[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Rules and Regulations]
[Pages 45873-45874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-1034]


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 expanded safe use of 
naphthalene sulfonic acid-formaldehyde condensate, sodium salt as an 
emulsifier in vinylidene chloride copolymer or homopolymer coatings 
applied to polypropylene films and polyethylene phthalate films 
intended for use in contact with food. This action is in response to a 
petition filed by Solvay S.A.

DATES:  This regulation is effective August 23, 1999. Submit written 
objections and requests for a hearing by September 22, 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 2, 1998 (63 FR 66549), as corrected (64 FR 1023, 
January 7, 1999), FDA announced that a food additive petition (FAP 
9B4634) had been filed by Solvay S.A., 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. 178.3400 Emulsifiers 
and/or surface active agents (21 CFR 178.3400) to provide for the 
expanded safe use of naphthalene sulfonic acid-formaldehyde condensate, 
sodium salt as an emulsifier in vinylidene chloride copolymer or 
homopolymer coatings applied to polypropylene films and polyethylene 
phthalate films intended for use in contact with food.
    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. 178.3400 
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 9B4634 (63 FR 
66549). 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 September 22, 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:

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.


[[Page 45874]]


    2. Section 178.3400 is amended in the table in paragraph (c) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 178.3400   Emulsifiers and/or surface active agents.

* * * * *
     (c) * * *

 
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         List of substances                      Limitations
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  *                    *                    *                    *
                   *                    *                    *
Naphthalene sulfonic acid-           For use only:
 formaldehyde condensate, sodium
 salt (CAS Reg. No. 9084-06-4).
                                     1. At levels not to exceed 10
                                      micrograms/in2 (0.16 mg/dm2) in
                                      vinylidene chloride copolymer or
                                      homopolymer coatings applied to
                                      films of propylene polymers
                                      complying with Sec.  177.1520 of
                                      this chapter.
                                     2. At levels not to exceed 14
                                      micrograms/in2 (0.21 mg/dm2) in
                                      vinylidene chloride copolymer or
                                      homopolymer coatings applied to
                                      films of polyethylene phthalate
                                      polymers complying with Sec.
                                      177.1630 of this chapter.
  *                    *                    *                    *
                   *                    *                    *
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* * * * *

    Dated: August 10, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-21728 Filed 8-20-99; 8:45 am]
BILLING CODE 4160-01-F