[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Rules and Regulations]
[Pages 48291-48292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23001]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 98F-1122]
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 dimethylolpropionic
acid as a pigment dispersant for pigments used as components of food-
contact articles. This action is in response to a petition filed by Geo
Specialty Chemicals.
DATES: This regulation is effective September 3, 1999. Submit written
objections and requests for a hearing October 4, 1999.
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: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December, 14, 1998 (63 FR 68777), FDA announced that a food
additive petition (FAP 9B4637) 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 dimethylolpropionic acid as a dispersant
for pigments used as components of food-contact articles.
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 9B4637 (63 FR
68778). 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 provisions
of 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 October 4, 1999, 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 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:
[[Page 48292]]
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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Substances Limitations
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Dimethylolpropionic acid (CAS Reg. No. For use only at levels not to
4767-03-7).. exceed 0.45 percent by weight
of the pigment. The pigmented
articles may contact all foods
under conditions of use A
through H as described in
Table 2 of Sec. 176.170(c) of
this chapter.
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Dated: August 26, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-23001 Filed 9-2-99; 8:45 am]
BILLING CODE 4160-01-F
