[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