### United States

Department of Agriculture Anim al and Plant Health Inspection Service September 2013 **Analysis in Support of Certification that the** 

**Rule will not have a Significant Economic Impact on a Substantial Number of Small**  **Entities Proposed**  **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 proposing to amend the regulations 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 proposed changes would clarify when the results of a prescribed test can be reported
as “ satisfactory , ” “ unsatisfactory , ” “ inconclusive, ” or can be designated as a “n o t est. ” The definitional changes would improve communication between APHI S and the regulated industry , and enable APHI S 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 engaged 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 employ ees. While most firms that would be affected by this rule are small, the proposed changes would not impose a financial burden on them , but rather help make the product approval process timelier. The propose d rule, if promulgated, will not have a significant economic impact on a substantial number of small entities.ii

**Table of Contents** Summary
................................ ................................ ................................ .............................. i Introduction
................................ ................................ ................................ ......................... 1 Potential I mpact 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 license 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 proposing to amend the regulations in order to bring them up to date with current industry

standards and to better define the terminology used whe n reporting the results of tests performed on veterinary biological products. L icensees and permittees of veterinary biological products must 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 clarify ing the circumstances under which the results of a prescribed test can be reported as “ satisfactory , ” “ unsatisfactory , ”

“ inconclusive ,” or as a “ n o t est . ” These changes will improve communication between regulators and product s’ 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 proposed amendments wou ld clarify this definition and add definitions for the designations of “satisfactory ,” “unsatisfactory ,” and “inconclusive.” Clarifying the definitions will help the industry more efficiently describe the status of product testing, helping APHI S release t he product as quickl y as possible. APHI S is also proposing to delete §§ 113.201, 113.202, 113.213, and 113.214 , because the standards in these sections 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 vaccines, 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 industry 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 would be directl y affected by the proposed rule are likely

small according to the SBA standard
. The changes proposed in this rule are not expected to impose any costs on the firms that would be affected. The definitional changes would improve communication between APHI S and the regulated industry , and enable APHI S to more efficiently process the release of a tested product using current industry standards for reporting of test resul ts . While most firms that would be affected b y this rule are small, the proposed changes would not impose a financial burden on them, but rather help make the product approval process timelier. The proposed rule, if promulgated, 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