[Federal Register Volume 66, Number 114 (Wednesday, June 13, 2001)]
[Notices]
[Pages 31936-31938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0236]


New Food Chemicals Codex Monographs, Revisions of Certain Food 
Chemicals Codex Monographs, Revision of a General Test Procedure, and 
New Test Solutions; 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 proposed new Food Chemicals Codex 
specification monographs, proposed changes to certain Food Chemicals 
Codex specification monographs, a proposed revision of a general test 
procedure, and proposed new test solutions. Additions, revisions, and 
corrections to current specification monographs for certain substances 
used as food ingredients, as well as new monographs and test solutions, 
and a revised test procedure, are being prepared by the National 
Academies, Institute of Medicine (IOM), Committee on Food Chemicals 
Codex (the committee). This material is expected to be included in the 
next publication of the Food Chemicals Codex (the third supplement to 
the fourth edition), scheduled for public release in the summer of 
2001.

DATES: Submit written comments by July 30, 2001. (The committee advises 
that comments received after this date may not be considered for the 
third supplement to the fourth edition. Comments received too late for 
consideration for the third supplement will be considered for the fifth 
edition of the Food Chemicals Codex.)

ADDRESSES: Submit written comments and supporting data and 
documentation to the Committee on Food Chemicals Codex/FO-3038, Food 
and Nutrition Board, Institute of Medicine, 2101 Constitution Ave. NW., 
Washington, DC 20418. Copies of the proposed new Food Chemicals Codex 
specification monographs, proposed new test solutions, proposed changes 
to certain monographs, and proposed revision to a

[[Page 31937]]

general test procedure may be obtained upon written request from the 
IOM (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, test procedure, or test solutions desired. For electronic 
access see the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Ricardo A. Molins, Project Director/
FO-3038, Committee on Food Chemicals Codex, Food and Nutrition Board, 
Institute of Medicine, 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 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 August 8, 2000 (65 FR 48521), and of 
January 22, 2001 (66 FR 6624), as corrected on February 9, 2001 (66 FR 
9710), FDA announced that the committee was considering new and revised 
monographs, new and revised general test procedures, revised test 
solutions, and revisions to a policy for inclusion in the third 
supplement to the fourth edition of the Food Chemicals Codex. FDA is 
now announcing that the committee is soliciting comments and 
information on additional proposed new Food Chemicals Codex 
specification monographs, on additional proposed changes to certain 
monographs, on an additional proposed revised general test procedure, 
and on proposed new test solutions. These new and revised monographs, 
revised test procedure, and new test solutions are also expected to be 
published in the third supplement to the fourth edition of the Food 
Chemicals Codex. If comments are received that cannot be addressed by 
the committee before publication of the third supplement, the new 
monographs or test solutions, revised monographs, or revised test 
procedure affected will be considered for the fifth edition of the Food 
Chemicals Codex. Copies of the proposed items may be obtained upon 
written request from IOM at the address listed above or through the 
Internet at http://www.iom.edu/fcc.
    FDA emphasizes, however, that it will not consider adopting and 
incorporating any of the committee's new or revised monographs, revised 
test procedure, or new test solutions into FDA regulations without 
ample opportunity for public comment. If FDA decides to propose the 
adoption of new monographs and test solutions 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 33 proposed new 
monographs, 22 proposed revisions of current monographs, proposed 
revised general test procedure, and 2 proposed new test solutions 
listed below:

I. Proposed New Monographs

Acidified sodium chlorite solutions
Aspartame-acesulfame salt
Curdlan
Flavor Chemicals
    2,6-Dimethoxyphenol
    3,4-Dimethyl-1,2-cyclopentandione
    5-Ethyl-3-hydroxy-4-methyl-2(5H)-furanone
    3-Ethyl pyridine
    Furfuryl mercaptan
    Geranyl isovalerate
    2,3-Heptandione
    Hexyl butyrate
    Hexyl hexanoate
    Isoamyl isobutyrate
    Isobutyl formate
    Isobutyl hexanoate
    Linalool oxide
    Methyl hexanoate
    Methyl isovalerate
    Methyl thiobutyrate
    Methyl valerate
    5-Methyl furfural
    beta-Naphthylethyl ether
    Phenylethyl cinnamate
    Phenylethyl propionate
    Propyl mercaptan
    Propyl formate
    delta-Tetradecalactone
    2-Tridecanone
gamma-Cyclodextrin
Polyglycerol polyricinoleic acid
Pork collagen
Solin oil
Sucrose acetate isobutyrate

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

Calcium sulfate (Formula weight and CAS number revised to show the 
dihydrate; Heavy Metals determination deleted)
Canola oil (Description and Functional Use in Foods modified; Heavy 
Metals determination deleted)
Cellulose gum (Specifications for Degree of Substitution and Sodium 
modified; Heavy Metals determination deleted)
Citric acid (Description revised; Heavy Metals and Ultraviolet 
Absorbance specifications deleted; Tridodecylamine specification 
revised; Readily Carbonizable Substances test replaced; Residue on 
Ignition test reworded)
Cocoa butter substitute (Description corrected; Heavy Metals 
determination deleted)
Ethoxyquin (Description, Assay Limit, and Assay Test modified; Heavy 
Metals specification deleted; Lead, p-Phenetidine, and p-Phenetidine-
Related Impurities specifications added)
Flavor Chemicals
    Acetoin (structures revised)
    2-Acetylpyrrole (physical form and melting range revised; water 
deleted)
    Anisole (assay revised)
    Ethylene brassylate (assay revised)
    Ethyl phenylglycidate (assay revised)
    Geranyl benzoate (assay revised)
    alpha-Ionone (assay revised)
    dl-Menthyl acetate (solubility in alcohol added)
    4-Methyl-2-pentanone (refractive index revised)
    delta-Nonalactone (refractive index and specific gravity 
revised)
    (E)-2-Nonen-1-ol (refractive index revised)
    delta-Octalactone (specific gravity revised)
    (E)-2-Undecenol (solubility in alcohol added)
    Maltitol (Description corrected; Assay limit of D-Maltitol revised; 
entire Identification, Assay, and Reducing Sugars tests provided; Other 
Hydrogenated Saccharides specifications added)
    Rapeseed oil, fully hydrogenated (Description and Functional Use in 
Foods modified; Heavy Metals determination deleted)
    Rapeseed oil, superglycerinated (Description and Functional Use in 
Foods modified; Heavy Metals determination deleted)

III. Proposed Revised General Test Procedure

Peroxide Value (A second Peroxide Value test has been added to Appendix 
VII: Fats and Related Substances)

IV. Proposed New Test Solutions

Nickel Standard Solution TS (10 milligrams per kilogram)
Acetic Acid TS, Strong (5 Normal)

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V. Comments and Electronic Access

    Interested persons may submit to the Committee on Food Chemicals 
Codex written comments regarding the monographs, general test 
procedure, and test solutions identified in this notice by July 30, 
2001. Timely submission will allow comments to be considered for the 
third supplement to the fourth edition of the Food Chemicals Codex. 
Comments received after this date may not be considered for the third 
supplement, but will be considered for the fifth 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, the general test 
procedure, or the test solutions listed in this notice are to be 
submitted to the Committee on Food Chemicals Codex (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. The committee staff 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. Copies of the proposed 
changes may also be obtained through the Internet at http://www.iom.edu/fcc.

    Dated: June 4, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-14864 Filed 6-12-01; 8:45 am]
BILLING CODE 4160-01-S