Analysis in Support of Certification that the Rule will not 

have a Significant Economic Impact on a Substantial 

Number of Small Entities

Proposed Rule

Amend 9 CFR 92.1 and 92.2, to modify the information 

requested from foreign regions applying for recognition of 

animal health status

Docket No. APHIS-2007-0158

U.S. Department of Agriculture

Animal and Plant Health Inspection Service

April, 2010
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Summary

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

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

factor questionnaire. However, we believe that the 11 factors are currently written in a way that 

is causing delays in the evaluation process. Additionally, the 11 factors do not specifically 

address regions that are considered to be historically free of a disease in accordance with OIE 

standards.

The proposed rule would consolidate the questionnaire into an eight-factor format, 

provide explanatory paragraphs for each factor, and make provisions for regions that are 

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 would reduce the time required for completion of the 

questionnaire, 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 

proposed rule, wholesalers and producers of animals and animal products, are largely composed 

of small entities. However, based on expected impacts, the proposed rule would not have a 

significant economic effect on a substantial number of small entities. 
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Introduction 

This analysis provides the basis, as required by the Regulatory Flexibility Act, for 

certification by the APHIS Administrator that the proposed rule, if promulgated, would 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-Import (RESI) 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. 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 would amend the 11 factors used to evaluate the animal health status of foreign 

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

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

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

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

areas of misunderstanding and help eliminate delays that APHIS and the foreign regions have 

experienced using the current 11-factor format.

The proposed rule would also provide for the recognition of regions as historically free of 

a given disease, which would be determined using a historically free status questionnaire aligned 

with World Organization for Animal Health (OIE) standards. The questionnaire would facilitate 
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the status evaluation for a region that is unable to provide surveillance information about a 

disease simply because it has been historically-free of the disease. 

Potential Impact on Small Entities

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

processing 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 

animal or animal product imports following the updating of a region’s disease status would begin 

sooner, on average, than currently. 

The RESI 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 proposed rule would reduce the amount of time that it normally 

takes to complete Phase 1 of the evaluation process. 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 requiring about an equal share of this time.1Phase 2 has averaged about 14 months, 

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

about one-fourth.

RESI receives about eight questionnaires a year from regions requesting an updating of 

disease status.2 We do not know the extent to which the proposed rule would result in more 

efficient use of APHIS resources. As an example of potential time savings per evaluation, if the 

revised questionnaire were to result in foreign regions’, on average, completing their Phase 1 

tasks using 10 percent less time than at present, the time saved would be about 0.75 month, or 

three weeks (i.e., 7.5 months--the time required by foreign regions, on average, to complete their 

Phase 1 tasks--multiplied by 0.10). Multiplying this time savings by an average of 8 

questionnaires submitted per year yields a total time savings of about 24 weeks per year for 

 

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

region.

2 Dr. Kelly Rhodes, USDA APHIS RESI, personal communication.
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completing Phase 1 tasks. We reiterate that we are unable to quantify the reduction in time that is 

expected to be achieved because of this rule, but as the above scenario suggests, program-wide 

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 

would 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 would 

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. 

Expected Costs

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

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

minimal, since the new questionnaire would be a consolidation of the 11-factor questionnaire. 

Small-Entity Effects

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

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

small governmental jurisdictions. The proposed rule supports a continuing policy to allow the 

importation of foreign animal products that pose no significant risk of introducing pests or 

diseases into the United States. This rule would amend 9 CFR 92.1 and 92.2. Its legal basis rests

on the statutes that underlie this regulation, namely, 21 U.S.C. 104.

Potentially affected entities of the proposed rule 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.

 

3 The possibility of importation would require that there were no other prohibitive sanitary restrictions in place. 
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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 time savings that would 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. 

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.

References

Census of Agriculture, 2002, http://www.nass.usda.gov/Census_of_Agriculture/index.asp

Economic Census, 2002, http://www.census.gov/econ/census02/

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