### United States

Department of Agriculture Animal and Plant Health Inspection Service August 201 4 **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**  **- 2013**  **- 0034**  **RIN 0579 -**  **AD86 Viruses, Toxins, and Analogous Products;**  **Standard Requirements; Addition of Terminology to define test results** 

Policy & Program Development Policy Analysis & Developmenti



### Summary APHI S administers and enforces the Virus - Serum - Toxin Act , under which a veterinary biological product must be shown to be pure, safe, potent, and efficacious before a veterinary biological product license may be issued. APHIS is amend ing the regul ations in order to better define the terminology

used when reporting the results of tests performed on veterinary biological products, thereby bringing the regulations up to date with current industry standards. The changes clarify

when the results of a pr escribed test can be reported as “ satisfactory , ”

“ unsatisfactory , ” “ inconclusive, ” or can be designated as a “n o t est. ” The definitional changes improve communication between APHI S and the regulated industry , and enable APHIS to more efficientl y process the release of a tested product using current industry standards for reporting of test results . There are about 330 firms in the United States that manufacture biological products. It is not known how many

of these firms are eng aged in manufacturing biologic products specifically for veterinary

purposes. The Small Business Administration (SBA) standard for a small business in this industry

is a firm with not more than 500 employ ees ; the average firm in this industry has 93 emplo ye es. While most firms that are affected by this rule are small, the changes w ill not impose a financial burden on them , but rather help make the product approval process timelier. The APHI S Administrator has determined that this action will not have a s ignificant economic impact on a substantial number of small entities.ii

**Table of Contents** Summary ................................ ................................ ................................ .............................. i Introduction ................................ ................................ ................................ ......................... 1 Potential Impact on Small Entities ................................ ................................ ...................... 21



### Introduction APHI S administers and enforces the Virus - Serum - Toxin Act (21 U.S.C. 151 et seq . ) , und er which a veterinary

biological product must be shown to be pure, safe, potent, and efficacious before a veterinary biological product lice nse may be issued. The regulations in 9 CFR part 113 prohibit the release of biological products prior to the completion and reporting of tests identified in the filed Outline of Production or in the Standard Requirements. APHI S is amend ing the regulati ons in order to bring them up to date with current industry standards and to better define the terminology used when reporting the results of tests performed on veterinary

biological products. L icensees and permittees of veterinary biological products mus t conduct these tests and report the results to APHI S so that the Agency can determine if the products are eligible for release. We are clarifying the circumstances under which the results of a prescribed test can be reported as “ satisfactory , ” “ unsatisfa ctory , ”

“ inconclusive ,” or as a “ n o t est . ” These changes will improve communication between regulators and products’ licensees and permittees regarding their test results. T he regulations currentl y define a “ n o t est ” as “ a test which produces inconclusive or invalid results and, therefore, cannot be used to evaluate a biological product. ” The amendments clarify this definition and add definitions for the designations of “satisfactory ,” “unsatisfactory ,” and “inconclusive.” Clarifyin g the definitions will help the industry more efficientl y describe the status of product testing, helping APHIS release the product as quickl y as possible. APHI S is also delet ing §§ 113.201, 113.202, 113.213, and 113.214 , because the standards in these se ctions are no longer used b y the industry .2



### Potential Impact on Small Entities There are about 33 0 firms in the U .S. industry that manufacture s biological products (NAICS code 325414 ) . They comprise establishments primarily engaged in manufacturing vacc ines, toxoids, blood fractions, and culture media of plant or animal origin except diagnostic . 1 The Small Business Administration (SBA) standard for a small business in this industry is a firm with not more than 500 employ ees. The average firm in this ind ustry has 93 employ ees. 2 While i t is not known how many of these firms are engaged in manufacturing biologic products specificall y for veterinary purposes , m ost firms that are directl y affected b y the rule are likely small according to the SBA standard . The changes in this rule are not expected to impose an y costs on the affected firms. The definitional changes improve communication between APHIS and the regulated industry , and enable APHIS to more efficiently process the release of a tested product usi ng current industry standards for reporting of test results . While most firms affected b y this rule are small, the c hanges do not impose a financial burden on them, but rather help make the product approval process timelier. The APHI S Administrator has d etermined that this action will not have a significant economic impact on a substantial number of small entities.

1 http://www.census.gov/epcd/ec97/def/325414.HTM 2 http://www.sba.gov/content/small - business - size - standards