[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Pages 6624-6625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1685]


New Food Chemicals Codex Monographs, Revisions of Certain Food 
Chemicals Codex Monographs, a New General Test Procedure, and Revisions 
to a Policy; 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 new general test procedure, 
and proposed changes to a policy in the fourth edition. Additions, 
revisions, and corrections to current specification monographs for 
certain substances used as food ingredients and to a policy, as well as 
new monographs and a new general 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 March 8, 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 later 
supplements or for a new edition of the Food Chemicals Codex.)

ADDRESSES: Submit written comments and supporting data and 
documentation to the Committee on Food Chemicals Codex/FO-3042, 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 changes to certain monographs, the 
proposed new general test procedure, and the proposed changes to a 
policy 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, 
general test procedure, or policy desired. For electronic access see 
the Supplementary Information section of this document.

FOR FURTHER INFORMATION CONTACT: Ricardo Molins, Project Director/FO-
3042, 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 the 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.

[[Page 6625]]

    In the Federal Register of August 8, 2000 (65 FR 48521), FDA 
announced that the committee was considering revised monographs, new 
and revised general test procedures, and revised test solutions 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 proposed new Food Chemicals Codex 
specification monographs, additional proposed changes to certain 
monographs, a proposed new general test procedure, and proposed changes 
to a policy. These new and revised monographs, new general test 
procedure, and revised policy are also expected to be published in the 
third supplement to the fourth 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/fnb/fcc.
    FDA emphasizes, however, that it will not consider adopting and 
incorporating any of the committee's new and revised monographs, new 
general test procedure, or revised policy 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 14 proposed new 
monographs, proposed revisions of 24 current monographs, proposed new 
general test procedure, and proposed revisions to a policy listed 
below:

I. Proposed New Monographs

Flavor Chemicals
Acetaldehyde Diethyl Acetal
2-Acetyl Thiazole
Allyl Phenoxy Acetate
Allyl Propionate
Borneol
Butyl 2-Methyl Butyrate
2-sec-Butyl Cyclohexanone
Diphenyl Ether
d-Fenchone
Fenchyl Alcohol
Furfuryl Alcohol
2-Furyl Methyl Ketone
Salatrim
Soy Protein Concentrate

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

    Ammonium Phosphate, Monobasic (fluoride test corrected)
    Carmine (description and assay test revised)
    Enzyme Preparations (classifications and reactions added for 
-Acetolactatedecarboxylase;
    Aminopeptidase, Leucine; and Lysozyme)
    Flavor Chemicals
    Cinnamic Acid (solubility in alcohol revised)
    d-Dihydrocarvone (solubility in alcohol revised)
    2-Heptanone (specific gravity revised)
    Hexyl Isovalerate (solubility in alcohol revised)
    Isoamyl Benzoate (solubility in alcohol revised)
    Nerolidol (assay revised)
    (Z)-6-Nonen-1-ol (refractive index revised)
    alpha-Pinene (angular rotation revised)
    2-Undecenol (specific gravity revised)
    Potassium Phosphate, Monobasic (fluoride test corrected)
    Potassium Phosphate, Tribasic (fluoride test corrected)
    Potassium Pyrophosphate (fluoride test corrected)
    Potassium Tripolyphosphate (fluoride test corrected)
    Sodium Acid Pyrophosphate (fluoride test corrected)
    Sodium Metaphosphate, Insoluble (fluoride test corrected)
    Sodium Phosphate, Dibasic (fluoride test corrected)
    Sodium Phosphate, Monobasic (fluoride test corrected)
    Sodium Polyphosphate, Glassy (fluoride test corrected)
    Sodium Potassium Tripolyphosphate (fluoride test corrected)
    Sodium Trimetaphosphate (fluoride test corrected)
    Sodium Tripolyphosphate (fluoride test corrected)

III. Proposed New General Test Procedure

    Lipase (Microbial) Activity for Medium- and Long-Chain Fatty Acids 
(new enzyme assay)

IV. Proposed Revised Policy

    Heavy Metals Limits Policy (reference to heavy metals as lead 
removed, additional revisions)

V. Comments and Electronic Access

    Interested persons may, on or before March 8, 2001, submit to the 
Committee on Food Chemicals Codex written comments regarding the 
monographs, general test procedure, and proposed revision of the policy 
identified in this notice. Timely submission will ensure that comments 
are 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 
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, general test procedure, or 
policy 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 may also be obtained through the Internet at 
http://www.iom.edu/fnb/fcc.

    Dated: January 10, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-1713 Filed 1-19-01; 8:45 am]
BILLING CODE 4160-01-F