[Docket No. 93NÄ0405]

New Monographs and Revisions of Certain Food Chemicals Codex Monographs;
Opportunity for Public Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity
for public comment on pending changes to certain Food Chemicals Codex
monographs from the third edition and its supplements and is also soliciting
public review of specifications for proposed new monographs. For certain
substances used as food ingredients, specifications consisting of new
monographs and additions, revisions, and corrections to current monographs are
being prepared by the National Academy of Sciences/Institute of Medicine
(NAS/IOM) Committee on Food Chemicals Codex. This material will be presented
in the next publication of the Food Chemicals Codex (fourth edition). Upon
completion of the review of the comments by the Committee on Food Chemicals
Codex, an announcement will be made in the Federal Register that copies of the
new and revised monographs, as they will appear in the fourth edition of the
Food Chemicals Codex, are available on request to NAS/IOM. FDA also is giving
notice that the fourth supplement to the third edition has been published and
is available from the National Academy Press.

DATES: Submit written comments by March 7, 1994. The NAS/IOM Committee on Food
Chemicals Codex advises that comments not received by this date cannot be
considered for the next publication but will be considered for later
supplements.

ADDRESSES: Submit written comments to the NAS/IOM Committee on Food Chemicals
Codex, National Academy of Sciences, 2101 Constitution Ave. NW., Washington,
DC 20418.

FOR FURTHER INFORMATION CONTACT:

 Fatima N. Johnson, Committee on Food Chemicals Codex, Food and Nutrition
Board, National Academy of Sciences, 2101 Constitution Ave. NW., Washington,
DC 20418, 202Ä334Ä2580;

 or

 Paul M. Kuznesof, Center for Food Safety and Applied Nutrition (HFSÄ247),
Food and Drug Administration, 200 C St. SW., Washington, DC 20204,
202Ä254Ä9537.

SUPPLEMENTARY INFORMATION: FDA provides research contracts to the NAS/IOM to
support the preparation of the Food Chemicals Codex, a compendium of
specifications for substances used as food ingredients. Before the inclusion
of any specifications in a Food Chemicals Codex publication, public
announcement will be made in the Federal Register. All interested parties are
invited to comment and to make suggestions for consideration. Suggestions
should be accompanied by supporting data or documentation to facilitate and
expedite review by the Committee on Food Chemicals Codex.

In the Federal Registers of January 11, 1991 (56 FR 1198), and April 9, 1991
(56 FR 14382), FDA announced that the NAS/IOM Committee on Food Chemicals
Codex was considering new monographs and monograph revisions for inclusion in
the third supplement to the Food Chemicals Codex, third edition, which has
since been published. In the Federal Register of November 22, 1991 (56 FR
58910), FDA announced that the NAS/IOM Committee on Food Chemicals Codex was
considering new monographs and monograph revisions for inclusion in the fourth
supplement to the Food Chemicals Codex, third edition, which also has been
published. Both supplements are available from the National Academy Press at
the address given above for NAS.

FDA now gives notice that the NAS/IOM Committee on Food Chemicals Codex is
soliciting comments and information on proposed new monographs and proposed
changes to certain current monographs. These new monographs and changes will
be published in the fourth edition of the Food Chemicals Codex. Copies of the
proposed new monographs and revisions to current monographs may be obtained
from NAS at the address listed above.

FDA emphasizes, however, that it will not consider adopting new monographs and
monograph revisions until the public has had ample opportunity to comment on
the changes and the new monographs. Such opportunity for public comment will
be announced in a subsequent notice published in the Federal Register.

The NAS/IOM Committee on Food Chemicals Codex invites comments and suggestions
of specifications by all interested parties on the proposed new monographs and
revisions of current monographs, which follow:

I. Proposed New Monographs

Acesulfame potassium

Glyceryl monooleate

II. Current Monographs to which the Committee Proposes to Make Revisions

Calcium carbonate (lead and heavy metals)

Caramel (numerous revisions)

Calcium disodium EDTA (arsenic, nitrilotriacetic acid)

Disodium EDTA (arsenic, assay, identification, calcium and nitrilotriacetic
acid)

Ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose,

methylcellulose, methyl ethyl cellulose, and sodium carboxymethyl cellulose
(add synonym)

Fumaric acid (assay, identification, maleic acid)

Glutamine (identification)

Hexanes (heavy metals, nonvolatile residue)

Malic Acid (identification, maleic acid)

Methylene chloride (foreign odor)

Sodium stearyl fumarate (sodium stearyl maleate and stearyl alcohol)

Two copies of written comments regarding the monographs listed in this notice
are to be submitted to NAS (address above). Each submission should include the
statement that it is in response to this Federal Register notice. NAS will
forward a copy of each comment to the Dockets Management Branch (HFAÄ305),
Food and Drug Administration, rm. 1Ä23, 12420 Parklawn Dr., Rockville, MD
20857, to be placed under Docket No. 93NÄ0405 for public review.

Dated: December 21,1993.

Fred R. Shank,

Director, Center for Food Safety and Applied Nutrition.

[FR Doc. 94Ä38 Filed 1Ä3Ä94; 8:45 am]

BILLING CODE 4160Ä01ÄF