[Federal Register Volume 61, Number 233 (Tuesday, December 3, 1996)]
[Notices]
[Pages 64098-64099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0326]


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 in the fourth edition and on specifications 
for proposed new monographs. Specifications consisting of new 
monographs for certain substances used as food ingredients 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 (the first supplement to the fourth edition), scheduled 
for publication in late summer 1997.

DATES: Written comments by February 18, 1997. (The committee advises 
that comments received after this date may not be considered for the 
first 

[[Page 64099]]

supplement to the fourth edition. Comments received too late for 
consideration for the first supplement will be considered for later 
supplements.)

ADDRESSES: Submit written comments and supporting data and 
documentation to the NAS/IOM Committee on Food Chemicals Codex, 
National Academy of Sciences, 2101 Constitution Ave. NW., Washington, 
DC 20418. Copies of the new monographs and proposed revisions to 
current monographs may be obtained upon written request from NAS 
(address above) or from the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 
20857. Requests for copies should specify the monographs desired by 
name. New and revised monographs may also be obtained through the 
Internet at http://www2.nas.edu/codex.

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, 202-418-3009.

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 May 31, 1995 (60 FR 28413) , FDA last 
announced that the committee was considering an additional monograph 
and a number of monograph revisions for inclusion in the fourth edition 
of the Food Chemicals Codex. The fourth edition of the Food Chemicals 
Codex was released by the National Academy Press (NAP) in March 1996. 
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 and proposed changes 
to certain current monographs. These new monographs and changes will be 
published in the first supplement to the fourth edition of the Food 
Chemicals Codex, which is scheduled for publication in late summer, 
1997. Copies of the proposed new monographs and revisions to current 
monographs 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 or monograph 
revisions 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 
(12) and revisions of current monographs (22) that follow:

I. Proposed New Monographs

Beta-Cyclodextrin
Calcium Lignosulfonate
Dimethyl Dicarbonate
Glyceryl Palmitostearate
4-Hexylresorcinol
Sodium Lignosulfonate
Sucrose Fatty Acid Esters
Sugar Beet Fiber
Reduced Lactose Whey
Reduced Minerals Whey
Whey Protein Concentrate
Autolyzed Yeast

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

Aspartame (delete transmittance test)
Calcium Phosphate, Dibasic (decrease lead limit)
Calcium Phosphate, Monobasic (decrease lead limit)
Calcium Phosphate, Tribasic (decrease lead limit)
Calcium Silicate (revise fluoride test)
Carbon Dioxide (combine nitric oxide and nitrogen dioxide limits, and 
revise test)
Dextrin (add sulfur dioxide test)
Dioctyl Sodium Sulfosuccinate (revise identification test)
Enzyme-Modified Fats (modify enzyme-modified milkfat monograph)
L-Glutamic Acid (revise identification test B)
Konjac Flour (revise identification test B)
Magnesium Phosphate, Dibasic (decrease loss on ignition limits)
Niacin (revise identification tests)
Niacinamide (revise identification tests, assay)
Pectins (revise identification tests)
Potassium Phosphate, Dibasic (decrease lead limit)
Potassium Phosphate, Monobasic (decrease lead limit)
Sodium Acid Pyrophosphate (revise assay limit)
Sodium Carboxymethylcellulose (change primary name to Cellulose Gel)
Sodium Tripolyphosphate (reduce lead limit)
Spice Oleoresins (add oleoresin rosemary)
Whey
    Interested persons may, on or before February 18, 1997, submit to 
NAS written comments regarding the monographs listed in this notice. 
Timely submission will ensure that comments are considered for the 
first supplement to the Fourth Edition of the Food Chemicals Codex. 
Comments received after this date may not be considered for the first 
supplement, but will be considered for subsequent supplements. Those 
wishing to make comments are encouraged to submit supporting data and 
documentation with their comments. Two copies of any comments regarding 
the monographs 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: November 14, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-30727 Filed 12-2-96; 8:45 am]
BILLING CODE 4160-01-F