### 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 & Development1



### 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 require s 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. Th e exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to anima ls in the course of a State

- licensed professional practice of veterinary medicine under a veterinarian

- client

- patient relationship. N o provision in the Act or the regulations allows a veterinary practitioner to take advantage of the licensing exemption wh ile 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. Th is rulemaking is necessary to ensure that veterinar y biologics are not prepared in unlicensed establishments through any a rrangement that is contrary to the statutory requirement prohibit ing a person, firm, or corporation from preparing, selling, bartering, exchanging, or shipping a veterinary biologic int ended 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

. T he VSTA does not have a provision allowing a veterinary practitioner to consign the prepa ration and shipment of veterinary exempt products to a third party contract laboratory/unlicensed manufacturing facility. Therefore, t h e VSTA regulations are being amended to c larify the requirements regarding the preparation of veterinary biologics by aveterinary practitioner under a veterinarian

- client

- patient relationship. The amendment to the

regulation s is simply a clarification of an existing and longstanding prohibition. 

### Potential Impact on Small Entities
The Regulatory Flexibility Act requires age ncies 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 $865,0 0 0 in 2007 for the 28,400 business es within the Veterinary Service s classification , that is, above the S BA small

- entity standard

. 4
C oncerns expressed through public comment were t hat the regulation would adversely affect how veterinary practitioners conduct day

- to

- day activities connected with their practice s , prevent veterinarians from working with commercial labs or m anufacturing facilities in preparing vaccines , and hinder the development of innovative practices. For the most part, there should be little or no effect on veterinary practitioner s as t he amendment to the regulation is simply a clarification of an existing and longstanding prohibition. V eterinary practitioner s who are in compliance with VSTA do not need to alter the way they conduct their veterinarian

- client

patient relationship s. The amendment w ill 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 20 12 [ 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 surger y 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=541940veterinary 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 w ill 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.