United States 

Department of 

Agriculture

Animal 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 & Development
i

Summary

APHIS received a petition to allow an irradiation facility to be established in McAllen, 

TX, to provide phytosanitary treatment of articles for importation, exportation, or interstate 

movement within the United States. In response to this petition and in anticipation of other, 

similar petitions, APHIS is providing 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 currently authorized to operate in the southern United States, represent a 

minimum standard to which future facilities will need to comply. 

The rule will benefit U.S. entities by clearly and transparently presenting the criteria that 

will 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 the 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 this rule will 

result in economic impacts on U.S. entities, large or small. The Administrator 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...................................................................................... 2
1

Introduction 

This analysis 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 

phytosanitary 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 been

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 fly host 

materials through this region unless strict measures were applied to manage the associated risks.1

Since then, APHIS has authorized 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.

APHIS received a petition to allow an irradiation facility to be established in McAllen, 

TX, to provide phytosanitary treatments for importation, exportation, or interstate movement 

within the United States. In response 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 fly host material into the United States for cold treatment at certain ports. 

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 will need to comply. Additional 

measures based on pests of concern associated with specific regulated articles and the specific 

location of a facility will supplement the generic criteria.

The final rule will benefit U.S. entities by clearly presenting the criteria that will govern 

the approval of additional irradiation facilities in the southern United States, thereby facilitating 

their establishment. Stakeholders will be aware of the requirements when planning additional 

irradiation facilities. Rulemaking specifying the criteria for approving each additional facility

will be unnecessary. 

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 this rule will 

result in economic impacts on U.S. entities, large or small. APHIS has not identified any costs 

that would result from establishing the generic criteria for irradiation facility approval described 

in the final rule.

Potential Impact on Small Entities

For the purpose of this analysis and following the Small Business Administration (SBA) 

guidelines, the entities affected by the rule will 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). 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 this 
3

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 more than 100 

persons. According to the 2007 Economic Census, there were 5,074 establishments of which 

4,463 operated the entire year. Of the 4,463 that operated the entire year, 487 had more than 100 

employees. Therefore, 89 percent of the establishments in this category employed fewer than 

100 people and are considered small by SBA standards.2

The final rule will establish criteria for the approval of irradiation facilities in the 

southern United States. We expect entities to be affected by this rule only 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 substantial number of small entities.

 

2 Retrieved from the Economic Census:

http://factfinder2.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_42SSSZ5&prod

Type=table