[Federal Register Volume 62, Number 60 (Friday, March 28, 1997)]
[Notices]
[Pages 14911-14912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0026]


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 specification monographs in the fourth edition and on 
proposed new specification monographs. 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 is expected to 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 May 12, 1997. (The committee advises that 
comments received after this date may not be considered for the first 
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 may be examined at 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 December 3, 1996 (61 FR 64098), FDA last 
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, which is 
scheduled for publication in late summer, 1997. 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 are 
also expected to be published in the first supplement to the fourth 
edition of the Food Chemicals Codex. 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 
(3) and revisions of current monographs (8) listed below:

I. Proposed New Monographs

Manganese Citrate
Olestra
Vitamin K

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

Acid Hydrolysates of Proteins (add new limit tests for 3-chloropropane-
1,2-diol and 1,3- dichloro-2-propanol; correct limit tests for 
potassium and sodium)
Calcium Chloride (change description)
Calcium Chloride Solution (reduce lead limit)
Glycerol Ester of Partially Dimerized Rosin (change softening point 
test procedure)
Hydroxylated Lecithin (reduce heavy metals and lead limits)
Iron, Reduced (revise arsenic specification)
Lecithin (change description, add labeling requirement, increase acid 
value limit, reduce heavy metals and lead limits, and revise peroxide 
value limit for enzyme-modified material)
Phosphoric Acid (increase heavy metals limit, add lead requirement)
    Interested persons may, on or before May 12, 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

[[Page 14912]]

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: March 20, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-7836 Filed 3-27-97; 8:45 am]
BILLING CODE 4160-01-F