[Federal Register Volume 63, Number 106 (Wednesday, June 3, 1998)]
[Proposed Rules]
[Page 30160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14719]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 70, 73, 74, 80, 81, 82, 101, 178, 201, and 701

[Docket Nos. 79N-0043 and 92N-0334]


Permanent Listing of Color Additive Lakes; Additions to the 
Administrative Record; Reopening of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule; reopening of comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of certain documents that are being added to the 
administrative record for the agency's proposal to permanently list 
certain color additive lakes as suitable and safe for use in foods, 
drugs, and cosmetics. The proposal was published in the Federal 
Register of March 4, 1996 (61 FR 8372). The documents being added to 
the administrative record pertain to a modified in situ manufacturing 
process for D&C Red No. 34 lakes. FDA is also reopening the comment 
period for this proposal until July 6, 1998, for the sole purpose of 
providing an opportunity for public comment on these documents.

DATES:  Written comments by July 6, 1998.
ADDRESSES:  Submit written comments and requests for single copies of 
the documents added to the administrative record and comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:  Julie N. Barrows, Center for Food 
Safety and Applied Nutrition (HFS-105), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4662.

SUPPLEMENTARY INFORMATION:  In the Federal Register of March 4, 1996 
(61 FR 8372), FDA published a proposal to permanently list certain 
color additive lakes as suitable and safe for use in foods, drugs, and 
cosmetics. The agency proposed this action in response to the 
requirements of section 721(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379e(b)) and the transitional provisions of the Color 
Additive Amendments of 1960. Among other things, the agency proposed to 
require the preparation of lakes, including lakes that are currently 
prepared in situ, from previously certified batches of straight color. 
Lakes currently prepared in situ are lakes of D&C Red Nos. 6, 7, 31 and 
34. In the proposal, the agency tentatively concluded that the lack of 
adequate analytical methods to determine levels of intermediates and 
other impurities in lakes prepared from uncertified batches of straight 
color precludes the agency from prescribing conditions of safe use for 
such lakes, including lakes prepared in situ.
    Interested persons were initially given until June 3, 1996, to 
comment on the proposal. In the Federal Register of June 5, 1996 (61 FR 
28525), the comment period was extended to August 3, 1996.
    FDA is announcing that it has received a letter from a color 
additive manufacturer, Sun Chemical Corp., concerning the results of a 
modified in situ manufacturing process for D&C Red No. 34 lakes. (D&C 
Red No. 34 is the calcium salt of 3-hydroxy-4-[(1-sulfo-2-
naphthalenyl)azo]-2-naphthalenecarboxylic acid.) The letter, 
accompanied by samples, provided information on the total color and 
levels of intermediates in the isolated and purified sodium salt of 3-
hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid 
and in the calcium lake prepared from this sodium salt. FDA has 
analyzed the samples provided with the letter from Sun Chemical Corp. 
and has confirmed the results in the letter. The following documents 
have been added to the administrative record for the proposal: The 
letter from Sun Chemical Corp.; a memorandum summarizing the agency's 
analytical results for the samples received with the letter; two 
memoranda summarizing telephone conversations between FDA and Sun 
Chemical Corp. regarding the modified in situ manufacturing process for 
D&C Red No. 34; and a memorandum summarizing a telephone conversation 
between FDA and Kingfisher Colours, Ltd., in which FDA sought 
information on the same subject.
    FDA is reopening the comment period for 30 days to allow interested 
persons the opportunity to comment specifically on issues raised by the 
documents being added to the record. Only comments pertaining to such 
issues will be considered. This action will not delay the issuance of a 
final rule.
    Interested persons may, on or before July 6, 1998 submit to the 
Dockets Management Branch (address above) written comments regarding 
these document. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with Docket No. 79N-0043. Send a self-addressed adhesive label to 
assist in processing your requests. Received comments may be seen in 
the office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14719 Filed 6-2-98; 8:45 am]
BILLING CODE 4160-01-F