Dairy Ingredients for Food Processing

Figure 15.1. Administrative steps in a new food additive approval cycle.

A new petition is received.

↓

• OFAS evaluates the petition for adequacy of filing (if
  adequate, a filing notice is published in the Federal Register).


• The need for review outside CFSAN is determined.
  ↓
  The consumer safety officer distributes appropriate parts of the
  petition to experts for evaluation:
  ↓

Chemistry

review

Toxicology

review

Environ-

mental

review

Evaluation

by

other

government

experts

Evaluation by

outside

(nongovernment)

experts

The identity,

specifications,

manufacturing,

use,

functionality,

and exposure

estimate are

verified.

Analytical

methods are

evaluated.

Safety

studies

are

evaluated.

Environmental

data are

evaluated.

As needed

on a

case-by-

case

basis.

As needed on a

case-by-case

basis.

Probable

exposure is

calculated.

Acceptable

exposure

level is

determined.

An

environmental

memo is

prepared.

A report

is

prepared.

A report is

prepared.

↓

Decisions are made:

• A tentative safety conclusion is reached.


• Advisory committee input is received, if necessary.


• The final safety evaluation is made.


• The administrative record is compiled.


• A Federal Register final rule is drafted.

↓

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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