[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