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[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Rules and Regulations]
[Pages 25565-25572]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10385]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
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Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Rules 
and Regulations

[[Page 25565]]

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: Final rule.

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SUMMARY: We are amending 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 will 
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: Effective Date: June 3, 2013.

FOR FURTHER INFORMATION CONTACT: Mr. William Aley, Senior Regulatory 
Policy Specialist, Plant Health Programs, PPQ, APHIS, 4700 River Road 
Unit 133, Riverdale, MD 20737-1231; (301) 851-2130.

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.
    On October 25, 2011, we published in the Federal Register (76 FR 
65976-65985, Docket No. APHIS-2008-0055) a proposal \1\ to amend the 
regulations by establishing the controlled import permit (CIP) as the 
permit that would be used in place of departmental permits and the 
other types of authorizations 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 also 
proposed the CIP as the form of permit required for the importation of 
plant materials for postentry quarantine (PEQ).
---------------------------------------------------------------------------

    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0055.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days ending 
December 27, 2011. We received eight comments by that date. They were 
from a State department of agriculture, plant nursery associations, a 
biotechnology firm, an organization of State plant regulatory agencies, 
and a member of the general public. Two commenters supported the 
proposed action. One commenter opposed the establishment of the CIP 
without raising any issues related to the proposed rule. The remaining 
comments are discussed below by topic.
    One commenter expressed support for the proposed rule while 
suggesting that the new CIP and the new regulatory category for plants 
for planting whose importation is not authorized pending pest risk 
analysis (NAPPRA) be implemented simultaneously.
    We agree that the CIP and NAPPRA are related initiatives, and we 
have made significant progress in implementing both. A notice adding 
certain taxa of plants for planting to the NAPPRA lists was published 
in the Federal Register on April 18, 2013 (78 FR 23209-23219, Docket 
No. APHIS-2011-0072), and their addition to the NAPPRA lists will be 
effective on May 20, 2013; this final rule, establishing the CIP 
program, will be effective 30 days from its date of publication.

Pre-Shipping Conditions

    We proposed to require plant material imported under a CIP to be 
selected from apparently disease-free sources. One commenter asked how 
``apparently disease free source'' is defined.
    ``Apparently disease-free'' status is specific to each type and 
taxon of plant material. The importer will specify how it will meet the 
``apparently disease-free'' requirement in the CIP application, and the 
CIP application will be reviewed by the Animal and Plant Health 
Inspection Service (APHIS) before a CIP is issued.
    One commenter asked if APHIS will inspect the source facility of 
the articles for which the CIP is issued.
    In most cases, APHIS does not inspect foreign facilities. The 
United States is a signatory to the International Plant Protection 
Convention and cooperates with the national plant protection 
organizations (NPPO) of our trading partners to ensure that plant 
material exported to the United States meets any pre-export 
requirements that may be assigned as a condition of the permit, such as 
the inspection of a source facility. In some cases, APHIS may jointly 
inspect a facility with officials of the exporting country's NPPO.

Shipping Conditions

    A commenter said that the proposed CIP shipping conditions, which 
require the plant material to be free of soil, foreign matter or 
debris, prohibited plants, noxious weed seeds, and living organisms, 
contradict the proposed definition of therapeutic purposes, which 
allows the application of specific processes to eliminate, isolate, or 
remove potential plant pests or diseases.
    Unless otherwise specified under the conditions of the CIP, 
consignments of plant material imported under a CIP must meet certain 
shipping requirements, including the requirement that the plant 
material be free of living organisms. However, an importer of plant 
material intended for therapeutic purposes may specify in the CIP 
application different shipping conditions for the specific article (for 
example, an importer could apply to import material infected with a 
plant disease to test diagnostic techniques.). APHIS will review the 
proposed shipping conditions and may issue a CIP for the alternate 
shipping conditions.

[[Page 25566]]

Mitigation of Pest Risk

    Two commenters asked for clarification on how APHIS will determine 
that the plant pest risks associated with the plant material and its 
intended use can be effectively mitigated.
    Mitigation of the risk associated with prohibited or restricted 
articles varies by commodity and origin and will be determined on a 
case-by-case basis. APHIS' goal is to permit importation of an 
otherwise prohibited or restricted plant only after scientists and risk 
evaluation experts have reviewed and approved the measures that the 
applicant proposes to reduce the likelihood of pest importation to an 
acceptable level. The importer will provide the proposed mitigation 
strategy in the CIP application. APHIS will use information provided by 
the permit applicant and a review of scientific literature to determine 
whether the proposed control measures would adequately address the 
identified risks. APHIS will communicate with the importer throughout 
the review process. The CIP would specify the required mitigation 
measures that are identified as necessary by APHIS based upon the 
intended use of the plant material and as being adequate to prevent 
plant pest introduction.

Post Entry Quarantine

    Under Sec.  319.37-7, certain restricted articles from designated 
areas must be grown under specific post entry quarantine (PEQ) 
conditions and may be imported into the United States only if: The 
articles are destined for a State that has completed a State PEQ 
growing agreement; a PEQ growing agreement has been completed and 
submitted to the Plant Protection and Quarantine (PPQ) program; and PPQ 
has determined that the completed PEQ growing agreement fulfills the 
applicable requirements and that services by State inspectors are 
available to monitor and enforce the post entry quarantine.
    We proposed that PEQ material be imported with a CIP, rather than 
the permit normally issued for planting under Sec.  319.37-3, in 
addition to a PEQ growing agreement. One commenter stated that, while 
the proposed rule specifies that a CIP may be issued to authorize the 
importation of plant material for developmental purposes, experimental 
purposes, or therapeutic purposes, PEQ material is rarely brought in 
for any of these purposes. The commenter stated that PEQ material is 
imported because the material is not available domestically, is not 
available in a specific caliper or phenological state domestically, or 
is cheaper to acquire from a foreign source. The commenter suggested 
that the proposed rule be amended to exempt plants currently imported 
under the PEQ provisions in Sec.  319.37-7 from the requirement that 
plants imported under a CIP be imported for developmental, 
experimental, or therapeutic purposes.
    The purpose of a PEQ agreement is to allow for monitoring of 
consignments after entry into the country for the presence of pests, 
time for the expression of signs or symptoms, and, if necessary, 
appropriate treatment.
    We proposed to define developmental purposes 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. The term is intended to be of wide scope and will not 
exclusively cover material for scientific or experimental uses. Given 
that, we continue to believe that the CIP is the appropriate type of 
permit for the importation of plant material that will be held in PEQ.
    One commenter said that most PEQ material requires two growing 
season inspections, which take more than 1 year of growth in PEQ to 
conduct. The commenter said that, because a CIP would be valid for a 
period of 1 year, the CIP would require a permit renewal for most PEQ 
material, resulting in permit lapses and additional administrative work 
for both the permit holder and the agencies.
    As specified in Sec.  319.37-7(d)(7) of the regulations, most 
articles that are imported under a PEQ agreement must be grown in PEQ 
for a period of 2 years. While a CIP requires plant material to be 
imported within a specified 12-month period, any additional time 
necessary to complete the evaluation process after importation will be 
specified in the application and the permit. Therefore, multiple CIPs 
for a single shipment of PEQ material will not be necessary.
    One commenter said that requiring a CIP to accompany material 
imported for monitoring under a PEQ agreement could result in each lot 
of PEQ plants having a different set of growing conditions, 
complicating both the inspection and production processes and 
increasing the rate of errors and non-compliance at the growing site.
    We do not believe the problems cited by the commenter will arise. 
The same plant material shipped for the same purpose would by 
definition have the same growing conditions, which will be specified in 
the accompanying CIP.

Post-Importation Conditions

    Some comments concerned the post-importation conditions associated 
with the CIP. As explained in the proposed rule, we may require that 
the plant material imported under a CIP be transported from the plant 
inspection station through which it is imported for release only to 
preapproved facilities depending on the intended purpose of the plant 
material and the risks associated its importation.
    One commenter opposed the proposed rule citing a lack of 
information on what constitutes an approved facility. The commenter 
expressed concern about the possible risk to his State's agricultural 
production if appropriate containment facilities are not in place.
    Because risks are specific to each taxon and type of plant 
material, the criteria for an approved facility will vary depending on 
the plant material that will be maintained in the given facility and 
the plant material's intended use. Prior to issuing a CIP, APHIS will 
consider the risks associated with imported plant material and assign 
conditions, including facility infrastructure and equipment 
requirements, determined to be sufficient. APHIS will work with the 
applicant to ensure that those conditions or equivalent measures can be 
instituted by the applicant prior to issuance of the permit. It is 
APHIS policy to work with State officials in order to identify and 
address any concerns prior to the issuance of the permit.
    One commenter asked about the requirements for obtaining permission 
to transfer a CIP from the original permit holder to another person and 
if APHIS would grant permission to transfer the material to another 
person only if the permit conditions remain the same, or if the 
material could be distributed commercially for planting or as breeding 
stock.
    If import materials are transferred from the original CIP holder to 
another person, the person to whom the materials are transferred is 
bound by the requirements of the original CIP. Permission to move or 
distribute plant material that was authorized for importation under a 
CIP to another person can be obtained by contacting the PPQ Permit 
Unit. We have added language to paragraph (e)(5) of Sec.  319.6 
explaining that, should the permit holder be otherwise unavailable to 
maintain the plant material for which the CIP was issued, the plant 
material must be destroyed unless another person assumes responsibility 
for the

[[Page 25567]]

continued maintenance of the plant material and such person obtains a 
new CIP for the plant material.
    Two commenters asked if material held under CIP and/or PEQ may be 
commercialized once released from permit.
    Plant material or material propagated from plant material that is 
imported with the intent to be used for commercial purposes would fall 
under the category of importation for developmental purposes. The 
importer must state in the CIP application that he intends to 
commercialize the article. If APHIS approves the CIP application with 
this condition, then the article may be commercialized after the CIP is 
closed and the imported material is released from the corresponding PEQ 
agreement.

CIP Reporting

    One commenter said that she understood that the current 
departmental permit could be used for multiple importations of the same 
material and would be valid for a period of 5 years. The commenter 
noted that the proposed CIP would require the importer to apply for a 
separate and unique CIP for each and every shipment, would be valid for 
1 year, and would involve annual inspections and reporting, which have 
not been required for permits in the past.
    While in some instances importers have imported multiple shipments 
under a single departmental permit, we note that the intent of the 
regulations always has been that a permit be issued for each 
importation. We are retaining this requirement for the CIP.
    The time period for a valid import permit is not being changed. The 
existing APHIS departmental permits are valid for 1 year, not 5 years. 
A CIP will be valid for 1 year, and the CIP holder may request the 
permit be renewed for an additional 2 years. Importers will be required 
to conduct an annual inspection and submit an annual report in order to 
allow APHIS to better track the importation of plant materials for 
which a permit is issued.

Permits for Plants for Planting

    One commenter asked what will happen to the provisions in 
Sec. Sec.  319.37-3(a)(3) through 319.37-3(a)(19) when they are 
replaced by Sec.  319.6. The commenter asked that the agency permitting 
process continue to apply these regional prohibitions to protect key 
plant industries and natural resources from exotic pests and pathogens.
    Section 319.37-3 requires a permit for the importation of plants 
for planting. Paragraphs (a)(3) through (a)(19) of Sec.  319.37-3, 
which specify various categories of plants for planting whose 
importation requires a permit, will not be replaced or changed in any 
way. The only changes proposed for this section are the revision of 
paragraph (d) and the addition of paragraphs (g) and (h). The CIP does 
not remove or change quarantine requirements previously established 
through scientific review. In paragraph (d), we are replacing the term 
``Deputy Administrator'' with ``Administrator'' and making minor 
editorial changes. New paragraph (g) will require a CIP for articles 
imported for experimental, therapeutic, or developmental purposes, 
while new paragraph (h) will require that materials grown under a PEQ 
to also have a CIP.

Hearings

    In our proposed rule, proposed paragraph (g)(5) of Sec.  319.6 
specified the appeals process for individuals who have their 
application for a permit denied or permit revoked. The paragraph 
specified that a hearing could be held in certain instances. To reflect 
current Agency practices, we have removed references to such a hearing 
in this final rule.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final 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.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on 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 this rule 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 non-
agricultural industries in terms of being comprised largely of small 
entities. According to the Census of Agriculture, these 2 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 rule. These entities are considered small by SBA standards if 
they employ not more than 500 persons. According to the 2007 Economic 
Census, 82 percent of these establishments are small.
    The CIP would replace the departmental permits and other types of 
authorizations that we have used to allow the importation of otherwise 
prohibited articles or of articles under different conditions other 
than in the current regulations. In addition, the CIP will be used as a 
form of permit required for the importation of plant materials for 
postentry quarantine (PEQ). 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 final 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 will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this final rule, which were 
filed under control number 0579-0384, have been submitted for approval 
to the Office of Management and Budget (OMB). When OMB notifies us of 
its decision, if approval is denied, we will publish a document in the 
Federal Register providing notice of what action we plan to take.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to

[[Page 25568]]

compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this 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 are amending 7 CFR part 319 as follows:

PART 319-FOREIGN QUARANTINE NOTICES

0
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.

0
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.

    (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 
(APHIS), 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 mail, by fax, 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; and
    (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, including the 
specifications for the facility where the plant will be held. 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, and wood packing material used in the 
consignment must meet the requirements of Sec.  319.40-3(b) and (c).
    (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.

[[Page 25569]]

    (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 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. Should the permit holder be otherwise unavailable to maintain 
the plant material for which the CIP was issued, the plant material 
must be destroyed unless another person assumes responsibility for the 
continued maintenance of the plant material and such person obtains a 
new CIP for the plant material. Permission to move or distribute plant 
material that was authorized for importation under a CIP to another 
person must be obtained by contacting the PPQ Permit Unit.
    (6) CIPs issued by APHIS are valid for a period of 1 year. The 
permittee may request the existing permit be renewed for up to an 
additional 2 years prior to the expiration of the CIP and if no adverse 
indications exist from the previous year.
    (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 may deny 
an application for a CIP, 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. 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.

(Approved by the Office of Management and Budget under control 
number 0579-0384)

0
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.

0
4. Section 319.8-1 is amended as follows:
0
a. By removing the definition of Deputy Administrator, Plant Protection 
and Quarantine Programs;
0
b. By revising the definitions of approved; approved areas of Mexico; 
authorized; north, northern; treatment; and utilization, including 
removing footnote 1; and
0
c. By adding, in alphabetical order, a definition of Administrator.
    The revisions and addition 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

[[Page 25570]]

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 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]

0
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]

0
6. In Sec.  319.8-3, paragraphs (a) and (b) are amended by removing the 
word ``Deputy'' each time it appears.

Sec.  319.8-8  [Amended]

0
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]

0
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]

0
9. Sections 319.8-19 and 319.8-20 are removed and reserved.

0
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.
* * * * *

0
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.
* * * * *

0
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.
* * * * *

Sec.  319.24-1  [Amended]

0
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.

0
14. Section 319.28 is amended as follows:
0
a. By revising paragraph (d) to read as set forth below.
0
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.
* * * * *

0
15. Section 319.37-1 is amended by removing the definition of Deputy 
Administrator and by adding, in alphabetical order, definitions of 
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.
* * * * *

0
16. Section 319.37-2 is amended as follows:
0
a. By revising paragraph (c)(1) to read as set forth below.
0
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.
0
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;
* * * * *

0
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.

* * * * *

[[Page 25571]]

    (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.
* * * * *
    (g) Persons wishing to import restricted articles into the United 
States for experimental, therapeutic, or developmental purposes must 
apply for a controlled import permit in accordance with Sec.  319.6.
    (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.
* * * * *

Sec.  319.37-7  [Amended]

0
18. Section 319.37-7 is amended as follows:
0
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'' in its place.
0
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'' in its place.

0
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.
* * * * *

0
20. Section 319.40-2 is amended as follows:
0
a. In the heading of paragraph (d), by removing the words ``scientific 
or educational'' and adding the words ``therapeutic, or developmental'' 
in their place.
0
b. By revising paragraph (d)(1) to read as set forth below.
0
c. 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;
* * * * *

0
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.
* * * * *

Sec.  319.41-3  [Amended]

0
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.

0
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.
* * * * *

0
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.
* * * * *

Sec.  319.59-2  [Amended]

0
25. Section 319.59-2 is amended as follows:
0
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 under a controlled import permit issued in 
accordance with Sec.  319.6'' in their place.
0
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.

0
26. Section 319.69 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the words 
``supplemental to this quarantine'' and adding the words ``in this 
subpart'' in their place.
0
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.
* * * * *

0
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.
* * * * *

0
28. Section 319.74-3 is revised to read as follows:

[[Page 25572]]

Sec.  319.74-3  Importations for experimental or similar purposes.

    Cut flowers may be imported for experimental, therapeutic, or 
developmental purposes under conditions specified in a controlled 
import permit issued in accordance with Sec.  319.6.

0
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;
    (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; and
    (3) Imported with a controlled import tag or label securely 
attached to the outside of the container containing the 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.

0
30. Section 319.75-1 is amended as follows:
0
a. By removing the definition of Deputy Administrator.
0
b. In the definition of inspector, by removing the word ``Deputy''.
0
c. By adding, in alphabetical order, a definition of Administrator to 
read as set forth below.

Sec.  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.
* * * * *

Sec.  319.75-3  [Amended]

0
31. In Sec.  319.75-3, paragraph (d) is amended by removing the word 
``Deputy'' each time it appears.

Sec.  319.75-8  [Amended]

0
32. Section 319.75-8 is amended by removing the word ``Deputy''.

    Done in Washington, DC, this 26th day of April 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-10385 Filed 5-1-13; 8:45 am]
BILLING CODE 3410-34-P
```