U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

1

Serial Release of Licensed Biological Products

1. Purpose and Background

This memorandum conveys policy and procedures to comply with title 9, Code of Federal 

Regulations (9 CFR), parts 113 and 116, sections 113.3, 113.6, and 116.7. The Animal and 

Plant Health Inspection Service (APHIS) prohibits a licensee or permittee from marketing a 

serial of licensed/permitted product until they receive notification, from APHIS, of the APHIS 

disposition authorizing or prohibiting the market release or shipment of that product serial. 

This memorandum represents the Agency’s position on this topic. It does not create or 

confer any rights for or on any person and does not bind the U.S. Department of Agriculture 

(USDA) or the public. The information it contains may be made available to the public. While 

this document provides guidance for users outside VS, VS employees may not deviate from 

the directions provided herein without appropriate justification and supervisory 

concurrence.

Pursuant to the Congressional Review Act (5 U.S.C. § 801 et seq.), the Office of Information 

and Regulatory Affairs designated this rule as a non-major rule, as defined by 5 U.S.C. § 

804(2).

2. Document Status 

 

A. Issue date: 07/15/2020

B. This document replaces Veterinary Services Memorandum 800.53 dated October 25, 

2016, which is cancelled. 

 

3. Reason for Reissuance 

CVB is updating this document to harmonize procedures for serials intended for immediate 

marketing, prelicense evaluation, and technology transfers, as well as supporting changes to 

the Outline of Production. It also clarifies that CVB prefers electronic submission via the 

National Centers for Animal Health (NCAH) Portal for documents supporting release of 

biological products, serials submitted for prelicense evaluation, and technology transfer 

requests.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

2

4. Authority and References 

 

A. Authorities (Code of Federal Regulations (CFR)):

 7 CFR 371.4

 9 CFR part 101

 9 CFR part 102

 9 CFR part 113

 9 CFR part 114

 9 CFR part 116

B. References: 

 VS Memorandum 800.59; Biological Product Samples 

 VS Memorandum 800.62; Relabeling, Rebottling, and Reprocessing Veterinary 

Biological Products

 VS Memorandum 800.63; Personnel at Licensed Establishments 

 VS Memorandum 800.69; Guidelines for Autogenous Biologics

 VS Memorandum 800.101; U.S. Veterinary Biological Product Permits for Distribution 

and Sale

 VS Memorandum 800.214; Prescription Platform Product Biologics

C. Definitions: 

 

1) Released Product - A finished product released for marketing after all requirements 

are satisfactorily met.

2) Serial Release – The CVB evaluation process of a serial resulting in a final APHIS 

disposition.

3) APHIS Disposition – The final decision by CVB authorizing or prohibiting a licensee or 

permittee to begin marketing a serial.

4) NCAH Portal - Secure web-based electronic submission portal between registered 

biologics licensees and permittees and CVB. CVB considers NCAH Portal submissions 

an acceptable equivalent to hard-copy APHIS Form 2008 and APHIS Form 2020 

submissions.

5) Authorized firm representative - Personnel responsible for any phase of development, 

manufacture, or distribution of a veterinary biological product, and who have access 

to submit official correspondence to CVB.

5. Audience 

VS employees and members of the biologics industry.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

3

6. Guidance 

A. Procedures for Shipment and Receipt of Biologics Samples (APHIS Form 2020) 

1) CVB encourages licensees and permittees to send an APHIS Form 2020 (Form 2020) 

from an authorized firm representative through the NCAH Portal. Form 2020s on the 

Biologics Forms page within the CVB website and previous editions are also 

acceptable for submission as hard copies. Licensees or permittees must either 

generate a packing slip through the NCAH Portal or prepare a Form 2020 for each 

shipment of samples. Use a separate Form for each sample type indicated in block 4 

(Purpose). If CVB requests additional samples, the licensee/permittee must use a 

separate Packing Slip or Form 2020 and mark “RESUBMISSION” in block 4. For more 

information, refer to VS Memorandum 800.59 or the instructions on the CVB website 

for submitting an APHIS Form 2020.

a. Only employees with the “Sampler, authorized” role and USDA Level 2 

eAuthentication can submit the information to CVB through the NCAH Portal. 

b. Alternatively, an Authorized Firm Representative (authorized government

samplers) may submit a paper copy of the Form 2020.

c. Send shipments of biological samples, with accompanying packing slip or Form 

2020, to the following address:

Center for Veterinary Biologics 

NVSL, Laboratory Resources Unit – Sample Processing 

1920 Dayton Avenue 

Ames, IA 50010

2) APHIS acknowledges receipt of samples with entries in blocks 9 and 17 through 19. 

CVB returns a signed copy of Form 2020, with the assigned sample number notated, 

to the licensee or permittee if the licensee/permittee submitted a hard-copy Form 

2020. Alternatively, CVB provides a response containing the assigned sample number 

in the NCAH Portal if the licensee/permittee submitted via the NCAH Portal.

B. Procedures for Submission of Veterinary Biologics Production and Test Report (APHIS Form 

2008, APHIS Form 2008A, and Acceptable Equivalent) 

1) CVB encourages licensees and permittees to submit an APHIS Form 2008 (Form 2008) 

from an authorized firm representative through the NCAH Portal. Alternatively, the 

authorized firm representative may submit paper copies of Forms 2008 available on 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

4

the Biologics Form page within the CVB website or use an approved substitute. 

Submit forms not previously approved by CVB for review and approval prior to use.

a. Only employees with the Liaison, Alternate Liaison, or Serial Release roles and 

USDA Level 2 eAuthentication may submit the information to CVB through the 

NCAH Portal. For more information, see VS Memorandum 800.63.

b. Alternatively, authorized firm representatives may submit a paper Form 2008 

with an original signature, and one copy, to the following address:

CVB – Inspection and Compliance

USDA-APHIS-VS

1920 Dayton Avenue

P.O. Box 844

Ames, IA 50010

2) CVB considers the submission of a Form 2008, 2008A, or equivalent as confirmation 

by the licensee or permittee that all manufacturing, including that prior to Section V 

of the approved Outline of Production, complies with the Outline of Production and 

the applicable regulations. 

3) When licensees/permittees submit completed product samples in bulk form to APHIS, 

they must submit a Form 2008, clearly marked as a “BULK” submission, showing the 

manufacturer’s test results on the bulk samples. Receiving an APHIS disposition 

allowing the release of bulk material does not exempt a licensee or permittee from 

submitting a Form 2008 for the release of finished product.

4) Licensees and permittees must submit a Form 2008 for each completed serial or 

subserial prepared. The licensee/permittee must submit all completed Form 2008s, 

regardless of whether the serial is intended for release immediately or in support of 

product licensure, to CVB-Inspection and Compliance (CVB-IC).

5) Serials (Form 2008) Submissions Requested by CVB-Policy, Evaluation, and Licensing 

(CVB-PEL)

a. Serials Prepared for Prelicensing Evaluation

1. Serials may be prepared for various reasons during the product licensing 

process. Typically three serials are prepared for prelicense evaluation that 

may become eligible for release when the license issuance occurs. Firms 

should discuss this requirement with their CVB-PEL Reviewer in advance of 

serial preparation. This section does not apply to preliminary or partial data 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

5

that CVB may request prior to availability of all testing data or to testing of 

experimental product.

2. For Forms 2008 meeting the above criteria, the firm representative should 

ensure that “Other” is marked in Block 12 and add the word “Prelicense” in 

remarks (Section 11). If submitting via the NCAH Portal, the firm 

representative should indicate the Disposition by Firm to be “OtherPrelicensing”. Reviewers in CVB-PEL receive notification when Forms 2008 are 

submitted for prelicense serials. Cite the Form 2008 submission date in any 

subsequent related correspondence to CVB-PEL in which a copy of Form 2008 

historically would have been included.

3. CVB-IC still processes serials made for prelicense evaluation that CVB-PEL 

does not test. Submit samples as “Prelicense”, as they are still required.

b. Serials Supporting Outline of Production Revisions

1. Firms may make changes to the Outline of Production after product licensure. 

CVB-PEL may not approve certain changes until CVB has satisfactorily tested 

at least one serial produced and/or tested under the new method(s). Such 

Outline changes typically include, but are not limited to, changes in Section V

testing methods or material changes to manufacture that may impact product 

quality. Discuss testing requirements with the Reviewer.

2. When a Reviewer directs a licensee or permittee to provide a serial or serials 

for confirmatory testing to support a proposed Outline change, the 

Disposition by Firm on the Form 2008 for the applicable serial should be 

“Other-Outline Change.” As with other Form 2008 submissions, cite any 

correspondence with the Reviewer by the Mail Log number on the Form 

2008.

c. Serials Supporting Technology Transfer Requests

1. Firms may make changes to the Outline of Production for the location of 

product production and/or testing. CVB-PEL must accept this change before 

marketing of the product, for which production and/or testing at the new 

location applies, may occur. CVB-IC may perform an inspection or request 

additional documentation to substantiate the facility has the proper 

equipment and personnel to manufacture the product prior to the release of 

a serial.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

6

2. When a Reviewer directs a licensee or permittee to provide a serial or serials 

for confirmatory testing and/or approval to support a proposed change to the 

location of serial production and/or testing, the Disposition by Firm on the 

Form 2008 for the applicable serial should be “Other-Technology Transfer.”

6) Preparation of a Form 2008 or 2008A

a. A firm representative must complete the paper Form 2008 as follows (See NCAH 

Portal User Guide for guidance on corresponding NCAH Portal fields):

 Block 1. Enter the page number. For subsequent pages, use Form 2008A.

 Block 2. Enter the Establishment license or permit number (9 CFR 102.4(c) and 

104.7(a)).

 Block 3. Enter the name and mailing address of the licensee or permittee.

 Block 4. Enter the fill date for the final containers. Enter N/A (not applicable) 

for bulk submissions.

 Block 5. Enter the Veterinary Biologics Product Code number from the current 

product license or permit (9 CFR 101.3(k) and 102.5(b)(3)). For prelicense 

serials, enter the assigned Product Code.

 Block 6. Enter the expiration date on the final container labels. Compute the 

expiration date in accordance with the Outline of Production (9 CFR 101.4(f)

and 114.13).

 Block 7. Enter the serial or subserial number (9 CFR, 101.3(h) and (i) and 

101.4(e)). Serial and subserial numbers are limited to no more than 15 

alphanumeric characters.

 Block 8. Enter the true name of the veterinary biological product as stated on 

the current product license or permit (9 CFR 101.4(d)). 

 Block 9. Enter all tests conducted to support release of the serial or subserial 

as defined in Section V of the Outline of Production, including No Tests and 

Inconclusive Tests. If the space in block 9 is not adequate, use a Form 2008A 

to report additional test results.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

7

o Block 9A. Enter the test reference by entering the paragraph identification 

from the filed Outline of Production in which the specific test is described 

(e.g., V.C.2) and, if applicable, 9 CFR reference.

o Blocks 9B & 9C. Enter the Started and Concluded dates for each test 

conducted on bulk or final product. For animal potency tests, the dates 

entered in 9B and 9C should be all inclusive for the complete test, 

including vaccination, challenge, and/or serological testing dates.

o Block 9D. Enter all test results, including the validity and control 

requirements as described in the filed Outline of Production.

o Block 9E. Insert the letter code as noted on the Form 2008 that 

corresponds to the test conclusion. Explain in block 11, Remarks, the basis 

for a "No Test" or "Inconclusive" entry.

 A satisfactory (S) test designation. The firm makes this final 

conclusion for a valid test with results that meet the release criteria 

stated in the filed Outline of Production or 9 CFR Standard 

Requirement (9 CFR 101.5(l)(2)).

 An unsatisfactory (U) test designation. The firm makes this final 

conclusion for a valid test with results that do not meet the release 

criteria stated in the filed Outline of Production or 9 CFR Standard 

Requirement (9 CFR 101.5(l)(3)).

 An inconclusive (I) test designation. The firm uses this designation for 

an initial test when a sequential test design established in the filed 

Outline of Production or Standard Requirement allows further testing 

if a valid initial test is not satisfactory. When the initial or any 

subsequent test is declared inconclusive, the reasons shall be 

reported in the test records, the result shall not be considered as 

final, and the test may be repeated as established in the filed Outline 

of Production or Standard Requirement. If the firm designates a test 

as inconclusive and the biological product is not further tested, the 

test designation of unsatisfactory is the final conclusion. (9 CFR 

101.5(l)(4))

 A No Test (NT) designation. The firm uses this designation when a 

deficiency in the test system has rendered a test unsuitable for 

drawing a valid conclusion. When the firm declares an initial or any 

subsequent test is a No Test, report the reasons in the test records. 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

8

CVB shall not consider the results to be final, and firms may repeat 

the test. If the firm designates a test a No Test and the biological 

product is not further tested, the test designation of unsatisfactory is 

the final conclusion (9 CFR 101.5(l)(1)).

 Block 10. Enter the inventory of product containers or quantities to which 

testing and disposition apply. For serials or subserials designated as “Eligible 

for Release,” this quantity is the entire inventory of product prepared for 

marketing. For serials or subserials designated as “Destroyed by Firm,” 

indicate at least an estimated quantity. For imported material, enter the 

entire inventory of a completed serial prepared for marketing.

o Block 10A. Enter the number of containers, using a separate line for each 

size of container. Entities must maintain accurate accountability of 

product. If an inventory of product reported on the Form 2008 is 

inaccurate and falls outside the control limits as determined by the 

manufacturer, submit an amended Form 2008 with a corrected inventory.

o Block 10B. Indicate the quantity in each container or the number of tests 

in each kit (doses, mL, or units). Enter doses for vaccines and bacterins. 

For product with more than one dose size, enter the maximum number of 

doses that could be marketed. Enter number of tests, not plates, for 

diagnostic test kits. Indicate the volume in milliliters (mL) for products “For 

Further Manufacture” (FFM) not shipped in final container. Specify which 

unit of measure applies to each entry.

o Block 10C. Enter the total quantity (10A x 10B) for each line of inventory 

and include the unit of measure for each size (doses, mL, or units).

o Total columns A and C and enter the respective totals, including the unit 

of measure for each (doses, mL, or units).

 Block 11. Place any pertinent remarks in this block.

o Enter information explaining the reason a test conclusion indicated a “No 

Test” or “Inconclusive,” as noted in block 9E.

o Serials of finished product which contain material from FFM serials must 

indicate the establishment number, Product Code, and serial number of all 

FFM serials contained in the finished product serial.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

9

o Note the amount of imported product shipped for marketing in the United 

States. An authorized sampler at the permittee’s quarantine facility must 

certify the amount and condition of inventory received per shipment of 

product imported for sale and distribution. Include the date that the 

product arrived at the permittee's quarantine facility. For more 

information, refer to VS Memorandum 800.101.

o Indicate whether the submission is in support of prelicensing, a revision to 

the Outline of Production, or a technology transfer request.

o Reference test results previously submitted on a Form 2008 for another 

subserial.

o Indicate if the submission is for a “Bulk” sample.

o If the serial is the result of an approved reprocessing or rebottling 

submission, note the original Product Code and serial number.

o If the serial is the result of an approved for inventory transfer submission, 

note the original establishment number, Product Code, and serial number.

o If the serial has been reprocessed by adding one completed serial of 

product to another completed serial of product, note both serial numbers.

o Indicate the identity and expiration date of all reference preparations used 

for potency testing of serials.

o For autogenous biologics, include the identification of the component 

organisms and the host animal species for which the product is intended. 

See VS Memorandum 800.69 for further information on autogenous 

biologics. For Prescription Platform Products, include the information as 

indicated in VS Memorandum 800.214.

 Block 12. Mark the applicable firm disposition block.

o “Eligible for Release” is a certification by the licensee/permittee that the 

serial is prepared and tested in accordance with the Outline of Production 

and is eligible for market release. 

o “Destroyed” is a certification of actual destruction and not the intent to 

destroy. Indicate the date of destruction. If destruction is for a reason 

other than unsatisfactory tests, state the reason in block 11.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

10

o “To be Reprocessed and Retested” is a request that requires approval in 

accordance with 9 CFR 114.18 and VS Memorandum 800.62.

o Use “Other” for prelicense serials, inventory or expiration date 

corrections, extensions or shortening of dating, rebottling, transfer 

requests, serials to support Outline of Production changes, technology 

transfers, or additional information. Provide an appropriate explanation in 

block 12. Record additional remarks in block 11. Note that these individual 

requests have their own Firm Dispositions in the NCAH Portal.

 Block 13. The Form 2008 and 2008A must have the original signature of a 

person whose authorization has been previously filed with APHIS, in 

accordance with 9 CFR 114.7(a) and VS Memorandum 800.63.

 Block 14. Enter the title for the person whose signature appears in block 13.

 Block 15. Enter the signature date for the Form 2008.

b. Preparation of Form 2008A. All instructions given for Form 2008 apply to Form 

2008A or acceptable substitute. Block 5 of Form 2008A is not applicable; no entry 

needed.

1. If Section V testing per the Outline of Production is performed by the 

licensee/permittee after APHIS marketing release, the licensee/permittee 

must report unsatisfactory testing to CVB-IC in adherence to 9 CFR 116.5. 

2. CVB does not require the manufacturer to report satisfactory testing 

performed after marketing release to CVB-IC unless CVB requests the testing 

records. However, the manufacturer must maintain the testing records.

C. Procedure for Determination of an APHIS Disposition 

 

CVB uses the serial release process to review test summaries related to the purity, safety,

potency, or efficacy of each serial and subsequently provides an APHIS Disposition to the 

firm. This section applies to product serials manufactured after the license/permit of the 

product. It also applies to those prelicense serials produced shortly before license 

issuance that subsequently may become marketable after the license/permit of the 

product.

1) CVB-IC examines the final results of the licensee/permittee on a Form 2008 and 

evaluates whether a serial meets the criteria with testing requirements within the 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

11

Outline of Production or Standard Requirement(s). CVB notifies the 

licensee/permittee of the necessary corrections or additions if there are any noted 

exceptions. CVB-IC may use the Audit and Correction Transmittal for this purpose. 

Once CVB-IC makes an authorization determination regarding whether the 

licensee/permittee may market or ship the serial, an authorized representative of 

CVB-IC signs the Form 2008. This signed form (whether on the Form 2008 or 

electronically) is the exclusive documentation of CVB’s marketing authorization. If 

CVB-IC does not authorize release or determines it is subject to restrictions, CVB-IC 

provides an explanation on the APHIS Form 2008. CVB-IC may also provide additional 

information for action by the licensee/permittee.

a. Market Serials Not Selected for Testing. CVB-IC will document its decision to 

authorize or prohibit marketing of a serial which the CVB-PEL Laboratory has not 

tested, by selecting an APHIS Disposition in blocks 16 through 19 on the APHIS 

Form 2008.

b. Market Serials Selected for Testing

1. The CVB-PEL Laboratory may select any serial of a licensed product for testing, 

but it must make a decision whether to test a specific serial within seven (7) 

full calendar days after receipt and processing of representative samples of 

that serial from the firm. The CVB-PEL Laboratory has three (3) full calendar 

days after receipt and processing of a specific diagnostic test kit sample to 

make a decision whether to test that specific sample.

2. CVB-IC may select a serial of a licensed product for testing beyond the three 

(3) or seven (7) calendar day selection period after sample receipt. CVB-IC 

may notify licensees and permittees whenever such exceptions occur.

2) CVB-IC documents its decision to authorize or prohibit the release of a product serial 

in blocks 16 through 19 on the Form 2008. See Section IX.C and IX.D for the APHIS 

Dispositions that authorize and prohibit marketing or shipment of a serial. 

3) Distribution. CVB-IC retains the completed original Form 2008. CVB-IC sends one 

completed copy of the Form 2008, with additional documentation, as applicable, to 

the licensee or permittee. Likewise, CVB-IC notifies the licensee or permittee by 

means of the NCAH Portal.

D. CVB Laboratory Test Reports 

1) Preparation and Processing
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

12

a. Serials for Marketing. CVB-PEL Laboratory reports test results to CVB-IC on each 

serial or subserial tested. CVB appends supplementary reports if additional data 

and explanatory comments, beyond those included on a standard report, are 

necessary.

b. Serials Involved in Prelicensing Evaluation, Outline of Production Revisions, and 

Technology Transfer. CVB-PEL Laboratory reports test results to CVB-PEL with 

supplementary reports, if indicated. CVB-PEL makes recommendations to CVB-IC 

on the final APHIS disposition.

2) Distribution. CVB-IC sends completed test report(s) to the licensee or permittee. 

APHIS retains copies, as appropriate.

E. Exceptions 

 

1) First Serial Autogenous Biologics

a. Refer to VS Memorandum 800.69, Guidelines for Autogenous Biologics.

b. If the disposition of the serial is “Destroyed By Firm” (DBF), the date of final 

disposition and the reason the firm destroyed the serial should be included in the 

“Remarks” column.

c. The licensee/permittee must make test results for specific serials available to CVB 

on request.

F. Electronic Notification of Marketing Authorization (Serial Release) 

 

1) Electronic same-day notification is sent for final APHIS disposition of serials. This 

notification process is standard for all Forms 2008 CVB receives, if the 

licensee/permittee has provided an email address for this purpose. See Attachment 1 

for an example of electronic notification.

a. A licensee or permittee receives email notification from CVB Serial Release, 

cvb.serialrelease@usda.gov, for each Form 2008 CVB processes. The email 

notifications may be any APHIS disposition, including notifications that a serial is 

not eligible for marketing. The recipient is responsible for review of the APHIS 

disposition and appropriate action based on the market status of the serial as 

determined by APHIS.

b. The establishment may market the product in accordance with the final 

disposition designated by APHIS on receipt of the electronic notification.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

13

c. There is no U.S. regulatory requirement that the manufacturing site physically 

have a signed hard-copy of the Form 2008 before shipping an approved serial. 

The electronic notification is the official notification for marketing purposes.

2) The following statement is included on each electronic notification: This electronic 

notification is equivalent to an APHIS Form 2008 signed by an Authorized APHIS 

Representative and is appropriate for marketing authorizations. 

3) APHIS dispositions authorizing the market release or shipment of serials are as 

follows:

a. Not to be Tested

b. Tests Completed Satisfactory

c. Shorten Dating Approved

d. Other – Release for Further Manufacture

e. Other – Serial Released for Market

f. Other – Subsequent Shipment Approved (for permitted product)

g. Other – Conditional Release Granted

h. Prelicense – Test Completed Satisfactory

i. Prelicense Serial – Release for Market

4) The following APHIS dispositions prohibiting the market release or shipment of the 

serial:

a. Test Completed UNSATISFACTORY

b. Shorten Dating DENIED

c. Other – UNSATISFACTORY Based on Firm’s Results

d. Other – Serial NOT RELEASED FOR MARKET

e. Other – Subsequent Shipment DENIED
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

14

f. Prelicense – EXPIRED

g. Prelicense – Tests completed UNSATISFACTORY

5) If a licensee/permittee submits a hard-copy APHIS Form 2008 for processing, the 

signed hard-copy Form 2008 and related CVB test reports are returned to the 

licensee/permittee’s mailing address. CVB performs these mailings once a week. Use 

only one route of submission per serial submission. 

6) CVB uses electronic notification for audit and correction transmittals. Conditions of 

release (Serial Release Requirements) are included within the electronic notification, 

if applicable.

 

G. Implementation/Applicability 

 

Updated policy in this memorandum is effective immediately.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS MEMORANDUM 800.53 

15

Attachment 1