Issuing

Agency/Office:

Animal and Plant Health Inspection Service (APHIS),

Biotechnology Regulatory Services (BRS)

Title of

Document:

Guide for Claiming Confidential Business Information (CBI) in

Submission to APHIS BRS

Document ID: BRS-GD-2020-0004

Date of

Issuance:

December 20, 2021

Replaces: Guidance for Confidential Business Information Guidance 

Instructions issued on June 18, 2020

Summary: This guide assists the public with submitting documents to 

APHIS BRS by describing formatting and justification

procedures for indicating CBI.

Disclaimer: The contents of this guide do not have the force and effect 

of law and are not meant to bind the public in any way. This 

guide is intended only to provide clarity to the public 

regarding existing requirements under the law or agency 

regulations.
USDA-APHIS-BRS CBI Submission User Guide

ii

APHIS Biotechnology Regulatory Services

Guide for Claiming Confidential 

Business Information (CBI) in 

Submission to APHIS BRS

v. December 20, 2021

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service

United States Department of Agriculture 

4700 River Road

Riverdale, MD 20737

The information contained in this document is intended solely as guidance. Except where 

noted, persons may choose to follow APHIS guidance or follow different procedures, 

practices, or protocols that meet applicable statutes and regulations.

Language implying that guidance is mandatory (e.g., “shall,” “must,” “required,” or 

“requirement”) should not be construed as binding unless the terms are used to refer to a 

statutory or regulatory requirement.

Following the guidelines contained in this document should not be construed as a guarantee 

of compliance with applicable statutes and regulations.
USDA-APHIS-BRS CBI Submission User Guide

3

 Table of Contents

Introduction to Understanding Confidential Business Information.......................................3

What is CBI?................................................................................................................................4

CBI Justification..........................................................................................................................5

Preparation and Submission of Documents ............................................................................6

CBI, CBI-Deleted, and No CBI Document Formats ..................................................................6

All documents are subject to the Freedom of Information Act (FOIA) 5 U.S.C. § 552, which 

requires federal agencies to provide the public with access to information. BRS provides the 

public with access to information in response to requests submitted through the APHIS FOIA 

office and by publishing subsets of information on the APHIS BRS website. When providing 

such access, BRS considers section (b)(4) of the FOIA, which exempts from disclosure 

certain types of information that are customarily kept as confidential by the business 

submitter. BRS follows USDA regulations (7 CFR §§ 1.8, 340.7) and Executive Order 12600 

in ensuring submitters have the opportunity to claim CBI, consistent with federal law. 

Examples of information BRS publishes on the APHIS BRS website include:

• Confirmation requests seeking to confirm exemption from regulation under 7 CFR part 

340.

• Regulatory Status Review requests to determine whether a plant developed using 

genetic engineering is regulated under 7 CFR part 340.

• Petitions seeking a determination of non-regulated status for a plant developed using 

genetic engineering submitted under the legacy 7 CFR part 340.

Guide for Claiming CBI in Submission to 

APHIS BRS

Introduction to Understanding Confidential Business 

Information
USDA-APHIS-BRS CBI Submission User Guide

4

What is CBI?

Section (b)(4) of the FOIA (also known as Exemption 4) protects (or exempts) from disclosure

information that comprises “trade secrets and commercial or financial information obtained from 

a person and privileged or confidential.” BRS refers to this type of information as CBI. BRS 

follows Department of Justice guidance when analyzing CBI claims.

When a submitter provides BRS with information and seeks to claim CBI, the submitter must 

demonstrate the information is customarily kept private or closely held, in the context of industry 

practices concerning the information. 

Information that is often justified as CBI in submissions to BRS includes:

• Genotypes, phenotypes (also known as phenotype descriptions), mechanisms of action, 

donor organisms, gene or genetic sequence names, gene descriptions, and transformation 

methods

• Points of origin and destination such as location name and description, and address and 

contacts (except for County and State names)

• Name, location, and contact information of suppliers or developers of plants or organisms 

developed using genetic engineering (except for County and State names)

• Detailed descriptions of the country (or countries) and locality (or localities) where the 

organisms was collected, developed, manufactured, reared, cultivated, and cultured (as 

applicable)

• Field test location sites such as cities, zip codes, and descriptions (except for County and 

State names)

• Acreage location (descriptions, drawings, maps, addresses, and GPS coordinates)

• Release site history if it reveals the location (e.g., describing a location as being next to a 

known landmark)

• Acreage and Material Quantities

• Individuals who are connected to a field test site location

• Contractual information between the submitter and a cooperator

• Literature references that describe CBI 

• Novel methods, processes, procedures, or safeguards

• Novel design protocols/production design/standard operating procedures

• Novel destruction/devitalization methods

• Novel species names of soil microbial biocontrol agents or pests/diseases

Information that does not typically qualify as CBI in submission to BRS (and, thus, is 

typically released publicly) includes: 

• Information published or otherwise publicly available may not be claimed as confidential or 

CBI

• Common plant, pest, or pathogen names for which many permits have been issued

• Trait (e.g., “Herbicide Resistance,” “Product Quality,” etc.)

• County and State names found anywhere in documentation

• Field test or other location site codes/coded location identifiers, and other reference 

numbers not distinguishable outside of the submitter’s business

• BRS assigned numbers

• Release site history that does not reveal the location 

• Critical habitat specific site locations
USDA-APHIS-BRS CBI Submission User Guide

5

• Applicant information submitted to ePermits or eFile: Applicant’s name, position, 

organization, organization unique identification name or number, full address including 

number and street, county/providence, township or island, zip codes, country, day 

telephone, fax, email addresses, and any alternate information. Note that is information 

found in Block 1 of an ePermit or eFile application.*

• Responsible person(s)/entity names

• Signatures of responsible person(s)*

• Document or table headings

• Most literature references

• Commercialized or widely known production methods, processes, or procedures

• Plant names/organism names along with general descriptions of the plant or organism

• Plant traits

• General descriptions of the phenotype and mechanism of action for plants developed 

using genetic engineering

• All of the above for Petitions, Regulatory Status Reviews, Confirmation Requests, and 

Compliance Submissions, and:

• Submitter’s individual names/phone numbers/addresses/email address/fax 

number(s)

• Identifying line names

Note that these are not exhaustive lists. BRS will review each claim of confidentiality and will discuss with the 

submitter any claims that do not meet the criteria for CBI. BRS encourages submitters to release genotypic, 

phenotypic, mechanism of action, and any lab and field data submitted to support RSR requests that proceed to 

the second step of the RSR process to facilitate public understanding and comment on APHIS reviews. If and 

when BRS determines that a plant is not regulated under 7 CFR part 340, BRS will release a subset of 

information that is published in the PTMOA and RSR tables (e.g., specific phenotype and mechanism of action) 

even if such information was previously claimed as CBI. BRS will not remove redacted areas from submitter 

documents but will make such information publicly available in tables that appear on the BRS website, as seen 

here. 

*Although some information is not eligible for withholding as CBI, it may qualify for protection as 

Personally Identifiable Information (PII) under FOIA Section 6(b)(6), such as the signatures of 

responsible persons. 

CBI Justification

All claims of CBI must include a CBI justification and such claims expire 10 years after the date 

of the submission unless the submitter requests and provides justification that supports a longer 

designation period.

CBI justifications must be detailed enough to demonstrate that each piece of information 

claimed as CBI is customarily kept private or closely held, in the context of industry practices 

concerning the information. Information is not protected from disclosure simply because the 

submitter does not want the information to be made public. The language used to prepare your 

CBI justification should be in non-technical terms when possible and should not reveal any 

information marked as confidential.

When evaluating CBI claims, BRS considers the factors outlined in the Department of Justice’s

guidance, the submitter’s previous document submissions and CBI claims (if any), and publicly 

available information. BRS will consult with the APHIS FOIA Office as necessary when 
USDA-APHIS-BRS CBI Submission User Guide

6

considering CBI claims and the release of submitted information. 

Preparation and Submission of Documents

If a document intended for submission to BRS does not contain CBI, only submit one copy. These 

documents should be clearly marked “No CBI” in the upper right corner of the first page.

If a document intended for submission to BRS contains information the submitter claims as 

CBI, the submitter must submit two versions of the document along with the justification: a 

complete version containing CBI (the “CBI Copy”), and an edited version with the CBI 

redacted (the “CBI-deleted Copy”).

• submit Petition documents to: BRS.Petitions@usda.gov

• submit Confirmation Requests documents to: ConfirmationRequests@usda.gov

• submit Regulatory Status Review documents to: RSRrequests@usda.gov

• submit Permit and Compliance documents within USDA APHIS online eFile 

system: https://efile.aphis.usda.gov

• note Compliance documents may also be submitted via: BRSCompliance@usda.gov

• each page of a document containing CBI must have “CBI Copy” marked in the upper right corner 

• each page of a CBI-redacted document must have “CBI-deleted Copy” marked in the upper right corner 

• in a document containing CBI, mark with square brackets (“[ ]”) only the specific 

words, phrases or sentences claimed as CBI, and in the right margin for each set of 

brackets write “CBI”

• in the CBI-deleted version, replace with blank spaces the words or phrases marked in 

the CBI version, mark the spaces with square brackets, and in the right margin for each 

set of brackets write “CBI-deleted”

• the CBI-deleted version should be identical to the CBI version, except blank spaces 

surrounded by square brackets occurring in the text where the CBI text has been 

redacted and “CBI-deleted Copy” should appear in the upper right corner of each page 

instead of “CBI Copy”

• the CBI-deleted version must be paginated identically to the CBI copy and should be made directly from 

the same document that originally contained CBI 

• do not insert additional text (transitions, paraphrasing, or generic substitutions, etc.) into 

the spaces of the CBI-deleted version

• all published references that appear in the reference list of a CBI copy should be 

included in the reference list of the CBI-deleted copy

CBI, CBI-Deleted, and No CBI Document Formats

See Sample Letters on following pages.
CBI 

Bernadette Juarez

U.S. Department of Agriculture 

APHIS Deputy Administrator 

Biotechnology Regulatory Services

Contains Confidential Business Information

Dear Ms. Juarez,

The following example document demonstrates proper formatting and composition of submissions 

containing Confidential Business Information (CBI) to Biotechnology Regulatory Services (BRS).

Arranging content in this way ensures clarity and protection for an institution’s CBI data.

This sentence gives background on the purpose of the communication without disclosing novel 

business methods, practices, or data. This sentence names and describes [specific genotypes, phenotypes, 

donor organisms, gene names, gene descriptions and transformation methods] to provide BRS with 

context needed for a decision or response. Square brackets should surround the CBI data to denote its 

sensitivity.

Publicly available information is not eligible to be claimed as CBI. However, [trade secrets and 

information that is customarily kept private by the submitter] may be claimed with the proper 

justification. This justification letter should be submitted along with the request and should detail each 

category of information that was claimed, without revealing the data itself. A CBI deleted copy of the 

document should also be provided along with the submission.

For example, if [Gene ABC] is CBI and used in transformation of the organism, [Gene ABC] 

should be surrounded by brackets and not visible anywhere in the CBI deleted copy of the document. In 

the justification document, a submitter should explain .how the information is customarily kept private 

by the submitter without revealing the actual information that was enclosed in square brackets.

For proper formatting of CBI Deleted or No CBI materials, please see the following pages.

CBI 

CBI

CBI 

CBI

CBI, CBI

 Sincerely,

Your Name

Your Title 

Your Address

Your Phone

Your Email

Contact Info is not considered CBI but 

may be protected as Personally 

Identifiable Information (PII), 

if requested

 

 

 

Each page 

should 

denote 

that the 

document 

contains

CBI

 

 

 

 

 

 
CBI Deleted 

Bernadette Juarez

U.S. Department of Agriculture 

APHIS Deputy Administrator 

Biotechnology Regulatory Services

Confidential Business Information Deleted

Dear Ms. Juarez,

The following example document demonstrates proper formatting and composition of CBI Deleted 

documents that must be included with CBI submissions to Biotechnology Regulatory Services (BRS). 

This document should be identical to the confidential copy, but have all CBI replaced with blank space.

This sentence gives background on the purpose of the communication without disclosing novel business 

methods, practices, or data. This sentence names and describes [

] to provide BRS with context needed 

for a decision or response. Square brackets should surround the CBI data to denote its sensitivity.

Publicly available information is not eligible to be claimed as CBI. However, [

] may be claimed with the proper justification. This justification letter 

should be submitted along with the request and should detail each category of information that was claimed, without 

revealing the data itself. A CBI deleted copy of the document should also be provided along with the submission.

For example, if [ ] is CBI and used in transformation of the organism, [ ] should be 

surrounded by brackets and not visible anywhere in the CBI deleted copy of the document. In the justification 

document, a submitter should explain how the information is customarily kept private by the submitter without

revealing the actual information that was enclosed in square brackets.

For proper formatting of CBI documents, please see the previous page. A No CBI example follows.

Sincerely,

Your Name 

Your Title 

Your Address 

Your Phone

Your Email

Each page 

should 

denote 

that the 

document 

is 

CBI 

deleted

 

 

 

 

 

 

Contact Info is not considered CBI but 

may be protected as Personally 

Identifiable Information (PII), if 

requested

 

 

 

 

 
No CBI

Bernadette Juarez

U.S. Department of Agriculture 

APHIS Deputy Administrator 

Biotechnology Regulatory Services

Does Not Contain Confidential Business Information

Dear Ms. Juarez,

The following example document demonstrates proper formatting and composition of submissions 

that do not contain Confidential Business Information to Biotechnology Regulatory Services (BRS). 

Arranging content in this way ensures clarity that the document does not contain sensitive CBI data.

This sentence gives background on the purpose of the communication to provide BRS with context 

needed for a decision or response. Square brackets should not be included anywhere in the document.

No CBI should be in this document. A justification document is not required with the submission, 

and no CBI-deleted copy is necessary.

For example, if Gene ABC is not considered to be novel, proprietary, or secret, Gene ABC should 

not be surrounded by brackets. Regardless of whether a document is marked as containing CBI, BRS and 

APHIS FOIA routinely allow submitters to conduct a “Requestor CBI” review prior to any public 

disclosure of the materials. Submitters have a second opportunity to review the document for justifiable 

claims of CBI at that time.

For proper formatting of CBI and CBI-deleted documents, please see the previous pages.

Sincerely,

Your Name 

Your Title 

Your Address 

Your Phone 

Your Email

.

First page 

denotes

No CBI 

is 

contained 

in the 

document

 

 

 

 

 

 

 

 

 

Contact Info is not considered CBI but 

may be protected as Personally 

Identifiable Information (PII), if 

requested