United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

September 

2011

Final Regulatory Flexibility Analysis

Final Rule

APHIS-2010-113

RIN 0579-AD40

Importation of pitaya fruit from Belize, Costa 

Rica, El Salvador, Guatemala, Honduras, 

Nicaragua, and Panama into the continental 

United States

Policy & Program Development

Policy Analysis & Development
i

Summary

This rule will allow the importation of fresh pitaya fruit into the continental United States 

from the Central American countries of Belize, Costa Rica, El Salvador, Guatemala, Honduras, 

Nicaragua, and Panama, using one or more of the designated phytosanitary measures listed in 7 

CFR 319.56-4(b). Entities potentially affected by the rule are U.S. pitaya fruit growers, of which 

most, if not all, are small entities.

Pitaya fruit is produced in Hawaii, California, and Florida, but the quantities produced, 

numbers of U.S. producers, quantities imported, and other factors needed to assess likely

economic effects of this rule are not known. The quantity of pitaya fruit expected to be imported 

from Belize, Costa Rica, El Salvador, Guatemala, Honduras, and Panama is also unknown. 

Nicaragua estimates exporting 1,200 metric tons (60 forty-foot containers) of pitaya fruit to the 

continental U.S. annually, and it is thought that the other countries may ship similar or less 

amounts.

Lack of information about the quantity of pitaya fruit that will be imported from this 

group of countries, and about the quantities produced and already imported by the United States, 

prevents a clear understanding of what the economic effects of the final rule may be.
ii

Table of Contents

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

Introduction......................................................................................................................... 3

Final Regulatory Flexibility Analysis................................................................................. 3

Need for and Objectives of the Rule............................................................................... 3

Significant Issues raised by Public Comment in response to the Initial Regulatory

Flexibility Analysis ........................................................................................................ 2

Significant Issues raised by the Small Business Administration in response to the 

Initial Regulatory Flexibility Analysis........................................................................... 2

Potentially Affected Small Entities................................................................................. 2

Projected Reporting, Recordkeeping, and Other Compliance Requirements................. 3

Steps taken by APHIS to minimize Significant Economic Impacts on Small Entities .. 4
iii

Introduction

APHIS received requests from the national plant protection organizations of Belize, 

Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama to export pitaya fruit to 

the continental United States. Pitaya fruit (also commonly referred to as pitahaya or dragon 

fruit) is a form of cacti fruit native to Central America. The popularity of pitaya fruit in the 

United States has been steadily rising due to increased interest in exotic fruits and their health 

benefits. Health benefits of pitaya fruit include lowering blood glucose levels in type 2 diabetes, 

high antioxidant amounts, high vitamin C levels, and dietary fiber.1

Final Regulatory Flexibility Analysis

The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their 

proposed and final rules on small businesses, small organizations and small governmental 

jurisdictions. Section 604 of the Act requires agencies to prepare and make available for public 

comment a final regulatory flexibility analysis that describes expected impacts of a rule on small 

entities. 

Need for and Objectives of the Rule

The rule is in response to requests made by Belize, Costa Rica, El Salvador, Guatemala, 

Honduras, Nicaragua, and Panama for APHIS to amend the regulations to allow fresh pitaya fruit 

from these countries to be imported into the continental United States.

The objective of the rule is to allow fresh pitaya fruit to be imported into the continental 

United States from Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and 

 

1

http://dragonfruitpitaya.com/
2

Panama. APHIS has determined that fresh pitaya fruit can be safely imported from these

countries under certain conditions. The legal basis for this action is the Plant Protection Act (7 

U.S.C. 7701-7772), which authorizes the Secretary of Agriculture to prohibit or restrict the 

importation of any plant product if the Secretary determines that the prohibition or restriction is 

necessary to prevent the introduction of a plant pest or noxious weed into the United States. The 

rule is part of a continuing program to allow the importation of foreign agricultural products that 

APHIS has determined are without significant risk of introducing pests or diseases into the 

United States.

Significant Issues raised by Public Comment in response to the Initial 

Regulatory Flexibility Analysis

No significant issues were raised by public comment in response to the Initial Regulatory

Flexibility Analysis.

Significant Issues raised by the Small Business Administration in 

response to the Initial Regulatory Flexibility Analysis

No significant issues were raised by the Small Business Administration in response to the 

Initial Regulatory Flexibility Analysis.

Potentially Affected Small Entities

Farms producing pitaya fruit are classified within the North American Industry

Classification System under Other Noncitrus Fruit Farming (NAICS 111339). For this industry

classification, a business is considered to be a small entity if its annual receipts are not more than 

$750,000.2 The average 2007 market value of crops sold by farms classified within Fruit and 

 

2 U.S. Small Business Administration, Table of Small Business Size Standards. 

http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf
3

Tree Nut Farming (which includes Other Noncitrus Fruit Farming) was less than $188,000.3 We 

infer that the majority of farms producing pitaya fruit are small entities. 

APHIS has been unsuccessful in acquiring information on the U.S. market for pitaya 

fruit. At this point, we do not know the quantity of pitaya fruit domestically produced, numbers 

of U.S. producers, the quantity imported, or other factors needed to assess likely economic 

effects of this rule. Pitaya fruit is produced in Hawaii, California, and Florida. Hawaii’s pitaya 

production is mainly consumed within that State. 

The quantity of pitaya fruit that is expected to be imported from Belize, Costa Rica, El 

Salvador, Guatemala, Honduras, and Panama is unknown. Nicaragua estimates exporting 1,200 

metric tons (60 forty-foot containers) of pitaya fruit to the continental U.S. annually. The other 

countries may ship similar or less amounts.4 Lack of information about the quantity of pitaya 

fruit that will be imported from this group of countries, and about the quantities produced and 

already imported by the United States, prevents a clear understanding of what the economic 

effects of the final rule may be.

Projected Reporting, Recordkeeping, and Other Compliance 

Requirements

Reporting and recordkeeping requirements associated with the final rule are discussed in 

the rule under the heading "Paperwork Reduction Act."

 

3

2007 Census of Agriculture, Table 62. Selected Characteristics of Farms by North American Industry 

Classification System: 2007, http://www.agcensus.usda.gov/Publications/2007/Full_Report/usv1.pdf

4 USDA-APHIS-PPQ Importation of Fresh Pitaya Fruit, Hylocereus spp. and several other genera and species, from 

Central America into the Continental United States: A Multi-Genus, Regional, Pathway-Initiated Pest Risk 

Assessment
4

Steps taken by APHIS to minimize Significant Economic Impacts on 

Small Entities

Based on our review of available information, APHIS does not expect the rule to have a 

significant economic impact on small entities. In the absence of significant economic impacts, 

we have not identified alternatives that would minimize such impacts.