[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
List of substances Limitations
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
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.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
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