### United States

Department of Agriculture Anim al and Plant Health Inspection Service January 2012 Analysis in Support of Certification that the

Rule will not have a Significant Economic Impact on a Substantial Number of Small Entities
Final Rule APHIS - 2009 - 0100 RIN 0579 -AD35 Amendment of Irradiation Treatments for Fruit Flies and Other Pests of Concern in Southern United States

Policy & Program Development Policy Analysis & Developmenti



### Summary
APHI S received a petition to allow an irradiation facility to be established in McAllen, TX, to provide ph yt osanitary treatment of articles for importation, exportation, or interstate movement within the United States. In response to this petition and in antici pation of other, similar petitions, APHI S is provid ing generic criteria for the establishment of irradiation facilities in the southern United States. The criteria , based on criteria for three locations where irradiation facilities are currentl y authorized to operate in the southern United States , represent a minimum standard to which future facilities w ill need to compl y. The rule w ill benefit U.S. entities by clearl y and transparentl y presenting the criteria that will govern the approval of a dditional irradiation facilities in the southern United States, thereb y facilitating their establishment. APHI S has not identified any costs associated with establishing the generic criteria for irradiation facility approval described in the rule. Be yo nd 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 this rule will result in economic impacts on U.S. entities, large or small. T he Admini strator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.ii

Table of Contents Summary ................................ ................................ ................................ .............................. i Introduction

................................ ................................ ................................ ......................... 1 Potential Impact on Small Entities

................................ ................................ ...................... 21



### Introduction This analy sis provides the basis, as required by the Regulatory

Flexibility Act, for certification by

the APHIS Administrator that the rule will not have a significant economic impact on a substantial number of small entities. Regulations in 7 CFR part 305 allow irradiation facilities for the application of phy tosanitary treatments to be located in any State except Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Tennessee, Texas, and Virginia. The purpose of this geographical restriction has bee n to safeguard against the possibility that fruit flies could escape from regulated articles prior to treatment and become established in the United States. The restriction was based on identification of these States as comprising a region favorable for the establishment of exotic fruit flies. Stewart (1994) recommended restricting or prohibiting the movement of fruit fl y host materials through this region unless strict measures were applied to manage the associated risks. 1 Since then, APHI S has authorize d several locations in the southern United States to have cold treatment facilities and three locations to have irradiation facilities

–the maritime ports in Gulfport, MS, and Wilmington, NC, and the airport in Atlanta, GA

– although no irradiation facilities have been established in these locations. APHI S received a petition to allow an irradiation facility to be established in McAllen, TX, to provide ph yt osanitary treatments for importation, exportation, or interstate movement within the United States. In r esponse to this petition , this rule will provide generic criteria under

1 Stewart, R.D. 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 por ts. USDA

- APHIS

- PPQ

- BATS. pp. 16.2

which new irradiation facilities can be established in the southern United States. The criteria , based on criteria for the three authorized locations for irradiation facilities in the southern United States , represent a minimum standard to which future facilities w ill need to comply

. Additional measures based on pests of concern associated with specific regulated articles and the specific location of a facility

w ill supplement the generic criteria. The final rule will benefit U.S. entities by clearl y presenting the criteria that w ill govern the approval of additional irradiation facilities in the southern United States, thereby facilitating their establishment. Stakeholders w ill b e aware of the requirements when planning additional irradiation facilities. Rulemaking specifying the criteria for approvin g ea ch additional facility will be unnecessary

. Be yond helping to make the approval of future irradiation facilities in the south ern United States an efficient process, we do not anticipate that the criteria set forth in this rule w ill result in economic impacts on U.S. entities, large or small. APHI S has not identified any costs that would result from establishing the generic crit eria for irradiation facility approval described in the final rule. 

### Potential Impact on Small Entities For the purpose of this analy sis and following the Small Business Administration (SBA) guidelines, the entities affected b y the rule will be the eventual clients of irradiation facilities established in the southern United States. They can be largel y cl assified within the following two industries: Post Harvest Crop Activities (except cotton ginning) (NAI CS 115114), and Fresh Fruit and Vegetable Merchant Wholesalers (NAICS 424480). Establishments classified within Post Harvest Crop Activities (except cotton ginning) are considered small by SBA standards if annual sales are not more than $7.0 million. The percentage of establishments that meet this3

standard is not known; neither the Census of Agriculture nor the Economic Census reports revenue for these establishments. Establishments classified within Fresh Fruit and Vegetable Merchant Wholesalers are considered small by SBA standards if they

employ not mo re than 100 persons. According to the 200 7 Economic Census, there were 5,074 establishments of which 4,463 operated the entire year. Of the 4,463 that operated the entire ye ar , 487 had more than 100 employees. Therefore, 89 percent of the establishments in this category employed fewer than 100 people and are considered small b y SBA standards. 2 The final rule will establish criteria for the app roval of irradiation facilities in the southern United States. We expect entities to be affected b y this rule on ly to the extent that it helps to make the approval process more efficient. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a sub stantial number of small entities.

2 Retrieved f

r om the Economic Census: http://factfinder2.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_42SSSZ5&prod Ty pe=table