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ICSOP0005.03

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United States Department of Agriculture

Center for Veterinary Biologics

Standard Operating Policy/Procedure

Product Destruction

Date: June 27, 2011

Number: ICSOP0005.03

Supersedes: ICSOP0005.02, February 1, 2010

Contact: Renee M. Schnurr, (515) 337-6103

Approvals:

/s/Daniel C. Coyle for Date: 11Jul11 

Steven A. Karli, Director

Inspection and Compliance

Center for Veterinary Biologics

/s/Rebecca L.W. Hyde Date: 11Jul11 

Rebecca L.W. Hyde, Section Leader

Quality Management

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.
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Table of Contents

1. Purpose and Scope

2. Authority for Product Destruction

3. Other Laws and Regulations

4. VS Memorandum 800.56

5. Disposal Methods 

5.1 Products Containing Live Agents or Toxins

5.2 Refuse, Carcasses, Undesirable By-products Containing Live Agents 

or Toxins

5.3 Products Containing Hazardous Compounds, including Thimerosal

6. Transport of Materials

7. Products Found Unsatisfactory by CVB

8. Documentation of Destruction

8.1 APHIS Form 2045

8.2 APHIS Form 2008

9. Products Found Unsatisfactory by Licensee

10. Other Types of Products or By-products

11. Disposal Routine

12. VS Observer Responsibilities

13. Summary of Revisions
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1. Purpose and Scope

The purpose of this document is to describe the various methods for the destruction and/or 

disposal of unsatisfactory biological products, carcasses, refuse, or materials unsatisfactory for 

production or marketing purposes. In addition, this document describes the Center for 

Veterinary Biologics (CVB)-Inspection and Compliance’s (IC) procedure for observing product 

destruction and processing of destruction records. This document does not cover disposal of 

known or suspected Transmissible Spongiform Encephalopathy (TSE) contaminated or infected 

materials. 

2. Authority for Product Destruction

The Virus Serum Toxin Act (VSTA) makes it unlawful to prepare, ship, or deliver for shipment, 

any worthless, dangerous, contaminated or harmful products for use in domestic animals. The 

Code of Federal Regulations, Title 9 (9 CFR) Part 114.15 requires that “all biological products 

found to be unsatisfactory for marketing, all biological products which have become worthless 

subsequent to the expiration date, all refuse, other materials deemed unsatisfactory for 

production purposes, all carcasses (part or whole) of production or test animals, and any

undesirable by-products of manufacture shall be disposed of as may be required by the 

Administrator.”

3. Other Laws and Regulations

Disposal of destroyed materials are subject to all federal, state, and local laws and regulations 

pertaining to the disposal of waste and the maintenance of environmental quality in the final 

disposition of materials.

4. VS Memorandum 800.56

Veterinary Services (VS) Memorandum 800.56 contains guidance on product destruction. The 

decision to destroy such products can be made only by an authorized agent of the licensee. Once 

decided upon, destruction must be by approved methods.

5. Disposal Methods

The disposal method depends upon: 1) whether the product contains live agents or toxins or is 

inactivated or contains hazardous compounds (i.e. thimerosal), and 2) whether it has been found 

unsatisfactory by the CVB testing or by licensee testing.

Live agents or toxins may be potentially hazardous to the health of humans, or other animals, or 

the environment, and must be inactivated by approved procedures. Serials found contaminated 
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are considered to contain live agents. The following approved destruction methods are described 

in VS Memorandum 800.56 unless otherwise noted.

5.1 Products Containing Live Agents or Toxins

5.1.1 Incineration

The application of flame for a period of time sufficient to degrade all infectious 

organic material to a noninfectious state.

5.1.2 Dry Heat

The application of dry heat at a temperature of at least 160°C for a period of time, 

minimum of 1 hour, adequate to inactivate, detoxify, and/or sterilize the material 

involved (9 CFR 109.1[a]).

5.1.3 Autoclaving

The application of live steam at a temperature of at least 120°C for a period of 

time, not less than one-half hour, adequate to inactivate, detoxify, and/or sterilize 

the material involved (9 CFR 109.1[a]).

5.1.4 Chemical

The addition of chemicals such as sodium hypochlorite (bleach), formalin, 

phenol, cresol, beta-propiolactone, phenylmercuric nitrate, or equivalent 

inactivating agents at sufficient concentration for sufficient time and under proper 

conditions to inactivate, detoxify, and/or sterilize the material involved.

Note: Bleach is not listed in VS Memorandum 800.56 but may be approved 

by VS for use in appropriate situations.

5.2 Refuse, Carcasses, and Other Undesirable By-products Containing Live 

Agents or Toxins

The by-products of veterinary biologics manufacture (such as refuse, carcasses, 

contaminated disposable plastic-ware, etc.) may also contain live agents or toxins. The 

following methods are approved ways of disposal of these materials.

5.2.1 Rendering

The denaturing and cooking of carcasses or other organic material in closed tanks 

for a period of time sufficient to effectively destroy the material for human food 

purposes and to degrade to a noninfectious state. 
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5.2.2 Burial

The internment of carcasses, contaminated feed, manure, bedding, and other items 

below ground level with sufficient covering material to prevent any further 

dissemination of microorganisms. 

5.2.3 Composting 

The controlled aerobic biological decomposition of organic matter into an 

environmentally stable product called compost. It is used as an alternative 

method of managing manure and other organic wastes, such as poultry or 

livestock waste.

Note: Composting is not listed in VS Memorandum 800.56, but may be

approved by VS for use in appropriate situations. 

5.2.4 Incineration (see Section 5.1.1)

5.2.5 Tissue Digestion

The digestion and liquefaction of organic matter by alkaline hydrolysis in a heated 

sealed vessel under constant agitation. The alkali and water are added in precise 

proportion to the weight of tissue and the system is heated to a specified operating 

temperature for a specified period of time.

Note: Tissue digestion is not listed in VS Memorandum 800.56, but may be 

approved by VS for use in appropriate situations.

5.3 Products Containing Hazardous Compounds, including Thimerosal

Some veterinary biologics may contain hazardous compounds, including, but not limited 

to, Thimerosal/Merthiolate, that are used as preservatives, inactivants, etc. The improper 

treatment and disposal of products containing hazardous compounds may pose a 

substantial present or potential hazard to human health or the environment. Disposal of 

such products must comply with all applicable federal, state, and local regulations. 

Contractors and facilities used to dispose of hazardous waste should be registered with 

the Environmental Protection Agency (EPA) and have a United States EPA ID number.

6. Transport of Materials

The conveyances used to transport carcasses or other infectious materials are to be constructed so 

as to be leak-proof and equipped to permit thorough cleaning and disinfecting. Vehicles used for 

the transportation of hazardous waste should be properly placarded.
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7. Products Found Unsatisfactory by CVB

It is Animal and Plant Health Inspection Services (APHIS) policy to have VS personnel 

physically present at the firm to observe the destruction of product that has been found 

unsatisfactory as a result of CVB testing (9 CFR 114.15, VS Memorandum 800.56 III.C.3.).

Unsatisfactory testing is reported to the licensee by the CVB on the Biologics Test Report and is

sent to the firm with the APHIS Form 2008 (Form 2008) submitted by the licensee or permittee

(9 CFR 113.5[c]).

The Biologics Test Report details the CVB testing, indicating how the serial tested 

unsatisfactorily.

8. Documentation of Destruction

8.1 APHIS Form 2045

APHIS Form 2045 (Form 2045) is only to be used by APHIS personnel for recording the 

observation of destruction of serials. 

The form is completed by the APHIS observer after destruction has been performed. All 

copies should be legible.

8.1.1 Processing the completed Form 2045

The completed Form 2045 is distributed as follows:

The white copy (original) is filed with inspection notes.

The yellow copy is forwarded to the Biologics Compliance Assistant 

(BCA) for entry into the LSRTIS database.

The pink copy is left with the licensee or permittee (firm is to be given 

a legible copy).

Upon receipt of the yellow copy of the Form 2045, the BCA records the 

destruction in the LSRTIS as follows:

Scan the Form 2045 and attach the electronic copy to the serial record 

in LSRTIS.

The Form 2045 is initialed and dated by the BCA to confirm data entry and 

attachment of the serial record.
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The processed Form 2045 (yellow copy) is filed in the firm’s product file.

8.2 APHIS Form 2008

The licensee or permittee may request permission to destroy product found unsatisfactory 

by CVB without APHIS supervision. If authorized, the licensee reports the destruction of 

the serial(s) on a Form 2008. The method of destruction and date performed is reported 

in Block 11 or 12 of the Form 2008.

In cases where the licensee or permittee is authorized to dispose of a serial, the CVB will 

verify destruction records during an inspection of the establishment and refer to this 

verification in the inspection report.

9. Products Found Unsatisfactory by Licensee

The CVB does not require licensees to destroy products under APHIS supervision that have been 

found unsatisfactory by the licensee or permittee prior to the release of the serial(s) for 

distribution and sale.

Reporting on Form 2008

See the current version of ICSOP0010 for procedures on processing the Form 2008.

The destruction of product by the firm is reported in Block 12, Disposition by Firm, Destroyed.

If not apparent from the test results reported on the Form 2008, the reason for determining the 

serial is unsatisfactory should be provided in Block 11, Remarks.

Note: The notice of destruction on a Form 2008 is not the intent to destroy but a 

certification of destruction. The Form 2008 should include the date of destruction.

10. Other Types of Products or By-products

Products or by-products not containing live agents or toxins are subject to applicable federal, 

state, or local laws and regulations pertaining to the treatment and disposal of waste and to 

environmental quality.

VS employees are to complete the Form 2045 for inactivated products after witnessing the 

destruction of such products found unsatisfactory as a result of CVB testing.

If a sanitary landfill is used, the VS employee is to verify that the landfill is a state approved site

and that the unsatisfactory product is destroyed.
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11. Disposal Routine

The firm is required to hold the unsatisfactory serial(s) on licensed premises until disposal is 

witnessed by APHIS or until other arrangements have been authorized. Storage at 2°- 7°C is not 

required.

Product destruction should be scheduled as part of an inspection or other visit to the 

establishment. 

In unusual situations, arrangements may be made with the USDA Area-Veterinarian-In-Charge 

for a VS field veterinarian to witness the destruction. This option should be discussed with the 

Inspection Section Leader prior to making such arrangements.

12. VS Observer Responsibilities

The VS observer is responsible for the following:

Review of production records and Form 2008 for each serial or subserial to be 

destroyed. 

Determine if the method of destruction the firm proposes to use is allowed in VS 

Memorandum 800.56.

Ensure the entire inventory is presented for destruction. This should include all 

reserve and retention samples. To retain any portion of an unsatisfactory serial, the 

licensee must obtain permission from the CVB prior to presenting the serial for 

destruction.

Perform an actual count of the serial or material presented for destruction.

Maintain the inventory under observation and control until the destruction cycle has 

progressed enough to make all product unmarketable (i.e., until the maximum heat of 

the autoclave has been applied, or final containers have been dumped into barrels for 

hazardous waste disposal). 

Observe completion of cycle (i.e., removal from the autoclave or incinerator).

Certify destruction by completing the Form 2045. Note on the form if any samples 

are retained. A legible pink copy is left with the licensee or permittee.

Offsite product destruction: In addition to above, the VS observer is responsible 

for the following:
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a. Ensure all cartons or containers are appropriately packed, sealed, and clearly 

identified as for destruction and labeled hazardous waste, if applicable.

b. Render all barrels or pallets tamper-evident by the use of locking seals, shrink 

wrap, or other acceptable device/material. 

c. If the VS observer is present for the pick-up of product, after loading, ensure 

the vehicle transporting the product to the destruction site is locked. Render the 

lock tamper-evident.

d. In addition to information required on the Form 2045, the form should also list 

the weight and corresponding identification of the barrel(s), pallet(s) or other 

containers.

e. If the product(s) is to be picked up by a contractor at a later date, request a 

copy of the shipping manifest when available. The manifest should be traceable 

to the information listed on the Form 2045.

f. Request that the firm provide a copy of the records from the contractor 

confirming destruction and the method of destruction, including landfill or burial. 

The records should be traceable to the information listed on the Form 2045.

13. Summary of Revisions

Version .03

The Contact information has been updated.

8.1: Changes have been made to reflect the process change from VBIS to LSRTIS 

system.

Version .02

The Contact has been changed from Mark Pagala to Dennis Page.