### United States

Department of Agriculture Animal and Plant Health Inspection Service Septem ber 2010 Regulatory Impact Analysis &

Analysis in Support of Certification that the Rule will not have a Significant Economic Impact on a Subst antial 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 & Developmenti



### Sum mary APHI S has received a petition to allow an irradiation facility to be established in McAllen, TX , that would provide phy tosanitary 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 propo sed criteria would be based on the current criteria for the three irradiation facilities authorized to operat e in the southern United States and would represent a minimum standard to which future facilities would need to compl y. Benefits and costs of th e rule are examined in accordance with Executive Order 12866. The proposed rule would benefit U.S. entities by clearl y and transparently presenting the criteria that would govern the approval of additional 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 prop osed rule. Possible impacts on small entities are considered in acc ordance with the Regulatory Flexibility Act.
Be yond helping to make the approval o f future irradiation facilities in the southern United States an efficient process , w e do not anticipate that the criteria set forth in the proposed rule would result in eco nomic impact s 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 entitie s .ii

Table of Contents Summary

................................ ................................ ................................ .............................. i Overview of the Action

................................ ................................ ................................ ....... 1 Potential Impact on S mall Entities

................................ ................................ ...................... 2 References

................................ ................................ ................................ ........................... 41



### Overview of the Action Regulations in 7 CFR 305.31(b), allow irradiation facilities for the application of phy tosanitary treatments to be located in any S tate 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 safe guard 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, APHI S 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. APHI S has received a petition to allow an irradiation facility to be established in McAllen, TX , that would provide phy tosanitary 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 facil ities 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 whi ch future facilities would need to comply

. Additional2

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. entiti es by clearl y presenting the criteria that would govern the approval of additional irradiation facilities in the southern United States, thereb y facilitating their establishment. Stakeholders would be aware of the requirements when planning additional irradiation facilities

. R ulemaking specifyingthe criteria for approving each additional facility would be unnecessary

. Be yond helping to make the approval of future irradiation facilities in the southern United States an efficient process, we do not antic ipate that the criteria set forth in the proposed rule would 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 criteria for irradiation facility approval describ ed 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 irradiati on facilities established in the southern United States. They can be largel y classified within the following two industries: Post Harvest Crop Activities (except cotton ginning) (NAICS 115114), and Fresh Fruit and Vegetable Merchant Wholesalers (NAI CS 424 480). Establishments classified within Post Harvest Crop Activities (except cotton ginning) are considered small b y 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 SBA3

standards if they

employ not more than 100 persons. A ccording to the 2002 Survey of Business Owners, 97 percent of the establishments in this category employed fewer than 100 people and are considered small b y SBA standards. The proposed rule would establish criteria for the approval of irradiation facilitie s established in the southern United States. We expect entities to be affected by this rule onl y 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 Governmen t 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 Classi fication 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 U nited States for Cold Treatment at Certain Ports
. USDA APHI S PPQ BATS. February , 1994.