United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service

September 2010

Regulatory Impact Analysis &

Analysis in Support of Certification that 

the Rule will not have a Significant 

Economic Impact on a Substantial Number 

of Small Entities

Proposed 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 has received a petition to allow an irradiation facility to be established in 

McAllen, TX, that would provide phytosanitary treatments. This facility, if approved, would be 

used to treat articles for importation, exportation, or interstate movement within the United 

States. In response to this petition and in anticipation of other, similar petitions, the proposed 

rule would provide generic criteria under which irradiation facilities could be established in the 

southern United States. The proposed criteria would be based on the current criteria for the three 

irradiation facilities authorized to operate in the southern United States and would represent a 

minimum standard to which future facilities would need to comply. 

Benefits and costs of the rule are examined in accordance with Executive Order 12866. 

The proposed rule would benefit U.S. entities by clearly and transparently 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 the proposed rule. 

Possible impacts on small entities are considered in accordance with the Regulatory Flexibility

Act.

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 on U.S. entities, large or small. 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.
ii

Table of Contents

Summary.............................................................................................................................. i

Overview of the Action....................................................................................................... 1

Potential Impact on Small Entities...................................................................................... 2

References........................................................................................................................... 4
1

Overview of the Action

Regulations in 7 CFR 305.31(b), 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 is 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 is based on 

recommendations set forth by Stewart (1994), who identified these States as comprising a region

favorable for the establishment of exotic fruit flies. The study recommended restricting or 

prohibiting the movement of fruit fly host materials through this region unless strict measures 

were applied to manage the associated risks. Since then, APHIS has authorized several locations 

in the southern Unites 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 has received a petition to allow an irradiation facility to be established in 

McAllen, TX, that would provide phytosanitary treatments. This facility, if approved, would be 

used to treat articles for importation, exportation, or interstate movement within the United 

States. In response to this petition and in anticipation of other, similar petitions, the proposed 

rule would provide generic criteria under which new irradiation facilities could be established in 

the southern United States. The proposed criteria would be based on the current criteria for the 

three authorized locations for irradiation facilities in the southern United States and would 

represent a minimum standard to which future facilities would need to comply. Additional 
2

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

location of a facility would supplement the generic criteria.

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. Stakeholders would be aware of the requirements when planning

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

facility would 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 the proposed 

rule would 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 proposed rule.

Potential Impact on Small Entities

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

guidelines, 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). 

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 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 
3

standards if they employ not more than 100 persons. According to the 2002 Survey of Business 

Owners, 97 percent of the establishments in this category employed fewer than 100 people and 

are considered small by SBA standards.

The proposed rule would establish criteria for the approval of irradiation facilities 

established 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 would not have a significant economic impact on a substantial number of small entities.
4

References

Census of Agriculture, 2007, 

http://www.agcensus.usda.gov/Publications/2007/Full_Report/index.asp

Economic Census, 2002, http://www.census.gov/econ/census02/

Small Business Administration. A Guide for Government Agencies How to Comply with the 

Regulatory Flexibility Act. http://www.sba.gov/advo/laws/regflex.html

Small Business Administration. Small Business Standard Match to North American Industry 

Classification System http://www.sba.gov/size/sizetable2007.html

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. February, 1994.