United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

July 2014

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-2011-0048

RIN 0579-AD66

Viruses, Serums, Toxins, and Analogous 

Products; Exemptions from Preparation 

Pursuant to an Unsuspended and Unrevoked 

License

Policy & Program Development

Policy Analysis & Development
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 Virus-Serum-Toxin Act (VSTA) already requires that veterinary biologics prepared 

under the veterinary practitioner exemption must be prepared at the same facility the veterinarian 

utilizes in conducting the day-to-day activities associated with his or her practice. The

exemption applies to veterinary biologics prepared by a veterinary practitioner solely for 

administration to animals in the course of a State-licensed professional practice of veterinary 

medicine under a veterinarian-client-patient relationship. No provision in the Act or the 

regulations allows a veterinary practitioner to take advantage of the licensing exemption while at 

the same time consigning the actual preparation of the product to a commercial laboratory or 

other manufacturing establishment which would then exchange or deliver the product to a third 

party. 

This rulemaking is necessary to ensure that veterinary biologics are not prepared in 

unlicensed establishments through any arrangement that is contrary to the statutory requirement 

prohibiting a person, firm, or corporation from preparing, selling, bartering, exchanging, or 

shipping a veterinary biologic intended for use in the treatment of animals unless and until such 

product shall have been prepared in compliance with the regulations in a USDA licensed 

establishment. The VSTA does not have a provision allowing a veterinary practitioner to consign 

the preparation and shipment of veterinary exempt products to a third party contract 

laboratory/unlicensed manufacturing facility. Therefore, the VSTA regulations are being 

amended to clarify the requirements regarding the preparation of veterinary biologics by a 
veterinary practitioner under a veterinarian-client-patient relationship. The amendment to the 

regulations is simply a clarification of an existing and longstanding prohibition.

Potential Impact on Small Entities

The Regulatory Flexibility Act requires agencies to consider whether a rule will “have a 

significant economic impact on a substantial number of small entities.”1 The SBA small-entity 

standard for entities involved in Veterinary Services is $750,000 or less in annual receipts

(NAICS 541940).

2,3

 According to the U.S. Census Bureau, average annual receipts was about

$865,000 in 2007 for the 28,400 businesses within the Veterinary Services classification, that is, 

above the SBA small-entity standard.

4

Concerns expressed through public comment were that the regulation would adversely 

affect how veterinary practitioners conduct day-to-day activities connected with their practices, 

prevent veterinarians from working with commercial labs or manufacturing facilities in 

preparing vaccines, and hinder the development of innovative practices. For the most part, there 

should be little or no effect on veterinary practitioners as the amendment to the regulation is 

simply a clarification of an existing and longstanding prohibition. Veterinary practitioners who 

are in compliance with VSTA do not need to alter the way they conduct their veterinarian-clientpatient relationships. The amendment will not change the nature of the exemption, the number of 

 

1

SBA-Office of Advocacy, a Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act.

Washington DC, U.S. Small Business Administration, p. 8, September 2009.

2 Table of Size Standards based on NAICS 2012 [Veterinary Services: NAICS code 541940] Washington, D.C.: 

U.S. Small Business Administration, effective October 1, 2007.

3 Veterinary Services comprises establishments of licensed veterinary practitioners primarily engaged in the practice 

of veterinary medicine, dentistry, or surgery for animals; and establishments primarily engaged in providing testing 

services for licensed veterinary practitioners.

4

Economic Census, Industry Snapshot – Veterinary Services (NAICS 541940). Economic Census, U.S. Census 

Bureau, Washington D.C, 2007. 

.http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=541940
veterinary practitioners eligible to take advantage of the exemption, or the criteria that must be 

satisfied in order to establish the existence of a veterinarian-client-patient relationship. Also, the 

amendment will not add any additional reporting or recordkeeping burden. 

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.