[Federal Register Volume 65, Number 170 (Thursday, August 31, 2000)]
[Rules and Regulations]
[Pages 52908-52909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22226]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-0127]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of trimethylolethane 
as a 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 rule is effective August 31, 2000. Submit written 
objections and requests for a hearing by October 2, 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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 3, 1999 (64 FR 5300), FDA announced that a food 
additive petition (FAP 9B4635) had been filed by GEO Specialty 
Chemicals, c/o Keller and Heckman, 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 trimethylolethane as a dispersant for 
pigments used as components of food-contact articles.
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of the additive is safe, that the additive will achieve 
its intended technical effect, and therefore, that 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 carefully considered the environmental effects of 
this rule as announced in the notice of filing for the petition. 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 file with the Dockets Management Branch (address above) 
written objections by October 2, 2000. 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

[[Page 52909]]

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.

* * * * *

 
------------------------------------------------------------------------
             Substances                          Limitations
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Trimethylolethane (CAS Reg. No. 77-  For use only at levels not to
 85-0).                               exceed 0.45 percent by weight of
                                      inorganic pigment. The pigmented
                                      articles may contact all food
                                      under conditions of use A through
                                      H described in Table 2 of Sec.
                                      176.170(c) of this chapter.
------------------------------------------------------------------------


    Dated: August 21, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-22226 Filed 8-30-00; 8:45 am]
BILLING CODE 4160-01-F