U. S. Department of Health and Human Services
U. S. Food and Drug Administration

Center for Food Safety & Applied Nutrition
Office of Food Additive Safety
Questions About the Petition Process

Whom do I contact to determine if I need to submit a petition to the Office of Food Additive Safety?

After I submit a petition, who is the point of contact for my petition?

How do I prepare the scientific documentation to support the safe use of my proposed food additive?

What are the basic elements of a safety assessment for a food additive?

What is meant by the administrative record for a food additive?

What are the essential elements of a good petition?

How do I prepare a petition that contains the appropriate chemistry information?

How do I prepare an adequate environmental assessment?

How do I determine the type of toxicological information necessary to support the safety of my proposed food additive?

How do I design toxicological studies that will provide the information necessary to establish safety?

What other factors can help to make my submission of toxicological information successful?

How should the results of the toxicity studies be presented and discussed?

What are some factors to consider when assessing the significance of treatment-related effects in toxicity studies?

Can you give a very simplified overview of the process a petition undergoes after it is filed?

What are some characteristics of the food additive approval process?

After a notice of filing is published, how long does it usually take until a final regulation is published in the Federal Register?





Obtaining Information through the Office of Food Additive Safety

A Consumer Safety Officer (CSO) is assigned to each petition

To contact a CSO, write, call, FAX or e-mail:

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Technical Guidelines for Scientific Documentation


*Note: Regulations are requirements defined by law in the U.S. code of Federal Regulations (CFR). The format required for a food additive petition is outlined in 21CFR 171.1 and it must be followed exactly because it is a regulation. Guidance documents are neither requirements nor are they binding by law, but are agency documents that provide assistance to the petitioner in preparing information for scientific review. These documents provide information that helps the petitioner submit information in a consistent and appropriate manner.

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Elements of Safety Assessment

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Administrative Record for a Food Additive

Food Chart - Administrative Record pyramid

Data are submitted by the petitioner

There is communication between FDA and the petitioner

FDA reviews the data as clarified by the communication, and prepares memoranda

FDA prepares a final administrative memorandum summarizing its findings

FDA publishes a final regulation, which

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Food Additive Petition Required Content

*As required by the National Environmental Policy Act, as revised (62 FR 40570; July 29, 1997)

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Chemistry Information

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Environmental Information

The draft guidance listed below is intended to assist submitters in the preparation of claims of categorical exclusion and environmental assessments (EA). The draft guidance recommends the types of information that would be helpful to the agency's review of environmental submissions and refers to the National Environmental Policy Act (NEPA) implementing regulations in 21 CFR Part 25 that were revised in July 29, 1997.

Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.

If extraordinary circumstances indicate that the proposed action might have significant environmental impacts, the agency will require the preparation of an EA for any normally excluded action. Examples of extraordinary circumstances are listed under Council on Environmental Quality regulations (40 CFR 1508.27) at http://ceq.eh.doe.gov/nepa/regs/ceq/1508.htm. In most instances, a categorical exclusion can be determined or confirmed by review of other information in the submission. In limited instances, CFSAN will recommend additional information to establish that the criteria for a categorical exclusion have been met, particularly for exclusions claimed under 21 CFR 25.32(i) and (q).

When testing is necessary, consult the Environmental Assessment Technical Assistance Handbook.

Please contact the Environmental Review Group at ERG@CFSAN.FDA.GOV for assistance in preparing a claim of categorical exclusion or an EA and before doing environmental fate and effects testing. If an EA is necessary, we recommend that you:

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Toxicology Information

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Toxicology Information

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Toxicology Information

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Toxicology Information

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Toxicology Information

From: Principles and Methods of Toxicology, Third Edition (1994), Chapter 17, page 668.

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The Food Additive Petition Review Process

The schematic below represents an extremely simplified picture of some of the elements that contribute to the food additive petition review process. This is an iterative process in which some steps may be repeated several times until there is an agency consensus that there is a reasonable certainty of no harm from the use of the petitioned additive.



A new food additive petition is received

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OFAS begins the initial review:

The Consumer Safety Officer distributes appropriate parts of the petition to experts for evaluation:

Chemistry Review Health Effects Evaluation Environ-
mental Review
Evaluation by Other Govern-
ment Experts
Evaluation by "Outside" Experts
The identity, functionality, manufacturing process and specifications are verified. Toxicology and Nutrition studies are verified. A toxicity NOEL is established. Enviromental data are evaluated. As needed on a case-by-case basis As needed on a case-by-case basis
An EDI is calculated. An ADI is calculated. An Environmental Review is prepared. A report is prepared. A report is prepared.

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Decisions are made:

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The final agency review is completed.
The final regulation is published in the Federal Register.
The regulation appears in the Code of Federal Regulations.

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Some Characteristics of the Food Additives Approval Process

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Time to Final Rule

Type of Submission Average Time Between Submission Until a Final Rule is Published
Threshold of Regulation (1) 4 months
Indirect Additive Petition (1) 13 - 18 months
Color Additive Petition 6 - 72 months
Direct Additive Petition 24 months
GRAS Petition (2) N/A



The time to final rule for a petitioned chemical is dependent on:

1. Many Food Contact Substances should be covered by the new Premarket Notification Program.

2. The Agency has proposed a GRAS notification process and has accepted a number of GRAS notifications.

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