[Federal Register Volume 63, Number 126 (Wednesday, July 1, 1998)]
[Rules and Regulations]
[Pages 35798-35799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17412]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0305]
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 expanded safe use of siloxanes
and silicones; cetylmethyl, dimethyl, methyl 11-methoxy-11-oxoundecyl
as a pigment dispersant in all pigmented polymers intended for use in
contact with food. This action is in response to a petition filed by
Goldschmidt Chemical Corp.
DATES: The regulation is effective July 1, 1998; written objections and
requests for a hearing by July 31, 1998.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-216), 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 July 31, 1997 (62 FR 41053), FDA announced that a food
additive petition (FAP 7B4550) had been filed by Goldschmidt Chemical
Corp., c/o Keller and Heckman, 1001 G St. NW., suite 500 West,
Washington, DC 20001. The petition proposed to amend the food additive
regulations in Sec. 178.3725 Pigment dispersants (21 CFR 178.3725) to
provide for the expanded safe use of siloxanes and silicones;
cetylmethyl, dimethyl, methyl 11-methoxy-11-oxoundecyl as a pigment
dispersant in all pigmented polymers 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 the proposed use
of the additive is safe, that the additive will achieve its intended
technical effect, and therefore, that the regulations in Sec. 178.3725
should be amended as set forth below.
Information in the petition indicates that one of the constituents
of the additive, i.e., hexadecene which is a starting material for the
additive, leads to the formation in rabbits of a transient metabolite,
1,2-epoxyhexadecane (EHD). In a published study, EHD was reported to be
a weak skin carcinogen in female Swiss mice (Ref. 1). FDA evaluated
this study (Ref. 2) and has concluded that the evidence that EHD may be
a weak dermal carcinogen in female Swiss mice does not preclude a
conclusion that the petitioned use of the substance is safe\1\.
---------------------------------------------------------------------------
\1\ As noted, EHD is reported to be a weak skin carcinogen in
female Swiss mice. This finding does not mean that EHD is a
carcinogenic impurity of the additive.
If EHD were a carcinogenic impurity, FDA would evaluate such
impurity under the general safety clause, using risk assessment
procedures to determine whether there is a reasonable certainty of
no harm that would result from the proposed use of the additive,
Scott v. FDA, 728 F. 2d 322 (6th Cir. 1984).
---------------------------------------------------------------------------
First, the incidence of dermal tumors in EHD-treated mice was small
(2 or 3 of 40 mice) and not statistically significant, assuming that
control animals had no dermal tumors. Second, there were deficiencies
in the conduct and reporting of this study. Third, dermal
carcinogenicity is not highly predictive of carcinogenicity by other
routes of exposure (Ref. 3). These observations support the agency's
view that there is no evidence that suggests that EHD is likely to be a
carcinogen when orally ingested, which is the route of exposure most
directly relevant to the safety assessment of food additives.
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 determined under 21 CFR 25.31(i) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under 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 July 31, 1998, file with the Dockets Management
Branch (address above) written objections thereto. Each objection shall
be
[[Page 35799]]
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.
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Van Duuren, B. L., L. Langseth, B. M. Goldschmidt, and L.
Orris, ``Carcinogenicity of Epoxides, Lactones, and Epoxy Compounds.
VI. Structure and Carcinogenic Activity,'' Journal of the National
Cancer Institute, vol. 39, No. 6., pp. 1217-1228, 1967.
2. Memorandum from Executive Secretary of the Cancer Assessment
Committee, FDA, to Quantitative Risk Assessment Committee, FDA,
concerning ``Potential Carcinogenicity of 1,2-epoxyhexadecane (EHD):
Subject of Food Additive Petition No. 7B4550 (Goldschmidt Chemical
Corp.),'' dated January 8, 1998.
3. Tobin, Paul S. et al., ``An Evaluation of Skin Painting
Studies as Determinants of Tumorigenesis Potential Following Skin
Contact with Carcinogens,'' Regulatory Toxicology and Pharmacology,
vol. 2, 22-37, 1982.
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, 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.
2. Section 178.3725 is amended in the table by alphabetically
adding an entry under the headings ``Substances'' and ``Limitations''
to read as follows:
Sec. 178.3725 Pigment dispersants.
* * * * *
----------------------------------------------------------------------------------------------------------------
Substances Limitations
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Siloxanes and silicones; cetylmethyl, dimethyl, methyl For use only at levels not to exceed 0.5 percent by
11-methoxy-11-oxoundecyl (CAS Reg. No. 155419-59-3). weight of the pigment. The pigmented polymers may
contact all foods under conditions of use C, D, E, F,
and G described in Table 2 of Sec. 176.170(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
Dated: June 19, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-17412 Filed 6-30-98; 8:45 am]
BILLING CODE 4160-01-F
