[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)]
[Notices]
[Pages 28204-28205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1270]


New Monographs, Revisions of Certain Food Chemicals Codex 
Monographs, and New General Analytical Procedure; 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 specification monographs in the fourth edition, on 
proposed new specification monographs, and on a proposed new general 
analytical procedure. New specification monographs for certain 
substances used as food ingredients; additions, revisions, and 
corrections to current monographs; and a new general analytical 
procedure to replace an existing procedure are being prepared by the 
National Academy of Sciences/Institute of Medicine (NAS/IOM) Committee 
on Food Chemicals Codex (the committee). This material is expected to 
be presented in the next publication of the Food Chemicals Codex (the 
second supplement to the fourth edition) scheduled for public release 
in the spring of 2000.

DATES: Written comments by July 9, 1999. (The committee advises that 
comments received after this date may not be considered for the second 
supplement to the fourth edition. Comments received too late for 
consideration for the second supplement will be considered for later 
supplements or for a new edition of the Food Chemicals Codex.)

ADDRESSES: Submit written comments and supporting data and 
documentation to the NAS/IOM Committee on Food Chemicals Codex/FO-3042, 
National Academy of Sciences, 2101 Constitution Ave. NW., Washington, 
DC 20418. Copies of the new monographs, the proposed revisions to 
current monographs, and the proposed new general analytical procedure 
may be obtained upon written request from NAS (address above) or may be 
examined at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests for copies should specify by name the monographs or general 
analytical procedure desired. Copies may also be obtained through the 
Internet at ``http://www2.nas.edu/codex''.

FOR FURTHER INFORMATION CONTACT: Project Director/FO-3042, 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, Division of Product Manufacture and Use 
(HFS-246), Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, 202-418-3009.

SUPPLEMENTARY INFORMATION: By contract with NAS/IOM, FDA supports the 
preparation of the Food Chemicals Codex, a compendium of specification 
monographs for substances used as food ingredients. Before any 
specifications are included 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 
other documentation to facilitate and expedite review by the committee.
    In the Federal Register of March 28, 1997 (62 FR 14911), and 
December 3, 1996 (61 FR 64098), FDA announced that the committee was 
considering additional new monographs and a number of monograph 
revisions for inclusion in the first supplement to the fourth edition 
of the Food Chemicals Codex. The first supplement to the fourth edition 
of the Food Chemicals Codex was released by the National Academy Press 
(NAP) in September 1997. It is now available for sale from NAP (1-800-
624-6242; 202-334-3313; FAX 202-334-2451; Internet ``http://
www.nap.edu'') 2101 Constitution Ave. NW., Lockbox 285, Washington, DC 
20055. In the Federal Register of January 29, 1999 (64 FR 4667), FDA 
announced that the committee is considering new and revised monographs 
and new and revised general analytical procedures for inclusion in the 
second supplement to the fourth edition of the Food Chemicals Codex.
    FDA now gives notice that the committee is soliciting comments and 
information on additional proposed new monographs, proposed changes to 
certain current monographs, and a proposed new general analytical 
procedure. These new monographs, revised monographs, and the new 
general analytical procedure are also expected to be published in the 
second supplement to the fourth edition of the Food Chemicals Codex. 
Copies may be obtained upon written request from NAS at the address 
listed previously or through the Internet at ``http://www2.nas.edu/
codex''.
    FDA emphasizes, however, that it will not consider adopting and 
incorporating any of the committee's new monographs and general 
analytical procedures or revised monographs into FDA regulations 
without ample opportunity for public comment. If FDA decides to propose 
the adoption of new monographs and changes that have received final 
approval of the committee, it will announce its intention and provide 
an opportunity for public comment in the Federal Register.
    The committee invites comments and suggestions by all interested 
parties on specifications to be included in the proposed new monographs 
(4), revisions of current monographs (8), and a new general analytical 
procedure listed below:

I. Proposed New Monographs

Sheanut Oil, Refined
l-Carnitine

[[Page 28205]]

Ferric Citrate
Ferrous Citrate

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

Calcium Citrate (reduce the lead limit and revise the fluoride limit 
test to an ion-selective electrode procedure)
Cellulose Gum (change the identification tests and heavy metals 
procedures)
Diatomaceous Earth (modify the description and the pH specification to 
include acid-washed powders)
Magnesium Phosphate, Tribasic (change the assay procedure, reduce the 
lead and heavy metals limits)
Nickel (revise the assay procedure for sponge nickel catalyst to 
provide sufficient complexing agent, dimethylglyoxime)
Sodium Erythorbate (add specification for loss on drying)
Sucrose (reduce lead limit)
Terpene Resin, Synthetic (delete the arsenic specification, revise the 
saponification value test)

III. Proposed New General Analytical Procedure

Total Unsaturation (replace method with one using Fourier transform 
infrared multivariate analysis)
    Interested persons may, on or before July 9, 1999, submit to NAS 
written comments regarding the monographs and general analytical 
procedure listed in this notice. Timely submission will ensure that 
comments are considered for the second supplement to the fourth edition 
of the Food Chemicals Codex. Comments received after this date may not 
be considered for the second supplement, but will be considered for 
subsequent supplements or for a new edition of the Food Chemicals 
Codex. Those wishing to make comments are encouraged to submit 
supporting data and documentation with their comments. Two copies of 
any comments regarding the monographs or the general analytical 
procedure listed in this notice are to be submitted to NAS (address 
above). Comments and supporting data or documentation are to be 
identified with the docket number found in brackets in the heading of 
this document and 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 (address above). 
Received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 17, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-13092 Filed 5-24-99; 8:45 am]
BILLING CODE 4160-01-F