[Federal Register Volume 64, Number 19 (Friday, January 29, 1999)]
[Notices]
[Pages 4667-4668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-1234]


New Monographs, Revisions of Certain Food Chemicals Codex 
Monographs, New General Analytical Procedures, and Revisions of General 
Analytical Procedures; 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 and on 
proposed new specification monographs and proposed new and revised 
general analytical procedures. New specification monographs for certain 
substances used as food ingredients; additions, revisions, and 
corrections to current monographs; and new and revised general 
analytical procedures 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) at a date yet to be determined.

DATES: Written comments by March 15, 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 and revised general analytical 
procedures may be obtained upon written request from NAS (address 
above) or from 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 analytical 
procedures desired. Copies may also be obtained through the Internet at 
``http://www2.nas.edu/codex''.

FOR FURTHER INFORMATION CONTACT:
    Fatima N. Johnson/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, Office 
of Premarket Approval, Center for Food Safety and Applied Nutrition 
(HFS-246), 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 December 3, 1996 (61 FR 64098), and 
March 28, 1997 (62 FR 14911), 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.
    FDA now gives notice that the committee is soliciting comments and 
information on additional proposed new monographs, proposed changes to 
certain current monographs, and proposed new and revised general 
analytical procedures. These new monographs and analytical procedures 
and changes are expected to be published in the second supplement to 
the fourth edition of the Food Chemicals Codex. Copies of the proposed 
new monographs and analytical procedures and revisions to current 
monographs and analytical procedures may be obtained upon written 
request from NAS at the address listed above 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 revisions to monographs or analytical 
procedures into FDA regulations without ample opportunity for public 
comment. If FDA decides to propose the adoption of new monographs or 
analytical procedures or 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 or analytical procedures to be included in 
the proposed new monographs (4), revisions of current monographs (30), 
and new and revised general analytical procedures (3) listed below:

I. Proposed New Monographs

Erythritol
Maltitol
Menhaden Oil, Hydrogenated
Menhaden Oil, Refined

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

l-Aspartic Acid (correct identification test)
Butadiene-Styrene 50/50 Rubber (delete arsenic specification)
Butadiene-Styrene 25/75 Rubber (delete arsenic specification)
Calcium Phosphate, Monobasic (correct limits for loss on drying and 
loss on ignition)
Carbon, Activated (reinstate arsenic specification)
Carmine (correct assay calculation; revise assay limit, description, 
and ash determination)
Dimethylpolysiloxane (modify identification test)
Disodium Inosinate (delete barium specification)

[[Page 4668]]

Fructose (delete arsenic specification)
Glucose Syrup (delete arsenic specification)
Glucose Syrup, Dried (delete arsenic specification)
Grape Skin Extract (delete arsenic specification)
Invert Sugar (delete arsenic specification)
Lemon Oil, Coldpressed (delete foreign oils specification)
Malic Acid (correct CAS number)
Maltitol Syrup (modify synonym and description, delete heavy metals 
specification, add nickel specification)
Methyl Ester of Rosin, Partially Hydrogenated (delete arsenic 
specification)
Pentaerythritol Ester of Partially Hydrogenated Wood Rosin (delete 
arsenic specification)
Pentaerythritol Ester of Wood Rosin (delete arsenic specification)
Polydextrose (modify description, add nickel specification, modify pH 
of a 10% solution specification)
Polyisobutylene (delete arsenic specification)
Potassium Phosphate, Tribasic (correct loss on ignition limit for the 
anhydrous material)
Potassium Polymetaphosphate (correct CAS number)
Sodium Acid Pyrophosphate (correct fluoride limit test to method III)
Sodium Polyphosphates, Glassy (correct fluoride limit test to method 
III)
Sorbitol (delete arsenic specification)
Terpene Resin, Natural (delete arsenic specification)
Terpene Resin, Synthetic (delete arsenic specification)
dl--Tocopherol (correct CAS number)
Xylitol (delete arsenic specification, add nickel specification, lower 
limits for other polyols and for residue on ignition)

III. Proposed New and Revised General Analytical Procedures

Fatty Acid Composition (Revised)
Nickel Limit Test (New)
Peroxide Value Test (New)
    Interested persons may, on or before March 15, 1999, submit to NAS 
written comments regarding the monographs and general analytical 
procedures 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 analytical procedures 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: January 14, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-2159 Filed 1-28-99; 8:45 am]
BILLING CODE 4160-01-F