United States 

Department of 

Agriculture

Animal 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 & Development
i

Summary

APHIS 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 “no test.” The 

definitional changes would improve communication between APHIS and the regulated industry,

and enable APHIS to more efficiently 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 employees; the average firm in this industry has 

93 employees. 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 proposed 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 Impact on Small Entities...................................................................................... 2
1

Introduction 

APHIS administers and enforces the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), 

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. 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. 

APHIS 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 when reporting the results of 

tests performed on veterinary biological products. Licensees and permittees of veterinary

biological products must conduct these tests and report the results to APHIS 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,” “unsatisfactory,”

“inconclusive,” or as a “no test.” These changes will improve communication between 

regulators and products’ licensees and permittees regarding their test results.

The regulations currently define a “no test” as “a test which produces inconclusive or 

invalid results and, therefore, cannot be used to evaluate a biological product.” The proposed 

amendments would 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 APHIS release the 

product as quickly as possible. APHIS is also proposing to delete §§ 113.201, 113.202, 113.213, 

and 113.214, because the standards in these sections are no longer used by the industry.
2

Potential Impact on Small Entities

There are about 330 firms in the U.S. industry that manufactures 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 employees. The average firm in this industry has 93 employees.2 While 

it is not known how many of these firms are engaged in manufacturing biologic products 

specifically for veterinary purposes, most firms that would be directly 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 APHIS 

and the regulated industry, and enable APHIS to more efficiently process the release of a tested 

product using current industry standards for reporting of test results. 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 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