[Federal Register: January 29, 1999 (Volume 64, Number 19)]
[Notices]
[Page 4667-4668]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja99-77]
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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-<greek-a>-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