Food for human consumption: Food Chemicals Codex; 4th Edition— New monographs and revisions,

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Federal Register: January 29, 1999 (Volume 64, Number 19)NoticesPage 4667-4668From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr29ja99-77

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 98N-1234New Monographs, Revisions of Certain Food Chemicals Codex Monographs, New General Analytical Procedures, and Revisions of General Analytical Procedures; Opportunity for Public Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on pending changes to certain Food Chemicals Codex specification monographs in the fourth edition and on proposed new specification monographs and proposed new and revised general analytical procedures. New specification monographs for certain substances used as food ingredients; additions, revisions, and corrections to current monographs; and new and revised general analytical procedures are being prepared by the National Academy of Sciences/Institute of Medicine (NAS/IOM) Committee on Food Chemicals Codex (the committee). This material is expected to be presented in the next publication of the Food Chemicals Codex (the second supplement to the fourth edition) at a date yet to be determined.

DATES: Written comments by March 15, 1999. (The committee advises that comments received after this date may not be considered for the second supplement to the fourth edition. Comments received too late for consideration for the second 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 NAS/IOM Committee on Food Chemicals Codex/FO-3042, National Academy of Sciences, 2101 Constitution Ave. NW., Washington, DC 20418. Copies of the new monographs, the proposed revisions to current monographs, and the proposed new and revised general analytical procedures may be obtained upon written request from NAS (address above) or from 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 or analytical procedures desired. Copies may also be obtained through the Internet at ``http://www2.nas.edu/codex''.

FOR FURTHER INFORMATION CONTACT:

Fatima N. Johnson/FO-3042, 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, Division of Product Manufacture and Use, Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-246), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3009.

SUPPLEMENTARY INFORMATION: By contract with NAS/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 December 3, 1996 (61 FR 64098), and March 28, 1997 (62 FR 14911), FDA announced that the committee was considering additional new monographs and a number of monograph revisions for inclusion in the first supplement to the fourth edition of the Food Chemicals Codex. The first supplement to the fourth edition of the Food Chemicals Codex was released by the National Academy Press (NAP) in September 1997. It is now 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.

FDA now gives notice that the committee is soliciting comments and information on additional proposed new monographs, proposed changes to certain current monographs, and proposed new and revised general analytical procedures. These new monographs and analytical procedures and changes are expected to be published in the second supplement to the fourth edition of the Food Chemicals Codex. Copies of the proposed new monographs and analytical procedures and revisions to current monographs and analytical procedures may be obtained upon written request from NAS at the address listed above or through the Internet at ``http://www2.nas.edu/codex''.

FDA emphasizes, however, that it will not consider adopting and incorporating any of the committee's new monographs and general analytical procedures, or revisions to monographs or analytical procedures into FDA regulations without ample opportunity for public comment. If FDA decides to propose the adoption of new monographs or analytical procedures or 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 or analytical procedures to be included in the proposed new monographs (4), revisions of current monographs (30), and new and revised general analytical procedures (3) listed below:

I. Proposed New Monographs

Erythritol Maltitol Menhaden Oil, Hydrogenated Menhaden Oil, Refined

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

l-Aspartic Acid (correct identification test) Butadiene-Styrene 50/50 Rubber (delete arsenic specification) Butadiene-Styrene 25/75 Rubber (delete arsenic specification) Calcium Phosphate, Monobasic (correct limits for loss on drying and loss on ignition) Carbon, Activated (reinstate arsenic specification) Carmine (correct assay calculation; revise assay limit, description, and ash determination) Dimethylpolysiloxane (modify identification test) Disodium Inosinate (delete barium specification)

[Page 4668]Fructose (delete arsenic specification) Glucose Syrup (delete arsenic specification) Glucose Syrup, Dried (delete arsenic specification) Grape Skin Extract (delete arsenic specification) Invert Sugar (delete arsenic specification) Lemon Oil, Coldpressed (delete foreign oils specification) Malic Acid (correct CAS number) Maltitol Syrup (modify synonym and description, delete heavy metals specification, add nickel specification) Methyl Ester of Rosin, Partially Hydrogenated (delete arsenic specification) Pentaerythritol Ester of Partially Hydrogenated Wood Rosin (delete arsenic specification) Pentaerythritol Ester of Wood Rosin (delete arsenic specification) Polydextrose (modify description, add nickel specification, modify pH of a 10% solution specification) Polyisobutylene (delete arsenic specification) Potassium Phosphate, Tribasic (correct loss on ignition limit for the anhydrous material) Potassium Polymetaphosphate (correct CAS number) Sodium Acid Pyrophosphate (correct fluoride limit test to method III) Sodium Polyphosphates, Glassy (correct fluoride limit test to method III) Sorbitol (delete arsenic specification) Terpene Resin, Natural (delete arsenic specification) Terpene Resin, Synthetic (delete arsenic specification) dl-<greek-a>-Tocopherol (correct CAS number) Xylitol (delete arsenic specification, add nickel specification, lower limits for other polyols and for residue on ignition)

III. Proposed New and Revised General Analytical Procedures

Fatty Acid Composition (Revised) Nickel Limit Test (New) Peroxide Value Test (New)

Interested persons may, on or before March 15, 1999, submit to NAS written comments regarding the monographs and general analytical procedures listed in this notice. Timely submission will ensure that comments are considered for the second supplement to the fourth edition of the Food Chemicals Codex. Comments received after this date may not be considered for the second 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 or analytical procedures listed in this notice are to be submitted to NAS (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. 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: January 14, 1999. L. Robert Lake, Director, Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition.

FR Doc. 99-2159Filed1-28-99; 8:45 amBILLING CODE 4160-01-F

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