**United States Department of Agriculture Animal and Plant Health Inspection Service**  **Plant Protection and Quarantine**

**Generic Phytosanitary**  **Criteria for Establishing Location s**  **for Irradiation Facilit ies**  **1 in the**  **S outhern United States**  **Treatment Ev aluation Document** 

**Date** : December 2010 **Treatment Type:** Irradiation **Commodity:** An y regulated article approved to receive irradiation **Country of origin:** Various **Objective :**  To provide supporting in formation and justification for a proposed change to 7 CFR Part 305 to incorporate ph yt osanitary criteria with which facilities must comply prior to establishing an irradiation facility in the southern United States. **Overview:** The c urrent regulations on irradiation, 7CFR 305.9 , restrict the establishment of i rradiation facilities for phy tosanitary applications in areas of the United States as follows: F or 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 St ates 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 onl y be located at the mariti me 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 . F or articles that are moved interstate from areas quarantined for fruit flies, irradiation facili ties 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 phy tosanitary purposes to meet United S tates entry conditions, APHI S has become aware of a considerable interest in having APHI S expedite the approval of additional facilities in the

1 Th e criteria once adopted via a rule change will eliminate the need for further rule changes for approving new facilities

.2

southern United S tates , particularl y in proximity to the Mexican Border to irradiate articles for mov ement across the border. APHI S 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 s uch petitions to come in the near future. Therefore , u sing 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 escap e from regulated articles prior to the treatment

. Having generic criteria will make explicit to stakeholders our criteria for approving irradi ation treatment facilities in the southern United States and save time from the otherwise repetitive rule making process in approving new facility locations

. T his set of criteria represents a minimum standard with which the facilities must comply to preve nt pest escape, in particular fruit fly escape . A dditional 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 d e em ed necessary by APHIS

. Any

additional measures mandated for a particular facility will be stipulated in a facility

compliance agreement (FCA)

. **Historical Background:** APHI S conducts an evaluation of pest risk when considering approving locations for the establishment of phy tosanitary treatment facilities in certain areas of the United States. A study was conducted by APHIS in 1994 w ith the objective of characteriz ing risks from fruit flies associated with the movement of tropical fruit fl y hosts and to determine where in the United States cold treatment facilities could be established to safel y treat such fruit fl y hosts (USDA, 1994) . In addition to determining areas in the northeastern United States as relatively safe to allow such facilities, the s tudy also identified areas in the southern United States as relativel y 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 re strictions 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 a pplied to manage the associated risks (Stewart, 1994)

. Subsequently in response to petitions and after site

- specific evaluation s , APHI S 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 7 CFR 305.6(h) and determined by APHIS to result in the safe transport of regulated articles to the treatment facility , were followed ( USDA, 1996 ). T hese 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 material s under conditions similar to those for the cold treatment facilities3

(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 pes t

- proof packaging ; the irradiation facility

and APHI S 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 packag ing 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 b y APHIS, for safel y destro yi ng or disposing of regulated articles. Prior to treatment, articles to be irradiated may not move into or through any of the States that are currentl y not allo wed 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 b y air but that are subsequently

trans

- loaded into trucks for overland m ovement from Dallas/Fort Worth into an authorized State by the shortest route. For articles moving interstate from areas quarantined for frui t flies to be irradiated outside of the quarantined area, the articles must be accompanied to the facility b y a li mited permit issued in accordance with 7CFR 301.32

- 5(b) and must be moved in accordance with any safeguards determined to be appropriate b y APHI S. 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, especial ly fruit fl y , escape during the transport of regulated articles to locat ions approved for irradiation treatment in th e 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 ha s been on the ris ks 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 al so 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 , an y additional measures , if determined necessary by APHI S , to safeguard the movement or handling of a specific article would be added to the list of criteria to be followed b y the particular facility

.4

**Required Generic**  **Phytosanitary Criteria**  **to Allow Irradiation Facilit**  **ies to be Located**  **in the S** **outhern United States** The following generic cri teria 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. APHI S will require that the owner/operator of the proposed facility o btain 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 explanati on of valid phy tosanitary concern s , based on pest risks , which formed the basis for the State’s d enial

. 3. APHI S will require that the owner/operator of the proposed f acility submit to APHI S a detailed layout of the facility l ocation for APHIS to evaluate safeguards in light of the plant health risks involved

. 4. The location of the facility must be a site that minimize s 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 mile s 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 safel y transported to the fa cility 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 ti me, 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.5

3. Only app roved 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 b y the facility for treatment. The facility must ensure that the conveyance transpo rting 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 facili ty

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 phy sical separation of treated artic les 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 APHI S approved contingency plan for safel y destroying or disposing of untreated or improperly treated article

. 6. The facility must compl y with any additional requirements that APHIS may require for a particular facility

based on local conditions , which will be described in the FC A

. **Evaluation:** APH IS 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 ph yt osanitary criteria with which irradiation facilities must comply in ord er 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 accordingl y 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 laye rs 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. T hat articles arriving for irradiation must be transported in either refrigerated conveyances or at a temperature that w ould minimize the mobility of the pests of concern wo uld ensure that an y pest dispersal is significantly retarded . This would provide sufficient time for the affected party to notify APHI S 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 saf

el y destro yi ng 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.6

**Decision :**  Amend 7CFR 305 to include criteria for all the southern United States to establish an irradiation facility for ph yt osanitary purposes under the special conditions as described above. **Am endment of regulations**  **allowing importation of**  **articles from India and Thailand**  **with irradiation**  Currently , APHI S regulations ( 7 CFR 319.56 ) allow import ation of certain fruits from India (mango), Mexico (guavas), Thailand (litchi s, longans, man goes, mangosteen s, 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 H awaii 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. T he regulations ( 7 CFR 305.9 ) allow for irradiation treatment of ar ticles either prior to or after arrival in the United States, provided an APHI S

- certified facility is available. Using APHI S

- 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 Unite d States

. APHI S 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 fl y host material into the United States for cold treatment at certain ports. Stewart, R.D. , USDA

- APHIS

- PPQ

- BATS. 16 pp. USDA

. 199 6

. Importation of Fruits and Vegetables. Federal Register. 61: 47663

- 47667. Published Sept. 10, 1996. USDA

. 2002. Irradiatio n Phy tosanitary Treatments of Imported Fruits and V egetables. Federal Register. 67; 65016

– 65029

. P ublished Oct. 23, 2002. USDA. 2003. Cold Treatment for Fresh Fruits; Port of Corpus Christi, TX. Federal Register. 68: 2684

- 2686. P ublished Jan.21, 2003.

**Author s/Reviewers**  **:** In der P.S. Gadh, Ph.D., Se nior Risk Manager

– Treatments, USDA APHIS PPQ RPM Walter P. Gould, Ph.D.7

Se nior Risk Manager

– Entomology / Acting Branch Chief

, Regulatory

Coordination and Compliance, USDA APHI S PPQ RPM Donna L. West, Senior Import Specialist, USDA APHI S PPQ RPM