[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Proposed Rules]
[Pages 60390-60395]
From the Federal Register Online via the Government Publishing 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