1 of 6

Policy Statement on the Protection of Privileged or Confidential Business 

Information

DIALOG Accession Number: 02010988 Supplier Number: 850905353

Volume: 50 Issue: 184 Page:38561 

Citation Number: 50 FR 38561 Date: 

MONDAY, SEPTEMBER 23, 1985

Agency: Animal and Plant Health Inspection Service--

(APHIS) Document Type: Notices

Numbers: No. 85-406

Dates: Effective: 19850918

Dated: 19850918

Action: Notice

Internal Data: (FR Doc. 85-22715 Filed 9-20-85; 8:45 

am) Word Count: 1462

Text:

Animal and Plant Health Inspection Service

(Docket No. 85-406)

This notice sets forth in full a document establishing the policy of the Animal and 

Plant Health Inspection Service for protecting certain privileged or confidential 

business information. This document reads as follows:

APHIS POLICY STATEMENT ON THE PROTECTION OF 

PRIVILEGED OR CONFIDENTIAL BUSINESS INFORMATION

I. Purpose

The purpose of this policy statement is to establish minimum requirements to control and protect 

documents received by the Animal and Plant Health Inspection Service (APHIS) that in its 

judgement contain privileged or confidential business information (CBI), as defined in section IVE. of this policy statement, concerning biotechnology and the Veterinary Biologics Program..

II. Policy

Title 7, Code of Federal Regulations, sections 1.1-1.16 contain the regulations of the United 

States Department of Agriculture (USDA) implementing the Freedom of Information Act (FOIA) 

(5 U.S.C. 552). The FOIA generally provides that federal agencies must make available to the 

public all records not specifically exempt from disclosure. Section (b) (4) of the FOIA exempts from 

disclosure "trade secrets and commercial or financial information obtained from a person and 

privileged or confidential." 5 U.S.C. 552(b)(4). This policy statement applies to the disclosure of 

CBI concerning biotechnology and the Veterinary Biologics Program. APHIS will release 

such CBI only if disclosure is otherwise required by law, such as a specific statute or court 

order, by the source of the information, or as provided herein. In addition, APHIS 
CBI Policy 2 of 6

employees shall take whatever measures are necessary to preclude unauthorized 

disclosure. APHIS employees who make unauthorized disclosures of information 

classified as CBI can be subject to prosecution under the Trade Secrets Act, 18 U.S.C.

1905. Under this statute, a federal employee who discloses trade secrets and certain 

confidential data without authorization shall be fined up to $1,000 and/or imprisoned 

for up to one year.

III. Applicable Statutes

Freedom of Information Act Section (b)(4), 5 U.S.C. 552(b)(4) B. Trade Secrets Act, 18 

U.S.C. 1905

IV. Definitions

A. Access

The ability and opportunity to gain knowledge of Confidential business Information in any 

manner.

B. Administrator

The Administrator of the Animal and Plant Health Inspection Service, United States 

Department of Agriculture, or any other official of the Animal and Plant Health Inspection 

Service to whom the Administrator has delegated authority to act.

C. Authorized User

An APHIS employee or other person whom the Administrator has certified as requiring 

access to Confidential Business Information. 

D. Biotechnology

Any technique that uses living biological systems to make or modify products, to improve 

plants or animals, or to develop microorganisms for specific uses.

E. Confidential Business Information (CBI)

Information that would be protected from disclosure under section (b) (4) of the Freedom of 

Information Act (5 U.S.C. 552(b)(4)) will be classified as Confidential Business Information 

(CBI). This includes trade secrets and commercial or financial information found to the 

confidential.

1. Trade Secrets

Documents containing trade secrets and which the person submitting asserts are trade 

secrets will be deemed CBI. "Trade secrets" means information relating to the 

production process. This includes production data, formulas, and processes, and 

quality control tests and data, as well as research methodology and data generated in 

the development of the production process. Such information must be (1) commercially 

valuable, (2) used in one's business and (3) maintained in secrecy.

2. Commercial or Financial Information
CBI Policy 3 of 6

Documents containing commercial or financial information will be deemed confidential 

if review establishes that substantial competitive harm would result from disclosure. 

Information such as safety data, efficacy or potency data, and environmental data may 

be such confidential information. Persons desiring protection for confidential 

information must submit a detailed statement containing facts to show that the person 

faces active competition in the area to which the information relates, and that substantial 

competitive harm would result form disclosure.

F. Destruction

Pulverization by a paper shredder, burning, or other approved method. 

G. Information

Knowledge that can be communicated by any means. 

H. Secured Storage Area

A room or equipment that is locked.

I. Staff Office

A staff administering a particular program within the Animal and Plant Health Inspection 

Service.

J. Unique Identification Number

The number permanently assisgned to a document containing CBI when the document is 

logged in, and which enables the document to be tracked. Each document containing 

CBI will be assigned a separate number.

V. Identification of Confidential Business Information

A. The applicable staff office shall review documents it receives to determine 

whether they contain Confidential Business Information.

B. The applicable staff office shall log in Confidential Business Information it 

receives, and shall assign unique identification numbers to allow for tracking.

C. A red cover sheet printed with the unique identification number shall

be attached to the original and each copy of a CBI doucment.

D. In addition to the cover sheet, each page of each copy of a CBI

document shall be stamped "CONFIDENTIAL".

E. A record of each copy of a CBI document and its disposition shall be maintained.

VI. Physical Security of Confidential Business Information 

A. Storage of CBI Documents

1. CBI documents are to be stored in secured storage areas when not in use.
CBI Policy 4 of 6

2. At the close of a business day, doors in secured work areas shall be locked, alarms 

activated if appropriate, and documents containing CBI in unsecured work areas shall be 

placed in secured storage.

B. Access To CBI Documents By Authorized Users

1. The APHIS Administrator's office will maintain a list of persons authorized to have 

access to Confidential Business Information, and will furnish this list to staff office 

supervisors.

2. Persons will receive training on safeguarding CBI before obtaining authorized user 

status.

3. Authorized users shall obtain CBI documents through a person in each applicable staff 

office designated to be responsible for document control.

4. Requestors must present identification when obtaining CBI material from the applicable 

staff office. The requestor's name must appear on the authorized user list.

5. For each person on the authorized user list, a charge-out record will be kept. Requestors 

shall sign the record when receiving and returning CBI documents.

6. Person who terminates USDA employment will not receive exit clearance until all CBI 

documents that were charged out to the employee have been returned.

7. When an authorized user no longer requires access to CBI, the locks to which the 

person has had access must be changed.

C. Safeguards During Individual Use of CBI Documents

1. All CBI documents must be handled by authorized personnel only.

2. Authorized users shall not in any manner disclose Confidential Business Information 

to unauthorized persons. Authorized users shall determine whether persons are 

authorized to have access to CBI before discussing CBI with them.

3. When unauthorized persons are present, CBI documents must be covered,

turned face down, removed from the area, or otherwise protected.

4. All persons are individually responsible for securing any CBI documents in their 

possession. When persons are reviewing or processing documents containing CBI, the 

documents are their responsibility until they are returned to the staff person responsible for 

document control. Persons handling CBI documents must secure them before leaving their 

work area.

5. Where working areas cannot provide privacy, private meeting areas will be provided 
CBI Policy 5 of 6

for review of CBI documents.

6. Each person must safeguard keys to files, safes, rooms, etc. Keys to CBI files must be 

kept in a secured place. Lost keys or suspected breaches of security must be reported 

immediately to the person responsible for document control, so that changes can be 

immediately effected.

D. Meetings

Precautions shall be taken so that unauthorized persons are not present at meetings where CBI 

is discussed.

VII. Copying and Destruction

A. Photocopying

1. Reproduction of documents containing Confidential Business Information shall be 

kept to a minimum.

2. A record of each copy of a CBI document and its disposition shall be maintained.

3. Bad copies shall be destroyed.

B. Destruction

1. The person responsible for document control in each applicable staff office shall keep 

records of copies of CBI documents and their disposition.

2. The person responsible for document control shall perform any destruction of 

documents containing CBI.

3. When users of CBI documents have no further need for them, they shallreturn CBI 

documents to the staff office from which they obtained them. Unneeded copes will be 

destroyed in the staff office. 

VIII. Transfer of Confidential Business Information

A. Within APHIS

1. The applicable staff office shall assign unique identification numbers to CBI 

documents it receives. Copies to be sent to field offices or laboratories shall also be 

marked with the unique identification number.

2. All transfers of CBI materials within APHIS shall be recorded by the person responsible 

for document control in each applicable staff office.

3. All CBI documents transferred to field offices, laboratories, or other parts of APHIS 
CBI Policy 6 of 6

must be logged in and out by a person responsible for document control in that office.

(a) Incoming CBI documents will be entered in the log, using the previously assigned 

unique identification number printed on the cover sheet. The date of receipt will be 

recorded.

(b) Documents will then be filed in secured file cabinets.

4. Field offices and laboratories shall maintain security procedures equivalent to those 

described in this document. Field offices and laboratories shall be responsible for tracking 

and disposition of the CBI documents in their files.

B. From APHIS to Other Parts of USDA, Other Federal Agencies, and Other Persons

1. Persons from outside of APHIS must show that they need Confidential Business 

Information for a proper official purpose.

2. Persons from outside of APHIS must maintain security procedures equivalent to 

those of APHIS before they may receive Confidential Business Information.

3. The person submitting the CBI will be notified of any requests by the public for 

disclosure and the scope of information to be disclosed, if any. 

C. Mail

CBI documents shall be transmitted by registered mail, return receipt requested.

Effective date: September 18, 1985.

Dated: September 18, 1985.

Bert W. Hawkins,

Administrator Animal and Plant Health Inspection Service. (FR Doc. 85-22715 Filed 9-20-

85; 8:45 am)

BILLING CODE 3410-34-M

Legal Publications:

Pub. Law 90-23 -- Freedom of Information Act, Amendment (6/5/67)

Pub. Law 80-772 -- Crimes and Criminal Procedure, Title 18 U.S.C., Enactment (Act of 

6/25/48); Trade Secrets Act (Act of 6/25/48)

Federal Register (Dialog® File 180): (c) 1999 format only The DIALOG Corp. All 

rights reserved.