[Federal Register Volume 64, Number 247 (Monday, December 27, 1999)]
[Rules and Regulations]
[Pages 72272-72273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33398]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 98F-1201]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
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 provide for the safe use of propanoic acid, 3-
hydroxy-2-(hydroxymethyl)-2-methyl-, compd. with 1,1',1''-
nitrilotris[2-propanol] (1:1) (CAS Reg. No. 221281-21-6) as a pigment
dispersant. This action is in response to a petition filed by GEO
Specialty Chemicals.
DATES: This rule is effective December 27, 1999; written objections and
requests for a hearing by January 26, 2000.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3089.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December 28, 1998 (63 FR 71492), FDA announced that a food
additive petition (FAP 9B4636) had been filed by GEO Specialty
Chemicals, c/o Keller and Heckman LLP, 1001 G St. NW., suite 500 West,
Washington, DC 20001. The petition proposed to amend the food additive
regulations in Sec. 178.3725 Pigment dispersants (21 CFR 178.3725) to
provide for the safe use of the salt of dimethylolpropionic acid and
triisopropanolamine as a dispersant for pigments intended for food-
contact applications. Since the filing notice published, the Chemical
Abstracts Service (CAS) Registry number and nomenclature, which is
propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. with
1,1',1''-nitrilotris[2-propanol] (1:1) (CAS Reg. No. 221281-21-6), was
provided for the additive, and the agency has determined that the
additive should be listed using this nomenclature.
FDA has evaluated data in the petition and other relevant
material. Based on this information, the agency concludes that: (1) The
proposed use of the additive is safe, (2) the additive will achieve its
intended technical effect, and therefore, (3) the regulations in
Sec. 178.3725 should be amended as set forth below.
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 Sec. 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 previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 9B4636 (63 FR
71492). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may
at any time on or before January 26, 2000, 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 are to be
submitted and are to 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 178
Food additives, Food packaging.
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, 21 CFR part 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 178.3725 is amended in the table by alphabetically
adding an entry under the headings ``Substances'' and ``Limitations''
to read as follows:
Sec. 178.3725 Pigment dispersants.
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[[Page 72273]]
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Substances Limitations
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Propanoic acid, 3-hydroxy-2- For use only at levels not to
(hydroxymethyl)-2-methyl-, compd. exceed 0.45 percent by weight of
with the pigment. The pigmented
1,1',1''-nitrilotris [2- articles may contact all food
propanol] (1:1) (CAS Reg. No. under conditions of use A through
221281-21-6) H as described in Table 2 of Sec.
176.170(c) of this chapter.
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Dated: December 17, 1999.
L. Robert Lake,
Director, Office of Policy, Planning, and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-33398 Filed 12-23-99; 8:45 am]
BILLING CODE 4160-01-F
