[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
Federal Register
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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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