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March 1, 2006 

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 06-06 

Subject: Type (Species) Designation of Vaccines Containing 

 Bovine Viral Diarrhea Virus(es) 

 

To: Biologics Licensees, Permittees, and Applicants 

 Veterinary Services Management Team 

 Directors, Center for Veterinary Biologics 

 Area Veterinarians in Charge, VS 

 State Veterinarians 

I. PURPOSE 

This notice informs licensees, permittees, and applicants of current Center for Veterinary 

Biologics (CVB) guidance for label disclosure of Bovine Viral Diarrhea (BVD) Virus 

Type (species) used in vaccines and challenge studies. 

II. BACKGROUND 

Historically, BVD viruses (BVDV) were considered to be a single species within the 

pestivirus genus of the flavivirus family of viruses. Accordingly, the CVB did not 

require that BVDV type be specified on product labels or in the Outline of Production, 

although firms were allowed to provide that information voluntarily. Similarly, the CVB 

did not require that firms disclose to the consumer the type of BVD used in challenge 

studies to demonstrate vaccine efficacy. 

The International Committee on Taxonomy of Viruses has recently designated BVDV 

Types 1 and 2 as separate species within the pestivirus genus.1

 Their findings are that 

BVDV Type 1 and 2 are genetically distinct, based primarily on nucleotide sequence and 

serological relatedness. Current literature and taxonomy conventions now designate 

these distinct viruses as BVDV Type 1 and BVDV Type 2. Given the status of 

taxonomic classification and scientific literature, the CVB has reviewed policy regarding 

the use of Type designations for BVD products, and has determined that it is appropriate 

for this information to be included on product labeling and in Outlines of Production. 

III. GUIDANCE 

The CVB is not considering changing the True Names of BVD-containing products. 

However, the BVDV Type(s) included in the product should be disclosed on the label as 

part of the indications statement. In addition, the label should indicate, as part of the 

 product claim, the Type of the BVD challenge virus for which efficacy has been 

 demonstrated. 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Center for Veterinary 

Biologics 

510 S. 17th Street, 

Suite 104 

Ames, IA 50010 

(515) 232-5785 

FAX (515) 232-7120 
 Center for Veterinary Biologics Notice No. 06-06 2 

Example: 

“This product contains BVD Type 1 and is recommended for the vaccination of healthy 

cattle as an aid in the control of disease caused by BVD Type X.” 

In this example, “X” is the Type(s) of the BVD challenge strain used in the efficacy trial. 

The BVD Type of the Master Seed and challenge strains should be determined by genetic 

sequencing of the 5’ untranslated region (UTR), or by some other method acceptable to 

the CVB. The results of this characterization should be submitted to the CVB to support 

the label and Outline of Production. 

If the challenge strain used in a previous efficacy study is no longer available, contact the 

CVB to discuss acceptable disclosure language on product labels. 

IV. ACTION 

For BVD-containing products, all labels and Section VI of the Outline of Production 

should be revised to include the Type(s) of BVDV contained in the product and to 

indicate the Type(s) of BVDV used for challenge in the efficacy trial. In addition, 

Section I of the Outline of Production should be amended to specify the Type of the 

BVDV Master Seed(s). 

Previously approved Master Seeds that were not originally characterized to the species 

level (BVDV Type) should be sequenced in the 5’ UTR or characterized by some other 

method acceptable to the CVB. Data confirming the Master Seed species should be 

submitted to the CVB along with label and Outline of Production changes. The CVB 

may perform confirmatory testing. 

Characterization of Master Seeds and modifications to Outlines of Production and labels 

should be completed within 1 year from the date of this Notice. 

/s/ Richard E. Hill, Jr. 

Richard E. Hill, Jr. 

Director 

Center for Veterinary Biologics 

1

 Heinz FX, Collett MS, Purcell RH, et al.: 2000, Genus pestivirus. In: Virus taxonomy, 

eds. van Regenmortel MHV, Fauquet CM, Bishop DHL, et al., pp. 867-872. Academic 

Press, New York.