United States Department of Agriculture

Animal and Plant Health Inspection Service

Plant Protection and Quarantine

Generic Phytosanitary Criteria for Establishing Locations for Irradiation Facilities1

in the Southern United States

Treatment Evaluation Document

Date: December 2010

Treatment Type: Irradiation

Commodity: Any regulated article approved to receive irradiation

Country of origin: Various

Objective: To provide supporting information and justification for a proposed change to 

7CFR Part 305 to incorporate phytosanitary criteria with which facilities must comply

prior to establishing an irradiation facility in the southern United States.

Overview: The current regulations on irradiation, 7CFR 305.9, restrict the establishment 

of irradiation facilities for phytosanitary applications in areas of the United States as 

follows: For articles that are imported or moved interstate from Hawaii or U.S. 

territories, irradiation facilities may be located in any State on the mainland United States 

except Alabama, Arizona, California, Florida, Kentucky, Louisiana, Nevada, New 

Mexico, South Carolina, Tennessee, Texas, and Virginia. In the States of Georgia, 

Mississippi, and North Carolina, irradiation facilities may only be located at the maritime 

ports of Gulfport, MS, or Wilmington, NC, or the airport of Atlanta, GA, and must follow 

certain conditions as described in paragraph (a)(1) of 7CFR 305.9. For articles that are 

moved interstate from areas quarantined for fruit flies, irradiation facilities may be 

located either within or outside of the quarantined area and follow conditions of 

paragraph (a)(2) of 7CFR 305.9.

Subsequent to the publication of rules allowing the use of irradiation for phytosanitary

purposes to meet United States entry conditions, APHIS has become aware of a 

considerable interest in having APHIS expedite the approval of additional facilities in the 

 

1 The criteria once adopted via a rule change will eliminate the need for further rule changes for 

approving new facilities.
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southern United States, particularly in proximity to the Mexican Border to irradiate 

articles for movement across the border. APHIS is now in receipt of a petition from the 

irradiation industry to open an irradiation facility at McAllen, TX. The facility, if 

approved, would irradiate articles for importation, exportation or movement within the 

United States. We anticipate more such petitions to come in the near future. Therefore, 

using the criteria established for facilities at the maritime ports of Gulfport, MS and 

Wilmington, NC, as well as the airport of Atlanta, GA, we are proposing to establish a set 

of generic criteria that any irradiation treatment facility in the southern United States

must follow to minimize the risk of pest escape from regulated articles prior to the 

treatment. Having generic criteria will make explicit to stakeholders our criteria for 

approving irradiation treatment facilities in the southern United States and save time from 

the otherwise repetitive rule making process in approving new facility locations. This set 

of criteria represents a minimum standard with which the facilities must comply to 

prevent pest escape, in particular fruit fly escape. Additional measures, based on 

quarantine pests associated with specific regulated articles and location of the specific 

facility, will be added to the set of criteria for the facility to follow if they are deemed 

necessary by APHIS. Any additional measures mandated for a particular facility will be 

stipulated in a facility compliance agreement (FCA).

Historical Background: APHIS conducts an evaluation of pest risk when considering 

approving locations for the establishment of phytosanitary treatment facilities in certain 

areas of the United States. A study was conducted by APHIS in 1994 with the objective 

of characterizing risks from fruit flies associated with the movement of tropical fruit fly 

hosts and to determine where in the United States cold treatment facilities could be 

established to safely treat such fruit fly hosts (USDA, 1994). In addition to determining 

areas in the northeastern United States as relatively safe to allow such facilities, the study

also identified areas in the southern United States as relatively unsafe to have such 

facilities. These were areas where conditions would favor the establishment of exotic 

fruit flies. The study also determined that, despite container and movement restrictions 

designed to prevent this possibility, fruit flies could escape from regulated articles prior 

to cold treatment and recommended restricting or prohibiting the movement of host 

materials through southern United States unless strict measures were applied to manage 

the associated risks (Stewart, 1994). 

Subsequently in response to petitions and after site-specific evaluations, APHIS approved 

several southern locations where facilities could be established to receive and cold treat 

foreign fruits or vegetables provided certain special conditions, as described in 7CFR 

305.6(h) and determined by APHIS to result in the safe transport of regulated articles to 

the treatment facility, were followed (USDA, 1996). These approved locations included 

the maritime ports of Seattle, WA, Gulfport, MS, and Wilmington, NC, and the airport of 

Atlanta, GA. The maritime port of Corpus Christie, TX, was later added to southern 

ports that were approved to receive and cold treat fruit fly host materials (USDA, 2003). 

In 2002, three of these ports (the maritime ports of Gulfport, MS, and Wilmington, NC, 

and the airport of Atlanta, GA) were also approved to have irradiation facilities to treat 

fruit fly host materials under conditions similar to those for the cold treatment facilities 
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(USDA, 2002). The specific conditions for irradiation treatment at those three ports 

included: The articles to be irradiated must be imported or moved interstate packaged in 

accordance with paragraph (f)(3) of 7CFR 305.9, which addresses pest-proof packaging; 

the irradiation facility and APHIS must agree in advance on the route by which 

consignments are allowed to move between the vessel on which they arrive and the 

irradiation facility; untreated articles may not be removed from their packaging prior to 

treatment under any circumstances; black light or sticky paper must be used within the 

irradiation facility, and other trapping methods, including APHIS-approved fruit fly traps, 

must be used within the 4 square miles surrounding the facility; and the facility must 

have contingency plans, approved by APHIS, for safely destroying or disposing of 

regulated articles. Prior to treatment, articles to be irradiated may not move into or 

through any of the States that are currently not allowed to have irradiation facilities, 

except that movement is allowed through Dallas/Fort Worth, TX, as an authorized stop 

for air cargo, or as a trans-loading location for consignments that arrive by air but that are 

subsequently trans-loaded into trucks for overland movement from Dallas/Fort Worth 

into an authorized State by the shortest route. For articles moving interstate from areas 

quarantined for fruit flies to be irradiated outside of the quarantined area, the articles

must be accompanied to the facility by a limited permit issued in accordance with 7CFR 

301.32-5(b) and must be moved in accordance with any safeguards determined to be 

appropriate by APHIS. 

The special conditions as described above and required for the approved facility locations 

in the southern States were not considered in the USDA (1994) study and are seldom 

required for fruit arriving in northeastern United States that requires treatment as a 

condition of entry. The special conditions were put in place to minimize the risk of pest, 

especially fruit fly, escape during the transport of regulated articles to locations approved 

for irradiation treatment in the southern United States. 

The conditions for the three southern locations currently approved for irradiation 

facilities were used as the basis for developing the conditions which we are proposing for 

allowing the establishment of new irradiation facilities at locations in the prohibited 

southern States. In developing the proposed criteria, although our primary emphasis has 

been on the risks associated with fruit flies ― which initially formed the basis for the

USDA (1994) study and for not allowing cold treatment facilities in the southern United 

States ― we are also cognizant of the fact that quarantine pests other than fruit flies may

also accompany a consignment and additional safeguards may be needed. At the time of 

approval of irradiation treatment for a regulated article at a particular facility, any 

additional measures, if determined necessary by APHIS, to safeguard the movement or

handling of a specific article would be added to the list of criteria to be followed by the 

particular facility.
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Required Generic Phytosanitary Criteria to Allow Irradiation Facilities to be Located 

in the Southern United States

The following generic criteria will be used to allow for the establishment of irradiation 

facilities in the southern United States:

1. For articles being moved interstate or intrastate that require irradiation, the location for 

the facility needs to be within the local commuting area for APHIS employees to perform 

oversight and monitoring activities as provided in the regulations in 7CFR 305. For 

imported articles that require irradiation, the location for the facility must also be within 

an area over which the U.S. Department of Homeland Security is assigned the authority 

to accept entries of merchandise, to collect duties, and to enforce the various provisions 

of the customs and navigation laws in force. 

2. APHIS will require that the owner/operator of the proposed facility obtain in writing 

from the State where the facility is to be located either the State’s concurrence for the 

establishment of a facility or the State’s explanation of valid phytosanitary concerns,

based on pest risks, which formed the basis for the State’s denial. 

3. APHIS will require that the owner/operator of the proposed facility submit to APHIS a 

detailed layout of the facility location for APHIS to evaluate safeguards in light of the 

plant health risks involved.

4. The location of the facility must be a site that minimizes the presence of host material 

for the pests of concern in the southern United States. The facility must maintain and 

provide an updated map identifying places where horticultural or other crops are grown 

within four square miles of the facility. Trapping or other pest monitoring activities may

be required based on the crops present and the pest risks involved. 

Required Generic Phytosanitary Criteria for Irradiation Facilities Located in the 

Southern United States

The following generic criteria will be used to establish an irradiation facility at a specific 

location in the southern United States:

1. The facility will only be certified if the Administrator determines that any regulated

articles can be safely transported to the facility from the point of entry or origin without 

significant risk that plant pests will escape in transit to the facility or while the regulated 

articles are at the facility.

2. The facility and APHIS must agree in advance about all parameters, such as time, 

routing and conveyance, by which the consignment will move from the point of entry or 

origin to the treatment facility. Also, arrangements for treatment must be made before 

the departure of a consignment from its point of entry or origin.
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3. Only approved articles described in the FCA, in approved insect proof 

containers/pallets/bins, from approved places of production, State, or countries of export 

are to be accepted by the facility for treatment. The facility must ensure that the 

conveyance transporting the article to the facility are either refrigerated (via motorized 

refrigeration equipment or other methods including ice or insulation) or set at a

temperature based on the article that would minimize the mobility of the pests of concern.

The facility must ensure that cartons are off loaded from conveyances in a safeguarded 

environment and at no time are the articles to be removed from the insect proof cartons 

prior to the treatment.

4. The facility must maintain physical separation of treated articles from untreated 

articles and apply all required safeguards e.g. the treated articles are packaged in insect 

proof containers, before releasing or for movement to other States.

5. The facility must have an APHIS approved contingency plan for safely destroying or 

disposing of untreated or improperly treated article. 

6. The facility must comply with any additional requirements that APHIS may require 

for a particular facility based on local conditions, which will be described in the FCA.

Evaluation: APHIS has determined that the set of criteria described above is adequate to 

manage the pest risks associated with this action and recommends amending the rule to 

incorporate required phytosanitary criteria with which irradiation facilities must comply

in order to operate in the southern United States. If during the approval process for 

regulated articles, additional safeguards are deemed necessary for the pests of concern, 

the criteria for the facility would be revised accordingly and reflected in the FCA. If the 

pest risks associated with a particular regulated article could not be managed at the 

proposed facility, then that particular article would not qualify for irradiation treatment at 

that location.

The criteria as described above include multiple layers of protection to minimize risk 

from pest escape, particularly fruit flies, during transport or at the facility. By requiring 

that the article arrive only in sealed insect-proof cartons which are then placed in sealed 

maritime or other similar conveyances provides a double layer of protection from pest

escape. That articles arriving for irradiation must be transported in either refrigerated 

conveyances or at a temperature that would minimize the mobility of the pests of concern

would ensure that any pest dispersal is significantly retarded. This would provide

sufficient time for the affected party to notify APHIS and manage any risk of pest escape 

following untoward incidents in transit. As would be explained in the compliance 

agreement, the facility must provide details about time, route and conveyance by which 

articles would be moved and contingency plans for safely destroying or disposing of 

regulated article should facility fail to deliver the prescribed treatment. The facility must 

ensure that cartons are off loaded from conveyances in a safeguarded environment and 

that at no time are the articles to be removed from the insect proof cartons prior to 

treatment. APHIS must also require and approve use of traps and other measures should 

site specific evaluation determine their need based on presence of host material. 
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Decision: Amend 7CFR 305 to include criteria for all the southern United States to 

establish an irradiation facility for phytosanitary purposes under the special conditions as 

described above.

Amendment of regulations allowing importation of articles from India and Thailand

with irradiation

Currently, APHIS regulations (7CFR 319.56) allow importation of certain fruits from 

India (mango), Mexico (guavas), Thailand (litchis, longans, mangoes, mangosteens, 

pineapples and rambutans) and Vietnam (dragon fruits) and interstate movement of about 

fifteen fruits from Hawaii after these fruits have received irradiation treatment as a 

condition of entry. While the fruit 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 into the mainland. The 

regulations (7CFR 305.9) allow for irradiation treatment of articles either prior to or after 

arrival in the United States, provided an APHIS-certified facility is available. Using

APHIS-certified facilities to treat imported articles after arrival in the United States offers 

the advantage of greater ease of monitoring treatment. Therefore, we are also 

recommending that the regulations 7CFR 319.56-46 and 319.56-47 be amended to allow 

for irradiation treatment of fruit from India and Thailand after arrival in the mainland 

United States. APHIS may evaluate the pest risks associated with the regulated articles 

to determine whether additional safeguarding measures are needed for specific facilities.

References:

USDA. 1994. Characterizing and mitigating relative risk associated with the movement 

of tropical fruit fly host material into the United States for cold treatment at certain 

ports. Stewart, R.D., USDA-APHIS-PPQ-BATS. 16 pp.

USDA. 1996. Importation of Fruits and Vegetables. Federal Register. 61: 47663-47667. 

Published Sept. 10, 1996.

USDA. 2002. Irradiation Phytosanitary Treatments of Imported Fruits and Vegetables. 

Federal Register. 67; 65016 – 65029. Published Oct. 23, 2002.

USDA. 2003. Cold Treatment for Fresh Fruits; Port of Corpus Christi, TX. Federal 

Register. 68: 2684-2686. Published Jan.21, 2003.

Authors/Reviewers:

Inder P.S. Gadh, Ph.D.,

Senior Risk Manager – Treatments, USDA APHIS PPQ RPM

Walter P. Gould, Ph.D.
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Senior Risk Manager – Entomology / Acting Branch Chief, Regulatory Coordination 

and Compliance, USDA APHIS PPQ RPM

Donna L. West, 

Senior Import Specialist, USDA APHIS PPQ RPM