[Federal Register Volume 60, Number 104 (Wednesday, May 31, 1995)]
[Notices]
[Pages 28413-28414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13204]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0097]


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 specifications monographs from the third edition and 
its four supplements. One new monograph and additions, revisions, and 
corrections to current monographs for certain substances used as food 
ingredients 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 published in the fourth edition of 
the Food Chemicals Codex, which is scheduled for release in March 1996. 
When the committee completes its review of the comments, it will 
incorporate any changes that it makes in response to comments in 
monographs published in supplements to the fourth edition.

DATES: Written comments by August 14, 1995.

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 from NAS (address above) or the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857. Requests for copies 
should specify the monographs desired.

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 Street, SW., Washington, 
DC 20204, 202-418-3009.

SUPPLEMENTARY INFORMATION: By contract with NAS/IOM, FDA supports the 
preparation of the Food Chemicals Codex, which is a compendium of 
specifications 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.
    FDA previously announced that the committee was considering new 
monographs and monograph revisions for inclusion in the fourth edition 
of the Food Chemicals Codex, which NAS/IOM is now preparing. In 
addition, FDA has given notice and an opportunity for public comment on 
the policies adopted by the committee for the fourth edition on lead 
and heavy metals specifications (58 FR 38129, July 15, 1993), and on 
arsenic specifications (59 FR 11789, March 14, 1994).
    The committee will continue to provide the opportunity for public 
comment on intended changes in monographs by means of Federal Register 
notices before their inclusion in supplements to the fourth edition. 
Interested parties should submit all suggestions with supporting 
documentation to the National Academy of Sciences at the above address.
    FDA now gives notice that the committee is soliciting comments and 
information on certain proposed new monographs and revisions to certain 
additional current monographs. These new monographs and revisions will 
be published in the fourth edition of the Food Chemicals Codex. The 
proposed new monographs and revisions to current monographs may be seen 
at the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday. Because the publication timeframe for the 
fourth edition, comments on monographs that are the subject of this 
notice cannot be considered for incorporation in the fourth edition, 
which is scheduled for release in March 1996, but will be considered 
for incorporation in supplements to the fourth edition. Copies of the 
new monographs and proposed revisions to current monographs may be 
obtained from NAS or the Dockets Management Branch. Requests for copies 
should be identified with the docket number found in brackets in the 
heading of this [[Page 28414]] document and should specify the 
monographs desired.
    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 on specifications by 
all interested parties on the proposed new monographs and revisions of 
current monographs that follow:

I. Proposed New Monograph

Food Starch, Unmodified

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

Aluminum Potassium Sulfate (Assay, Heavy Metals, Lead)
Aluminum Sulfate (Heavy Metals)
 Ammonium Carbonate (Heavy Metals, Sulfur Compounds)
Azodicarbonamide (Assay, Heavy Metals)
Beeswax, White (Heavy Metals)
Beeswax, Yellow (Heavy Metals)
Caffeine (Description, Identification, Assay, Heavy Metals, Lead, 
Water)
Calcium Acetate (Assay, Heavy Metals, Lead)
Calcium Bromate (Assay, Heavy Metals)
Calcium Chloride (Description, Labeling, Assay, Acid-Insoluble Matter,
Magnesium and Alkali Salts)
Calcium Citrate (Assay, Loss on Drying)
Calcium Hydroxide (Assay, Acid-Insoluble Substances, Heavy Metals, 
Magnesium and Alkali Salts)
Calcium Oxide (Assay, Acid-Insoluble Substances, Alkalies or Magnesium, 
Heavy Metals, Lead, Loss on Ignition)
Calcium Propionate (Identification, Assay)
Calcium Saccharin (Assay)
Calcium Sorbate (Lead)
Candelilla Wax (Identification, Heavy Metals)
Carrageenan (Delete monograph from the Food Chemicals Codex)
Castor Oil (Saponification Value, Specific Gravity)
Cellulose Gel (formerly Microcrystalline Cellulose, Description, 
Identification, Loss on Drying, pH, Water-Soluble Substances)
Chlorine (Assay, Heavy Metals, Moisture and Residue)
Dextrin (Heavy Metals, Lead, pH of Dispersions)
Disodium EDTA (Identification, Assay, Calcium, Nitrilotriacetic Acid)
Erythorbic Acid (Assay, Heavy Metals, Lead, Loss on Drying)
Ethyl Cellulose (Heavy Metals, Lead)
Food Starch, Modified (Numerous Changes)
Fumaric Acid (Identification, Assay, Heavy Metals, Maleic Acid)
Hydrochloric Acid (Numerous Changes)
Hydroxypropyl Cellulose (Heavy Metals, Lead)
Iron, Carbonyl (Arsenic, Lead)
Iron, Electrolytic (Arsenic, Lead)
Iron, Reduced (Arsenic, Lead, Acid-Insoluble Substances)
Isobutylene-Isoprene Copolymer (Identification, Heavy Metals, Total 
Unsaturation)
Lactic Acid (Labeling, Chloride, Sulfate)
Magnesium Carbonate (Heavy Metals, Acid-Insoluble Substances, Calcium 
Oxide)
Magnesium Hydroxide (Assay, Calcium Oxide, Heavy Metals, Oxide, Loss on 
Ignition)
Magnesium Oxide (Assay, Acid-Insoluble Substances, Calcium Oxide, Heavy 
Metals, Loss on Ignition)
Malic Acid (Identification, Assay, Fumaric and Maleic Acids, Heavy 
Metals, Lead, Residue on Ignition, Specific Rotation)
Maltodextrin (Labeling, Assay, Protein, Sulfur Dioxide, Total Solids)
Methyl Ethyl Cellulose (Heavy Metals, Lead)
Nisin Preparation (Lead)
Nitrous Oxide (Identification)
Phosphoric Acid (Labeling, Heavy Metals)
Poloxamer 331 (1,4-Dioxane; Ethylene Oxide, Propylene Oxide, and 1,4-
Dioxane)
Poloxamer 407 (1,4-Dioxane; Ethylene Oxide, Propylene Oxide, and 1,4-
Dioxane)
Polydextrose (Description, Lead, Monomers, Molecular Weight Limit, 
Residue on Ignition)
Polydextrose Solution (Monomers)
Polyethylene (Identification, Heavy Metals)
Polyethylene Glycols (1,4-Dioxane, Ethylene Glycol and Diethylene 
Glycol,
Ethylene Oxide, Heavy Metals)
Polysorbate 20 (1,4-Dioxane)
Polysorbate 60 (1,4-Dioxane, Stearic and Palmitic Acids)
Polysorbate 65 (1,4-Dioxane)
Polysorbate 80 (1,4-Dioxane)
Polyvinyl Acetate (Loss on Drying, Heavy Metals, Volatiles)
Polyvinylpolypyrrolidone (Extractable Substances, Soluble Substances, 
Unsaturation, Water)
Potassium Bromate (Chloride, Heavy Metals, Loss on Drying, Sulfate)
Potassium Hydroxide (Assay, Heavy Metals, Mercury)
Potassium Sorbate (Lead)
Potassium Sulfate (Description, Assay)
Propylene Glycol Alginate (Ash, Esterified Carboxyl Groups, Heavy 
Metals, Lead, Neutralized Carboxyl Groups)
Rice Bran Wax (Heavy Metals)
Silicon Dioxide (Heavy Metals, Lead, Loss on Drying)
Sodium Carboxymethylcellulose (Heavy Metals, Lead)
Sodium Hydroxide (Assay, Heavy Metals)
Sodium Hydroxide Solution (Labeling, Heavy Metals)
Sodium Metabisulfite (Assay, Heavy Metals, Lead)
Sodium Potassium Tartrate (Assay)
Titanium Dioxide (Identification, Assay, Lead, Water-Soluble 
Substances)
Vitamin A (Assay)
    Interested persons may, on or before August 14, 1995, submit to NAS 
written comments regarding the monographs listed in this notice. Those 
wishing to make comments are encouraged to submit supporting data and 
documentation with their comments. Two copies of any comments are to be 
submitted. Comments and supporting data or documentation are to be 
identified with the docket number found in brackets in the heading of 
this document and should include a statement that the comment 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: May 18, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-13204 Filed 5-30-95; 8:45 am]
BILLING CODE 4160-01-F