United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

August 2013

Regulatory Impact Analysis &

Initial Regulatory Flexibility Analysis

Proposed Rule

APHIS 2010-0082

RIN 0579- AD71

Establishing a Performance Standard for 

Authorizing the Importation and Interstate 

Movement of Fruits and Vegetables

Policy & Program Development

Policy Analysis & Development
i

Summary

Requirements for the importation of fruits and vegetables include risk mitigation 

measures such as treatments, inspections, and certifications. A fruit or vegetable is not allowed 

to be imported until APHIS has completed the rulemaking process or the notice-based process to 

approve entry of the fruit or vegetable, based on specific phytosanitary measures. The proposed 

rule would allow us to approve all new fruits and vegetables for importation into the United 

States using a notice-based process, rather than through rulemaking. As a result, we are 

proposing to remove the region- and commodity-specific phytosanitary requirements from the 

regulations and replace them with a single performance standard. A similar standard would be 

used for allowing the interstate movement of fruits and vegetables from Hawaii and the U.S. 

territories. 

The proposed rule would benefit both APHIS in its operations and U.S. businesses and 

consumers. APHIS would be able to use its resources more efficiently and the public would 

have more timely access to many of the fruits and vegetables for which importation or movement 

from Hawaii and the U.S. territories has yet to be approved.

APHIS has already established a notice-based process for allowing the importation or 

movement from Hawaii and the U.S. territories of certain fruits and vegetables, subject to one or 

more specified phytosanitary measures. For fruits and vegetables for which the risks are not 

adequately mitigated by these specified measures and thereby do not qualify under the current

notice-based process, the rulemaking process can range from 18 months to over 3 years. Under 

the notice-based process, this time would range from 6 to 12 months.
ii

Consumers and businesses would benefit from the more timely access to fruits and 

vegetables for which entry or movement would currently require rulemaking. However, certain 

businesses would face increased competition for the subject fruits and vegetables sooner due to 

their more timely approval. APHIS has not identified other costs that may be incurred because 

of the proposed rule. The rule would not alter the manner in which the risks associated with a 

fruit or vegetable import or interstate movement request are evaluated and mitigated.

To illustrate potential benefits of more timely access to U.S. markets, we reviewed fruit 

and vegetable import rules since 2010 for which import values were estimated. For imports that 

do not already qualify for notice-based approval, the time savings afforded by the proposed rule 

may range from 6 months to 21⁄2 years (6 to 12 months under the proposed notice-based approval 

process versus 18 months to 3 years under current rulemaking). The estimated annual import 

value of the selected commodities is about $46 million. Based on this estimate, the value of 

more timely access of 6 months to 2 1⁄2 years for these commodities would be between $23 

million and $115 million. 

Similar benefits would result from more timely approval for the movement of fruits and 

vegetables from Hawaii and U.S. territories. The proposed rule also is expected to result in more 

efficient use of APHIS resources.

Principal industries that could be affected by the proposed rule, fruit and vegetable farms 

and fruit and vegetable importers, are largely composed of small entities. We welcome comment 

on anticipated impacts for businesses of the proposed rule. 
iii

Table of Contents

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

Introduction......................................................................................................................... 1

Expected Benefits and Costs of the Rule............................................................................ 2

Alternatives to the Proposed Rule....................................................................................... 5

Initial Regulatory Flexibility Analysis................................................................................ 5

Reasons Action is Being Considered.............................................................................. 5

Objectives of and Legal Basis for the Rule .................................................................... 6

Potentially Affected Small Entities................................................................................. 7

Projected Reporting, Recordkeeping, and Other Compliance Requirements................. 8

Duplication, Overlap, or Conflict with Existing Rules and Regulations........................ 8

Alternatives to minimize Significant Economic Impacts of the Rule............................. 8

References......................................................................................................................... 10
1

Introduction

Requirements for the importation of fruits and vegetables (7 CFR 319.56 to 319.56-68) 

include pest risk mitigation measures such as treatments, inspections, and certifications. These 

mitigation measures are specific for each fruit and vegetable that is allowed entry into the United 

States. A fruit or vegetable is not allowed to be imported until APHIS has completed the 

rulemaking process or the notice-based process to approve entry of the fruit or vegetable, based 

on specific phytosanitary measures.

The proposed rule would remove the region- and commodity-specific phytosanitary

requirements from the regulations and replace them with a single performance standard.1 APHIS 

would issue commodity-specific permits for the importation of fruits and vegetables only after 

analyzing the pest risk and making a determination that the risk posed by the quarantine pest can 

be mitigated by the application of one or more phytosanitary measures. APHIS is proposing a 

similar performance standard for approving the interstate movement of fruits and vegetables 

from Hawaii and the U.S. territories. 

APHIS would maintain a list of all approved fruits and vegetables and their respective 

import requirements on its Web site. For fruits and vegetables from Hawaii and the U.S. 

territories, the list of all approved fruits and vegetables and their requirements would be 

maintained in the relevant online manual.

This document provides a benefit-cost analysis, as required by Executive Orders 12866 

and 13563, which direct agencies to assess all costs and benefits of available regulatory

 

1

Performance standard: “No fruit or vegetable is authorized importation into the United States unless the 

Administrator has determined that the risk posed by each quarantine pest associated with the fruit or vegetable can 

be mitigated by the application of one or more phytosanitary measures designated by the Administrator and the fruit 

or vegetable is imported into the United States in accordance with, and as stipulated in, the permit issued by the 

Administrator.”
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alternatives and, if regulation is necessary, to select regulatory approaches that maximize net 

benefits (including potential economic, environmental, public health and safety effects, and 

equity). Executive Order 13563 emphasizes the importance of quantifying both costs and 

benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This document 

also examines the potential economic effects of the rule on small entities, as required by the 

Regulatory Flexibility Act.

Expected Benefits and Costs of the Rule

APHIS has identified benefits of the proposed rule with respect to its own operations and 

for U.S. businesses and consumers. The proposed rule would allow for more efficient use of 

APHIS resources, and the public would have more timely access to fruits and vegetables yet to 

be approved for importation or movement from Hawaii and the U.S. territories.

APHIS has already established a notice-based process for the importation or movement 

from Hawaii and the U.S. territories of fruits and vegetables, subject to one or more specified 

phytosanitary measures. For those fruits and vegetables for which the pest risks would not be 

adequately mitigated by the specified measures, rulemaking is required. The proposed rule 

would remove the region- and commodity-specific requirements from the regulations, replacing 

them with the single performance standard. The commodity-specific risk mitigation 

requirements would be listed on the permit issued for importation or movement of the particular 

fruit or vegetable.

The current rulemaking process for importation or interstate movement from Hawaii and 

the U.S. territories of new fruits and vegetables for which the notice-based process is not 

applicable can take from 18 months to upward of 3 years to complete the administrative 

rulemaking process. The proposed rule would reduce the administrative rulemaking process 
3

needed for approval of these fruits and vegetables while maintaining the science-based process,

without eliminating the opportunity for public participation in providing comments. Under the 

new process, the time for approval would range from 6 to 12 months. Consumers and businesses 

would benefit from the more timely access to fruits and vegetables for which importation or 

movement from Hawaii and the U.S territories currently requires rulemaking. Certain private 

sector entities may potentially face increased competition sooner than they would under approval 

through rulemaking. 

To illustrate potential benefits of more timely access to U.S. markets, we reviewed fruit 

and vegetable import rules since 2010 for which import values were estimated (table 1). For 

imports that do not already qualify for notice-based approval, the time savings afforded by the 

proposed rule may range from 6 months to 21⁄2 years (6 to 12 months under the proposed noticebased approval process versus 18 months to 3 years under current rulemaking). The estimated 

annual import value of the selected commodities is about $46 million. Based on this estimate, 

the value of more timely access of 6 months to 2 1⁄2 years for these commodities would be 

between $23 million and $115 million.
4

Table 1: Expected annual value of certain fruit and vegetable imports for which import rules are 

being prepared or have been published since 2010 

Commodity Country of Origin Estimated Annual Value

($ Million)

Litchis Australia, Vietnam 3.31

Longan Vietnam 6.61

Jackfruit Malaysia 5.12

Starfruit Malaysia 10.47

Pineapple Malaysia 10.25

Bananas Philippines 2.40

Apricot Spain 0.80

Beans Jordan 1.43

Blueberries Morocco 0.90

Avocados Spain 0.61

Unshu Oranges Japan 1.05

Papaya Peru 0.03

Mango Jamaica, Australia 3.45

Total 46.00

We expect impacts on U.S. consumers and businesses because of more the timely

approval of movement from Hawaii and the U.S. territories of fruits and vegetables would be of 

a similar nature. U.S. agricultural and natural resource interests, in general, would benefit from 

APHIS’ improved capacity to respond quickly to pest risk changes that necessitate altering 

permit requirements. Importers and the public would also benefit from having all import 

requirements removed from the regulations and included in the fruits and vegetables import 

requirement (FAVIR) database, which is readily accessible via the PPQ Web site, and the APHIS 

Fresh Fruits and Vegetables Import Manual.

APHIS has not identified costs that would be incurred because of the proposed rule, other 

than the possible increased level of competition for affected businesses occurring sooner than 

otherwise. The rule would not change the manner in which the risks associated with a 

commodity import or interstate movement request are evaluated and mitigated. Commodities 

approved for import or movement from Hawaii or the U.S. territories prior to this rule would 

continue to be allowed importation or movement under the same requirements.
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Alternatives to the Proposed Rule

One alternative to the proposed rule would be to leave the regulations regarding imports 

and interstate movement of fruits and vegetables unchanged. In doing so, the expected benefits 

would not be realized. Import and movement requests for fruits and vegetables that do not 

qualify for the existing notice-based process would require rulemaking, a much more lengthy

regulatory process. The usefulness of the FAVIR database and online manuals to importers and 

the general public would not be fully exploited, as commodity-specific importation and interstate 

movement requirements would remain in the regulations.

The proposed rule would improve the use of APHIS resources and enable the Agency to 

be more flexible and responsive relative to evolving pest situations in the United States and 

exporting regions, as well as provide for more timely access to many of the fruits and vegetables 

not yet allowed to be imported or moved from Hawaii and the U.S. territories.

Initial 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. This initial regulatory flexibility analysis describes expected impacts of this 

proposed rule on small entities, as required by section 603 of the Act.

Reasons Action is Being Considered

We are proposing to amend our regulations governing the importations of fruits and 

vegetables by broadening our existing performance standard to provide for approval of all new 

fruits and vegetables for importation into the United States using a notice-based process. We are 

also proposing to remove the region- or commodity-specific phytosanitary requirements 

currently found in these regulations. Likewise, we are proposing an equivalent revision of the 
6

performance standard in our regulations governing the interstate movements of fruits and 

vegetables from Hawaii and the U.S. territories and the removal of commodity-specific 

phytosanitary requirements from those regulations. 

This proposal would allow for the approval of requests to authorize the importation or 

interstate movement of new fruits and vegetables in a manner that enables a more flexible and 

responsive regulatory approach to evolving pest situations in both the United States and 

exporting countries. It would not however, alter the science-based process in which the risk 

associated with importation or interstate movement of a given fruit or vegetable is evaluated or 

the manner in which risks associated with the importation or interstate movement of a fruit or 

vegetable are mitigated.

Objectives of and Legal Basis for the Rule

In August 2007, APHIS established a notice-based process for approving the importation 

of certain fruits or vegetables. Under this process, approval rests on a determination that the fruit 

or vegetable can be safely imported subject to one or more designated phytosanitary measures. 

Amendments to the regulations are not needed, as approval is accomplished via the publication 

of notices in the Federal Register. APHIS established a similar notice-based process for 

approval of interstate movement of fruits or vegetables from Hawaii and U.S. territories in 

January 2009.

The 2007 and 2009 rules streamlined the authorization process for those fruits or 

vegetables whose phytosanitary requirements consisted of measures used frequently. The noticebased process established by those rules is as transparent and accessible to our stakeholders and 

other interested parties as the rulemaking process, while providing APHIS with the ability to 
7

make more responsive decisions on import issues and by reducing the time involved in 

approving the commodity for importation or interstate movement.

Our objective, by expanding the use of the notice-based process to all decisions related to 

the importation and interstate movement of new fruits and vegetables and removing the 

remaining region- or commodity-specific phytosanitary requirements currently found in the 

regulations, is to reduce APHIS’ administrative burden while carrying out the same rigorous risk 

analysis process we use to support decisions made via rulemaking.

Under the Plant Protection Act, the Secretary of Agriculture is authorized to regulate the 

importation of plants, plant products, and other articles to prevent the introduction of plant pests 

into the United States or the dissemination of plant pests within the United States. 

Potentially Affected Small Entities

We expect that most of the entities potentially affected by the proposed rule are small. 

Many of them can be classified within the following industries, categorized according to the 

North American Industry Classification System: Vegetable and Melon Farming (NAICS 1112), 

Fruit and Tree Nut Farming (NAICS 1113), Post Harvest Crop Activities (except cotton ginning) 

(NAICS 115114), and Fresh Fruit and Vegetable Merchant Wholesalers (NAICS 424480).

Establishments classified within Vegetable and Melon Farming are considered small 

according to the Small Business Administration (SBA) standard if they have annual receipts that 

do not exceed $750,000.2In 2007, the Census of Agriculture reports there were 40,589 farms in 

this category and 36,752 (91 percent) had annual receipts of $500,000 or less, which is well 

below the small-entity threshold. According to the 2007 Census of Agriculture, there were 

98,281 farms in the Fruit and Tree Nut Farming category, of which 92,348 (94 percent) had 

 

2

2007 Census of Agriculture, Table 62: Summary by North American Industry Classification System.
8

annual receipts of $500,000 or less, also well below the same SBA small-entity standard of 

$750,000.

Establishments classified within Post Harvest Crop Activities (except cotton ginning) are 

considered small by the SBA standard if annual sales are not more than $7 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.

The SBA small-entity standard for establishments classified within Fresh Fruit and 

Vegetable Merchant Wholesalers is not more than 100 employees. According to the 2007

Survey of Business Owners, 97 percent of the establishments in this category employed fewer 

than 100 people.

Projected Reporting, Recordkeeping, and Other Compliance 

Requirements

This proposed rule contains no new information collection or recordkeeping requirements 

under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Duplication, Overlap, or Conflict with Existing Rules and Regulations

APHIS has not identified any duplication, overlap, or conflict of the proposed rule with 

other Federal rules.

Alternatives to minimize Significant Economic Impacts of the Rule

The proposed rule would enable APHIS to take a more flexible and responsive regulatory

approach to requests to authorize the importation or interstate movement of new fruits and 

vegetables. We expect the overall impact for effected entities to be positive. In some instances, 

entities may bear some level of additional business competition sooner than they would under 

normal rulemaking, due to the approval of imports and the interstate movement of products from 

Hawaii or U.S. territories occurring more quickly. We do not expect these potential effects to be 
9

significant and therefore have not identified alternatives to minimize them. We expect entities to 

generally benefit from the proposed streamlined process. We welcome comment on anticipated 

impacts for businesses of the proposed rule. 
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References

Census of Agriculture, 2007, 

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

Economic Census, 2007, http://www.census.gov/econ/census07/

U.S. Small Business Administration. U.S. Small Business Administration: Table of Small 

Business Size Standards Match to North American Industry Classification System 

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