[Federal Register Volume 67, Number 112 (Tuesday, June 11, 2002)]
[Notices]
[Pages 39999-40001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0125]


New Food Chemicals Codex Monographs, Revisions of Certain Food 
Chemicals Codex Monographs, New and Revised General Test Procedures, 
Revised Policy, and Revised Guideline; 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, proposed new and revised general test 
procedures, a proposed revised policy, and a proposed revised 
guideline. Additions, revisions, and corrections to current 
specification monographs for certain substances used as food 
ingredients, as well as new monographs, new and revised test 
procedures, a revised policy, and a revised guideline 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 fifth edition). The committee is in the process of revising 
the entire fourth edition of the Food Chemicals Codex and its 
supplements to produce a comprehensive fifth edition, scheduled for 
public release in the autumn of 2003. Comments are being invited on the 
changes proposed in this notice or on any other item in the fourth 
edition of the Food Chemicals Codex or its supplements.

DATES: Submit written or electronic comments by August 12, 2002.

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, 2001 Wisconsin Ave. NW., 
Washington, DC 20007. (NOTE: This is a temporary address to be used for 
sending responses to this notice by U.S. mail only.) Submit all 
responses to be delivered by other carriers to the Committee on Food 
Chemicals Codex/FO-3038, Food and Nutrition Board, Institute of 
Medicine, 2101 Constitution Ave. NW., Washington, DC 20418. Submit 
electronic comments to [email protected]. Copies of the proposed new Food 
Chemicals Codex specification monographs, proposed changes to certain 
monographs, proposed new and revised general test procedures, and 
proposed revisions to a policy and to a guideline, may be obtained upon 
written request from the IOM 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, policy or guideline 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, Office of Food Additive 
Safety (HFS-205), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 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.
    In the Federal Register of August 8, 2000 (65 FR 48521), January 
22, 2001 (66 FR 6624), as corrected on February 9, 2001 (66 FR 9710), 
and June 13, 2001 (66 FR 31936), FDA announced that the committee was 
considering new and revised monographs, new and revised general test 
procedures, new and revised test solutions, and revisions to a policy 
for inclusion in the third supplement to the fourth edition of the Food 
Chemicals Codex. The third supplement to the fourth edition of the Food 
Chemicals Codex was released by the National Academy Press (NAP) in 
November 2001. It is 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.
    The committee is in the process of revising the entire fourth 
edition of the Food Chemicals Codex and its supplements to produce a 
comprehensive fifth edition. This revision encompasses policies, 
general monographs, flavor chemical monographs, and general tests and 
procedures. Notice of items that have undergone substantive revision 
will be given in the Federal Register and also

[[Page 40000]]

made available electronically. FDA now is announcing that the committee 
is soliciting comments and information on proposed new Food Chemicals 
Codex specification monographs, on proposed changes to certain 
monographs, on proposed new and revised general test procedures, on a 
proposed revised policy and on a proposed revised guideline; as well as 
comments and information on any other item in the fourth edition of the 
Food Chemicals Codex or its supplements. These new and revised 
monographs, new and revised test procedures, and revised policy and 
guideline are expected to be published in the fifth edition of the Food 
Chemicals Codex. If comments are received that cannot be addressed by 
the committee before publication of the fifth edition, the new 
monographs or test procedures, revised monographs or test procedures, 
or revised policy or guideline affected will be considered for the 
first supplement to 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 previously 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, new or 
revised test procedures, revised policy, or revised guideline into FDA 
regulations without ample opportunity for public comment. If FDA 
decides to propose the adoption of new monographs and test procedures 
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 2 proposed new 
monographs, 75 proposed revisions of current monographs, 2 proposed new 
general test procedures, 2 proposed revised general test procedures, 
proposed revised policy, and proposed revised guideline included in 
this document. The committee notes that in all of the monographs 
included in this document, the heavy metals (such as lead) 
specification and test have been removed, new heavy metals 
specifications and tests have been added as necessary, and taste and 
scent references have been removed from all descriptions, except those 
for flavors. In all of these proposed documents, the language has been 
modified to be more specific and consistent.

I. Proposed New Monographs

Ferrous Glycinate
Transglutaminase

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

Acetic Acid, Glacial (FEMA Number added; Description revised; Lead 
specifications revised)
Aconitic Acid (Synonym and FEMA Number added; Description and 
Identification revised; Lead specifications added; Tridodecylamine and 
Ultraviolet Absorbance specifications deleted)
Adipic Acid (Lead specifications added)
Agar (Description revised)
Aluminum Ammonium Sulfate (Lead requirement and test revised; Assay 
test revised; Fluoride test moved to Appendix IIIB)
Aluminum Potassium Sulfate (Lead specifications added; Assay test 
revised; Fluoride test moved to Appendix IIIB)
Aluminum Sodium Sulfate (Formula deleted; CAS Numbers added and 
revised; Lead specifications added; Assay test revised; Fluoride test 
moved to Appendix IIIB)
Aluminum Sulfate (Lead requirement and test revised; Assay test 
revised)
Ammonium Bicarbonate (Lead specifications added)
Ammonium Sulfate (Lead specifications added)
Aspartame (Lead specifications added)
Azodicarbonamide (Lead requirement and test revised)
Balsam Peru Oil (CAS Number added)
Basil Oil, European Type (CAS Number added; Description revised)
Beeswax, White (Functional Use in Foods and Lead specifications 
revised)
Beeswax, Yellow (Functional Use in Foods and Lead specifications 
revised)
Bergamot Oil, Coldpressed (FEMA Number added; Angular Rotation 
requirement revised; Lead specifications deleted)
Butane (Description revised)
1,3-Butylene Glycol (Synonym added; Lead specifications added)
Calcium Ascorbate (Arsenic and Fluoride specifications deleted)
Calcium Bromate (CAS Number added; Lead specifications revised)
Calcium Chloride (Functional Use in Foods revised)
Calcium Glycerophosphate (Lead requirement revised)
Calcium Hydroxide (Lead specifications revised)
Calcium Oxide (Lead requirement revised)
Calcium Sulfate (Lead specifications added)
Canola Oil (Synonyms revised; CAS Number added; Functional Use in Foods 
modified; Sulfur test modified)
Carnauba Wax (Functional Use in Foods and Lead specifications revised)
beta-Carotene (INS Number revised; Lead specifications added)
Carrot Seed Oil (CAS and FEMA numbers added)
Cassia Oil (CAS and FEMA numbers added)
Castor Oil (Synonym added; Description revised; Identification Test B 
added; Lead specifications added)
Cellulose, Powdered (Structure added; Functional Use in Foods revised; 
Lead specifications added)
Cinnamon Bark Oil, Ceylon Type (CAS and FEMA Numbers added)
Cinnamon Leaf Oil (CAS Number revised; FEMA Number added)
Copper Gluconate (Identification Test B revised; Lead specifications 
revised)
Cottonseed Oil (Unhydrogenated) (Description revised; Functional Use in 
Foods revised; Arsenic specifications deleted)
beta-Cyclodextrin (Substance Name now hyphenated; Lead test revised; 
Microbial Limits Specifications deleted)
Dammar Gum (Microbial Limits deleted)
Decanoic Acid (FEMA Number added; Description and Functional Use in 
Foods revised)
Diacetyl Tartaric Acid Esters of Mono- and Diglycerides (Synonym, INS 
Number, and CAS Numbers added; Description revised; Lead specifications 
added; Assay for Tartaric Acid, Acid Value, and Fatty Acids tests 
revised)
Diatomaceous Earth (CAS Number added, revised; Description revised; 
Arsenic specifications revised; Loss on Drying requirement revised)
Ethylene Dichloride (Lead specifications added)
Ferrous Fumarate (Synonym added; Description revised; Lead requirement 
and test revised; Mercury test moved to Appendix IIIB)
Ferrous Gluconate (Structure and Description revised; Lead requirement 
and test revised; Mercury test moved to Appendix IIIB)
Flavor Chemicals, Specifications for Flavor Chemicals (Note added; rest 
of notes renumbered sequentially)
Food Starch, Modified (Arsenic specifications deleted; Lead test 
revised)
Fumaric Acid (FEMA Number added; Description revised; Lead 
specifications added)
Gibberellic Acid (Lead specification revised)

[[Page 40001]]

Glycerol Ester of Gum Rosin (Lead and Ring-and-Ball Softening Point 
requirements revised)
Glycerol Ester of Partially Dimerized Rosin (Ring-and-Ball Softening 
Point requirement revised)
Glycerol Ester of Partially Hydrogenated Wood Rosin (Ring-and-Ball 
Softening Point requirement revised)
Glycerol Ester of Polymerized Rosin (Ring-and-Ball Softening Point 
requirement revised)
Glycerol Ester of Tall Oil Rosin (Ring-and-Ball Softening Point 
requirement revised)
Glyceryl-Lacto Esters of Fatty Acids (Synonym and INS Number added; 
Total Lactic Acid test revised)
Glyceryl Monooleate (Synonyms, Structure, INS Number, and FEMA Number 
added; Description and Functional Use in Foods revised)
Glyceryl Monostearate (CAS Number added)
Glyceryl Palmitostearate (Lead specifications added)
Glyceryl Tristearate (Synonym, Formula Weight, and Lead test revised)
Guar Gum (INS Number added; Description revised; Arsenic specifications 
deleted; Lead specifications revised)
4-Hexylresorcinol (Lead specifications revised)
Isobutane (CAS Number added; Description and Identification Test B 
revised)
Isobutylene--Isoprene Copolymer (Description and Total Unsaturation 
requirement revised)
Lard (Unhydrogenated) (Functional Use in Foods revised; Insoluble 
Matter renamed; Hexane-Insoluble Matter test added; Unsaponifiable 
Matter specifications added)
Lemongrass Oil (CAS and FEMA numbers added; Angular Rotation 
requirements revised; Steam-Volatile Oil specifications deleted)
Magnesium Sulfate (Formula Weight added, CAS Numbers added and revised, 
Lead limit added)
Myrrh Oil (CAS Number revised; FEMA Number added; Angular Rotation 
requirement revised)
Pectins (Functional Use in Foods revised; Identification test revised; 
Arsenic specifications deleted; Acid-Insoluble Ash, Degree of Amide 
Substitution and Total Galacturonic Acid in the Pectin Component, and 
Total Galacturonic Acid in Pectin Component specifications renamed; 
Total Insoluble Substances specifications added)
Pentaerythritol Ester of Partially Hydrogenated Wood Rosin (Ring-and-
Ball Softening Point requirement revised)
Pentaerythritol Ester of Wood Rosin (Ring-and-Ball Softening Point 
requirement revised)
Potassium Gibberellate (CAS Number added, Lead limit revised)
Potassium Metabisulfite (Lead specifications added; Selenium 
requirement revised; Assay test revised)
Propyl Gallate (Lead specifications added)
Pyridoxine Hydrochloride (Lead specifications added)
Soy Protein Concentrate (Lead test modified)

III. Proposed New General Test Procedures

Cadmium Limit Test (new)
Transglutaminase Activity (Appendix V: Enzyme Assays)

IV. Proposed Revised General Test Procedures

Curcumin Content, Appendix VIII: Oleoresins (Standard Preparation 
deleted; Sample Preparation and Procedure revised)
Hexane-Insoluble Matter, Appendix VII: Fats and Related Substances 
(Sample size increased to 100 g, and test scaled accordingly; test 
moved from the Lecithin monograph to Appendix VII (test also added to 
Lard and Tallow monographs))

V. Proposed Revised Policy and Guideline

Microbiological Attributes (Policy) (rewritten)
Fluoride Limits (Guideline) (rewritten)

VI. Comments and Electronic Access

    Interested persons may submit to the Committee on Food Chemicals 
Codex written and electronic comments regarding the monographs, general 
test procedures, policy and guideline identified in this notice, or 
comments on any other item in the fourth edition of the Food Chemicals 
Codex or its supplements, by August 12, 2002. Timely submission will 
allow comments to be considered for the fifth edition of the Food 
Chemicals Codex. Comments received after this date may not be 
considered for the fifth edition, but will be considered for the first 
supplement to 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 procedures, the policy, or the 
guideline listed in this notice, as well comments on any other item in 
the fourth edition of the Food Chemicals Codex or its supplements, are 
to be submitted to the Committee on Food Chemicals Codex (see 
ADDRESSES). 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 
(see ADDRESSES). 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: May 21, 2002.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 02-14546 Filed 6-10-02; 8:45 am]
BILLING CODE 4160-01-S