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ICSOP0044.02

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United States Department of Agriculture

Center for Veterinary Biologics

Standard Operating Policy/Procedure

Export Certificates and Certificates of Licensing and Inspection 

Date: July 5, 2018

Number: ICSOP0044.02

Supersedes: ICSOP0044.01, September 23, 2016

Contact: Ruben A. Osorio, (515) 337-6154

Approvals:

/s/Daniel C. Coyle for Date: 10Jul18

Steven A. Karli, Director

Inspection and Compliance

Center for Veterinary Biologics

United States Department of Agriculture

Animal and Plant Health Inspection Service

P. O. Box 844

Ames, IA 50010

INTERNAL USE ONLY

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA 

and does not imply its approval to the exclusion of other products that may be suitable.

Entered into CVB Quality Management System

by: /s/Linda S. Snavely 11Jul18 

 Linda S. Snavely Date

 Quality Management Program Assistant
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Export Certificates and Certificates of Licensing and Inspection

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Table of Contents

1. Purpose

2. Export Documents

3. Definitions, Roles, and Responsibilities

4. Requests for Attestations and Other Non-Standard Information 

5. Instructions for Data Entry in LSRTIS. 

6. Procedure

7. Additional Work Instructions for Using LSRTIS for Processing Certificates

8. Summary of Revisions
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1. Purpose

The Center for Veterinary Biologics (CVB) program implements the Virus-Serum-Toxin Act to 

ensure that veterinary biologics available for the diagnosis, prevention, and treatment of animal 

diseases are pure, safe, potent and effective. In support of satisfying the global demand for

agricultural products, the CVB program provides certification to assist in the trade of veterinary 

biologics manufactured by licensees and permittees. 

Licensees, permittees, or distributors may submit requests for certification regarding the 

preparation of the veterinary biological product and the marketability of those products in 

accordance with the Virus-Serum-Toxin Act [VSTA] (37 Stat. 832-833, 21 U.S.C. 151-158) and 

its regulations. This request may be either an Official Export Certificate for Animal Biological 

Products (APHIS Form 2017) or a Certification of Licensing and Inspection (APHIS Forms 

2046, 2046-S, 2047, or 2047-S), formerly known as a Certificate of Free Sale. APHIS does not 

require either document for the export of licensed/permitted veterinary biological products. The

authority to issue export documentation is granted under title 9, Code of Federal Regulations 

(9 CFR), part 112.2(e), and is further described in Veterinary Services Memorandum No. 800.52.

2. Export Documents

2.1 The Certificate of Licensing and Inspection (CLI) certifies that the manufacturer 

listed has been licensed and inspected as required under the laws and regulations of the 

United States. In addition, the document allows certification that the product(s) listed are 

also licensed, inspected, and freely marketed. This is a product based certification. CLIs 

include: 

2.1.1 APHIS Form 2046 – Certificate for use with unrestricted product licenses 

provided in English language

2.1.2 APHIS Form 2046-S – Certificate for use with unrestricted product 

licenses provided in Spanish language

2.1.3 APHIS Form 2047 – Certificate for use with restricted product licenses 

provided in English language

2.1.4 APHIS Form 2047-S – Certificate for use with restricted product licenses 

provided in Spanish language

2.1.5 A statement regarding good manufacturing practices (Attestation)

2.1.5.1 This statement may be an appended page to the CLI or may be 

submitted as a stand-alone document. Refer to Section 5 of this document. 
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2.1.6 A statement of ingredients of animal origin specific to the risk for the 

transmission of bovine spongiform encephalopathy. Refer to Section 5 of this 

document.

Note: These statements may be an appended page to the CLI or may be submitted 

as a stand-alone documents.

2.2 The Official Export Certificate for Animal Biological Products (APHIS Form 

2017) certifies the serials (batches) of product prepared by the listed manufacturer:

2.2.1 Are intended for the use in treatment of animals;

2.2.2 Have been prepared under a Veterinary Biological Product 

License/Permit; and

2.2.3 Are suitable for use in the United States. The APHIS Form 2017 can be 

used for both restricted and unrestricted licensed product and is a serial based 

certification. Only product released for market by CVB can be reflected on this 

certification.

2.3 APHIS Form 16-4 and 16-4A – Export Certificate for Animal Products is a form 

routinely used by the National Import Export Services. The CVB certifies this form on 

rare occasions for statement of ingredients used in production and the disease status in the 

United States. 

2.4 Electronic copies of APHIS forms can be downloaded from the CVB Website or 

may be submitted using the NCAH Portal.

2.5 Requirements of Importing Countries – CVB does not maintain current 

knowledge of importing requirements. Additional information regarding exports can be 

found in the current version of ICWI0063, Export Information. 

2.6 For the remainder of this document and applicable work instructions, the phrase 

“export document” will include both the APHIS Form 2017 and the Certificates of 

Licensing and Inspection. If a section applies to only one type of export document, it will 

be noted.

3. Definitions, Roles, and Responsibilities

3.1 Licensing, Serial Release, and Testing Information Service (LSRTIS)

The information system, LSRTIS, is used to process all export certification at the CVB. It 

integrates the licensing actions, market actions, compliance actions with export 
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certification requests. Access to this information is only available through APHIS 

designated personnel and equipment. 

3.2 Export Manager – Secondary review and authorization may be conducted by an 

employee acting for the Export Manager. The Program Coordinator may assist with the 

certification of APHIS Forms 2017. 

3.2.1 Reviews processes for all aspects of export certification to ensure 

consistent application of policy

3.2.2 Conducts secondary review of export documents

3.2.3 Authorizes (via signature) export documents

3.3 Export Document Examiner – The Biologics Compliance Assistants provide back 

up for support activities.

3.3.1 Enters incoming export requests into LSRTIS

3.3.2 Conducts preliminary review of export documents

3.3.3 Finalizes export documents

3.4 NCAH Portal – System used for the electronic submission of export documents. 

3.4.1 It is only used by firm employees with specific designated NCAH Portal 

roles. It is not for APHIS Forms 16-4, 16-4A, or certificates with request to use 

the date when the product or establishment was first licensed. 

4. Requests for Attestations and Other Non-Standard Information 

4.1 Certain importing countries may require United States exporters to provide 

governmental attestation about the manufacturer or product beyond that stated on the 

standard certificate. The exporting entity may submit additional export documents to 

CVB for signature that fulfill the specific requirements of the importing country. 

4.2 Requests for the CVB to attest to non-standard information are handled on a caseby-case basis. All statements on non-standard forms must be fully supported by data on 

file at the CVB. Statements that are too general to be fully supported by data on file shall 

not be signed. If the request is supplied in Spanish, a direct English translation must be 

provided.

4.3 Documents containing non-standard information must be appended to a 

certificate. The statements allowed as a separate document with a signature box are the 
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manufacturer’s attestations and the ingredients of animal origin statements specific to the 

negligible risk of transmitting Bovine Spongiform Encephalopathy (BSE) from product 

manufactured in the United States of America. 

4.4 The attestations indicate that the licensed veterinary biologics manufacturer is 

authorized to manufacture, package, and sell immunological veterinary medicinal 

products in the United States of America under the United States Veterinary Biologics 

Establishment License Number XXX using principles and practices of good 

manufacturing as required by the Virus-Serum-Toxin Act (37 Stat. 832-833, 21 U.S.C. 

151-159) and the regulations and standards issued pursuant to the Act (title 9, Code of 

Federal Regulations, parts 101.1 et. Seq.)

A template of attestations may be obtained from CVB on request to be submitted as a 

hard copy or may be requested through the NCAH Portal. 

4.5. Ingredients of animal origin statement specific to the negligible risk to 

transmit 

BSE from U.S. Licensed products indicates that the United States of America is 

recognized as having a negligible BSE risk according to the World Organisation for 

Animal Health, also known as Office International des Epizooties (OIE).

TSE/BSE Statement:

Ingredients of animal origin used in the preparation of licensed veterinary biological 

products will be procured from materials in compliance with the regulations for 

importation, from sources eligible for entry in the United States and in compliance with 

all USDA requirements. By meeting all USDA requirements for the use of ingredients of 

animal origin, Establishment License XXX will produce licensed veterinary biological 

products that present negligible risk for the transmission of transmissible spongiform 

encephalopathy (TSE’s) specifically Bovine Spongiform Encephalopathy, and other 

animal diseases foreign to the United States.

A template TSE/BSE statement may be obtained from CVB on request to be submitted as 

a hard copy or may be requested through the NCAH Portal.

4.6 APHIS Forms 16-4 and 16-4A are used on rare instances and for exporters that 

have received specific requests from a receiving country to use this form. The 

information declared in this form will match information on file at the CVB. The CVB 

encourages the exporters to use the routine export documents used by CVB. 

4.7 The United States State Department requests a current sample of signatures for 

export documents. CVB supplied a list of signatures in the Year 2011. Evidently, this 

government organization comes across with certain CVB documents and they proof the 

wet signature. Signatures from CVB-Inspection and Compliance (IC) personnel not 
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included in this list may be subjected to export delays from the State Department. CVB 

will routinely supply a list to the State Department. Follow work instructions ICWI0065,

Submitting Letter to the U.S. Department of State Office of Authentications.

5. Procedure

5.1 Receipt and Entry of Export Documents from Licensees, Permittees, or 

Distributors

5.1.1 Export documents are generated by the vaccine manufacturer or exporter. 

The documents are received hard copy, via mail or through the NCAH Portal. The 

requestor must use the hard copy forms listed on the CVB Website or the NCAH

Portal user guides for further guidance. Submitters must follow the directions 

provided in Veterinary Services Memorandum No. 800.52. 

5.1.2 Export documents are received and information is entered into the 

LSRTIS Database. NCAH Portal submissions are received real-time. See the 

current version of ICWI0068, Entry and Primary Review of Export Documents,

(APHIS Form 2017 and Certificates of Licensing and Inspection), for detailed 

processes. 

5.2 Primary Review of Export Document

5.2.1 The primary review of an export document is to ensure the document is 

complete and matches the data on file with CVB. 

5.2.2 If the forms are incomplete or do not match the data on file with CVB, the 

form may be audited back to the requestor for correction. See the current version 

of ICWI0075, Audits and Reference Slips for IC Documents, for more 

information on process. 

5.2.3 The preliminary review is documented using tools, such as Product 

License Profile, Serial Status, SharePoint, Mail Log, or any other tool that can be 

confirmed against information on file. The primary review is recorded in the 

LSRTIS database. See the current version of ICWI0068 for detailed process.

5.2.4 Export Certificate for Animal Products (16-4) – Information is 

reviewed case by case. The CVB may use Veterinary Services security paper to 

process these requests. The decision to process this form is made by the Export 

Manager. 

5.2.5 Discrepancies – If a discrepancy is identified on the certificate during the 

primary review that is verified by the official hard copy documents in the CVB
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File Room or on the SharePoint site, audit the certificate back. See current version 

of ICWI0075.

5.3 Secondary Review of Export Documents

5.3.1 The secondary review of an export document is to determine sufficiency 

and acceptability of the information to be certified. It is also validation that the 

product is freely marketed in the United States, and the serial has been prepared in 

accordance with the VSTA and ensuing regulations. 

5.3.2 The signing of the certificate does not exempt firms from following all 

applicable regulations and/or restrictions. 

5.4 Returning Certificates to the Licensee/Distributor Using an Audit Form or a 

Reference Slip

If a discrepancy is found during either the primary or secondary review, the discrepancy 

should be noted. Depending on the severity of the discrepancy, either a reference slip or 

an audit form may be used to document the discrepancy. A reference slip notes a 

discrepancy that is minor and would not preclude the certificate being signed. However, 

an audit form documents a discrepancy that is severe enough to warrant not signing the 

certificate. A reference slip might be used to document minor spacing or punctuation 

errors. An audit slip would be used when incorrect or missing information was found. See 

the current version of ICWI0075 for more information. 

5.5 Finalizing Certificate Requests 

Export documents reviewed and found to be acceptable are assigned an unique certificate 

number and a seal is applied. See current version of ICWI0070, Finalization and Mailing 

of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection),

for information regarding the process. 

6. Additional Work Instructions for Using LSRTIS for Processing Certificates 

Refer to the current versions of ICWI0068, ICWI0069, Secondary Review of Export Documents 

(APHIS Form 2017 and Certificates of Licensing and Inspection); ICWI0070 and ICWI0075.

7. Summary of Revisions

Version .02

 Addition of NCAH Portal submissions.