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Rules and Regulations Federal Register

25565 

Vol. 78, No. 85 

Thursday, May 2, 2013 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/

#!docketDetail;D=APHIS–2008–0055. 

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. 

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). 

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 diseasefree’’ 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. 


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25566 Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Rules and Regulations 

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 § 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 § 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 § 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 § 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 postimportation 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 § 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 


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Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Rules and Regulations 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 §§ 319.37– 

3(a)(3) through 319.37–3(a)(19) when 

they are replaced by § 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 

§ 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 § 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 


emcdonald on DSK67QTVN1PROD with RULES
25568 Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Rules and Regulations 

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 

■ 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 

§ 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 § 319.37– 

9, and wood packing material used in 

the consignment must meet the 

requirements of § 319.40–3(b) and (c). 

(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. 


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(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) 

■ 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 

(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. 

■ 4. Section 319.8–1 is amended as 

follows: 

■ a. By removing the definition of 

Deputy Administrator, Plant Protection 

and Quarantine Programs; 

■ b. By revising the definitions of 

approved; approved areas of Mexico; 

authorized; north, northern; treatment; 

and utilization, including removing 

footnote 1; and 

■ c. By adding, in alphabetical order, a 

definition of Administrator. 

The revisions and addition 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 


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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. 

* * * * * 

§§ 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 time 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 [Removed and 

Reserved] 

■ 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 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. 

* * * * * 

■ 11. In § 319.19, paragraph (b) is 

revised to read as follows: 

§ 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 § 319.6. 

* * * * * 

■ 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. 

* * * * * 

§ 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) to read as 

set forth below. 

■ b. In paragraphs (i) and (j), by 

removing the word ‘‘Deputy’’ each time 

it occurs. 

§ 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 § 319.6. 

* * * * * 

■ 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: 

§ 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 

§ 319.6. 

* * * * * 

■ 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; 

* * * * * 

■ 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. 

* * * * * 


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(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 § 319.6. 

(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. 

* * * * * 

§ 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 ‘‘§ 319.37–3’’ and 

adding the words ‘‘§ 319.6’’ 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’’ 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 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. 

* * * * * 

■ 20. Section 319.40–2 is amended as 

follows: 

■ a. In the heading of paragraph (d), by 

removing the words ‘‘scientific or 

educational’’ and adding the words 

‘‘therapeutic, or developmental’’ in their 

place. 

■ b. By revising paragraph (d)(1) to read 

as set forth below. 

■ 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. 

§ 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 § 319.6; 

* * * * * 

■ 21. In § 319.41, paragraph (c) is 

revised to read as follows: 

§ 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 § 319.6. 

* * * * * 

§ 319.41–3 [Amended] 

■ 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: 

§ 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 § 319.6. 

* * * * * 

■ 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. 

* * * * * 

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. 

* * * * * 

§ 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 under a 

controlled import permit issued in 

accordance with § 319.6’’ 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. 

§ 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 § 319.6. 

* * * * * 

■ 27. Section 319.74–1 is amended by 

adding, in alphabetical order, a 

definition for controlled import permit 

to read as follows: 

§ 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 

§ 319.6. 

* * * * * 

■ 28. Section 319.74–3 is revised to read 

as follows: 


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25572 Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Rules and Regulations 

§ 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 § 319.6. 

■ 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; 

(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; 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. 

■ 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 of 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 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2013–0287] 

RIN 1625–AA08 

Special Local Regulation; Wy-Hi 

Rowing Regatta, Trenton Channel; 

Detroit River, Wyandotte, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary special local 

regulation on the Trenton Channel of 

the Detroit River, Wyandotte, Michigan. 

This action is necessary and intended to 

ensure safety of life on the navigable 

waters immediately prior to, during, and 

immediately after the Wy-Hi Rowing 

Regatta. This special local regulation 

will establish restrictions upon, and 

control movement of, vessels in a 

portion of the Trenton Channel. During 

the enforcement period, no person or 

vessel may enter the regulated area 

without permission of the Captain of the 

Port. 

DATES: This rule is effective from 7:30 

a.m. until 5 p.m. on May 4, 2013. 

ADDRESSES: Documents mentioned in 

this preamble are part of docket USCG– 

2013–0287. To view documents 

mentioned in this preamble as being 

available in the docket, go to 

www.regulations.gov, type the docket 

number in the ‘‘SEARCH’’ box, and 

click ‘‘Search.’’ You may visit the 

Docket Management Facility, 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or email LT Adrian 

Palomeque, Prevention Department, 

Sector Detroit, Coast Guard; telephone 

(313) 568–9508, email 

Adrian.F.Palomeque@uscg.mil. If you 

have questions on viewing the docket, 

call Barbara Hairston, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Table of Acronyms 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of Proposed Rulemaking 

A. Regulatory History and Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because waiting 

for a notice and comment period to run 

is impracticable. The final details of this 

year’s regatta were not known to the 

Coast Guard with sufficient time for the 

Coast Guard to solicit public comments 

before the start of the event. Thus, 

delaying this temporary rule to wait for 

a notice and comment period to run 

would be impracticable and it would 

inhibit the Coast Guard’s ability to 

protect the public from the hazards 

associated with this event. 

Under 5 U.S.C. 553(d)(3), for the same 

reasons as discussed above, the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. 

B. Basis and Purpose 

On May 4, 2013, the Wyandotte Boat 

Club is holding a rowing race that will 

require the immediate area to be clear of 

all vessel traffic. The rowing race will 

occur between 7:30 a.m. and 5 p.m. on 

May 4, 2013. The Captain of the Port 

Detroit has determined that the likely 

combination of recreation vessels, 

commercial vessels, and large numbers 

of spectators in close proximity to 

rowing regatta pose extra and unusual 

hazards to public safety and property. 

Thus, the Captain of the Port Detroit has 

determined that establishing a Special 

Local Regulation, pursuant to the 

authority in 33 U.S.C. 1233, around the 

race’s course will help ensure the safety 

of life during this event. 

C. Discussion of Rule 

In light of the aforesaid hazards, the 

Captain of the Port Detroit has 


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