[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15668]


[Federal Register: June 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0136]


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 four 
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 (the committee). 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, 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.

DATES: Submit written comments by August 29, 1994. The committee 
advises that comments received after 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 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 is 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.
    In the Federal Register of January 4, 1994 (59 FR 307), FDA 
announced that the committee was considering new monographs and 
monograph revisions for inclusion in the fourth edition of the Food 
Chemicals Codex, which is now in preparation.
    Notice and opportunity for public comment have also been given on 
policies adopted by the committee for the fourth edition. In the 
Federal Register of July 15, 1993 (58 FR 38129), FDA announced the 
committee's policy on lead and heavy metals. In the Federal Register of 
March 14, 1994 (59 FR 11789), FDA announced the committee's policy on 
arsenic specifications.
    FDA now gives notice that the committee is soliciting comments and 
information on additional 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 is announced in a notice published in 
the Federal Register.
    The committee 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

Bentonite
Glyceryl tristearate

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

Ammonium bicarbonate (heavy metals, arsenic)
Ammonium carbonate (functional use in foods, arsenic)
-Apo-8'-carotenal (arsenic, melting range)
Aspartame (identification, arsenic, assay, other related substances, 5-
benzyl-3,6-dioxo-2-piperazineacetic acid)
Biotin (identification, arsenic)
Butadiene-styrene 50/50 rubber (description, arsenic, lithium, residual 
hexane)
Calcium gluconate (arsenic, sucrose and reducing sugars)
Calcium propionate (arsenic)
Canthaxanthin (arsenic, melting range)
Carnauba wax (arsenic, ester value, heavy metals)
Casein and caseinate salts (acid value, arsenic, heavy metals)
Glucono delta-lactone (arsenic, identification)
Polyvinylpyrrolidone (name change from PVP, arsenic, aldehydes, 
hydrazine, k-value, residue on ignition, loss on drying)
Potassium citrate (arsenic, rubric, loss on drying)
Propionic acid (arsenic, definition)
Sodium ascorbate (functional use in foods, arsenic, heavy metals, lead)
    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. 
94N-0136 for public review.

    Dated: June 21, 1994.
L. Robert Lake,
 Acting Director, Center for Food Safety and Applied Nutrition
[FR Doc. 94-15668 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F