Speakers

• Chessa Huff-Woodard Esq., Branch Chief, Policy 

Program and International Collaborations Group

• Rochelle Langley, PhD, BQMS Manager, Policy, 

Program and International Collaborations Group

• Cindy Eck, Document Control Officer, 

Team Lead for BRS Communications Group
1. Webinar Objectives

2. BQMS Program Overview

3. Confidential Business Information (CBI)

4. CBI Examples in Document Submissions
The participants will be able to describe:

1. BQMS Program in general

2. Confidential Business Information (CBI)

3. Use of CBI

Biotechnology Quality Management 

Support Program 

• Supports compliance with 7 CFR 340

• Voluntary program 

• Accessible to ALL organizations

• Online resources found on our BRS website 

• Targeted training from BRS
Quality Management System (QMS)

Procedures

Manuals

Forms &

Templates

Records
Quality Management System Cycle

Improve

Plan

Do

Check

Act
BQMS Program

Your Unique BQMS

Document 

Control Internal

Control

Critical 

Control 

Point

Process 

Improvement
BQMS Program

Your Unique BQMS

Document 

Control

Document control

Record Control
BQMS Program

Your Unique BQMS

Critical 

Control 

Point

1. Site Selection Planning

2. Storage

3. Transport, Movement, and Import

4. Environmental Release Planning and 

Monitoring

5. Post-harvest Handling and Transfer 

6. Devitalization and Final Disposition 

7. Potential Regulatory Compliance 

Incidents 

8. Reporting Form for Potential Regulatory 

Compliance Incidents
BQMS Program

Your Unique BQMS

Internal

Control

Competency 

Awareness

Management Review 

Meeting Form
BQMS Program

Your Unique BQMS

Process 

Improvement

Internal Audit

Corrective Actions

Preventive Actions

CARs and PARs Form
BQMS Program

Your Unique BQMS

Document 

Control Internal

Control

Critical 

Control 

Point

Process 

Improvement

The Federal Records Act of 1950

amended in 2014

E-Government Act of 2002

and other Laws & Regulations

36 CFR Parts 1220-1238

18 U.S. Code § 2071 

18 U.S. Code § § 793, 794, & 798

• Anyone can request government records

• Practices and policies fall in line with 5 U.S.C § 552 FOIA 

• All Federal Agencies receive CBI guidance/FOIA guidance 

through case law and the DoJ 

• Familiarize yourself with these current court decisions: 

http://www.justice.gov/oip/courtdecisions/exemption4.html
We want you to prepare your CBI justifications as though you 

were preparing them for release under the FOIA. 

• The APHIS FOIA Office says your justification should tell 

us: 

 What each category of information reveals about your 

organization's business 

 How a competitor could use this information to cause 

your company competitive harm 

 The specific competitive harm (e.g., financial, research & 

development, etc.) that could result if the information is 

released
• The term “CBI” is used for information that is 

protected from disclosure under section (b)(4) of 

the Freedom of Information Act (FOIA). This is 

sometimes referred to as “Exemption 4”. 

• BRS allows permit, notification, petition 

applicants, and Am I Regulated inquirers to make 

a claim of CBI for documentation they send to us 

(voluntarily). 

Confidential Business Information
• CBI includes TWO distinct categories of 

information:

1. Commercial and financial information that is 

privileged or confidential

2. Trade secrets 

Confidential Business Information
Commercial and Financial information
Trade Secrets
• Exemption 4 is intended to protect the 

interests of both the government and 

submitters of information. The very existence 

of Exemption 4 encourages submitters to 

voluntarily furnish useful commercial & 

financial info to the government and provides 

the government with an assurance that 

required submissions will be reliable.
• Exemption 4 also affords protection to those 

business submitters who are required to 

furnish commercial or financial information to 

the government by safeguarding them from 

the competitive disadvantages that could 

result from disclosure.
• Executive Order 12600

• FR- Vol. 52, No. 122/Thursday June 25, 1987

– Pre-disclosure Notification Procedures for 

Confidential Commercial Information

• Sections 1-10

• BRS’ CBI Instruction Package 

FOIA & BRS CBI 

Submission Requirements
• Field Test Location Sites - cities, zip codes and 

descriptions (this does not include County and State 

Names)

• Acreage Location (descriptions, drawings, maps, addresses 

and gps) and quantities 

• Literature references that point to gene/genotype and other 

area of the submission that is claimed as CBI

• Individuals who are connected to a field test site location 

• Novel: methods, design protocols, devitalization methods

• Voluntary submission of self-certifying audit reports.

What BRS Typically Accepts as CBI
• Any information found on the Web.

• Previously claimed CBI that is now publically 

available.

What BRS Does Not Consider CBI
• A detailed justification statement should 

include: 

1. Active competition 

2. Substantial competitive harm or 

disadvantage would result from 

disclosure

Submitting CBI Documentation 

must have a Justification
Sample justification: 

• Revealing genetic material (promoters, genes & 

terminators) is typically claimed as CBI. 

• You would tell us how providing the phenotype 

description, phenotype, and genetic material inserted 

and/or the donors would compromise the time and 

expense spent in developing the technology to produce 

the desired trait. You would state that: this particular 

genetic combination is unique because the arrangement 

is novel and the genetic constructs are also unique. 

Tell us HOW they are unique or novel.

Submitting a CBI Justification to BRS
Justifications Continued

• You would tell us: If this information was 

disclosed, replication by a competitor would 

cause the loss on many dollars in developing 

your technology. 

• Furthermore, the competitors would have 

access to this technology for free at your 

expense.
If you claim CBI, you must:

• Mark the document “Contains CBI” and 

• Provide us a CBI-deleted copy. 

• Provide us 

– A CBI justification and 

– Documentation using bracket formatting that we 

will discuss. READ our Regs 7 CFR 340 to know 

how to submit and how to mark up!

Let’s summarize: 

Submitting CBI Documentation 

Submitting CBI Documentation 

Full Life Cycle

Documents 

submitted 

to BRS

Maintained 

on site in 

BRS

Retired

Destroyed 

or 

Transferred 
• Officials and agents who receive, create, or handle 

CBI for BRS must prevent the unauthorized 

disclosure and maintain CBI under secure 

conditions while in their possession.

• Officials are responsible for ensuring the proper use 

of email to disseminate CBI and proper hardcopy 

handling of CBI.

• Officials and agents are responsible for maintaining 

the confidentiality of CBI as well as other 

documentation. 
• Must have a demonstrated need to know CBI

• Must sign or certify the APHIS BRS 

confidentiality agreement

• Must be trained annually

Authorized Employees
• Confirm the name, office location, phone 

number, & email of your BRS contact.

• USDA requires officials and agents to place 

the following legal disclaimer on emails we 

send out. Let us know if you do no see this 

message from your sender:

“This electronic message contains information generated by the USDA solely for the 

intended recipients. Any unauthorized interception of this message or the use or disclosure 

of the information it contains may violate the law and subject the violator to civil or criminal 

penalties. If you believe you have received this message in error, please notify the sender 

and delete the email immediately.”

We recommend some Practical Steps in 

Safeguarding YOUR CBI
• Only authorized officials and agents can handle your 

CBI

• Official and agents must return CBI documents to 

where they are controlled under our file plans. We 

place a file plan with our Agency’s Records Officer, 

which is sent to the NARA annually. 

• Remind attendees to treat all discussions as CBI

Practical Steps Continued
• Verify identity of participants on the call

• Conversation can be claimed as CBI – Tell 

us what is CBI 

– NOTE: telephone lines are not secure

• Meetings – We erase dry erase boards & 

collect materials at the end of meetings and 

refile according to our file plans

Practical Steps Continued
• Memory sticks are crushed

• Disks are physically destroyed in a

disk shredder

• Paper is shredded

• Typewriter ribbons are burned

Destruction of CBI Material
Confidential Business Information (CBI)

vs 

Personal Identifiable Information (PII) 

– Often confused

Let’s Go over one last Item
Personal Identifiable Information (PII)
• Privacy Act of 1974

5 U.S.C. § 552a & 

• FOIA’s Exemption 6 

Personal Identifiable 

Information Requirements
General Document Preparation 

for Submission to BRS

BRS User's Guide: General Document 

Preparation Guidelines for Submission to BRS
• General Text Formatting

• Scientific Names and Terminology

• References

• Tables

• Figures

• Equations 

• Sequence Data

• Color Printing Media Type and Number of Copies 
Documents submitted to BRS are primarily related 

to four types of regulatory procedures and one non 

regulatory solution:

• Permits for the introduction of regulated articles

• Notification of the introduction of regulated articles

• Petitions to determine nonregulated status of a 

regulated article

• Petition extensions 

• Providing developers with a determination of 

whether their organism or product is regulated 

according to 7 CFR part 340
e-Permits System

– Brackets [ ]

• Applications

– Supporting Documents

• Compliance Reports/Reporting

• Uploaded documents may need resubmission 

• Science Journals and the problem with brackets...

Permits & Notifications 

e-Permits Submission Requirements
Does your entire DP or SOP need to be 

claimed as CBI? Probably not.....

Design Protocol Submissions
• Guidance for New Users to the Petition 

Process

• Guidance for Submitting a Petition

• Guidance on Requests for Extensions of 

Non-Regulated Status

Petition & Extension Petition

Submission Requirements 
• 7 CFR 340.6 

The petitioner shall include copies of scientific literature, copies 

of unpublished studies, when available, and data from tests 

performed upon which to base a determination. The petition shall 

include all information set forth in paragraph (c) of 7 CFR 340.6. 

If there are portions of the petition deemed to contain trade 

secret or confidential business information (CBI), each page 

of the petition containing such information should be marked 

‘‘CBI Copy’’. In addition, those portions of the petition which 

are deemed ‘‘CBI’’ shall be so designated. The second copy shall 

have all such CBI deleted and shall have marked on each page 

where the CBI was deleted: ‘‘CBI Deleted.’’ If a petition does 

not contain CBI, the first page of both copies shall be 

marked: ‘‘No CBI.’’

Petition Submission Requirements
“Am I Regulated (AIR) Inquiry” 

Submission Requirements 

Am I Regulated Under 7 CFR part 340?

AIRinquiry@aphis.usda.gov
Transferring a 

Permit or Notification?

• Permit/Notification number(s)

• New Owner Username (eAuthentication User ID)

• New Owner Name First, Middle (if any), Last

• New Owner Email

• New Owner Phone Number(s)

• Organization Name

• Previous Owner Name (submitter)

• Previous Owner Username (eAuthentication User 

ID) – if available, for verification purposes
Transferring a 

Permit or Notification?

Send to

Cynthia A. Eck

Document Control Officer

USDA APHIS BRS 

4700 River Road, Unit 146, 

Riverdale, MD 20737 

You CAN email the signed company letterhead to:

Cynthia.a.eck@aphis.usda.gov
Compliance Report
• Planting ID - should not be CBI' d

• Location IDs - should not be CBI' d

Compliance Reporting 

Submission Requirements
How to Find 

More Information 
• Rochelle Langley – BQMS Quality Manager

• Cindy Eck – Document Control Officer

USDA/APHIS/BRS 

Riverdale, MD

(301) 851-3906 or (301)851-3892

Rochelle.A.Langley@APHIS.USDA.GOV

Cynthia.A.Eck@APHIS.USDA.GOV

Questions about CBI?
Closing Remarks