[Federal Register Volume 64, Number 167 (Monday, August 30, 1999)]
[Rules and Regulations]
[Pages 47109-47110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-0459]


Indirect Food Additives: Adjuvants, Production Aids, 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 isopropyl laurate 
in surface lubricants used in the manufacture of metallic articles 
intended for contact with food. This action is in response to a 
petition filed by Exxon Co. International.

DATES: This regulation is effective August 30, 1999; submit written 
objections and requests for a hearing September 29, 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 March 18, 1999 (64 FR 13431), FDA announced that a food 
additive petition (FAP 9B4647) had been filed by Exxon Co. 
International, 200 Park Ave., Florham Park, NJ 07932-1002. The petition 
proposed to amend the food additive regulations in Sec. 178.3910 
Surface lubricants used in the manufacture of metallic articles (21 CFR 
178.3910) to provide for the safe use of isopropyl laurate in surface 
lubricants used in the manufacture of metallic articles intended for 
contact with food.
    The March 18, 1999, filing notice for the petition stated that the 
action resulting from the petition qualified for a categorical 
exclusion under 21 CFR 25.32(i). This conclusion was not correct. Upon 
further review, the agency determined that such a categorical exclusion 
is not appropriate for this proposed action, because the lubricant does 
not remain with the finished food packaging material through use by the 
consumer. Consequently, as discussed below, the agency considered the 
environmental effects of this action.
    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

[[Page 47110]]

achieve its intended technical effect, and therefore, (3) the 
regulations in Sec. 178.3910 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 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.
    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 29, 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

    The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 178.3910 is amended in the table in paragraph (a)(2) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:

Sec. 178.3910  Surface lubricants used in the manufacture of metallic 
articles.

* * * * *
    (a) * * *
    (2) * * *

 
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                             List of substances                                                              Limitations
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            *                    *                    *                    *                    *                    *                    *
Isopropyl laurate (CAS Reg. No. 10233-13-3).                                 For use at a level not to exceed 10 percent by weight of the finished
                                                                              lubricant formulation.
            *                    *                    *                    *                    *                    *                    *
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* * * * *

    Dated: August 20, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-22476 Filed 8-27-99; 8:45 am]
BILLING CODE 4160-01-F