[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