[Federal Register Volume 61, Number 4 (Friday, January 5, 1996)]
[Rules and Regulations]
[Pages 385-386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-120]



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 Rules and Regulations
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  Federal Register / Vol. 61, No. 4 / Friday, January 5, 1996 / Rules 
and Regulations  

[[Page 385]]


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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to increase the 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, and to amend the 
specifications for the additives. This action is in response to a 
petition filed by Ciba-Geigy, Inc.

DATES: Effective January 5, 1996; written objections and requests for a 
hearing by February 5, 1996. The Director of the Office of the Federal 
Register approves the incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51 of a publication listed in 21 CFR 
173.45(a), effective January 5, 1996.

ADDRESSES: Submit written objections 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 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 (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 contained information on a new manufacturing process 
for polymaleic acid and its sodium salt, which results in a lower 
weight-average molecular weight and number-average molecular weight for 
the additives than those currently permitted. The molecular weight 
determinations were based on an improved analytical method. In the 
original filing notice for the petition, the agency gave notice of the 
proposal to increase the permitted use levels of polymaleic acid and 
its sodium salt, but it did not give notice of the part of the proposal 
that concerned amending the allowed molecular weight range for the 
additives or the method for determining the molecular weight. 
Therefore, FDA published a tentative final rule in the Federal Register 
of May 2, 1995 (60 FR 21474), to allow interested persons to comment on 
these changes. FDA did not receive any comments or responses to the 
tentative final rule. Therefore, the agency concludes that the 
tentative final rule should be issued as a final rule.
    As noted in the tentative final rule, 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 improved analytical method, which replaces the 
previous method, has the same title and a different date.
    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.
    Any person who will be adversely affected by this regulation may at 
any time on or before February 5, 1996, file with the Dockets 
Management Branch (address above) written objections thereto. Each 
objection shall be separately numbered, and each numbered objection 
shall specify with particularity the provisions of the regulation to 
which objection is made and the grounds for the objection. Each 
numbered objection on which a hearing is requested shall specifically 
so state. Failure to request a hearing for any particular objection 
shall constitute a waiver of the right to a hearing on that objection. 
Each numbered objection for which a hearing is requested shall include 
a detailed description and analysis of the specific factual information 
intended to be presented in support of the objection in the event that 
a hearing is held. Failure to include such a description and analysis 
for any particular objection shall constitute a waiver of the right to 
a hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
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 of the Center for Food Safety and Applied 
Nutrition, 21 CFR part 173 is amended as follows:

[[Page 386]]


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,'' March 17, 1992, produced by Ciba-
Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. 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 are available 
for inspection at the Center for Food Safety and Applied Nutrition's 
Library, 200 C St. SW., rm. 3321, Washington, DC, or 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: December 27, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-120 Filed 1-4-96; 8:45 am]
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