[Federal Register Volume 62, Number 150 (Tuesday, August 5, 1997)]
[Rules and Regulations]
[Pages 42050-42051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20498]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 89F-0176]
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 disodium 4-isodecyl
sulfosuccinate as an emulsifier in the production of food-contact
polymers. This action responds to a petition filed by American Cyanamid
Co.
DATES: The regulation is effective August 5, 1997; written objections
and request for a hearing by September 4, 1997.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Richard H. White, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3094.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of June 13, 1989 (54 FR 25174), FDA announced that a food
additive petition (FAP 9B4122) had been filed by American Cyanamid Co.,
One Cyanamid Plaza, Wayne, NJ 07470 (currently Cytec Industries Inc.,
c/o Keller and Heckman, 1001 G St. NW., Washington, DC 20001). The
petition proposed to amend the food additive regulations in
Sec. 175.105 Adhesives (21 CFR 175.105) and Sec. 178.3400 Emulsifiers
and/or surface active agents (21 CFR 178.3400) to provide for the safe
use of disodium 4-isodecyl sulfosuccinate as a component of adhesives
and as an emulsifier in the production of food-contact polymers. The
petitioner later requested that the agency proceed with a decision
regarding the regulation of the additive for use only as a component of
adhesives in food-contact materials. The agency published a final rule
in the Federal Register of April 20, 1993 (58 FR 21257) amending
Sec. 175.105 to provide for the use of disodium 4-isodecyl
sulfosuccinate as a component of adhesives. In that final rule, the
agency stated that its decision regarding the petitioned use of the
additive as an emulsifier in the production of food-contact polymers
would be addressed in a future Federal Register document. The agency is
addressing that decision in this final rule.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the subject additive as an emulsifier in the production of food-
contact polymeric coatings is safe, that the additive will have the
intended technical effect, and that therefore, 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 carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before September 4, 1997, 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
[[Page 42051]]
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: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
2. Section 178.3400 is amended in the table in paragraph (c) by
alphabetically adding a new entry under the headings ``List of
substances'' and ``Limitations'' to read as follows:
Sec. 178.3400 Emulsifiers and/or surface active agents.
* * * * *
(c) * * *
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
* * * *
* * *
Disodium 4-isodecyl sulfosuccinate (CAS For use only as an
Reg. No. 37294-49-8). emulsifier at levels not to
exceed 5 percent by weight
of polymers intended for
use in coatings.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
Dated: July 23, 1997.
Janice F. Oliver,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-20498 Filed 8-4-97; 8:45 am]
BILLING CODE 4160-01-F