United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

April 2011

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 2010-0036

RIN 0579-AD27

Amend 7 CFR Part 319, Revision of 

Clementines from Spain Regulations

Policy & Program Development

Policy Analysis & Development
i

Summary

The rule will amend the regulations governing the importation of clementines from Spain 

by changing the number of clementines that are required to be sampled by APHIS inspectors 

from “200 fruit” per consignment to “a sample of clementines determined by APHIS” per 

consignment based on level of risk. This action will allow APHIS to determine a sample number 

based on the risk level of Mediterranean fruit fly without having to amend the regulations. By

permitting the number of sampled clementines per consignment to vary, APHIS will have the 

flexibility to respond to changing risk levels while continuing to provide protection against the 

introduction of quarantine pests. Under the current regulation, the percentage of sampled 

clementines ranges from 0.02 percent to 0.1 percent per consignment inspected. Even if 

inspection amounts are increased two or three times when there is a higher pest risk, the 

percentage of clementines sampled will remain negligible. 

This rule will not have a significant economic effect on producers of clementines or other 

U.S. entities, regardless of their size or resources. As described, an increase in the number of 

fruit sampled due to pest risk level changes will have a negligible effect on the number of 

clementines imported from Spain. 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.
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.

The rule will amend the regulations governing the importation of clementines from 

Spain by changing the number of clementines that are required to be sampled by inspectors of 

APHIS from “200 fruit” per consignment to “a sample of clementines determined by APHIS” 

per consignment based on level of risk. This action will allow APHIS to determine a sample 

number based on the risk level of Mediterranean fruit fly without having to amend the 

regulations. By allowing the number of sampled clementines per consignment to vary, APHIS 

will have the flexibility to respond to changing risk levels while continuing to provide protection 

against the introduction of quarantine pests. 

A consignment of clementines consists of one or more lots containing no more than a 

combined total of 200,000 boxes of clementines that are presented to an inspector for

pre-treatment inspection. Under the current regulation, the percentage of sampled clementines 

ranges from 0.02 percent to 0.1 percent per consignment inspected. Even if inspection amounts 

are increased two or three times when there is a higher pest risk, the percentage of clementines 

sampled will remain negligible. 

While this rule will help reduce the risk of pest introduction, we are unable to quantify

the economic impact of decreasing the probability of introducing Medfly into the United States. 

Medfly introductions can be very costly to producers and to the Federal and State governments. 

The mean cost of eradicating six Medfly outbreaks in 2007 was $13.54 million. 
2

Potential Impact on Small Entities

The 2007 Census of Agriculture classifies orange varieties other than Valencia oranges as 

“other orange” varieties. They include navels, tangerines, tangelos, temples, satsumas, and other 

mandarin varieties, such as clementines. In 2007, there were 9,659 “other orange” operations, 

with California and Florida growers accounting for 89 percent of all U.S. operations, and the 

grove acreages in California and Florida accounting for 98 percent of the U.S. total. The Small 

Business Administration small-entity standard for citrus (except orange) groves is $750,000 or 

less in annual receipts.1 Average annual sales per “other orange” grower are estimated to have 

been about $124,000 in 2009.2 Clearly, “other orange” growers, including producers of 

clementines, are predominantly small entities.

According to the 2007 Census of Agriculture, there were 12,017 small family citrus 

farms, including 1,453 limited resource citrus farms (table 1).3 Small family citrus farms 

comprise about 77 percent of all citrus farms. 

 

1 NAICS 111320. http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf

2 Average sales per entity is based on the number of “other orange” growers recorded in the 2007 Census of 

Agriculture, i.e., 9,659 operations, and the total value of fresh and processed non-Valencia oranges reported in the 

2009 USDA-NASS Citrus fruits 2009 Summary, i.e., $1.2 billion. 

http://usda.mannlib.cornell.edu/usda/current/CitrFrui/CitrFrui-09-24-2009.pdf

3 USDA ERS. Structure and Finances of U.S. Family Farms: Family Farm Report, 2007 edition, EIB-24

Any farm where the operator and persons related to the operator own a majority of the business is considered a 

family farm. Small family farms have annual gross sales of less than $250,000. This category of farms is further 

divided into retirement farms (operators reporting they are retired, excluding limited resource farms), residential/ 

lifestyle farms (operators reporting a major occupation other than farming, excluding limited resource farms), and 

farming-occupation farms (operators reporting farming as their major occupation). Farming-occupation farms are 

further classified as low-sales small family farms (gross sales less than $100,000, excluding limited resource farms) 

and high-sales small family farms (gross sales between $100,000 and $249,000).

Limited resource farms have (a) direct or indirect gross farm sales of not more than $100,000 and (b) a total 

household income at or below the national poverty level for a family of four, or less than 50 percent of county 

median household income. By definition, limited resource farms qualify as small family farms, but they are 

identified as a separate category in the 2007 Census of Agriculture.
3

Table 1. Number and percentage of limited resource and other small family citrus farms, 2007

Limited 

resource 

farms

Retirement 

farms

Residential/

lifestyle 

farms

Farming 

occupation/

lower sales

Farming 

occupation/

higher sales

Total small 

family 

farms

All citrus 

farms

Number of 

citrus farms 1,453 3,567 4,866 1,639 492 12,017 15,658

Percentage 

of total 

citrus farms 9% 23% 31% 10% 3% 77% 100%

Source: USDA NASS, 2007 Census of Agriculture

The proposed rule proposed to amend the regulations governing the importation of 

clementines from Spain by removing from the regulations the specific number of clementines

(200) per consignment intended for export to the United States that are required to be sampled by

APHIS inspectors. In place of this number, we proposed that the number to be sampled would 

be determined by APHIS and included in the workplan agreement between APHIS and the 

Government of Spain. This change gives APHIS the flexibility to change the sample size as risk 

conditions warrant. As noted previously, even if inspection amounts are increased two or three 

times when there is a higher pest risk, the percentage of clementines sampled will remain 

negligible.

This rule will not have a significant economic effect on producers of clementines or other 

U.S. entities, regardless of their size or resources. As described, a change in the number of fruit 

sampled due to pest risk level changes will have a negligible effect on the number of clementines 

imported from Spain. 

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.