[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
