or certain other
purposes.
This proposed rule will require the
use of a controlled import permit,
annual inspection report, and the
identification of the commodity being
imported.
We are soliciting comments from the
public (as well as affected agencies)
concerning our proposed information
collection and recordkeeping
requirements. These comments will
help us:
(1) Evaluate whether the proposed
information collection is necessary for
the proper performance of our agency’s
functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
information collection on those who are
to respond (such as through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submission of responses).
Estimate of burden: Public reporting
burden for this collection of information
is estimated to average 0.8125 hours per
response.
Respondents: Researchers, for-profit
organizations, and foreign government
officials.
Estimated annual number of
respondents: 1,200.
Estimated annual number of
responses per respondent: 6.667.
Estimated annual number of
responses: 8,000.
Estimated total annual burden on
respondents: 6,500 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
Copies of this information collection
can be obtained from Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 851–2908.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
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E-Government Act compliance related
to this proposed rule, please contact
Mrs. Celeste Sickles, APHIS’
Information Collection Coordinator, at
(301) 851–2908.
List of Subjects in 7 CFR Part 319
Coffee, Cotton, Fruits, Imports, Logs,
Nursery stock, Plant diseases and pests,
Quarantine, Reporting and
recordkeeping requirements, Rice,
Vegetables.
Accordingly, we propose to amend 7
CFR part 319 as follows:
PART 319—FOREIGN QUARANTINE
NOTICES
1. The authority citation for part 319
continues to read as follows:
Authority: 7 U.S.C. 450, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
2. A new subpart consisting of § 319.6
is added to read as follows:
Subpart—Controlled Import Permits
Sec.
319.6 Controlled import permits.
Subpart—Controlled Import Permits
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§ 319.6
Controlled import permits.
(a) Definitions.
Administrator. The Administrator of
the Animal and Plant Health Inspection
Service, United States Department of
Agriculture, or any employee of the
United States Department of Agriculture
delegated to act in his or her stead.
Developmental purposes. The
evaluation, monitoring, or verification
of plant material for plant health risks
and/or the adaptability of the material
for certain uses or environments.
Experimental purposes. Scientific
testing which utilizes collected data and
employs analytical processes under
controlled conditions to create
qualitative or quantitative results.
Therapeutic purposes. The
application of specific scientific
processes designed to eliminate, isolate,
or remove potential plant pests or
diseases.
(b) Purpose and scope. The
regulations in this part prohibit or
restrict the importation into the United
States of certain plants, plant products,
and other articles to prevent the
introduction and dissemination of plant
pests and noxious weeds within and
throughout the United States. The
regulations in this subpart provide a
process under which a controlled
import permit (CIP) may be issued to
authorize the importation, for
experimental, therapeutic, or
developmental purposes, of an article
whose importation is prohibited under
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this part. A CIP may also be issued to
authorize, for those same purposes, the
importation of an article under
conditions that differ from those
prescribed in the relevant regulations in
this part.
(c) Application process. Applications
for a CIP are available without charge
from the Animal and Plant Health
Inspection Service, Plant Protection and
Quarantine (PPQ), Permit Unit, 4700
River Road, Unit 136, Riverdale, MD
20737–1236, or from local PPQ offices.
Applications may be submitted by fax,
mail, or electronically and must be
submitted at least 60 days prior to
arrival of the article at the port of entry.
Mailed applications must be submitted
to the address above, faxed applications
may be submitted to 301–734–4300, and
electronic applications may be
submitted through the ePermits Web
site at https://epermits.aphis.usda.gov/
epermits.
(1) The completed application for a
CIP must provide the following
information:
(i) Name, address in the United States,
and contact information of the
applicant;
(ii) Identity (common and botanical
[genus and species] names) of the plant
material to be imported, quantity of
importation, country of origin, and
country shipped from;
(iii) Intended experimental,
therapeutic, or developmental purpose
for the importation;
(iv) Intended ports of export and
entry, means of conveyance, and
estimated date of arrival.
(2) APHIS may issue a CIP if the
Administrator determines that the plant
pest risks associated with the plant
material and its intended experimental,
therapeutic, or developmental use can
be effectively mitigated. The CIP will
contain the applicable conditions for
importation and subsequent handling of
the plant material if it is deemed eligible
to be imported into the United States.
The plant material may be imported
only if all applicable requirements are
met.
(d) Shipping conditions.
Consignments of plant material to be
offered for importation under a CIP
must meet the following requirements,
unless otherwise specified under the
conditions of the CIP:
(1) The plant material must be
selected from apparently disease-free
and pest-free sources.
(2) The plant material must be free of
soil, other foreign matter or debris, other
prohibited plants, noxious weed seeds,
and living organisms such as parasitic
plants, pathogens, insects, snails, and
mites.
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(3) Fungicides, insecticides, and other
treatments such as coatings, dips, or
sprayings must not be applied before
shipment, unless otherwise specified.
Plant materials may be refused entry if
they are difficult or hazardous to inspect
because of the presence of such
treatments. Plant materials must not be
wrapped or otherwise packaged in a
manner that impedes or prevents
adequate inspection or treatment.
(4) The plant material must be moved
in an enclosed container or one
completely enclosed by a covering
adequate to prevent the possible escape
or introduction of plant pests during
shipment. Any packing material used in
the consignment of the plant material
must meet the requirements of § 319.37–
9 of this part, and wood packing
material used in the consignment must
meet the requirements of § 319.40–3(b)
and (c) of this part.
(5) Consignments may be shipped as
cargo, by mail or air freight, or handcarried, as specified in the conditions of
the CIP.
(6) The plant material must be offered
for importation at the port of entry or
plant inspection station as specified in
the conditions of the CIP.
(7) A copy of the CIP must accompany
each consignment, and all consignments
must be labeled in accordance with
instructions in the CIP.
(8) Each consignment must be
accompanied by an invoice or packing
list indicating its contents.
(e) Post-importation conditions. (1) At
the approved facility where the plant
material will be maintained following
its importation, plant material imported
under a CIP must be identified and
labeled as quarantined material to be
used only in accordance with a valid
CIP.
(2) Plant material must be stored in a
secure place or in the manner indicated
in the CIP and be under the supervision
and control of the permit holder. During
regular business hours, properly
identified officials, either Federal or
State, must be allowed to inspect the
plant material and the facilities in
which the plant material is maintained.
(3) The permit holder must keep the
permit valid for the duration of the
authorized experimental, therapeutic, or
developmental purpose. The PPQ
Permit Unit must be informed of a
change in contact information for the
permit holder within 10 business days
of such change.
(4) Plant material imported under a
CIP must not be moved or distributed to
another person without prior written
permission from the PPQ Permit Unit.
(5) Should the permit holder leave the
institution in which the plant material
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imported under a CIP is kept, the plant
material must be destroyed unless, prior
to the departure of the original permit
holder, another person assumes
responsibility for the continued
maintenance of the plant material and
such person obtains a new CIP for the
plant material.
(f) Failure to comply with all of the
conditions specified in the CIP or any
applicable regulations or administrative
instructions, or forging, counterfeiting,
or defacing permits or shipping labels,
may result in immediate revocation of
the permit, denial of future permits, and
civil or criminal penalties for the permit
holder.
(g) Denial and revocation of a CIP. (1)
The Administrator will deny an
application for a CIP permit, orally or in
writing, when the Administrator
determines that:
(i) No safeguards adequate or
appropriate to prevent the
dissemination of a plant pest or plant
disease can be implemented;
(ii) The applicant, as a previous
permittee, failed to maintain the
safeguards or otherwise comply with all
the conditions prescribed in a previous
permit and failed to demonstrate the
ability or intent to observe them in the
future;
(iii) The application for a permit is
found to be false or deceptive in any
material particular;
(iv) Such an importation would
involve the potential dissemination of a
plant pest or plant disease which
outweighs the probable benefit that
could be derived from the proposed
importation and use of the regulated
plant material;
(v) The importation is adverse to the
conduct of an APHIS eradication,
suppression, control, or regulatory
program; or
(vi) The government of the State or
Territory into which the plant material
would be imported objects to the
proposed importation and provides a
written explanation of its concerns
based on plant pest risks.
(2) The Administrator will revoke any
outstanding CIP, orally or in writing,
when the Administrator determines
that:
(i) Information is received subsequent
to the issuance of the CIP of
circumstances that would constitute
cause for the denial of an application
under paragraph (g)(1) of this section; or
(ii) The permittee has failed to
maintain the safeguards or otherwise
observe the conditions specified in the
CIP or in any applicable regulations or
administrative instructions.
(3) Upon revocation of a permit, the
permittee must either:
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(i) Surrender all regulated plant
material covered by the revoked CIP to
an APHIS inspector;
(ii) Destroy all regulated plant
material covered by the revoked CIP
under the supervision of an APHIS
inspector; or
(iii) Remove all regulated plant
material covered by the revoked CIP
from the United States.
(4) All denials of an application for a
permit, or revocation of an existing
permit, will be forwarded to the
applicant or permittee in writing. The
reasons for the denial or revocation will
be stated in writing as promptly as
circumstances permit.
(5) Any person whose application for
a permit has been denied or permit has
been revoked may appeal the decision
in writing to the Administrator within
10 days after receiving written
notification of the denial or revocation.
The appeal should state all facts and
reasons upon which the person relies to
show that the denial or revocation was
wrongfully denied or revoked.
(i) The Administrator will grant or
deny the appeal, in writing, as promptly
as circumstances permit, and will state
in writing the reason for the decision. If
there is a conflict as to any material fact,
a hearing will be held to resolve such
conflict. Rules of practice concerning
such a hearing will be adopted by the
Administrator. The permit denial or
revocation will remain in effect during
the resolution of the appeal.
(ii) [Reserved]
3. Section 319.8 is revised to read as
follows:
§ 319.8
Notice of quarantine.
Pursuant to sections 411–414 and 434
of the Plant Protection Act (7 U.S.C.
7711–7714 and 7754), the Administrator
of the Animal and Plant Health
Inspection Service has determined that
the unrestricted importation into the
United States from all foreign countries
and localities of any parts or products
of plants of the genus Gossypium,
including seed cotton; cottonseed;
cotton lint, linters, and other forms of
cotton fiber (not including yarn, thread,
and cloth); cottonseed hulls, cake, meal,
and other cottonseed products, except
oil; cotton waste, including gin waste
and thread waste; any other
unmanufactured parts of cotton plants;
second-hand burlap and other fabrics,
shredded or otherwise, that have been
used or are of the kinds ordinarily used,
for containing cotton, grains (including
grain products), field seeds, agricultural
roots, rhizomes, tubers, or other
underground crops, may result in the
entry into the United States of the pink
bollworm (Pectinophora gossypiella
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(Saund.)), the golden nematode of
potatoes (Heterodera rostochiensis Wr.),
the flag smut disease (Urocystis tritici
Koern.), and other injurious plant
diseases and insect pests. Accordingly,
to prevent the introduction into the
United States of plant pests, the
importation of those articles into the
United States is prohibited unless they
are imported in accordance with the
regulations in this subpart or their
importation has been authorized for
experimental, therapeutic, or
developmental purposes by a controlled
import permit issued in accordance
with § 319.6 of this part.
4. Section 319.8–1 is amended by
removing the definition of Deputy
Administrator, Plant Protection and
Quarantine Programs, revising the
definitions of approved; approved areas
of Mexico; authorized; north, northern;
treatment; and utilization, including
removing footnote 1, and adding, in
alphabetical order, a definition for
Administrator to read as follows:
§ 319.8–1
Definitions.
*
*
*
*
*
Administrator. The Administrator of
the Animal and Plant Health Inspection
Service, United States Department of
Agriculture, or any employee of the
United States Department of Agriculture
delegated to act in his or her stead.
*
*
*
*
*
Approved. Approved by the
Administrator.
Approved areas of Mexico. Any areas
of Mexico, other than Northwest Mexico
and the west coast of Mexico, which are
designated by the Administrator as areas
in which cotton and cotton products are
produced and handled under conditions
comparable to those under which like
cotton and cotton products are
produced and handled in the generally
infested pink bollworm regulated area
in the United States.
*
*
*
*
*
Authorized. Authorized by the
Administrator.
*
*
*
*
*
North, northern. When used to
designate ports of arrival, these terms
mean the port of Norfolk, VA, and all
Atlantic Coast ports north thereof, ports
along the Canadian border, and Pacific
Coast ports in the States of Washington
and Oregon. When used in a geographic
sense to designate areas or locations,
these terms mean any State in which
cotton is not grown commercially.
However, when cotton is grown
commercially in certain portions of a
State, as is the case in Illinois, Kansas,
and Missouri, these terms include those
portions of such State as may be
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determined by the Administrator as
remote from the main area of cotton
production.
*
*
*
*
*
Treatment. Procedures
administratively approved by the
Administrator for destroying
infestations or infections of insect pests
or plant diseases, such as fumigation,
application of chemicals or dry or moist
heat, or processing, utilization, or
storage.
*
*
*
*
*
Utilization. Processing or
manufacture, in lieu of fumigation at
time of entry, at a mill or plant
authorized by APHIS through a
compliance agreement for foreign cotton
processing or manufacturing.
*
*
*
*
*
§§ 319.8–2, 319.8–8, 319.8–11, and 319.8–17
[Amended]
5. Sections 319.8–2, 319.8–8, 319.8–
11, and 319.8–17 are amended by
redesignating footnotes 2 through 6 as
footnotes 1 through 5, respectively.
§ 319.8–3
[Amended]
6. In § 319.8–3, paragraphs (a) and (b)
are amended by removing the word
‘‘Deputy’’ each it appears.
§ 319.8–8
[Amended]
7. In § 319.8–8, paragraphs (a)(2)(v)
and (a)(4) are amended by removing the
words ‘‘Deputy Administrator of the
Plant Protection and Quarantine
Programs’’ each time they appear and
adding the word ‘‘Administrator’’ in
their place.
§ 319.8–12
[Amended]
8. In § 319.8–12, paragraphs (d) and (f)
are amended by removing the word
‘‘Deputy’’ each time it appears.
§§ 319.8–19 and 319.8–20
Reserved]
[Removed and
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Notice of quarantine.
(a) The importation into the United
States of sugarcane and its related
products, including cuttings, canes,
leaves and bagasse, from all foreign
countries and localities is prohibited,
except for importations for
experimental, therapeutic, or
developmental purposes under the
conditions specified in a controlled
import permit issued in accordance
with § 319.6 of this part.
*
*
*
*
*
11. In § 319.19, paragraph (b) is
revised to read as follows:
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Notice of quarantine.
*
*
*
*
*
(b) Plants or plant parts of all genera,
species, and varieties of the subfamilies
Aurantioideae, Rutoideae, and
Toddalioideae of the botanical family
Rutaceae may be imported into the
United States for experimental,
therapeutic, or developmental purposes
under the conditions specified in a
controlled import permit issued in
accordance with § 319.6 of this part.
*
*
*
*
*
12. In § 319.24, paragraph (b) is
amended by removing the second and
third sentences and adding a new
sentence in their place to read as
follows:
§ 319.24
Notice of quarantine.
*
*
*
*
*
(b) * * * However, this prohibition
does not apply to importations of such
items for experimental, therapeutic, or
developmental purposes under the
conditions specified in a controlled
import permit issued in accordance
with § 319.6 of this part.
*
*
*
*
*
§ 319.24–1
[Amended]
13. Section 319.24–1 is amended by
removing the words ‘‘Deputy
Administrator of the Plant Protection
and Quarantine Programs’’ and adding
the words ‘‘Administrator, Animal and
Plant Health Inspection Service’’ in
their place.
14. Section 319.28 is amended as
follows:
a. By revising paragraph (d) as set
forth below.
b. In paragraphs (i) and (j), by
removing the word ’’Deputy’’ each time
it occurs.
§ 319.28
Notice of quarantine.
*
9. Sections 319.8–19 and 319.8–20 are
removed and reserved.
10. In § 319.15, paragraph (a) is
revised to read as follows:
§ 319.15
§ 319.19
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*
*
*
*
(d) This prohibition shall not apply to
importations for experimental,
therapeutic, or developmental purposes
under the conditions specified in a
controlled import permit issued in
accordance with § 319.6 of this part.
*
*
*
*
*
15. Section 319.37–1 is amended by
removing the definition of Deputy
Administrator, and by adding, in
alphabetical order, definitions for
Administrator and controlled import
permit to read as follows:
§ 319.37–1
Definitions.
*
*
*
*
*
Administrator. The Administrator of
the Animal and Plant Health Inspection
Service, United States Department of
Agriculture, or any employee of the
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United States Department of Agriculture
delegated to act in his or her stead.
*
*
*
*
*
Controlled import permit. A written
or electronically transmitted
authorization issued by APHIS for the
importation into the United States of
otherwise prohibited or restricted plant
material for experimental, therapeutic,
or developmental purposes, under
controlled conditions as prescribed by
the Administrator in accordance with
§ 319.6 of this part.
*
*
*
*
*
16. Section 319.37–2 is amended as
follows:
a. By revising paragraph (c)(1) to read
as set forth below.
b. In paragraphs (c)(3), (c)(4), and
(c)(5), by removing the word
‘‘Departmental’’ each time it appears
and adding the words ‘‘controlled
import’’ in its place.
c. In paragraph (c)(4), by removing the
word ‘‘Deputy’’.
§ 319.37–2
Prohibited articles.
*
*
*
*
*
(c) * * *
(1) Imported for experimental,
therapeutic, or developmental purposes
under the conditions specified in a
controlled import permit issued in
accordance with § 319.6 of this part;
*
*
*
*
*
17. Section 319.37–3 is amended by
revising paragraph (d) and adding new
paragraphs (g) and (h) to read as follows:
§ 319.37–3
Permits.
*
*
*
*
*
(d) Any permit which has been issued
may be withdrawn by an inspector or
the Administrator if he or she
determines that the holder of the permit
has not complied with any condition for
the use of the document. The reasons for
the withdrawal will be confirmed in
writing as promptly as circumstances
permit. Any person whose permit has
been withdrawn may appeal the
decision in writing to the Administrator
within 10 days after receiving the
written notification of the withdrawal.
The appeal must state all of the facts
and reasons upon which the person
relies to show that the permit was
wrongfully withdrawn. The
Administrator will grant or deny the
appeal, in writing, stating the reasons
for the decision as promptly as
circumstances permit. If there is a
conflict as to any material fact, a hearing
will be held to resolve such conflict.
*
*
*
*
*
(g) Persons wishing to import
restricted articles into the United States
for experimental, therapeutic, or
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developmental purposes must apply for
a controlled import permit in
accordance with § 319.6 of this part.
(h) The importation of restricted
articles required to be grown under the
postentry quarantine provisions of
§ 319.37–7 must be authorized by a
controlled import permit obtained in
accordance with § 319.6 of this part.
*
*
*
*
*
§ 319.41
§ 319.37–7
22. In § 319.41–3, paragraphs (a) and
(b) are amended by removing the words
‘‘Deputy Administrator of the Plant
Protection and Quarantine Programs’’
each time they appear and adding the
word ‘‘Administrator’’ in their place.
23. In § 319.55, paragraph (c) is
revised to read as follows:
*
*
*
*
(c) The importation of plants and
plant products that are prohibited or
restricted under paragraphs (a) and (b)
of this section may be authorized for
experimental, therapeutic, or
developmental purposes under
conditions specified in a controlled
import permit issued in accordance
with § 319.6 of this part.
*
*
*
*
*
27. Section 319.74–1 is amended by
adding, in alphabetical order, a
definition for controlled import permit
to read as follows:
§ 319.55
§ 319.74–1
[Amended]
18. Section 319.37–7 is amended as
follows:
a. In paragraph (a)(2), in the second
sentence, by removing the word
‘‘written’’ and adding the words
‘‘controlled import’’ in its place, and by
removing the citation ‘‘§ 319.37–3’’ and
adding the words ‘‘§ 319.6 of this part’’
in its place.
b. In paragraph (d) introductory text,
in the first sentence, by removing the
word ‘‘written’’ and adding the words
‘‘controlled import’’ in its place, and by
removing the citation ‘‘§ 319.37–3’’ and
adding the words ‘‘§ 319.6 of this part’’
in its place.
19. Section 319.40–1 is amended by
removing the definition of departmental
permit and by adding, in alphabetical
order, a definition for controlled import
permit to read as follows:
§ 319.40–1
*
*
*
*
Controlled import permit. A written
or electronically transmitted
authorization issued by APHIS for the
importation into the United States of
otherwise prohibited or restricted plant
material for experimental, therapeutic,
or developmental purposes, under
controlled conditions as prescribed by
the Administrator in accordance with
§ 319.6 of this part.
*
*
*
*
*
20. Section 319.40–2 is amended as
follows:
a. By revising paragraph (d)(1) to read
as set forth below.
b. In paragraphs (d)(2) and (d)(3) by
removing the word ‘‘Departmental’’
each time it appears and adding the
words ‘‘controlled import’’ in its place.
§ 319.40–2 General prohibitions and
restrictions; relation to other regulations.
erowe on DSK2VPTVN1PROD with PROPOSALS
*
*
*
*
*
(d) * * *
(1) Imported for experimental,
therapeutic, or developmental purposes
under the conditions specified in a
controlled import permit issued in
accordance with § 319.6 of this part.
*
*
*
*
*
21. In § 319.41, paragraph (c) is
revised to read as follows:
15:38 Oct 24, 2011
*
*
*
*
(c) The Administrator may authorize
the importation of articles otherwise
prohibited under paragraph (b) of this
section under conditions specified in a
controlled import permit issued in
accordance with § 319.6 of this part.
*
*
*
*
*
§ 319.41–3
Jkt 226001
[Amended]
Notice of quarantine.
*
*
*
*
*
(c) The Administrator may authorize
the importation of articles otherwise
prohibited by this subpart under
conditions specified in a controlled
import permit issued in accordance
with § 319.6 of this part.
*
*
*
*
*
24. Section 319.59–1 is amended by
adding, in alphabetical order, a
definition for controlled import permit
to read as follows:
§ 319.59–1
Definitions.
*
VerDate Mar<15>2010
Notice of quarantine.
*
Definitions.
*
*
*
*
*
Controlled import permit. A written
or electronically transmitted
authorization issued by APHIS for the
importation into the United States of
otherwise prohibited or restricted plant
material for experimental, therapeutic,
or developmental purposes, under
controlled conditions as prescribed by
the Administrator in accordance with
§ 319.6 of this part.
*
*
*
*
*
§ 319.59–2
[Amended]
25. Section 319.59–2 is amended as
follows:
a. In paragraph (b) introductory text,
by removing the words ‘‘by the U.S.
Department of Agriculture for
experimental or scientific purposes’’
and adding the words ‘‘for
experimental, therapeutic, or
developmental purposes’’ in their place.
b. In paragraphs (b)(2), (b)(3), and
(b)(4), by removing the word
‘‘departmental’’ each time it appears
and adding the words ‘‘controlled
import’’ in its place.
26. Section 319.69 is amended as
follows:
a. In paragraph (b) introductory text,
by removing the words ‘‘supplemental
to this quarantine’’ and adding the
words ‘‘in this subpart’’ in their place.
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Frm 00009
Fmt 4702
Sfmt 4702
b. By revising paragraph (c) to read as
set forth below.
§ 319.69
Notice of quarantine.
*
Definitions.
*
*
*
*
*
Controlled import permit. A written
or electronically transmitted
authorization issued by APHIS for the
importation into the United States of
otherwise prohibited or restricted plant
material for experimental, therapeutic,
or developmental purposes, under
controlled conditions as prescribed by
the Administrator in accordance with
§ 319.6 of this part.
*
*
*
*
*
28. Section 319.74–3 is revised to read
as follows:
§ 319.74–3 Importations for experimental
or similar purposes.
Cut flowers may be imported for
experimental, therapeutic, or
developmental purposes under such
conditions as specified in a controlled
import permit issued in accordance
with § 319.6 of this part.
29. In § 319.75, paragraph (c) is
revised to read as follows:
§ 319.75 Restrictions on importation of
restricted articles; disposal of articles
refused importation.
*
*
*
*
*
(c) A restricted article may be
imported without complying with other
restrictions under this subpart if:
(1) Imported for experimental,
therapeutic, or developmental purposes
under the conditions specified in a
controlled import permit issued in
accordance with § 319.6 of this part.
(2) Imported at the National Plant
Germplasm Inspection Station, Building
580, Beltsville Agricultural Research
Center East, Beltsville, MD 20705, or
through any USDA plant inspection
station listed in § 319.37–14 of this part;
and
(3) Imported with a controlled import
tag or label securely attached to the
outside of the container containing the
E:\FR\FM\25OCP1.SGM
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Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 / Proposed Rules
article or securely attached to the article
itself if not in a container, and with
such tag or label bearing a controlled
import permit number corresponding to
the number of the controlled import
permit issued for such article.
30. Section 319.75–1 is amended as
follows:
a. By removing the definition of
Deputy Administrator.
b. In the definition of inspector, by
removing the word ‘‘Deputy’’.
c. By adding, in alphabetical order, a
definition for Administrator to read as
set forth below.
§ 319.75–1
Definitions.
*
*
*
*
*
Administrator. The Administrator of
the Animal and Plant Health Inspection
Service, United States Department of
Agriculture, or any employee of the
United States Department of Agriculture
delegated to act in his or her stead.
*
*
*
*
*
§ 319.75–3
[Amended]
31. In § 319.75–3, paragraph (d) is
amended by removing the word
‘‘Deputy’’ each time it appears.
§ 319.75–8
[Amended]
32. Section 319.75–8 is amended by
removing the word ‘‘Deputy’’.
Done in Washington, DC, this 19th day of
October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–27580 Filed 10–24–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Part 319
[Docket No. APHIS–2010–0116]
RIN 0579–AD51
Importation of Litchi and Longan Fruit
From Vietnam Into the Continental
United States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
erowe on DSK2VPTVN1PROD with PROPOSALS
AGENCY:
We are proposing to amend
the fruits and vegetables regulations to
allow the importation of litchi and
longan fruit from Vietnam into the
continental United States. As a
condition of entry, litchi and longan
fruit from Vietnam would be subject to
a systems approach that would include
SUMMARY:
VerDate Mar<15>2010
15:38 Oct 24, 2011
Jkt 226001
requirements for treatment and
inspection and restrictions on the
distribution of the fruit. This action
would allow for the importation of litchi
and longan fruit from Vietnam into the
United States while continuing to
provide protection against the
introduction of quarantine pests.
DATES: We will consider all comments
that we receive on or before December
27, 2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2010-01160001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2010–0116, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2010-0116 or
in our reading room, which is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue,
SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 690–2817
before coming.
FOR FURTHER INFORMATION CONTACT: Ms.
Claudia Ferguson, Regulatory Policy
Specialist, Regulatory Coordination and
Compliance, PPQ, APHIS, 4700 River
Road, Unit 133, Riverdale, MD 20737–
1236; (301) 734–0754.
SUPPLEMENTARY INFORMATION:
Background
The regulations in ‘‘Subpart-Fruits
and Vegetables’’ (7 CFR 319.56–1
through 319.56–52, referred to below as
the regulations) prohibit or restrict the
importation of fruits and vegetables into
the United States from certain parts of
the world to prevent the introduction
and dissemination of plant pests within
the United States.
The national plant protection
organization (NPPO) of Vietnam has
requested that the Animal and Plant
Health Inspection Service (APHIS)
amend the regulations to allow fresh
litchi (Litchi chinensis Sonn.) and
longan (Dimocarpus longan Lour.) to be
imported from Vietnam into the
continental United States. The NPPO of
Vietnam also proposed that the litchi
and longan fruit be treated with
irradiation at the 400 Gy dose approved
to neutralize most insect pests, except
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Frm 00010
Fmt 4702
Sfmt 4702
65985
pupae and adults of the order
Lepidoptera.
As part of our evaluation of that
request, we prepared a pest risk
assessment identifying all quarantine
pests of litchi and longan in Vietnam
and a risk management document
(RMD) that recommends risk mitigation
measures to prevent the quarantine
pests associated with these commodities
from being introduced into the United
States. Copies of the pest risk
assessment and the RMD may be
obtained from the person listed under
FOR FURTHER INFORMATION CONTACT or
viewed on the Regulations.gov Web site
(see ADDRESSES above for instructions
for accessing Regulations.gov).
The pest risk assessment identified 16
pests of quarantine significance present
in Vietnam that could be introduced
into the United States through the
importation of fresh litchi:
Lepidopteran Pests:
Conopomorpha sinensis.
Conogethes punctiferalis.
Cryptophlebia ombrodelta.
Non-Lepidopteran Insect Pests:
Bactrocera cucurbitae.
Bactrocera dorsalis.
Ceroplastes rubens.
Coccus viridis.
Dysmicoccus neobrevipes.
Nipaecoccus viridis.
Paracoccus interceptus.
Planococcus lilacinus.
Planococcus litchi.
Planococcus minor.
Pseudococcus cryptus.
Mite Pest:
Aceria litchii.
Fungi Pest:
Phytophthora litchii.
The pest risk assessment also
identified 17 pests of quarantine
significance present in Vietnam that
could be introduced into the United
States through the importation of fresh
longan:
Lepidopteran Pests:
Conopomorpha sinensis.
Conogethes punctiferalis.
Cryptophlebia ombrodelta.
Non-Lepidopteran Insect Pests:
Bactrocera dorsalis.
Ceroplastes rubens.
Coccus viridis.
Drepanococcus chiton.
Dysmicoccus neobrevipes.
Exallomochlus hispidus.
Maconellicoccus hirsutus.
Nipaecoccus viridis.
Paracoccus interceptus.
Planococcus lilacinus.
Planococcus litchi.
Planococcus minor.
Pseudococcus cryptus.
Mite Pest:
E:\FR\FM\25OCP1.SGM
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Agencies
[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Proposed Rules]
[Pages 65976-65985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27580]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 /
Proposed Rules
[[Page 65976]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 319
[Docket No. APHIS-2008-0055]
RIN 0579-AD53
Controlled Import Permits
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the regulations concerning the
importation of plants and plant products by establishing the controlled
import permit as a single type of authorization for the importation
into the United States of otherwise prohibited or restricted plant
material for experimental, therapeutic, or developmental purposes.
Currently, some sections of the regulations provide for those articles
to be imported under a departmental permit, while other sections
provide for their importation under administrative instructions or
conditions specified by the Administrator or Deputy Administrator. This
action would consolidate and harmonize the conditions for obtaining
authorization for the importation of otherwise prohibited or restricted
plant material for scientific or certain other purposes.
DATES: We will consider all comments that we receive on or before
December 27, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2008-0055-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2008-0055, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2008-
0055 or in our reading room, which is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr. William Aley, Senior Import
Specialist, Plant Health Programs, PPQ, APHIS, 4700 River Road, Unit
133, Riverdale, MD 20737-1231; (301) 734-5057.
SUPPLEMENTARY INFORMATION:
Background
The regulations contained in 7 CFR part 319, Foreign Quarantine
Notices, prohibit or restrict the importation into the United States of
certain plants and plant products to prevent plant pests and noxious
weeds from being introduced into and spread within the United States.
These regulations are administered and enforced by the Plant
Protection and Quarantine program (PPQ) of the Animal and Plant Health
Inspection Service (APHIS) under the authority of the Plant Protection
Act (7 U.S.C. 7701 et seq.). The regulations in part 319 designate
specific articles as prohibited or restricted, and assign conditions to
their movement, if allowed, into the United States according to the
risks posed by each article to agriculture in the United States.
The current regulations contain provisions for several different
means of authorizing the importation of plants and plant products.
These means of authorization have been used to allow restricted
articles to be imported under conditions that differ from the generally
applicable provisions of the particular subpart; other types have been
used to authorize the importation of articles that would otherwise be
prohibited under the regulations.
The means of authorizing these types of movements that is most
commonly found in the regulations is the departmental permit. In Sec.
319.40-1, we define a departmental permit as ``a document issued by the
Administrator authorizing the importation of a regulated article for
experimental, scientific, or educational purposes.'' The departmental
permit has been used to allow researchers and scientists affiliated
with the United States Department of Agriculture (USDA) to import
prohibited or restricted articles for scientific, analytical,
experimental, or research purposes. It is currently available under
several subparts of the regulations. In other areas of the regulations,
we have referred to the departmental permit when we have stated that a
regulated article may be allowed to be imported ``by the U.S.
Department of Agriculture for experimental or scientific purposes.'' In
still other areas of the regulations, the regulations state that, under
certain circumstances, regulated articles may be imported under
conditions ``modified to be less stringent'' than those contained in
the regulations.
In recent years, the number of requests to import, for research
purposes, articles that are otherwise prohibited or restricted has
increased as the number and types of possible uses for such articles in
the United States has expanded. Also, entities requesting to import
these articles now include private scientific and academic laboratories
and researchers, and commercial and other nongovernmental
organizations.
We recognize that research and investigations concerning restricted
or prohibited plant material may benefit agricultural interests in the
United States in several ways. Such benefits may include the
introduction of plants or varieties or cultivars of plants adaptable to
certain environments or resistant to domestic plant pests in the United
States, suitable to consumers in the United States, or with value to
certain markets. Other benefits may include the establishment of new
markets, the introduction of new plant varieties, or trade
opportunities.
We are committed to making our permit procedures found in the
various subparts of the regulations consistent according to the plant
pest risks associated with the plant material and its intended use. We
are also committed to making our regulations more
[[Page 65977]]
transparent and easier to use and implement.
Therefore, we are proposing to amend the regulations in part 319 to
standardize the type of authorization used to permit the importation of
plants and plant products for experimental, therapeutic, or
developmental purposes. We would also amend these portions of the
regulations that contain outdated language or that refer to procedures
for importation that we believe pose unnecessary risks to agriculture
in the United States.
We are proposing to establish the controlled import permit (CIP) as
the permit that would be used in place of departmental permits and the
other types of authorizations discussed previously that we have used to
allow the importation of otherwise prohibited articles or of articles
under different conditions than those found in the regulations. We are
also proposing to use the CIP as the form of permit required for the
importation of plant materials for postentry quarantine.
We propose to define controlled import permit as ``a written or
electronically transmitted authorization issued by APHIS for the
importation into the United States of otherwise prohibited or
restricted plant material for experimental, therapeutic, or
developmental purposes, under controlled conditions as prescribed by
the Administrator in accordance with Sec. 319.6.''
The CIP would be issued based on consideration of the plant pest
risks of the imported plant material, whether such risks can be
mitigated sufficiently, the intended use of the plant material, and the
plant pest risks associated with such use. We would also consider the
taxon of the plant material and country of origin. The CIP would be
available to all entities in the United States and no longer limited to
researchers and scientists affiliated with the USDA.
The CIP would be issued only for articles subject to the
regulations in part 319; we would not provide for the issuance of a CIP
for the movement of plant pests regulated under 7 CFR part 330,
genetically engineered plant material regulated under 7 CFR part 340,
noxious weeds regulated under 7 CFR part 360, or seeds regulated under
7 CFR part 361. We believe that the restrictions imposed on the
movement of these articles by the regulations in parts 330, 340, 360,
and 361 are effective in preventing the introduction and dissemination
of plant pests or noxious weeds into or within the United States.
General Requirements for a Controlled Import Permit
We would add a new ``Subpart--Controlled Import Permits'' (Sec.
319.6) that would contain the general requirements regarding the
proposed CIP.
In paragraph (a) of Sec. 319.6, we would define the terms
Administrator, developmental purposes, experimental purposes, and
therapeutic purposes, the latter three being the purposes for which the
CIP may be issued. We would define Administrator as the Administrator
of the Animal and Plant Health Inspection Service, United States
Department of Agriculture, or any employee of the United States
Department of Agriculture delegated to act in his or her stead.
Developmental purposes would be defined as the evaluation, monitoring,
or verification of plant material for plant health risks and/or the
adaptability of the material for certain uses or environments.
Experimental purposes would be defined as scientific testing of plant
material which utilizes collected data and employs analytical processes
under controlled conditions to create qualitative or quantitative
results. We would define therapeutic purposes as the application of
specific scientific processes designed to eliminate, isolate, or remove
potential plant pests or diseases.
An application for a CIP could be obtained through any of the means
currently available for applying for other types of permits to import
regulated plant material, i.e., through the Internet using the APHIS
ePermits Web site or using applications obtained from APHIS
headquarters or from local offices of PPQ; paper applications could be
submitted by fax or by mail. The regulations in Sec. 319.6(c) would
provide the necessary mailing address, fax number, and the address of
the APHIS ePermits Web site. An application would have to be submitted
at least 60 days prior to the proposed arrival of the article at the
port of entry.
The application for a CIP would have to contain the following
information:
Name, address in the United States, and contact
information of the applicant;
Identity (common and botanical [genus and species] names)
of the plant material to be imported; country of origin and country
shipped from;
Intended experimental, therapeutic, or developmental
purpose for the importation; and
Intended ports of departure and entry; quantity of
importation; means of conveyance; estimated date of arrival.
This information would allow us to evaluate the risks associated
with the proposed importation. A CIP would be issued only if APHIS
determines that the plant pest risks associated with the plant material
and the intended experimental, therapeutic, or developmental use of the
plant material can be effectively mitigated. The CIP would contain the
applicable conditions for importation and subsequent handling of the
plant material if it is deemed eligible for importation into the United
States.
With limited exceptions, plant material to be offered for
importation under a CIP would have to be selected from apparently
disease-free and pest-free sources, and be free of foreign matter or
debris, other prohibited plants, noxious weed seeds, soil, living
organisms such as parasitic plants, pathogens, insects, snails and
mites, and other prohibited matter. The plant material would also have
to be free of fungicide, insecticide, pesticide, coating, dipping,
spraying, or other applied treatments that would make the consignment
difficult or hazardous to inspect. Similarly, plant materials could not
be wrapped or otherwise packaged in a manner that impedes or prevents
adequate inspection or treatment at the port of entry.
Although we would generally require all material imported under a
CIP to be apparently disease-free and pest-free, under certain
circumstances and for specific purposes, we may permit plant material
to be imported under a CIP for scientifically approved treatment
therapies. For example, we may permit the importation under a CIP of
plant material not considered free of plant pests to an approved
facility capable of applying approved scientific techniques to
eliminate plant pests and verifying freedom from plant pests.
All plant material offered for importation under a CIP would have
to be moved in an enclosed container or one completely enclosed by a
covering adequate to prevent the possible escape or introduction of
plant pests during shipment. Any packing material used in the
consignment would have to meet the requirements of Sec. 319.37-9, and
wood packing material used in the consignment would have to meet the
requirements of Sec. 319.40-3(b) and (c). The CIP would identify the
manner in which the consignment is to be shipped (e.g., as cargo, by
mail, as air freight). Under certain circumstances, we may allow the
plant material to be hand-carried.
The plant material would have to be offered for importation at the
port of entry or plant inspection station specified in the CIP. A copy
of the CIP and an invoice or packing list indicating
[[Page 65978]]
the contents of the consignment would have to accompany each
consignment. All consignments would be required to be labeled as
specified in the permit, and to bear a tag provided with the CIP.
Depending on the intended purpose of the plant material presented
for importation and the risks associated with such importation, we may
require that the plant material be transported from the plant
inspection station for release only to preapproved facilities. We would
assess a facility prior to issuing a permit to ensure that it has the
infrastructure and equipment identified by APHIS as being necessary to
manage the risks associated with the imported plant material.
At the approved facility, the plant material imported under a CIP
would have to be identified and labeled as quarantined material to be
used only in accordance with a valid CIP. Such plant material would
have to be maintained in a secure place and be under the supervision
and control of the permit holder, and could not be moved or distributed
without prior written permission. During regular business hours,
properly identified officials, either Federal or State, would have to
be allowed to inspect the plant material and the facility in which the
plant material is maintained.
The permit holder would be required to keep the permit valid for
the duration of the authorized experimental, therapeutic, or
developmental activity. A CIP would be valid for a period of 1 year and
could be renewed if we believed the additional time was necessary to
complete the experimental, therapeutic, or developmental purpose for
which the permit was issued.
In the event the permit holder leaves the institution in which the
plant material is kept, another person would be required to assume
responsibility for the continued maintenance of the plant material and
obtain a new CIP for the material or it would have to be destroyed.
Any conditions of the CIP or assigned safeguarding or mitigation
measures would be clearly explained in the CIP. Failure to comply with
all of the conditions specified in the CIP or any applicable
regulations or administrative instructions, or forging, counterfeiting
or defacing permits or shipping labels, may result in immediate
revocation of the permit, denial of future permits, and civil or
criminal penalties for the permit holder.
Proposed paragraph (g) of Sec. 319.6 would address the
circumstances under which an application for a CIP may be denied or a
CIP may be revoked after issuance. Under these provisions, the
Administrator would deny an application for a CIP permit when the
Administrator determines that:
No safeguards adequate or appropriate to prevent the
dissemination of a plant pest or plant disease can be implemented;
The applicant, as a previous permittee, failed to maintain
the safeguards or otherwise comply with all the conditions prescribed
in a previous permit and failed to demonstrate the ability or intent to
observe them in the future;
The application for a permit is found to be false or
deceptive in any material particular;
Such an importation would involve the potential
dissemination of a plant pest or plant disease which outweighs the
probable benefit that could be derived from the proposed importation
and use of the regulated plant material;
The importation is adverse to the conduct of an APHIS
eradication, suppression, control, or regulatory program; or
The government of the State or Territory into which the
plant material would be imported objects to the proposed importation
and provides a written explanation of its concerns based on plant pest
risks.
The Administrator would revoke any outstanding CIP when the
Administrator determines that information is received subsequent to the
issuance of the CIP of circumstances that would constitute cause for
the denial of an application described above, or the permittee fails to
maintain the safeguards or otherwise observe the conditions specified
in the CIP or in any applicable regulations or administrative
instructions.
All denials of an application for a permit, or revocation of an
existing permit, would be provided to the applicant or permittee in
writing. The reasons for the denial or revocation would be stated in
writing as promptly as circumstances permit.
We would require that, upon revocation of a permit, the permittee
must either:
Surrender all regulated plant material covered by the
revoked CIP to an APHIS inspector;
Destroy all regulated plant material covered by the
revoked CIP under the supervision of an APHIS inspector; or
Remove all regulated plant material covered by the revoked
CIP from the United States.
We would provide for the appeal of the denial or revocation of a
CIP. Any person whose application for a permit has been denied or whose
permit has been revoked may appeal the decision in writing to the
Administrator within 10 days after receiving written notification of
the denial or revocation. The appeal would have to state all facts and
reasons upon which the person was relying to show that the CIP was
wrongfully denied or revoked. The Administrator would grant or deny the
appeal, in writing, as promptly as circumstances permit, and would
state in writing the reason for the decision. If there is a conflict as
to any material fact, a hearing would be held to resolve such conflict.
Rules of practice concerning such a hearing would be adopted by the
Administrator. The permit denial or revocation would remain in effect
during the resolution of the appeal.
Regulations That Would Include References to the CIP
We are proposing to use the CIP to authorize the importation of
certain prohibited or restricted plant material for experimental,
therapeutic, or developmental purposes in the current regulations in
part 319. In doing so, we would replace the current provisions for
importations for these purposes.
In the paragraphs that follow, we discuss the changes we are
proposing and cite the specific areas of the regulations we are
proposing to change.
Foreign cotton and covers regulated under Sec. Sec. 319.8
through 319.8-26. In Sec. 319.8, which establishes a notice of
quarantine for parts or products of plants of the genus Gossypium, we
would replace the current text, which is dated and difficult to follow,
with a clear statement that the importation of the plants and plant
products listed in the section is prohibited unless they are imported
in accordance with the regulations of the subpart or imported for
experimental, therapeutic, or developmental purposes under the
provisions of a CIP. We would remove and reserve Sec. Sec. 319.8-19
and 319.8-20, as provisions for the importation of plant material
regulated by the subpart for experimental or scientific purposes would
be covered in the revised Sec. 319.8.
Sugarcane regulated under Sec. 319.15. In Sec.
319.15(a), we would remove the provision that sugarcane and its related
products may be imported for scientific or experimental purposes under
a departmental permit only by the USDA, and provide that these articles
may be moved under the conditions specified in a CIP.
Citrus fruit and nursery stock regulated under Sec. Sec.
319.19 and 319.28. In Sec. Sec. 319.19(b) and 319.28(d) we would
remove the provision that plants or plant parts of the botanical family
Rutaceae may be imported for scientific or experimental purposes under
conditions as prescribed by the APHIS
[[Page 65979]]
Administrator or the PPQ Deputy Administrator, and instead provide that
these articles may be moved under the conditions specified in a CIP. We
would also remove the statement that the paragraph's provisions apply
only to importations by the USDA.
Indian corn or maize and related plants and their seeds
regulated under Sec. Sec. 319.24 through 319.24-5 (the corn diseases
subpart), and Sec. Sec. 319.41 through 319.41-6 (the Indian corn or
maize, broomcorn, and related plants subpart). In Sec. 319.24(b) we
would remove the provision that portions of Indian corn or maize and
related plants may be imported into Guam under conditions less
stringent than those of the subpart as prescribed by the Deputy
Administrator, and the statement that the paragraph's provisions apply
only to USDA importers and instead provide that these articles may be
moved under the conditions specified in a CIP. Paragraph (c) of Sec.
319.41 has an identical provision regarding importations into Guam
which we would also remove and instead provide that the articles may be
moved under the conditions specified in a CIP.
Nursery stock, plants, roots, bulbs, seeds, and other
plant products regulated under Sec. Sec. 319.37 through 319.37-14. In
Sec. 319.37-1 we would remove the definition of Deputy Administrator
and add definitions of Administrator and controlled import permit for
use in the subpart. In Sec. 319.37-2(c)(1), we would add that
importations for experimental, therapeutic, or developmental purposes
may be allowed under the conditions of a CIP, and remove the statement
that the paragraph's provisions apply only to importations by the USDA.
In paragraphs (c)(3) through (c)(5) we would replace references to a
departmental permit with references to the CIP. In Sec. 319.37-3, we
would add a new paragraph (g) requiring that the importation of
restricted articles into the United States for experimental,
therapeutic, or developmental purposes would require application for a
CIP in accordance with Sec. 319.6, and add a new paragraph (h)
indicating that restricted articles imported into the United States
that are required to be grown under postentry quarantine provisions
must be accompanied by a CIP obtained in accordance with Sec. 319.6.
Section 319.37-7 contains provisions governing postentry quarantine
activities. Postentry quarantine is required for an established length
of time following importation of certain restricted plants so they may
be investigated and monitored for freedom from plant pests of foreign
origin. Current paragraphs (a)(2) and (d) of this section require that
an importer of the listed restricted articles from the designated
regions complete and submit to PPQ a postentry quarantine growing
agreement and an application for a written permit for the importation
of the article in accordance with Sec. 319.37-3. Section 319.37-3
designates articles whose importation requires a permit and indicates
the information a permit application must contain, how a permit is
issued, and under which circumstances a permit may be withdrawn.
We are proposing to amend Sec. 319.37-7(a)(2) and (d) to state
that the CIP is the form of permit required to accompany a postentry
quarantine growing agreement. We believe that the information required
in the application for a CIP will allow us to make a more informed
decision about the specific article submitted for the postentry
quarantine program, and allow us to provide more specific conditions
for the issuance of the permit. It will also allow us more control over
the plant material selected for the postentry quarantine program.
As noted above, current Sec. 319.37-7(a)(2) and (d) require that
the application for the written permit be made in accordance with Sec.
319.37-3. We would add a new paragraph (h) to Sec. 319.37-3, which
would require that the importation of restricted articles into the
United States to be grown under the postentry quarantine provisions of
Sec. 319.37-7 must be authorized by a CIP obtained in accordance with
Sec. 319.6. Since we are proposing to change the type of permit
required by Sec. 319.37-7(a)(2) and (d) to accompany a postentry
quarantine growing agreement to the CIP, we would amend those
provisions to require that a CIP, as provided for in the newly added
Sec. 319.37-3(h), be obtained.
Logs, lumber, and other unmanufactured wood articles
regulated under Sec. Sec. 319.40-1 through 319.40-11. In Sec. 319.40-
1 we would add a definition of controlled import permit for use in the
subpart, and remove that of departmental permit. In Sec. 319.40-
2(d)(1), we would add that importations for experimental, therapeutic,
or developmental purposes may be allowed under the conditions of a CIP,
and we would remove the statement that the paragraph's provisions apply
only to importations by the USDA. In paragraphs (d)(2) and (d)(3), we
would replace the references to a Departmental permit with references
to a CIP.
Rice regulated under Sec. Sec. 319.55 through 319.55-7.
In Sec. 319.55(c), we would remove the provision that all seed or
paddy rice, rice straw, and rice hulls may be imported, when public
interests will permit, into Guam under conditions less stringent than
those of the subpart as prescribed by the Deputy Administrator, and in
its place provide that the articles may be moved under the conditions
specified in a CIP.
Plant material subject to wheat diseases regulated under
Sec. Sec. 319.59-1 through 319.59-4. In Sec. 319.59-1 we would add a
definition for the controlled import permit for use in the subpart. In
paragraph (b) of Sec. 319.59-2 we would remove the statement that the
paragraph's provisions apply only to importations by the USDA and in
its place provide that the articles may be moved under the conditions
specified in a CIP. We would replace the references to a departmental
permit with references to a CIP in paragraphs (b)(2), (b)(3), and
(b)(4).
Packing materials regulated under Sec. Sec. 319.69
through 319.69-5. Section 319.69 prohibits certain plants and plant
products and restricts certain others for use as packing materials. In
paragraph (c) we would replace outdated language with the statement
that the importation of those prohibited or restricted plant products
may be imported for experimental, therapeutic, or developmental
purposes under the provisions of a CIP.
Cut flowers regulated under Sec. Sec. 319.74-1 through
319.74-4. In Sec. 319.74-1 we would add a definition for the
controlled import permit for use in the subpart. We would remove the
provision that regulated articles may be imported for experimental or
scientific purposes if moved under conditions prescribed by the Deputy
Administrator in Sec. 319.74-3 and instead provide that the articles
may be moved under the conditions specified in a CIP.
Articles restricted in order to prevent the entry of
khapra beetle under Sec. Sec. 319.75 through 319.75-9. In Sec.
319.75(c), we would remove the statement that the paragraph's
provisions apply only to importations by the USDA and would replace
references to a departmental permit with references to a CIP.
We believe that these proposed changes would consolidate and
harmonize requirements for obtaining a permit for the importation of
plant material imported for scientific or certain other purposes, and
therefore make the requirements of part 319 clearer and easier to use
and implement.
In addition to these specific proposed changes regarding the CIP,
we are also proposing to update the subparts discussed above by
replacing references to ``Deputy Administrator'' wherever
[[Page 65980]]
they still appear with references to the Administrator. In some
subparts, this would include removing a definition of Deputy
Administrator and adding one for Administrator. Most APHIS regulations
refer to the Agency's Administrator rather than the Deputy
Administrators of specific programs like PPQ. This proposed change
would make the regulations in part 319 consistent with other APHIS
regulations.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866 and, therefore, has not been
reviewed by the Office of Management and Budget.
We have prepared an economic analysis for this proposed rule, which
is set out below. The analysis provides a basis for our determination
that this action would not have a significant economic impact on a
substantial number of small entities.
For the purpose of this analysis and following the Small Business
Administration (SBA) guidelines, we note that a major segment of
entities potentially affected by the proposed changes are classified
within the following industries: Nursery and Tree Production (NAICS
111421), and Floriculture Production (NAICS 111422). The nursery and
floriculture industries are representative of other agricultural and
nonagricultural industries in terms of being comprised largely of small
entities. According to the Census of Agriculture, these two categories
included 52,845 farms in 2007, and represented 3 percent of all farms
in the United States. These entities are considered small by SBA
standards if their annual sales are $750,000 or less. Over 93 percent
of the farms in these industries had annual sales of less than
$500,000.
Research and development establishments within Physical,
Engineering, and Life Sciences (NAICS 541711) that provide
professional, scientific, and technical services may also be affected
by this proposed rule. These entities are considered small by SBA
standards if they employ not more than 500 persons. According to the
2002 Economic Census, 82 percent of these establishments are small.
The CIP would replace the departmental permit and other forms of
authorizations that have been in use. Because this is an administrative
change, we do not anticipate that the replacement would have any
significant economic impact on the concerned entities. From January 1,
2007, to December 31, 2009, a total of 108 postentry quarantine permits
and 1,012 departmental permits were issued. The proposed rule is not
expected to affect the number of permits issued.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. APHIS-
2008-0055. Please send a copy of your comments to: (1) APHIS-2008-0055,
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700
River Road, Unit 118, Riverdale, MD 20737-1238, and (2) Clearance
Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue,
SW., Washington, DC 20250. A comment to OMB is best assured of having
its full effect if OMB receives it within 30 days of publication of
this proposed rule.
APHIS is proposing to amend the regulations concerning the
importation of plants and plant products by establishing the controlled
import permit as a single type of authorization for the importation
into the United States of otherwise prohibited or restricted plant
material for experimental, therapeutic, or developmental purposes.
Currently, some sections of the regulations provide for those articles
to be imported under a departmental permit, while other sections
provide for their importation under administrative instructions or
conditions specified by the Administrator or Deputy Administrator. This
action would consolidate and harmonize the conditions for obtaining
authorization for the importation of otherwise prohibited or restricted
plant material for scientific or certain other purposes.
This proposed rule will require the use of a controlled import
permit, annual inspection report, and the identification of the
commodity being imported.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 0.8125 hours per response.
Respondents: Researchers, for-profit organizations, and foreign
government officials.
Estimated annual number of respondents: 1,200.
Estimated annual number of responses per respondent: 6.667.
Estimated annual number of responses: 8,000.
Estimated total annual burden on respondents: 6,500 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
851-2908.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to
[[Page 65981]]
E-Government Act compliance related to this proposed rule, please
contact Mrs. Celeste Sickles, APHIS' Information Collection
Coordinator, at (301) 851-2908.
List of Subjects in 7 CFR Part 319
Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant
diseases and pests, Quarantine, Reporting and recordkeeping
requirements, Rice, Vegetables.
Accordingly, we propose to amend 7 CFR part 319 as follows:
PART 319--FOREIGN QUARANTINE NOTICES
1. The authority citation for part 319 continues to read as
follows:
Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C.
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
2. A new subpart consisting of Sec. 319.6 is added to read as
follows:
Subpart--Controlled Import Permits
Sec.
319.6 Controlled import permits.
Subpart--Controlled Import Permits
Sec. 319.6 Controlled import permits.
(a) Definitions.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, or any
employee of the United States Department of Agriculture delegated to
act in his or her stead.
Developmental purposes. The evaluation, monitoring, or verification
of plant material for plant health risks and/or the adaptability of the
material for certain uses or environments.
Experimental purposes. Scientific testing which utilizes collected
data and employs analytical processes under controlled conditions to
create qualitative or quantitative results.
Therapeutic purposes. The application of specific scientific
processes designed to eliminate, isolate, or remove potential plant
pests or diseases.
(b) Purpose and scope. The regulations in this part prohibit or
restrict the importation into the United States of certain plants,
plant products, and other articles to prevent the introduction and
dissemination of plant pests and noxious weeds within and throughout
the United States. The regulations in this subpart provide a process
under which a controlled import permit (CIP) may be issued to authorize
the importation, for experimental, therapeutic, or developmental
purposes, of an article whose importation is prohibited under this
part. A CIP may also be issued to authorize, for those same purposes,
the importation of an article under conditions that differ from those
prescribed in the relevant regulations in this part.
(c) Application process. Applications for a CIP are available
without charge from the Animal and Plant Health Inspection Service,
Plant Protection and Quarantine (PPQ), Permit Unit, 4700 River Road,
Unit 136, Riverdale, MD 20737-1236, or from local PPQ offices.
Applications may be submitted by fax, mail, or electronically and must
be submitted at least 60 days prior to arrival of the article at the
port of entry. Mailed applications must be submitted to the address
above, faxed applications may be submitted to 301-734-4300, and
electronic applications may be submitted through the ePermits Web site
at https://epermits.aphis.usda.gov/epermits.
(1) The completed application for a CIP must provide the following
information:
(i) Name, address in the United States, and contact information of
the applicant;
(ii) Identity (common and botanical [genus and species] names) of
the plant material to be imported, quantity of importation, country of
origin, and country shipped from;
(iii) Intended experimental, therapeutic, or developmental purpose
for the importation;
(iv) Intended ports of export and entry, means of conveyance, and
estimated date of arrival.
(2) APHIS may issue a CIP if the Administrator determines that the
plant pest risks associated with the plant material and its intended
experimental, therapeutic, or developmental use can be effectively
mitigated. The CIP will contain the applicable conditions for
importation and subsequent handling of the plant material if it is
deemed eligible to be imported into the United States. The plant
material may be imported only if all applicable requirements are met.
(d) Shipping conditions. Consignments of plant material to be
offered for importation under a CIP must meet the following
requirements, unless otherwise specified under the conditions of the
CIP:
(1) The plant material must be selected from apparently disease-
free and pest-free sources.
(2) The plant material must be free of soil, other foreign matter
or debris, other prohibited plants, noxious weed seeds, and living
organisms such as parasitic plants, pathogens, insects, snails, and
mites.
(3) Fungicides, insecticides, and other treatments such as
coatings, dips, or sprayings must not be applied before shipment,
unless otherwise specified. Plant materials may be refused entry if
they are difficult or hazardous to inspect because of the presence of
such treatments. Plant materials must not be wrapped or otherwise
packaged in a manner that impedes or prevents adequate inspection or
treatment.
(4) The plant material must be moved in an enclosed container or
one completely enclosed by a covering adequate to prevent the possible
escape or introduction of plant pests during shipment. Any packing
material used in the consignment of the plant material must meet the
requirements of Sec. 319.37-9 of this part, and wood packing material
used in the consignment must meet the requirements of Sec. 319.40-3(b)
and (c) of this part.
(5) Consignments may be shipped as cargo, by mail or air freight,
or hand-carried, as specified in the conditions of the CIP.
(6) The plant material must be offered for importation at the port
of entry or plant inspection station as specified in the conditions of
the CIP.
(7) A copy of the CIP must accompany each consignment, and all
consignments must be labeled in accordance with instructions in the
CIP.
(8) Each consignment must be accompanied by an invoice or packing
list indicating its contents.
(e) Post-importation conditions. (1) At the approved facility where
the plant material will be maintained following its importation, plant
material imported under a CIP must be identified and labeled as
quarantined material to be used only in accordance with a valid CIP.
(2) Plant material must be stored in a secure place or in the
manner indicated in the CIP and be under the supervision and control of
the permit holder. During regular business hours, properly identified
officials, either Federal or State, must be allowed to inspect the
plant material and the facilities in which the plant material is
maintained.
(3) The permit holder must keep the permit valid for the duration
of the authorized experimental, therapeutic, or developmental purpose.
The PPQ Permit Unit must be informed of a change in contact information
for the permit holder within 10 business days of such change.
(4) Plant material imported under a CIP must not be moved or
distributed to another person without prior written permission from the
PPQ Permit Unit.
(5) Should the permit holder leave the institution in which the
plant material
[[Page 65982]]
imported under a CIP is kept, the plant material must be destroyed
unless, prior to the departure of the original permit holder, another
person assumes responsibility for the continued maintenance of the
plant material and such person obtains a new CIP for the plant
material.
(f) Failure to comply with all of the conditions specified in the
CIP or any applicable regulations or administrative instructions, or
forging, counterfeiting, or defacing permits or shipping labels, may
result in immediate revocation of the permit, denial of future permits,
and civil or criminal penalties for the permit holder.
(g) Denial and revocation of a CIP. (1) The Administrator will deny
an application for a CIP permit, orally or in writing, when the
Administrator determines that:
(i) No safeguards adequate or appropriate to prevent the
dissemination of a plant pest or plant disease can be implemented;
(ii) The applicant, as a previous permittee, failed to maintain the
safeguards or otherwise comply with all the conditions prescribed in a
previous permit and failed to demonstrate the ability or intent to
observe them in the future;
(iii) The application for a permit is found to be false or
deceptive in any material particular;
(iv) Such an importation would involve the potential dissemination
of a plant pest or plant disease which outweighs the probable benefit
that could be derived from the proposed importation and use of the
regulated plant material;
(v) The importation is adverse to the conduct of an APHIS
eradication, suppression, control, or regulatory program; or
(vi) The government of the State or Territory into which the plant
material would be imported objects to the proposed importation and
provides a written explanation of its concerns based on plant pest
risks.
(2) The Administrator will revoke any outstanding CIP, orally or in
writing, when the Administrator determines that:
(i) Information is received subsequent to the issuance of the CIP
of circumstances that would constitute cause for the denial of an
application under paragraph (g)(1) of this section; or
(ii) The permittee has failed to maintain the safeguards or
otherwise observe the conditions specified in the CIP or in any
applicable regulations or administrative instructions.
(3) Upon revocation of a permit, the permittee must either:
(i) Surrender all regulated plant material covered by the revoked
CIP to an APHIS inspector;
(ii) Destroy all regulated plant material covered by the revoked
CIP under the supervision of an APHIS inspector; or
(iii) Remove all regulated plant material covered by the revoked
CIP from the United States.
(4) All denials of an application for a permit, or revocation of an
existing permit, will be forwarded to the applicant or permittee in
writing. The reasons for the denial or revocation will be stated in
writing as promptly as circumstances permit.
(5) Any person whose application for a permit has been denied or
permit has been revoked may appeal the decision in writing to the
Administrator within 10 days after receiving written notification of
the denial or revocation. The appeal should state all facts and reasons
upon which the person relies to show that the denial or revocation was
wrongfully denied or revoked.
(i) The Administrator will grant or deny the appeal, in writing, as
promptly as circumstances permit, and will state in writing the reason
for the decision. If there is a conflict as to any material fact, a
hearing will be held to resolve such conflict. Rules of practice
concerning such a hearing will be adopted by the Administrator. The
permit denial or revocation will remain in effect during the resolution
of the appeal.
(ii) [Reserved]
3. Section 319.8 is revised to read as follows:
Sec. 319.8 Notice of quarantine.
Pursuant to sections 411-414 and 434 of the Plant Protection Act (7
U.S.C. 7711-7714 and 7754), the Administrator of the Animal and Plant
Health Inspection Service has determined that the unrestricted
importation into the United States from all foreign countries and
localities of any parts or products of plants of the genus Gossypium,
including seed cotton; cottonseed; cotton lint, linters, and other
forms of cotton fiber (not including yarn, thread, and cloth);
cottonseed hulls, cake, meal, and other cottonseed products, except
oil; cotton waste, including gin waste and thread waste; any other
unmanufactured parts of cotton plants; second-hand burlap and other
fabrics, shredded or otherwise, that have been used or are of the kinds
ordinarily used, for containing cotton, grains (including grain
products), field seeds, agricultural roots, rhizomes, tubers, or other
underground crops, may result in the entry into the United States of
the pink bollworm (Pectinophora gossypiella (Saund.)), the golden
nematode of potatoes (Heterodera rostochiensis Wr.), the flag smut
disease (Urocystis tritici Koern.), and other injurious plant diseases
and insect pests. Accordingly, to prevent the introduction into the
United States of plant pests, the importation of those articles into
the United States is prohibited unless they are imported in accordance
with the regulations in this subpart or their importation has been
authorized for experimental, therapeutic, or developmental purposes by
a controlled import permit issued in accordance with Sec. 319.6 of
this part.
4. Section 319.8-1 is amended by removing the definition of Deputy
Administrator, Plant Protection and Quarantine Programs, revising the
definitions of approved; approved areas of Mexico; authorized; north,
northern; treatment; and utilization, including removing footnote 1,
and adding, in alphabetical order, a definition for Administrator to
read as follows:
Sec. 319.8-1 Definitions.
* * * * *
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, or any
employee of the United States Department of Agriculture delegated to
act in his or her stead.
* * * * *
Approved. Approved by the Administrator.
Approved areas of Mexico. Any areas of Mexico, other than Northwest
Mexico and the west coast of Mexico, which are designated by the
Administrator as areas in which cotton and cotton products are produced
and handled under conditions comparable to those under which like
cotton and cotton products are produced and handled in the generally
infested pink bollworm regulated area in the United States.
* * * * *
Authorized. Authorized by the Administrator.
* * * * *
North, northern. When used to designate ports of arrival, these
terms mean the port of Norfolk, VA, and all Atlantic Coast ports north
thereof, ports along the Canadian border, and Pacific Coast ports in
the States of Washington and Oregon. When used in a geographic sense to
designate areas or locations, these terms mean any State in which
cotton is not grown commercially. However, when cotton is grown
commercially in certain portions of a State, as is the case in
Illinois, Kansas, and Missouri, these terms include those portions of
such State as may be
[[Page 65983]]
determined by the Administrator as remote from the main area of cotton
production.
* * * * *
Treatment. Procedures administratively approved by the
Administrator for destroying infestations or infections of insect pests
or plant diseases, such as fumigation, application of chemicals or dry
or moist heat, or processing, utilization, or storage.
* * * * *
Utilization. Processing or manufacture, in lieu of fumigation at
time of entry, at a mill or plant authorized by APHIS through a
compliance agreement for foreign cotton processing or manufacturing.
* * * * *
Sec. Sec. 319.8-2, 319.8-8, 319.8-11, and 319.8-17 [Amended]
5. Sections 319.8-2, 319.8-8, 319.8-11, and 319.8-17 are amended by
redesignating footnotes 2 through 6 as footnotes 1 through 5,
respectively.
Sec. 319.8-3 [Amended]
6. In Sec. 319.8-3, paragraphs (a) and (b) are amended by removing
the word ``Deputy'' each it appears.
Sec. 319.8-8 [Amended]
7. In Sec. 319.8-8, paragraphs (a)(2)(v) and (a)(4) are amended by
removing the words ``Deputy Administrator of the Plant Protection and
Quarantine Programs'' each time they appear and adding the word
``Administrator'' in their place.
Sec. 319.8-12 [Amended]
8. In Sec. 319.8-12, paragraphs (d) and (f) are amended by
removing the word ``Deputy'' each time it appears.
Sec. Sec. 319.8-19 and 319.8-20 [Removed and Reserved]
9. Sections 319.8-19 and 319.8-20 are removed and reserved.
10. In Sec. 319.15, paragraph (a) is revised to read as follows:
Sec. 319.15 Notice of quarantine.
(a) The importation into the United States of sugarcane and its
related products, including cuttings, canes, leaves and bagasse, from
all foreign countries and localities is prohibited, except for
importations for experimental, therapeutic, or developmental purposes
under the conditions specified in a controlled import permit issued in
accordance with Sec. 319.6 of this part.
* * * * *
11. In Sec. 319.19, paragraph (b) is revised to read as follows:
Sec. 319.19 Notice of quarantine.
* * * * *
(b) Plants or plant parts of all genera, species, and varieties of
the subfamilies Aurantioideae, Rutoideae, and Toddalioideae of the
botanical family Rutaceae may be imported into the United States for
experimental, therapeutic, or developmental purposes under the
conditions specified in a controlled import permit issued in accordance
with Sec. 319.6 of this part.
* * * * *
12. In Sec. 319.24, paragraph (b) is amended by removing the
second and third sentences and adding a new sentence in their place to
read as follows:
Sec. 319.24 Notice of quarantine.
* * * * *
(b) * * * However, this prohibition does not apply to importations
of such items for experimental, therapeutic, or developmental purposes
under the conditions specified in a controlled import permit issued in
accordance with Sec. 319.6 of this part.
* * * * *
Sec. 319.24-1 [Amended]
13. Section 319.24-1 is amended by removing the words ``Deputy
Administrator of the Plant Protection and Quarantine Programs'' and
adding the words ``Administrator, Animal and Plant Health Inspection
Service'' in their place.
14. Section 319.28 is amended as follows:
a. By revising paragraph (d) as set forth below.
b. In paragraphs (i) and (j), by removing the word ''Deputy'' each
time it occurs.
Sec. 319.28 Notice of quarantine.
* * * * *
(d) This prohibition shall not apply to importations for
experimental, therapeutic, or developmental purposes under the
conditions specified in a controlled import permit issued in accordance
with Sec. 319.6 of this part.
* * * * *
15. Section 319.37-1 is amended by removing the definition of
Deputy Administrator, and by adding, in alphabetical order, definitions
for Administrator and controlled import permit to read as follows:
Sec. 319.37-1 Definitions.
* * * * *
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, or any
employee of the United States Department of Agriculture delegated to
act in his or her stead.
* * * * *
Controlled import permit. A written or electronically transmitted
authorization issued by APHIS for the importation into the United
States of otherwise prohibited or restricted plant material for
experimental, therapeutic, or developmental purposes, under controlled
conditions as prescribed by the Administrator in accordance with Sec.
319.6 of this part.
* * * * *
16. Section 319.37-2 is amended as follows:
a. By revising paragraph (c)(1) to read as set forth below.
b. In paragraphs (c)(3), (c)(4), and (c)(5), by removing the word
``Departmental'' each time it appears and adding the words ``controlled
import'' in its place.
c. In paragraph (c)(4), by removing the word ``Deputy''.
Sec. 319.37-2 Prohibited articles.
* * * * *
(c) * * *
(1) Imported for experimental, therapeutic, or developmental
purposes under the conditions specified in a controlled import permit
issued in accordance with Sec. 319.6 of this part;
* * * * *
17. Section 319.37-3 is amended by revising paragraph (d) and
adding new paragraphs (g) and (h) to read as follows:
Sec. 319.37-3 Permits.
* * * * *
(d) Any permit which has been issued may be withdrawn by an
inspector or the Administrator if he or she determines that the holder
of the permit has not complied with any condition for the use of the
document. The reasons for the withdrawal will be confirmed in writing
as promptly as circumstances permit. Any person whose permit has been
withdrawn may appeal the decision in writing to the Administrator
within 10 days after receiving the written notification of the
withdrawal. The appeal must state all of the facts and reasons upon
which the person relies to show that the permit was wrongfully
withdrawn. The Administrator will grant or deny the appeal, in writing,
stating the reasons for the decision as promptly as circumstances
permit. If there is a conflict as to any material fact, a hearing will
be held to resolve such conflict.
* * * * *
(g) Persons wishing to import restricted articles into the United
States for experimental, therapeutic, or
[[Page 65984]]
developmental purposes must apply for a controlled import permit in
accordance with Sec. 319.6 of this part.
(h) The importation of restricted articles required to be grown
under the postentry quarantine provisions of Sec. 319.37-7 must be
authorized by a controlled import permit obtained in accordance with
Sec. 319.6 of this part.
* * * * *
Sec. 319.37-7 [Amended]
18. Section 319.37-7 is amended as follows:
a. In paragraph (a)(2), in the second sentence, by removing the
word ``written'' and adding the words ``controlled import'' in its
place, and by removing the citation ``Sec. 319.37-3'' and adding the
words ``Sec. 319.6 of this part'' in its place.
b. In paragraph (d) introductory text, in the first sentence, by
removing the word ``written'' and adding the words ``controlled
import'' in its place, and by removing the citation ``Sec. 319.37-3''
and adding the words ``Sec. 319.6 of this part'' in its place.
19. Section 319.40-1 is amended by removing the definition of
departmental permit and by adding, in alphabetical order, a definition
for controlled import permit to read as follows:
Sec. 319.40-1 Definitions.
* * * * *
Controlled import permit. A written or electronically transmitted
authorization issued by APHIS for the importation into the United
States of otherwise prohibited or restricted plant material for
experimental, therapeutic, or developmental purposes, under controlled
conditions as prescribed by the Administrator in accordance with Sec.
319.6 of this part.
* * * * *
20. Section 319.40-2 is amended as follows:
a. By revising paragraph (d)(1) to read as set forth below.
b. In paragraphs (d)(2) and (d)(3) by removing the word
``Departmental'' each time it appears and adding the words ``controlled
import'' in its place.
Sec. 319.40-2 General prohibitions and restrictions; relation to
other regulations.
* * * * *
(d) * * *
(1) Imported for experimental, therapeutic, or developmental
purposes under the conditions specified in a controlled import permit
issued in accordance with Sec. 319.6 of this part.
* * * * *
21. In Sec. 319.41, paragraph (c) is revised to read as follows:
Sec. 319.41 Notice of quarantine.
* * * * *
(c) The Administrator may authorize the importation of articles
otherwise prohibited under paragraph (b) of this section under
conditions specified in a controlled import permit issued in accordance
with Sec. 319.6 of this part.
* * * * *
Sec. 319.41-3 [Amended]
22. In Sec. 319.41-3, paragraphs (a) and (b) are amended by
removing the words ``Deputy Administrator of the Plant Protection and
Quarantine Programs'' each time they appear and adding the word
``Administrator'' in their place.
23. In Sec. 319.55, paragraph (c) is revised to read as follows:
Sec. 319.55 Notice of quarantine.
* * * * *
(c) The Administrator may authorize the importation of articles
otherwise prohibited by this subpart under conditions specified in a
controlled import permit issued in accordance with Sec. 319.6 of this
part.
* * * * *
24. Section 319.59-1 is amended by adding, in alphabetical order, a
definition for controlled import permit to read as follows:
Sec. 319.59-1 Definitions.
* * * * *
Controlled import permit. A written or electronically transmitted
authorization issued by APHIS for the importation into the United
States of otherwise prohibited or restricted plant material for
experimental, therapeutic, or developmental purposes, under controlled
conditions as prescribed by the Administrator in accordance with Sec.
319.6 of this part.
* * * * *
Sec. 319.59-2 [Amended]
25. Section 319.59-2 is amended as follows:
a. In paragraph (b) introductory text, by removing the words ``by
the U.S. Department of Agriculture for experimental or scientific
purposes'' and adding the words ``for experimental, therapeutic, or
developmental purposes'' in their place.
b. In paragraphs (b)(2), (b)(3), and (b)(4), by removing the word
``departmental'' each time it appears and adding the words ``controlled
import'' in its place.
26. Section 319.69 is amended as follows:
a. In paragraph (b) introductory text, by removing the words
``supplemental to this quarantine'' and adding the words ``in this
subpart'' in their place.
b. By revising paragraph (c) to read as set forth below.
Sec. 319.69 Notice of quarantine.
* * * * *
(c) The importation of plants and plant products that are
prohibited or restricted under paragraphs (a) and (b) of this section
may be authorized for experimental, therapeutic, or developmental
purposes under conditions specified in a controlled import permit
issued in accordance with Sec. 319.6 of this part.
* * * * *
27. Section 319.74-1 is amended by adding, in alphabetical order, a
definition for controlled import permit to read as follows:
Sec. 319.74-1 Definitions.
* * * * *
Controlled import permit. A written or electronically transmitted
authorization issued by APHIS for the importation into the United
States of otherwise prohibited or restricted plant material for
experimental, therapeutic, or developmental purposes, under controlled
conditions as prescribed by the Administrator in accordance with Sec.
319.6 of this part.
* * * * *
28. Section 319.74-3 is revised to read as follows:
Sec. 319.74-3 Importations for experimental or similar purposes.
Cut flowers may be imported for experimental, therapeutic, or
developmental purposes under such conditions as specified in a
controlled import permit issued in accordance with Sec. 319.6 of this
part.
29. In Sec. 319.75, paragraph (c) is revised to read as follows:
Sec. 319.75 Restrictions on importation of restricted articles;
disposal of articles refused importation.
* * * * *
(c) A restricted article may be imported without complying with
other restrictions under this subpart if:
(1) Imported for experimental, therapeutic, or developmental
purposes under the conditions specified in a controlled import permit
issued in accordance with Sec. 319.6 of this part.
(2) Imported at the National Plant Germplasm Inspection Station,
Building 580, Beltsville Agricultural Research Center East, Beltsville,
MD 20705, or through any USDA plant inspection station listed in Sec.
319.37-14 of this part; and
(3) Imported with a controlled import tag or label securely
attached to the outside of the container containing the
[[Page 65985]]
article or securely attached to the article itself if not in a
container, and with such tag or label bearing a controlled import
permit number corresponding to the number of the controlled import
permit issued for such article.
30. Section 319.75-1 is amended as follows:
a. By removing the definition of Deputy Administrator.
b. In the definition of inspector, by removing the word ``Deputy''.
c. By adding, in alphabetical order, a definition for A