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Food Ingredients Approval and Sources of
Radiation For Use in Meat and Poultry
Introduction
The Food Safety and Inspection Service (FSIS) is
streamlining the approval process for food ingredients, including
food and color additives, and sources of radiation, by ending
the requirement that they be approved separately by both the Food
and Drug Administration (FDA) and FSIS.
Previously, once FDA approved a food ingredient,
FSIS had to conduct separate rulemaking in order for it to be
approved for use in meat or poultry. The rule, entitled Food Ingredients
and Sources of Radiation for Use in the Preparation of Meat and
Poultry Products, was published on December 23, 1999, and becomes
effective on January 24, 2000.
The
rule is the latest in a series of regulatory reform initiatives
published by the Agency to: (1) improve food safety, (2) make
regulations less burdensome and easier to use, (3) make regulations
more consistent with Hazard Analysis and Critical Control Point
(HACCP) Systems, and (4) eliminate outdated regulations.
Background:
Under the current system, both FDA and FSIS approval are needed
to use a new food ingredient or to change the level of use in
a meat or poultry product. A company must first petition FDA,
which reviews the petition to determine the safety and effectiveness
of the substance. Once approved, FSIS evaluates the suitability
of the food ingredient for use in meat or poultry products and
conducts formal rulemaking.
To
streamline this process, FSIS published a proposed rule on December
29, 1995, under the title Substances Approved for Use in the Preparation
of Meat and Poultry Products. The Agency received 22 comments
in response.
The
Final Rule: The new procedure will provide the same level
of consumer protection while eliminating the duplications of the
current system.
Effective
January 24, 2000, companies wanting approval to use a food ingredient
or source of radiation not currently permitted in the production
of meat and poultry products must petition FDA. If approved, FDA
will list these substances as safe for use in meat and poultry
products in its regulations, and FSIS will permit them to be used
based on FDA’s approval.
Under
a memorandum of understanding between FDA and FSIS, the two agencies
will discuss petitions that involve food ingredients for use in
meat or poultry products before FDA publishes a final rule. Through
this discussion, FSIS can raise concerns about the potential use
of the substances in meat or poultry products.
FSIS
will initiate separate rulemaking only when necessary to prohibit
or limit the use of food ingredients in meat and poultry products.
An example might be if a standard of identity or composition for
a meat or poultry product limits or prohibits the use of a specific
ingredient, when the ingredient is not expected in the product,
or when use of the ingredient would result in the product being
misbranded.
FSIS
also is consolidating currently separate regulations on food ingredient
approval for meat and poultry into one set of regulations and
eliminating unnecessary differences.
Food Ingredients - Approval
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