[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Notices]
[Pages 307-308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-38]


[[Page Unknown]]

[Federal Register: January 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0405]

 

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 202-334-2580;
     or
 Paul M. Kuznesof, Center for Food Safety and Applied Nutrition (HFS-
247), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-254-9537.

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 (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, to be placed under Docket No. 
93N-0405 for public review.

    Dated: December 21,1993.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-38 Filed 1-3-94; 8:45 am]
BILLING CODE 4160-01-F