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

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.

-----------------------------------------------------------------------

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