United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

March 2012

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-2007-0158

RIN 0579-AD30

Amend 9 CFR 92.1 and 92.2, to modify the 

information requested from foreign regions 

applying for recognition of animal health 

status

Policy & Program Development

Policy Analysis & Development
i

Summary

Foreign regions requesting an update of their animal disease status, as recognized by the 

United States, do so by undergoing an evaluation process that includes completing an 11-factor 

questionnaire. However, the content and format of the questionnaire may be causing delays in 

the evaluation process. Additionally, the 11 factors do not specifically address regions that may 

be considered historically free of a disease in accordance with OIE standards. This rule will 

consolidate the questionnaire into an eight-factor format, provide explanatory paragraphs for 

each factor, and make provisions for regions that may be considered historically free of a 

disease.

APHIS’ evaluation process consists of two phases, including a site visit. The foreign 

region requesting the change in disease status is required to complete the questionnaire in Phase 

1. We expect that the new format will reduce the time required for completion of the 

questionnaire and result in submission of more complete information, resulting in more efficient 

processing by APHIS of requests for updating of disease status. The time savings could have 

minor effects for U.S. businesses and consumers; subsequent animal or animal product imports 

allowed because of the updating of a region’s disease status could begin sooner, all things equal. 

Industries that could be affected by the final rule, wholesalers and producers of animals and 

animal products, are largely composed of small entities. However, based on expected impacts, 

the final rule will not have a significant economic effect on a substantial number of small 

entities. 
ii

Table of Contents

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

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

Potential Impacts................................................................................................................. 2

References........................................................................................................................... 5
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.

Foreign regions wishing to have their animal health status reviewed and updated 

normally provide the Animal and Plant Health Inspection Service (APHIS) with the requested 

information in the 11-factor format outlined in 9 CFR 92.2(b). Veterinary Services’ (VS) 

Regionalization Evaluation Services (RES) staff then initiates an evaluation of the status of the 

particular disease in the requesting region. However, there are often delays in the evaluation 

process due to gaps in the information submitted, which require additional time and resources to 

address. We believe that part of the reason for such insufficient information is that, in some 

cases, the 11 factors are not clear as to the information that is required.

This rule will amend the 11 factors used to evaluate the animal health status of foreign 

regions. The 11 factors will be consolidated to 8, thereby eliminating redundancies and 

improving the logical flow of the questionnaire. The more streamlined format will begin with a

narrative that describes APHIS’ evaluation process and the informational requirements, and will 

include explanatory descriptions under each factor. These changes are intended to remove areas 

of misunderstanding and help eliminate delays due to submission of insufficient information. 

The final rule will provide for the recognition of regions as historically free of a given 

disease, which will be determined using a historically free status questionnaire aligned with 

World Organization for Animal Health (OIE) standards. The questionnaire will facilitate the 

status evaluation for a region that does not conduct active surveillance for a disease simply 

because it has historically been free of the disease. 
2

Potential Impacts

APHIS has identified two potential benefits related to the expected reduction in the time 

required to process requests by foreign regions for updates of disease status: (i) more efficient 

use of APHIS resources, and (ii) the possibility of gains to U.S. businesses and consumers 

because importation of animals or animal products following the updating of a region’s disease 

status will begin sooner, on average, than currently.

APHIS will bear costs of developing the eight-factor questionnaire and training staff, if 

necessary, to evaluate the requesting regions under the new format. These costs will be minimal, 

since the new questionnaire will be a consolidation of the 11-factor questionnaire. 

The RES evaluation process has two phases, with their length of time dependent on the 

activities of both APHIS and the foreign region. During Phase 1, information is gathered using 

the 11-factor format and logistical arrangements are made for an in-country site visit. Phase 2 

spans the site visit and preliminary steps of rulemaking, including preparation of the risk analysis 

and the regulatory workplan. 

APHIS expects that the final rule will reduce the amount of time that it normally takes to 

complete Phase 1 of the evaluation process. Specifically, the final rule and new questionnaires 

will promote more complete initial information submissions and thereby reduce the time required 

for APHIS and the foreign region to address information gaps. A review of timelines for past 

evaluations found that Phase 1 has averaged about 15 months, with APHIS tasks and those of the 

foreign region each taking about an equal share of this time.1 Phase 2 has averaged about 14 

 

1 The maximum time spent in this phase was about 19 months by APHIS and nearly 28 months by the foreign 

region.
3

months, with APHIS tasks consuming about three-fourths of this time and the foreign region’s 

tasks, about one-fourth.

RES receives about four questionnaires a year from regions requesting an updating of 

disease status.2

 As an example of potential time savings per evaluation, if the revised 

questionnaire were to result in a 10 percent reduction of Phase I time compared to present, the 

time saved would be about 0.75 month, or three weeks, based on a Phase 1 average time 

requirement for foreign regions of 7.5 months. Multiplying this time savings by an average of 8 

questionnaires per year yields a total savings of about 24 weeks per year for completing Phase 1 

tasks. As this scenario suggests, the aggregate time savings from more rapid completion of the 

evaluation process could be sizable. 

Net benefits of the rule for the private sector are not as readily apparent. Using this same 

hypothetical example, a region would be able to begin to export the product of concern to the 

United States three weeks earlier than at present, all things equal.3 U.S. businesses and 

consumers could be affected by this earlier initial entry date, but we expect any such impacts will

be minor. For U.S. welfare as a whole, whatever benefits might accrue to consumers from a 

three-week earlier increased supply of the imported product and possible decline in price will be 

realized at the expense of domestic producers of the same commodity over the three-week 

period, in terms of the price decline and increased foreign competition.

In accordance with the Regulatory Flexibility Act of 1980 (Public Law 96-354), we

consider the expected impact of the final rule on small businesses, small organizations, and small 

governmental jurisdictions. The final rule supports a continuing policy to allow the importation

 

2 Personal Communication with Dr. Kelly Rhodes, USDA APHIS RES.

3 Importation will require that there were no other prohibitive sanitary restrictions in place. 
4

of foreign animal products that pose no significant risk of introducing pests or diseases into the 

United States. This rule will amend 9 CFR 92.1 and 92.2. 

Potentially affected entities are importers and producers of animals and animal products. 

The majority of such enterprises are small entities as defined by the Small Business 

Administration. For most categories of wholesale trade, the small-entity standard is not more 

than 100 employees. For most categories of animal production, the small-entity standard is not 

more than $750, 000 in annual receipts.

Most businesses that could be affected by this rule are small, but we expect the effects to 

be insignificant. Although we do not know the actual time savings that will be achieved, for a 

foreign region to be able to export a particular animal or animal product to the United States a 

few weeks –or even months–sooner than generally has been the case under the existing 

regulations is not expected to have a significant effect on U.S. businesses, either positively or 

negatively. The APHIS Administrator has determined that this action will not have a significant 

economic impact on a substantial number of small entities.
5

References

Census of Agriculture, 2007, http://www.nass.usda.gov/Census_of_Agriculture/index.asp

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

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/sizetable2002.html