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[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Proposed Rules]
[Pages 60390-60395]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25092]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 305 and 319

[Docket No. APHIS-2009-0100]
RIN 0579-AD35

Irradiation Treatment; Location of Facilities in the Southern 
United States

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the phytosanitary treatment 
regulations to provide generic criteria for new irradiation treatment 
facilities in the Southern States of the United States. This action 
would allow irradiation facilities to be located anywhere in these 
States, subject to approval, rather than only in the currently approved 
locations. We are also proposing to allow for the irradiation treatment 
of certain imported fruit from India and Thailand upon arrival in the 
United States. This action would facilitate the importation of fruit 
requiring irradiation treatment while continuing to provide protection 
against the introduction of pests of concern into the United States.

DATES: We will consider all comments that we receive on or before 
November 28, 2011.

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

[[Page 60391]]

     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0100-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2009-0100, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2009-
0100 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Inder P. S. Gadh, Senior Risk 
Manager-Treatments, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 
20737-1236; (301) 734-0627.

SUPPLEMENTARY INFORMATION:

Background

    The phytosanitary treatment regulations contained in 7 CFR part 305 
(referred to below as the regulations) set out the general requirements 
for performing treatments and certifying or approving treatment 
facilities for fruits, vegetables, and other articles to prevent the 
introduction or dissemination of plant pests or noxious weeds into or 
through the United States. The Animal and Plant Health Inspection 
Service (APHIS) of the U.S. Department of Agriculture administers these 
regulations.

Irradiation Treatment in Southern States

    The regulations in Sec.  305.9 set out irradiation treatment 
requirements for imported regulated articles; regulated articles moved 
interstate from Hawaii, Puerto Rico, and the U.S. Virgin Islands; and 
regulated articles moved interstate from areas quarantined for certain 
pests of concern. Under Sec.  305.9, all facilities used to provide 
irradiation treatment for these articles must operate under a 
compliance agreement with APHIS and be certified as capable of 
delivering required irradiation treatment dosages and handling articles 
to prevent reinfestation of treated articles. An inspector \1\ monitors 
all treatments. The regulations require regulated articles to be 
transported to the facility and handled prior to treatment without 
significant risk that pests will escape. Safeguards to prevent the 
escape of pests during transportation to and while at the facility 
include inspections, physical separation of untreated and treated 
articles, packaging of regulated articles in sealed, insect-proof 
cartons, and shipping cartons in sealed containers. Seals must visually 
indicate if the cartons or containers have been opened. The facility 
must maintain records of all treatments and must periodically be 
recertified. These conditions have allowed for the safe, effective 
treatment of many different kinds of articles, as is demonstrated by 
the track record of irradiation treatment facilities currently 
operating in Hawaii and other countries.
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    \1\ The regulations define an inspector as ``Any individual 
authorized by the Administrator of APHIS or the Commissioner of 
Customs and Border Protection, Department of Homeland Security, to 
enforce the regulations in this part.''
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    In Sec.  305.9, paragraph (a)(1) allows irradiation treatment 
facilities to be located in any State of the United States, except for 
the Southern States of Alabama, Arizona, California, Florida, Georgia, 
Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, 
South Carolina, Tennessee, Texas, and Virginia. When the irradiation 
regulations were established, these Southern States were identified as 
having conditions favorable for the establishment of exotic fruit 
flies. The location restrictions served as an additional safeguard 
against the possibility that fruit flies could escape from imported 
articles prior to treatment and become established in the United 
States.
    The regulations do allow irradiation facilities to be located at 
the maritime ports of Gulfport, MS, Wilmington, NC, and the airport of 
Atlanta, GA, although no irradiation facilities have been established 
in these locations. APHIS conducted site-specific evaluations for these 
three locations and determined that regulated articles can be safely 
transported to irradiation facilities at these locations under special 
conditions to mitigate the possible escape of pests of concern.
    APHIS has received a petition to open an irradiation facility in 
McAllen, TX, to treat imported articles or articles moved interstate 
within the United States. In addition, the irradiation industry has 
shown considerable interest in locating irradiation facilities in the 
Southern United States, especially in proximity to the Mexican border. 
Currently, no irradiation facility is available near the Mexican 
border. Locating irradiation facilities in the Southern States would 
allow importers to treat a number of imported articles with irradiation 
for which no other treatment is available and which currently must be 
shipped long distances for treatment, such as guavas from Mexico. 
Locating irradiation facilities in the Southern States would also 
facilitate the export of certain commodities such as peaches and stone 
fruits to countries to the south of the United States.
    In response to this request and in anticipation of future requests 
to locate additional irradiation facilities in the Southern States of 
the United States, we are proposing to establish generic phytosanitary 
criteria to replace the current criteria for irradiation facilities at 
the maritime ports of Gulfport, MS, Wilmington, NC, and the airport of 
Atlanta, GA, and apply to new irradiation treatment facilities in the 
Southern States of the United States. Under these criteria, in 
conjunction with the current criteria for irradiation facilities not 
located in the Southern States, new irradiation facilities could be 
established in all the Southern States for the treatment of regulated 
articles that are imported, moved interstate from Hawaii or U.S. 
territories, or moved interstate from areas quarantined for certain 
pests of concern. These generic criteria would be supplemented as 
necessary by additional measures, which would be described in a 
compliance agreement (discussed below), based on pests of concern 
associated with specific regulated articles to be treated at the 
facility and the location of the specific facility.
    Using APHIS-approved irradiation facilities located in the United 
States to treat imported articles offers the advantage of greater ease 
of monitoring treatment. Using generic criteria for future irradiation 
facilities located in Southern States would make explicit our criteria 
for approving these facilities while eliminating the need to undertake 
rulemaking in order to approve new facilities.
    As part of this action, we have prepared a treatment evaluation 
document (TED) entitled ``Generic Phytosanitary Criteria for 
Establishing Locations for Irradiation Facilities in the Southern 
United States.'' Copies of the TED may be obtained from the person 
listed under FOR FURTHER INFORMATION CONTACT and may be viewed on the 
Internet on the Regulations.gov Web site or in our reading room (see 
ADDRESSES above for a link to Regulations.gov and information on the 
location and hours of the reading room). In the TED, we concluded that 
the pest risks from irradiation facilities in the Southern States can 
be adequately managed

[[Page 60392]]

through the use of special conditions to mitigate the possible escape 
of pests of concern.
    We are therefore proposing to amend the regulations by replacing 
the current criteria for irradiation facilities at the maritime ports 
of Gulfport, MS, Wilmington, NC, and the airport of Atlanta, GA, in 
paragraph (a)(1) of Sec.  305.9 with generic phytosanitary criteria for 
any irradiation facility in a Southern State. The new criteria would 
have to be followed in addition to the current requirements that apply 
to all irradiation facilities. The proposed generic criteria for new 
facilities in the Southern States are based on the current conditions 
for allowing irradiation facilities at the maritime ports of Gulfport, 
MS, Wilmington, NC, and the airport of Atlanta, GA. As no irradiation 
facilities have been established in these three locations, the proposed 
generic criteria would not impact any existing irradiation facilities.
    In paragraph (a)(1)(i) of Sec.  305.9, we are proposing that 
prospective facility operators in Southern States would have to submit 
a detailed layout of the facility site and its location to APHIS. APHIS 
would evaluate plant health risks based on the proposed location and 
layout of the facility site before a facility was approved. APHIS would 
only approve a proposed facility if the Administrator determines that 
regulated articles can be safely transported to the facility from the 
port of entry or points of origin in the United States. Proposed 
paragraph (a)(1)(ii) of Sec.  305.9 provides that the government of the 
Southern State in which the facility would be located would also have 
to concur in writing with the establishment of the irradiation 
facility; if it does not concur, the State government must provide a 
written explanation of concern based on pest risks. In instances where 
the State government does not concur with the proposed facility 
location, APHIS and the State would need to agree on a strategy to 
resolve such risks before APHIS approved the facility.
    Under this proposal, paragraphs (a)(1)(iii) and (a)(1)(iv) of Sec.  
305.9 would require irradiation facilities in Southern States to meet 
certain conditions that are currently required for irradiation 
facilities at the maritime ports of Gulfport, MS, or Wilmington, NC, or 
the airport of Atlanta, GA. These paragraphs would provide, 
respectively, that untreated articles may not be removed from their 
packaging prior to treatment under any circumstances, and that 
facilities must have contingency plans, approved by APHIS, for safely 
destroying or disposing of regulated articles if the facility was 
unable to properly treat a shipment.
    Under this proposal, paragraph (a)(1)(v) of Sec.  305.9 would only 
allow irradiation facilities in Southern States to treat articles that 
are approved by APHIS for treatment at that facility. If, during the 
approval process for regulated articles at irradiation facilities in 
Southern States, additional safeguards are deemed necessary during 
transport or while at the irradiation facilities for the pests of 
concern, the compliance agreement for the facility would be amended 
accordingly.
    Under proposed paragraph (a)(1)(vi) of Sec.  305.9, arrangements 
for treatment would need to be made before the departure of a 
consignment from its port of entry or points of origin in the United 
States. This would mean that untreated shipments of regulated articles 
arriving at the facility would not have to wait for an extended period 
of time for irradiation treatment. The expeditious treatment of the 
articles would minimize the risk of pests of concern maturing in 
fruits, vegetables, and other articles.
    The current regulations for irradiation facilities at the maritime 
ports of Gulfport, MS, or Wilmington, NC, or the airport of Atlanta, 
GA, prohibit the movement of untreated fruits and vegetables through 
the Southern States and require that the irradiation facility and APHIS 
agree in advance on the route by which shipments are allowed to move to 
the irradiation facility. For irradiation facilities in Southern 
States, we are proposing in paragraph (a)(1)(vi) of Sec.  305.9 that 
APHIS and the irradiation facility would have to agree in advance about 
all parameters, such as time, routing, and conveyance, by which every 
consignment would move from the port of entry or points of origin in 
the United States to the irradiation facility. In most instances, the 
route would be determined by establishing the shortest route between 
the port of entry or points of origin in the United States and the 
irradiation facility that does not include an area that contains host 
material for pests of concern during the time of year that the host 
material is most abundant in the region. This route would then be used 
regardless of the time of year, as an area free of host material during 
the time of year that it is most abundant would be unlikely to grow 
host material at another time of year. This predetermined route would 
reduce the amount of time that a shipment would have to wait before 
undergoing irradiation treatment and would reduce the risk that any 
pests of concern in the shipments would come into contact with host 
material en route to the irradiation facility.
    In addition to the current requirements to ensure the safe 
transport of regulated material to and from the irradiation facility, 
we are also proposing to require in paragraph (a)(1)(vii) that the 
conveyance transporting the regulated article to the irradiation 
facility would need to be either refrigerated, via motorized 
refrigeration equipment or other methods including ice or insulation, 
or air conditioned to a temperature that would minimize the mobility of 
the pests of concern for the article. Fruits and vegetables are 
typically transported in refrigerated or air conditioned conveyances in 
order to preserve freshness of the commodity and prevent development of 
toxins that may affect their flavor.
    The current regulations for irradiation facilities at the maritime 
ports of Gulfport, MS, or Wilmington, NC, or the airport of Atlanta, 
GA, require blacklight or sticky paper to be used within the 
irradiation facility and other trapping methods to be used within the 4 
square miles surrounding the facility. To minimize the presence of host 
material for the pests of concern for irradiation facilities in 
Southern States generally, we are proposing in paragraph (a)(1)(viii) 
of Sec.  305.9 that the facility maintain and provide APHIS an updated 
map identifying places where horticultural or other crops are grown 
within 4 square miles of the facility. APHIS will use this information 
to determine if any host material of concern is present. To help 
prevent establishment of pests in the unlikely event that they escape 
despite the required precautions, the location of any host material 
within 4 square miles of the facility would necessitate specific 
trapping or other pest monitoring activities to help prevent 
establishment of any escaped pests of concern, which would be funded by 
the facility and described in the compliance agreement. All trapping 
and pest monitoring activities would need to be approved by APHIS. Such 
activities would include the use of blacklight or sticky paper within 
the irradiation facility, as required in the current regulations for 
irradiation facilities at the maritime ports of Gulfport, MS, or 
Wilmington, NC, or the airport of Atlanta, GA. The irradiation facility 
would also need to have a pest management plan within the facility.
    Irradiation facilities would also be required to comply with any 
additional requirements that APHIS might require for a particular 
facility based on local conditions and any other risk factors of

[[Page 60393]]

concern. This could include inspection for certain pests for which 
irradiation is not an approved treatment. Proposed paragraph (a)(1)(ix) 
of Sec.  305.9 would require that facilities comply with any additional 
APHIS requirements. These requirements would be contained in a 
compliance agreement, which is currently required for all facilities in 
paragraph (c) of Sec.  305.9. In that paragraph, we are proposing to 
add that compliance agreements for facilities in Southern States may 
contain additional provisions.

Irradiation Facilities in All the United States

    Currently, as part of the approval process for irradiation 
facilities, APHIS considers whether a proposed irradiation facility is 
located within the local commuting area for APHIS employees so that 
they will be able to perform the oversight and monitoring activities 
required by Sec.  305.9. When imported articles are to be treated at a 
facility, APHIS also considers whether the facility is located within 
an area over which the U.S. Department of Homeland Security \2\ has 
customs authority for enforcement purposes. We are proposing to revise 
paragraph (e), which contains requirements for monitoring and 
interagency agreements for irradiation treatment facilities, to require 
all irradiation facilities to be located within the local commuting 
area for APHIS employees \3\ for oversight and monitoring purposes. For 
facilities treating imported articles, we are also proposing to require 
in paragraph (e)(1) of Sec.  305.9, which pertains to monitoring of 
such facilities, that the location of the facility would have to be 
within an area over which the U.S. Department of Homeland Security has 
customs authority for enforcement purposes.
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    \2\ The U.S. Department of Homeland Security is assigned 
authority to accept entries of merchandise, to collect duties, and 
to enforce the provisions of the customs and navigation laws in 
force.
    \3\ Commuting area would be determined by contacting the local 
APHIS Plant Protection and Quarantine office, State Plant Health 
Director, located in each State, Eastern Regional Office, or Western 
Regional Office.
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    If regulatory oversight and requirements by other agencies also 
apply, we are also proposing to require in paragraph (b) of Sec.  
305.9, which describes requirements for approval of facilities, that 
they must concur in writing with the establishment of the facility 
prior to APHIS approval. For example, irradiation facilities that use a 
nuclear source would have to receive concurrence from the Nuclear 
Regulatory Commission, which has jurisdiction over nuclear facilities 
and materials.

Irradiation of Fruits From India and Thailand

    Currently, the regulations in parts 318 and 319 allow the 
importation of certain fruits from India (mangos), Mexico (guavas), 
Thailand (litchis, longans, mangoes, mangosteens, pineapples, and 
rambutans), and Vietnam (dragon fruits), and the interstate movement of 
several fruits and vegetables from Hawaii, after they have received 
irradiation treatment. While fruits and vegetables moving from Mexico, 
Vietnam, and Hawaii may receive irradiation at either the point of 
origin or upon arrival in the mainland United States, fruit from India 
and Thailand must be treated prior to arrival in the United States. The 
regulations in Sec.  305.9, however, allow for irradiation treatment of 
articles either prior to or after arrival in the United States, 
provided an APHIS-approved facility is available. The regulations 
require safeguards to ensure that regulated articles are safely 
transported to the irradiation facility from the port of arrival 
without escape of plant pests in transit or at the irradiation 
facility. These safeguards have successfully prevented the introduction 
or dissemination of plant pests into or through the United States via 
the importation or interstate movement of irradiated articles since 
1996 when irradiation was first used as a phytosanitary treatment.
    We are proposing to amend Sec.  319.56-46 to allow for irradiation 
treatment of mangos from India in either India or the United States and 
Sec.  319.56-47 to allow for irradiation treatment of tropical fruits 
from Thailand in either Thailand or the United States. Fruit from India 
and Thailand would still be subject to requirements designed to ensure 
safe transportation of the articles, including insect-proof packaging, 
inspection, and issuance of a phytosanitary certificate by the national 
plant protection organization of the country of export. Based on our 
experience with India's and Thailand's compliance with these 
requirements for fruit currently irradiated in these countries, we are 
confident that these countries have the ability to comply with all 
APHIS requirements and fruit from these countries could be safely 
treated in the United States.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Order 12866, and an analysis of the potential economic effects of this 
action on small entities, as required by the Regulatory Flexibility 
Act. The economic analysis is summarized below. Copies of the full 
analysis are available by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see 
ADDRESSES above for instructions for accessing Regulations.gov).
    The proposed rule would allow for irradiation treatment of tropical 
fruits from India and Thailand in either the exporting country or the 
United States and for the establishment of irradiation facilities in 
the Southern United States. Using APHIS-approved irradiation facilities 
located in the United States to treat imported articles offers the 
advantage of greater ease of monitoring treatment.
    The proposed rule would benefit U.S. entities by clearly presenting 
the criteria that would govern the approval of additional irradiation 
facilities in the Southern United States, thereby facilitating their 
establishment. APHIS has not identified any costs associated with 
establishing the generic criteria for irradiation facility approval 
described in this the proposed rule. Beyond helping to make the 
approval of future irradiation facilities in the Southern United States 
an efficient process, we do not anticipate that the criteria set forth 
in the proposed rule would result in economic impacts or any 
significant costs for U.S. entities, large or small based on the 
available data. APHIS is, however, interested in receiving comments on 
the potential economic costs associated with the proposed criteria. 
These criteria include requiring facilities to be within the local 
commuting area for APHIS employees and within an area over which the 
U.S. Department of Homeland Security customs authority for enforcement 
purposes, obtaining written concurrence from the government of the 
Southern State in which the facility would be located, providing a 
detailed layout of the facility location, maintaining and providing an 
updated map identifying places where horticultural or other crops are 
grown within 4 square miles of the facility, trapping or other pest 
monitoring activities, agreeing in advance about all parameters by 
which the consignment will move from the point of entry or origin to 
the treatment facility, using refrigerated or air

[[Page 60394]]

conditioned conveyance to transport articles to the facility, ensuring 
that cartons are off-loaded from conveyances in a safeguarded 
environment, maintaining physical separation of treated articles from 
untreated articles, and developing a contingency plan for safely 
destroying or disposing of untreated or improperly treated articles.
    The entities potentially affected by the proposed rule would be the 
eventual clients of irradiation facilities established in the southern 
United States. They can be largely classified within the following two 
industries: Post Harvest Crop Activities (except cotton ginning) (NAICS 
115114), and Fresh Fruit and Vegetable Merchant Wholesalers (NAICS 
424480).
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) No 
retroactive effect will be given to this rule; and (2) administrative 
proceedings will not be required before parties may file suit in court 
challenging this rule.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with 
providing generic criteria for new irradiation treatment facilities in 
the Southern States of the United States, we have prepared an 
environmental assessment. The environmental assessment was prepared in 
accordance with: (1) The National Environmental Policy Act of 1969 
(NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the 
Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations 
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    The environmental assessment may be viewed on the Regulations.gov 
Web site or in our reading room. (A link to Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this proposed rule.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2009-0100. Please send a copy of your comments to: (1) Docket No. 
APHIS-2009-0100, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and 
Independence Avenue, SW., Washington, DC 20250. A comment to OMB is 
best assured of having its full effect if OMB receives it within 30 
days of publication of this proposed rule.
    This proposed rule establishes criteria for irradiation facilities 
in the Southern States. Implementing this proposed rule will require 
respondents to provide APHIS with an updated map identifying 
horticultural/crop areas and contingency plans, approved by APHIS, for 
safely destroying or disposing of regulated articles.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2.3333 hours per response.
    Respondents: Irradiation facilities in Southern United States.
    Estimated annual number of respondents: 3.
    Estimated annual number of responses per respondent: 2.
    Estimated annual number of responses: 6.
    Estimated total annual burden on respondents: 14 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects

7 CFR Part 305

    Irradiation, Phytosanitary treatment, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements.

7 CFR Part 319

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

    Accordingly, we propose to amend 7 CFR parts 305 and 319 as 
follows:

PART 305--PHYTOSANITARY TREATMENTS

    1. The authority citation for part 305 continues to read as 
follows:

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

    2. Section 305.9 is amended as follows:
    a. By revising paragraph (a)(1) to read as set forth below.
    b. In paragraph (b), by adding a sentence after the first sentence 
to read as set forth below.
    c. By adding a sentence after the paragraph (c) introductory text 
heading to read as set forth below.

[[Page 60395]]

    d. In paragraph (e) introductory text, by adding a sentence after 
the second sentence to read as set forth below.
    e. By adding a sentence after the paragraph (e)(1) introductory 
text heading to read as set forth below.

Sec.  305.9  Irradiation treatment requirements.

* * * * *
    (a) * * *
    (1) Where certified irradiation facilities are available, an 
approved irradiation treatment may be conducted for any imported 
regulated article either prior to shipment to the United States or in 
the United States. For any regulated article moved interstate from 
Hawaii or U.S. territories, irradiation treatment may be conducted 
either prior to movement to the mainland United States or in the 
mainland United States. Irradiation facilities may be located in any 
State on the mainland United States. For irradiation facilities located 
in the States of Alabama, Arizona, California, Florida, Georgia, 
Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, 
South Carolina, Tennessee, Texas, and Virginia, the following 
additional conditions must be met:
    (i) Prospective facility operators must submit a detailed layout of 
the facility site and its location to APHIS. APHIS will evaluate plant 
health risks based on the proposed location and layout of the facility 
site. APHIS will only approve a proposed facility if the Administrator 
determines that regulated articles can be safely transported to the 
facility from port of entry or points of origin in the United States.
    (ii) The government of the State in which the facility is to be 
located must concur in writing with the establishment of the facility 
or, if it does not concur, must provide a written explanation of 
concern based on pest risks. In instances where the State government 
does not concur with the proposed facility location, APHIS and the 
State will agree on a strategy to resolve the pest risk concerns prior 
to APHIS approval.
    (iii) Untreated articles may not be removed from their packaging 
prior to treatment under any circumstances.
    (iv) The facility must have contingency plans, approved by APHIS, 
for safely destroying or disposing of regulated articles if the 
facility is unable to properly treat a shipment.
    (v) The facility may only treat articles approved by APHIS for 
treatment at the facility. Approved articles will be listed in the 
compliance agreement required in paragraph (c)(1)(i) of this section.
    (vi) Arrangements for treatment must be made before the departure 
of a consignment from its port of entry or points of origin in the 
United States. APHIS and the facility must agree on all parameters, 
such as time, routing, and conveyance, by which the consignment will 
move from the port of entry or points of origin in the United States to 
the treatment facility.
    (vii) Regulated articles must be conveyed to the facility in a 
refrigerated (via motorized refrigeration equipment or other methods 
including ice or insulation) or air-conditioned conveyance at a 
temperature that minimizes the mobility of the pests of concern for the 
article.
    (viii) The facility must maintain and provide APHIS with an updated 
map identifying places where horticultural or other crops are grown 
within 4 square miles of the facility. Proximity of host material to 
the facility will necessitate trapping or other pest monitoring 
activities to help prevent establishment of any escaped pests of 
concern, as approved by APHIS; these activities will be listed in the 
compliance agreement required in paragraph (c)(1)(i) of this section. 
The treatment facility must have a pest management plan within the 
facility.
    (ix) The facility must comply with any additional requirements that 
APHIS may require to prevent the escape of plant pests during transport 
to and from the irradiation facility itself, for a particular facility 
based on local conditions, and for any other risk factors of concern. 
These activities will be listed in the compliance agreement required in 
paragraph (c)(1)(i) of this section.
* * * * *
    (b) * * * Other agencies that have regulatory oversight and 
requirements must concur in writing with the establishment of the 
facility prior to APHIS approval.
    (c) * * * Compliance agreements for facilities located in States 
listed in paragraph (a)(1) of this section may also contain additional 
provisions as described in paragraphs (a)(1)(i) through (a)(1)(ix) of 
this section. * * *
* * * * *
    (e) * * * Facilities must be located within the local commuting 
area for APHIS employees for inspection purposes.
    (1) * * * Facilities shall be located within an area over which the 
U.S. Department of Homeland Security is assigned authority to accept 
entries of merchandise, to collect duties, and to enforce the 
provisions of the customs and navigation laws in force. * * *
* * * * *

PART 319--FOREIGN QUARANTINE NOTICES

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

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

Sec.  319.56-46  [Amended]

    4. Section Sec.  319.56-46 is amended as follows:
    a. In paragraph (a), by removing the words ``in India''.
    b. In paragraph (e) introductory text, by removing the words 
``certifying that the fruit received the required irradiation 
treatment. The phytosanitry certificate must also bear'' and adding the 
word ``with'' in their place.

Sec.  319.56-47  [Amended]

    5. Section 319.56-47 is amended as follows:
    a. In paragraph (b), by removing the second sentence.
    b. In paragraph (c)(1), by removing the words ``that the litchi 
were treated with irradiation as described in paragraph (b) of this 
section and''.
    c. In paragraph (c)(2), by removing the words ``with an additional 
declaration stating that the longan, mango, mangosteen, pineapple, or 
rambutan were treated with irradiation as described in paragraph (b) of 
this section''.

    Done in Washington, DC, this 22nd day of September 2011.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2011-25092 Filed 9-28-11; 8:45 am]
BILLING CODE 3410-34-P
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