[Federal Register Volume 60, Number 84 (Tuesday, May 2, 1995)]
[Proposed Rules]
[Pages 21474-21475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10646]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 90F-0344]


Secondary Direct Food Additives Permitted in Food for Human 
Consumption; Polymaleic Acid and its Sodium Salt

AGENCY: Food and Drug Administration, HHS.

ACTION: Tentative final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
tentative decision to amend the food additive regulations to increase 
the [[Page 21475]] permitted use level of polymaleic acid and its 
sodium salt to control mineral scale during the production of beet and 
cane sugar juice and liquor. FDA is also announcing its tentative 
decision to amend the specifications for the additives and to revise 
the analytical method for measuring those specifications. This action 
is in response to a petition filed by Ciba-Geigy, Inc.

DATES: Written comments by July 17, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vincent E. Zenger, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3105.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 28, 1990 (55 FR 49426), FDA announced that a food 
additive petition (FAP 0A4226) had been filed by Ciba-Geigy Inc., 
proposing that Sec. 173.45 Polymaleic acid and its sodium salt (21 CFR 
173.45) be amended to provide for the safe use of polymaleic acid and 
its sodium salt to control mineral scale during the production of beet 
and cane sugar juice and liquor at higher levels than the maximum 
currently permitted under the regulation.
    The petition also contained information on a new manufacturing 
process for polymaleic acid and its sodium salt which results in a 
lower weight-average molecular weight for the additives and number-
average molecular weight than those currently permitted. The molecular 
weight determinations were based on an improved analytical method.
    FDA has evaluated data in the petition (FAP 0A4226) and other 
relevant material. The agency concludes that the proposed increase in 
the food additive use level is safe, and that the regulations should be 
amended as set forth below. The agency tentatively concludes that the 
molecular weight specifications for the additives should be amended to 
allow for the use of products manufactured by the new technique, and 
that the molecular weight determinations of the additives are to be 
based on the improved analytical method entitled ``Determinations of 
Molecular Weight Distribution of Poly(Maleic)Acid'' submitted by Ciba-
Geigy, Inc., and dated March 17, 1992, which is incorporated by 
reference in amended Sec. 173.45(a). This replaces the previous method 
with the same title but different date that was incorporated by 
reference in the current Sec. 173.45(a).
    In the filing notice for the petition, the agency gave notice of 
the intent to increase the permitted use levels of polymaleic acid and 
its sodium salt but did not anticipate amending the allowed molecular 
weight range for the additives or the method for determining the 
molecular weight. The amended specifications are not intended to place 
new restrictions on the currently approved products, but to allow use 
of products manufactured by a new method and to take into account an 
improved method of molecular weight determination. Therefore, because 
the agency did not give notice of this change, it is publishing this 
document as a tentative final rule to allow interested parties an 
opportunity to comment on the amended product specifications.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in 21 CFR 
171.1(h), the agency will delete from the documents any materials that 
are not available for public disclosure before making the documents 
available for inspection.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 173

    Food additives, Incorporation by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, it is proposed that 21 CFR part 173 is amended as follows:

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 173 continues to read as 
follows:

    Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).
    2. Section 173.45 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec. 173.45  Polymaleic acid and its sodium salt.

 * * * * *
    (a) The additives have a weight-average molecular weight in the 
range of 540 to 850 and a number-average molecular weight in the range 
of 520 to 650, calculated as the acid. Molecular weights shall be 
determined by a method entitled ``Determination of Molecular Weight 
Distribution of Poly(Maleic) Acid'', dated March 17, 1992, produced by 
Ciba-Geigy, Seven Skyline Rd., Hathorne, NY 10532-2188, which is 
incorporated by reference. Copies are available from the Division of 
Product Policy, Center for Food Safety and Applied Nutrition (HFS-205), 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
* * * * *
    (c) The additives are to be used so that the amount of either or 
both additives does not exceed 4 parts per million (calculated as the 
acid) by weight of the beet or cane sugar juice or liquor process 
stream.

    Dated: April 19, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-10646 Filed 5-1-95; 8:45 am]
BILLING CODE 4160-01-F