United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

November

2011

Final Regulatory Flexibility Analysis

Final Rule

APHIS-2008-0112

RIN 0579-AD31

Importation of Horses from Contagious 

Equine Metritis-affected Countries

Policy & Program Development

Policy Analysis & Development
i

Summary

This final regulatory flexibility analysis examines expected impacts for U.S. small 

entities of amending the regulations under which stallions and mares are imported from CEMaffected countries. Nearly all operations that raise horses are considered to be small. For an 

importer of a mare from a CEM-affected country, we expect the additional costs will range from 

$80 to $255 per mare. For an importer of a stallion from a CEM-affected country, we expect the 

additional costs will range from $620 to $830 per stallion. 

Currently, CEM testing costs vary by State and within State, averaging about $1,760 for 

mares and $5,070 for stallions. The overall impact of the additional costs for the horse industry

is not expected to be significant, given the relatively small number of horses imported from CEM 

countries (less than 2 percent of imports). The additional costs are also not large when compared 

to expected benefits in terms of reduced risk of a CEM outbreak in the United States. 
ii

Table of Contents

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

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

U.S. Horse Industry......................................................................................................... 2

Costs of Contagious Equine Metritis.............................................................................. 3

Final Regulatory Flexibility Analysis................................................................................. 4

Need for and Objectives of the Rule............................................................................... 4

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

Flexibility Analysis ........................................................................................................ 5

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

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

Potentially Affected Small Entities................................................................................. 6

Projected Reporting, Recordkeeping, and Other Compliance Requirements................. 6

Steps taken by APHIS to minimize Significant Economic Impacts on Small Entities .. 8
iii

Introduction

Contagious equine metritis (CEM) is a venereal disease of horses caused by the 

bacterium Taylorella equigenitalis. This final regulatory flexibility analysis examines impacts 

for U.S. small entities of amending the regulations under which stallions and mares may be 

imported to the United States from countries where CEM is present.

The final rule affirms several interim rule amendments for horse imports from CEMaffected countries. The amendments include (1) requiring that the official health certificate state 

that horses under 731 days of age have not been used for breeding; (2) requiring an additional 

culture site, the distal urethra, for stallions; (3) changing the testing schedule to allow 3 sets of 

samples be taken over a 12-day period (compared to the current 7 days) with no fewer than 72 

hours between tests for imported mares; (4) requiring that imported mares be complementfixation (CF) tested on arrival at a CEM facility; and (5) requiring test mares to be CF tested on 

the twenty-first day instead of the fifteenth day after breeding.

The interim rule also required that 2 sets of cultures with negative results be collected 

from stallions prior to test breeding. In this final rule, APHIS is reinstating the original 

requirement of collecting 1 set of cultures with negative results prior to test breeding. As a

second change from the interim rule, cultures from the endometrial or distal cervix will not be 

required to be included with all three sets of cultures collected from mares; rather, only the third 

set of cultures will be required to include a swab from the endometrial or distal cervix.

As background, we provide a brief overview of the horse industry in the United States, 

including imports, and a description of expected benefits of the rule in terms of reduced risk of a 

CEM outbreak. 
2

U.S. Horse Industry

The horse industry plays an important role in the U.S. economy. According to the 

Census of Agriculture, there were about 576,000 farms with 4 million horses valued at $16.3 

billion in the United States in 2007.1 These statistics are low when compared to those from a 

recent study prepared for the American Horse Council, which found that there are about 2 

million people owning 9.2 million horses, with a direct value of about $39 billion.2 In addition, 

other agricultural and non-agricultural sectors are dependent on the horse industry for their 

economic activity.

3

 

Horses also play an important role in U.S. international trade. From 2004 through 2008, 

the value of U.S. horse exports ($430 million) was much more than the combined export value of 

cattle, hogs, sheep and goats ($74 million).4 The United States imported a total of 16,714 horses 

in 2008. Of this total, 2,048 (or about 12.3 percent) were purebred breeding horses, and of these, 

only 296 (less than 2 percent of all horse imports) were from CEM-affected countries.5 Over 95 

percent of all horses imported were from Canada, Argentina, Brazil, Mexico, the Netherlands, 

Germany, Chile, Peru, Venezuela, and the United Kingdom. 

Horses are a highly valued asset, especially those with specific pedigree. The average 

per-head import value of non-pure breeding horses was $14,170 between 2004 and 2008, while 

the import value of pure breeding horses averaged $12,270. Average prices for both domestic 

and imported thoroughbreds are much higher, with some imports valued at well over $300,000. 

 

1

2007 Census of Agriculture (NASS).

2 Deloitte Consulting LLP, National Economic Impact of the U.S. Horse Industry, 2005. This study reports that 9 

percent of horse imports were for racing, 30 percent for showing, 42 percent for recreation, and 19 percent for other 

purposes (http://www.manesandtailsorganization.org/American_Horse_Council_2005_Report.pdf )

3 A public comment received from American Horse Council on May 24, 2011 (APHIS 2008-0112-0016) states that 

“the horse industry has an annual $102 billion impact on the U.S. economy and supports 1.4 million jobs.”

4 GTIS, World Trade Atlas.

5

Ibid.
3

Costs of Contagious Equine Metritis

If CEM were to become established in the United States, the horse industry would suffer 

great economic loss. Because animals may be asymptomatic and CEM is highly contagious, the 

disease is difficult to detect and control. Direct consequences of a CEM outbreak could include 

the closure of breeding operations, production losses as a result of abortions, costs of control and 

restriction of both intrastate and interstate movements, vaccination costs, and surveillance and 

laboratory testing costs. Since mares can be bred only during certain seasons, CEM can have a 

devastating effect on equine reproductive efficiency. For some breeders, an outbreak could 

mean the loss of thousands or even millions of dollars in stud fees and breeding losses. 

Thoroughbred horses are more severely affected by CEM than other breeds. 

CEM outbreaks in the United States occurred on thoroughbred farms in central Kentucky 

in March 1978, and in April of the following year in Missouri. The cost of eradicating these two 

outbreaks totaled more than $47 million in 2011 dollars.6

More recently, there have been two incidents in which current testing methods failed to 

identify imported horses infected with or exposed to T. equigenitalis: a stallion released from 

quarantine in 2004 that had not cultured positive, and a mare imported in 2008 that showed a 

positive CF test upon entering CEM quarantine. These incidents are described more fully below.

The inadvertent release of a CEM-infected horse could have a profound effect on the 

equine industry, jeopardizing the United States’ status as CEM free and negatively impacting 

exports. The benefits of this final rule are the potential costs forgone through the strengthening 

of the CEM testing and certification requirements. These amended requirements will provide 

 

6 USDA/APHIS, A letter addressed to U.S. Senator, the Honorable Alfonse M. D’Amato, June 30 1995.
4

additional safeguards against the importation of CEM-infected horses through improved 

detection of the pathogen.

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 a final regulatory flexibility

analysis that describes expected impacts of a rule on small entities. 

Need for and Objectives of the Rule

In 2007, APHIS initiated a review and assessment of the CEM program by a team of 

State, Federal, and university officials, to identify needed improvements to lessen the risk of 

release of a CEM-positive stallion or mare within the United States. The amendments included 

in this final rule reflect the findings of the 2007 CEM review. The objective of the rule is to 

amend 9 CFR part 93 concerning the entry, quarantine and testing of horses from countries that 

are affected by CEM. The authority citations for part 93 are: 7 U.S.C. 1622 and 8301–8317; 21 

U.S.C. 136 and 136a; and 31 U.S.C. 9701.As mentioned, there have been two recent incidents 

involving horses infected with or exposed to T. equigenitalis, the first of which led to the CEM 

review. In 2006, the pathogen was found in a routine breeding soundness exam of a stallion that 

had been released from CEM quarantine in 2004. During its initial CEM quarantine, the stallion 

did not culture positive. During the epidemiological investigation of the positive stallion, two 

other stallions on the premises were identified as infected. This incident jeopardized the U.S. 

status as CEM free. 

The second incident occurred in April 2008, when an imported mare showed a positive 

CF test upon arrival at CEM quarantine despite negative cultures. At the time, this test was not 
5

required for imported mares. The attending veterinarian initiated the test based on her 

knowledge of the CEM review. 

Despite APHIS requirements for pre-import CEM testing in the country of origin, APHIS 

has identified over 28 CEM-positive horses intended for importation. The regulatory changes in 

this final rule are needed promptly to lessen the risk of introduction and spread of CEM. 

Significant Issues raised by Public Comment in response to the Initial 

Regulatory Flexibility Analysis

APHIS solicited comments concerning the interim rule for 60 days ending May 25, 2011,

and then extended the comment period until September 7, 2011. APHIS received 18 comments. 

Many of the commenters raised financial concerns and questioned the necessity of the rule’s 

increase of the number of negative culture tests for stallions prior to test breeding from one to 

two. APHIS agrees with the commenters and is reinstating the requirement that only one 

negative culture needs to be collected from the stallion prior to test breeding.

A few commenters also raised concerns regarding the validity of having the endometrial or 

distal cervix of the test mares cultured on three separate occasions due to the potential of 

overgrowth and contamination. The commenters suggested that cultures from the endometrial or 

distal cervix be collected on the third set of cultures only. APHIS agrees with the commenters 

and is amending the interim rule to require that only the third set of cultures include a swab from 

the endometrial or distal cervix. 

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.
6

Potentially Affected Small Entities

The Small Business Administration (SBA) has established guidelines for determining 

firms considered to be small under the Regulatory Flexibility Act. This rule will directly affect 

U.S. importers of mares and stallions from CEM countries. These entities will face increased 

quarantine and testing costs. The final rule will also indirectly affect all U.S. owners of mares 

and stallions, by reducing the risk of a CEM outbreak. 

SBA classifies these operations (horses and other equine production, North American 

Industry Classification System code 112920) as small entities if their annual receipts are not 

more than $750,000. According to the 2007 Census of Agriculture, there were 575,942 horse 

farms with 4,028,827 horses in the United States that year, of which 133,472 farms sold 506,503 

horses that had a total value of over $2.06 billion.7 These data imply an average price per horse 

of about $4,070. For those farms that sold horses, annual revenue from horse sales averaged less 

than $15,500 per farm. Nearly all operations that raise horses are considered to be small, 

although some of the horses imported and exported are highly valued. 

Projected Reporting, Recordkeeping, and Other Compliance 

Requirements

U.S. entities that may be directly affected by the rule voluntarily engage in import 

transactions. Any reporting or other requirements will be those normally associated with the 

regular transactions involved in doing business. However, we expect the following additional 

testing and quarantine costs due to the amended CEM regulations:

Certification: Official health certification that horses under 731 days of age have not 

been used for breeding – no additional cost.

 

7 USDA/NASS, 2007 Census of Agriculture 

(http://www.agcensus.usda.gov/Publications/2007/Full_Report/Volume_1,_Chapter_1_US/st99_1_029_031.pdf)
7

Imported mares:

 Three sets of samples over a possible 12-day period (compared to the current 7 

days), with no fewer than 3 days between tests. The decision to take advantage of 

the extended testing period of five days is at the discretion of the importer. A 

potential additional cost of up to $175 per imported mare ($35 per day x 5 days).

 Samples from the distal or endometrial cervix – no additional cost.

 CF test upon arrival at the CEM facility. An additional cost of $80 per imported 

mare.

Imported stallions:

 Culture the distal urethra – no additional cost.

 One culture to be collected from the stallion prior to test breeding with negative 

results. An additional cost of $200 per imported stallion ($40 per day x 5 days 

per imported stallion).

Test mares:

 Culture test mares using the same sites and intervals as imported mares. The 

decision to take advantage of the extended testing period of three days is at the 

discretion of the importer. A potential additional cost of up to $210 ($35 per day

x 3 days per test mare x 2 test mares).

 CF test on day 21 instead of day 15. An additional cost of $420 ($35 per day x 6 

days per test mare x 2 test mares).

For an importer of a mare from a CEM-affected country, the sum of the additional costs 

will range from $80 to $255 per mare, depending upon whether the five additional testing days 

are used. For an importer of a stallion from a CEM-affected country, the sum of the additional 
8

costs will range from $620 to $830 per stallion, depending upon whether the test mares are 

sampled over the three additional days possible. 

Currently, CEM testing costs vary by State and within State, averaging about $1,760 for 

mares and $5,070 for stallions. The additional costs are also not large when compared to 

expected benefits of the rule in terms of reduced risk of a CEM outbreak in the United States. 

Approximately 2,500 horses undergo CEM testing in the United States each year.

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.