Office of Food Additive Safety

1
Office of Food Additive Safety

• Information for Industry Steps to
  Implementation of Electronic Submissions

2
Overview by Dr. Alan Rulis, Director, Office of
Food Additive Safety

• Launch Electronic Submissions
• Accelerate the Rate of Review of Direct Food and
  Color Petitions
• Encourage Companies to Participate in
  Pre-Petition Consultations
• E-Submissions Component of Larger Program
• Food Additive Regulatory Management (FARM)
• Publish Future Guidance on Food Contact
  Notifications, Generally Recognized as Safe
  Notices, and Biotechnology Notifications.

3
Electronic Submissions Readiness

• Open for Business
• All Submissions are Converted to Electronic
  Format
• E-Submissions Made in Accordance with the New
  Petition Organization will Make Our Job More
  Efficient

4
Introduction To New Organization and Process

• Address Two Draft Guidance Documents Released
  7/31/01
• Providing Regulatory Submissions to Office of
  Food Additive Safety in Electronic Format for
  Food Additive and Color Additive Petitions
• Providing Regulatory Submissions to Office of
  Food Additive Safety in Electronic Format
  General Considerations
• Suggestions on the Best Way to Submit Petitions
  in Electronic Format - not Requirements

5
Introduction to New Organization and Process -
Continued

• Advantages to New Organization of Petition and
  Submitting Petitions in Electronic Format
• Fits with OFASs Electronic Systems for Handling
  the Petition Review
• Expedites Processing
• Increases the Accuracy of the Files OFAS Reviews
• Helps OFAS Reviewers Find and Understand All of
  the Information Submitted in the Petition

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Objectives

• Review the Key Aspects of the Food and Color
  Additive Guidance for e-Submissions
• Encourage Petitioners to Use Guidance to Submit
  Electronic Submissions

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Background
Old Petition Process
New Petition Process

• Paper Copy of Petition in Triplicate or
  Quadruplicate

• One Paper Copy in New Format
• or
• One e-Submission with Signed Application Form
• CD-ROM
• Diskettes/Zip Disk
• Electronic Tape

8
Review Process
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Guidance Overview Technical Perspective

• Roadmap.pdf Serves as the Organizer
• Standard Formats are Used to Submit Documents and
  Data
• Acrobat (Portable Document Format - PDF)
• Entire Petition in PDF Duplicate Information in
  Other Formats
• Statistical Analysis System (SAS)
• Chemical Structure Formats.
• Process Allows for Systematically Placing Files
  in Predetermined Folders

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Food Additive ApplicationFDA 3503
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Chemical Identities Section
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Submission Information
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Chemistry and Safety Sections
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Administrative and Environmental Sections
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Signature
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Organization of Food and Color Additive
Submissions
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Main Folder

• Folders
• Administrative Folder
• Chemistry Folder
• Safety Folder
• Environmental Folder
• Documents
• Roadmap.pdf
• Cover.pdf
• Executive Summary.pdf
• FAP or CAP Submission Application.pdf

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Administrative Subfolder

• Documents
• Administrative TOC.pdf
• Proposed Tolerances.pdf
• Proposed Regulation.pdf
• Folders
• Correspondence Folder
• Incoming Folder
• Supplement Cover.pdf

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Chemistry Subfolder

• Documents
• Chemistry TOC.pdf
• Identity.pdf
• Exposure.pdf
• Intended Technical Effect.pdf
• Analytical and Methodology.pdf
• Method of Manufacture.pdf
• Use.pdf
• Specifications.pdf
• Subfolders
• Studies
• References

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Chemistry Studies Folder

• Each Study Report Should be Provided as a
  Separate PDF File
• All Studies Should be Placed into a Single Folder
  Named Studies
• The Studies Folder Should be Placed in the
  Chemistry Subfolder

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Chemistry References Folder

• Each Reference Should be Provided as a Separate
  PDF File
• All References Should be Placed into a Single
  Folder Named References
• The References Folder Should be Placed in the
  Chemistry Subfolder

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Safety Subfolder

• Documents
• Safety TOC.pdf
• Safety Summary.pdf
• Folders
• Studies
• References

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Safety Studies Folders

• Studies Categories
• Make a Studies Folder for Each Type of Safety
  Study Included in a Petition
• Make Each Study a Single PDF File
• Place The Study in the Appropriate Topic Folder

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Safety References Folder

• Each Reference should be
  Provided as a Separate
  PDF File
• All References Should be
  Placed into a Single Folder
  Named References
• The References Folder
  Should be Placed in the
  Safety
  Subfolder

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Environmental Subfolder

• Documents
• Environmental TOC.pdf
• Environmental Assessment.pdf
• Categorical Exclusion.pdf
• Folders
• Studies
• References

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Supplements and Amendments

• Petitioner places Supplement or Amendment Cover
  Letter in the Administrative/Correspondence/Incomi
  ng Folder
• Cover Letter Should Include Hypertext Links to
  the Data in the Appropriate Folder
• Chemistry
• Safety
• Environmental

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Updating the Roadmap File

• Submission Amendments and Supplements are
  Accompanied by an Updated and Complete
  Roadmap.pdf
• Updated Roadmap.pdf Is Imported into FARM as Part
  of Original Module
• Links of New Roadmap.pdf Provides Hyperlinks to
  All Files
• Original Files
• Supplemental or Amended Files

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Summary

• Submissions
• New Culture for OFAS and Industry
• Files and Forms
• Roadmap.pdf - Improves Organization and
  Productivity
• Folder Structure
• Chemistry, Safety, Environmental
• Tools - Acrobat PDF, SAS, Chemical Structures
• Supplements and/or Amendments

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Questions?