Food Additives Permitted for Direct Addition to Food for Human Consumption

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 87F-0179]

Food Additives Permitted for Direct Addition to Food for Human

Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is in the final stages

of its review of a food additive petition filed by Procter & Gamble

Co., for the safe use of sucrose esterified with medium and long chain

fatty acids (olestra) as a replacement for fats and oils. Accordingly,

the agency is announcing that all data, information, and public

comments on the petition must be filed with FDA on or before December

1, 1995. This measure will facilitate the agency's decisionmaking

process and coming to closure on the petition by identifying precisely

which data and information FDA will consider in making its decision on

the petition.

DATES: Written comments by December 1, 1995.

ADDRESSES: Submit written 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: Helen R. Thorsheim, Center for Food

Safety and Applied Nutrition (HFS-216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-418-3092.

SUPPLEMENTARY INFORMATION:

In the Federal Register of June 23, 1987 (52 FR 23606), FDA

announced the filing of a petition (FAP 7A3997) by Procter & Gamble

Co., 6071 Center Hill Rd., Cincinnati, OH 45224-1703, proposing that

the food additive

[[Page 57587]]

regulations be amended to provide for the safe use of sucrose

esterified with medium and long chain fatty acids as a replacement for

fats and oils. (The additive is commonly referred to as olestra.) Since

its filing, FDA has had the petition under active review, and the

agency is in the final stages of its safety review of the additive.

In the Federal Register of October 17, 1995 (60 FR 53790), FDA

announced that a public meeting of the agency's Food Advisory Committee

(FAC) and a working group of the FAC would be held on November 14

through 17, 1995. The working group will undertake a scientific

discussion of the safety review that has been conducted for olestra for

its intended use as a fat replacer in savory snacks. The working group

will be asked to comment on whether all relevant issues associated with

olestra have been addressed. The discussion will cover all aspects of

the safety review, including nutrient effects and compensation,

gastrointestinal effects, and labeling. The recommendation of the

olestra working group will be formally referred to the agency, along

with any amendatory comments of the FAC. The agency will make the final

determination on the olestra food additive petition. (See 21 CFR 14.5).

Consistent with the Federal Advisory Committee Act (5 U.S.C. App.

2), and the agency's regulations in part 14 (21 CFR part 14), the

meeting of the working group and the FAC will be open to the public. In

addition, as provided for in Sec. 14.25, there will be an opportunity

for public participation, including an opportunity for members of the

public to present their views on the safety review of olestra, before

both the working group and the FAC.

Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is

required to announce the filing of a food additive petition (21 U.S.C.

348(b)(5)). Although public notice of a petition is required, the act

is silent with respect to public comment on a petition, and thus, the

act provides no defined period for such comments. Accordingly, the

filing notice did not expressly request comments on Procter & Gamble's

petition. Nevertheless, written comments could have been, and in fact,

have been submitted to the agency.

As noted above, FDA is in the final stages of review of the olestra

food additive petition. Unless significant new safety issues are raised

or important new data are submitted in the course of the advisory

committee process, the agency will very likely conclude its review and

be prepared to render a decision on Procter & Gamble's petition within

approximately 2 months of the conclusion of the FAC meeting. To

facilitate this decisionmaking process and the agency's coming to

closure on the petition, FDA believes that it is important to identify

precisely which data and information the agency will consider in making

its decision on the petition. Absent such boundaries, it will be

difficult for FDA to reach a decision because the underlying data set

could be shifting continuously. (See Sierra Club v. Costle, 657 F.2d

298, 399-400 (D.C. Cir. 1981) (a participant's mere wish for additional

time to respond to documents in the record to which it already had

opportunity to respond cannot force an agency to delay process because

new information may be forthcoming; otherwise participants could delay

the process indefinitely because new information continually comes to

light on the subject of many proposed rules.))

Given the importance of reaching a decision and the clear public

interest in a decision, FDA has determined that any data, information,

or comments received after December 1, 1995, will not be considered by

the agency in determining whether to approve the petition. Any data,

information, or comments received after that date will be filed in an

administrative file and will be evaluated along with any objections to

the final decision filed under 21 U.S.C. 348(f).

FDA believes that it is appropriate for the agency to manage its

administrative processes, see Sierra Club v. Gorsuch, 715 F.2d 653, 658

(D.C. Cir. 1983)) (agency has control over timetable of rulemaking and

such decisions are entitled to considerable deference); Cutler v.

Hayes, 818 F.2d 879, 896 n. 150 (D.C. Cir. 1987), citing Natural

Resources Defense Council, Inc. v. SEC, 606 F.2d 1031, 1056 (D.C. Cir.

1979) (agency is cognizant of the most effective structuring and timing

of proceedings to resolve competing demands over its resources), and

that in these circumstances, such management through defining a comment

period will not unnecessarily limit public participation in that

process.

In particular, for over 8 years, since the June 1987 publication of

the filing notice, the public has been aware that the food additive

petition for olestra has been under consideration by FDA, and has had

the opportunity to submit information and comments to the agency on

Procter & Gamble's proposal. In addition, under the applicable

regulations (21 CFR 171.1(h)(1)(i)), all safety and functionality data

for olestra submitted during this period by Procter & Gamble have been

available to the public for review and comment upon the submission of

such data to the agency. Interested persons have utilized this

opportunity to review these data and to provide the agency with their

views by submitting written comments. Finally, the agency has announced

a public advisory committee meeting on the olestra petition. This

meeting will provide interested persons with the opportunity to hear an

informed scientific discussion of the relevant safety issues, and to

present data, information, and views relevant to the safety of olestra.

The agency believes that with the conclusion of the FAC meeting,

there will have been more than a reasonable opportunity for the public

to provide data and information and to comment on the olestra food

additive petition. See Forester v. CPSC, 559 F.2d 774, 787 (D.C. Cir.

1977). Because there has been such an opportunity, FDA believes that it

is appropriate and consistent with the public interest to define a

specific period for the submission of data, information, and comments

on the food additive petition. Defining boundaries for those data,

information, and comments to be considered by FDA in rendering a

decision on the petition will facilitate the agency's coming to closure

on this petition. Therefore, the agency is establishing December 1,

1995, as the date by which all data, information, and comments on the

olestra food additive petition, including comments on the proceedings

before the FAC, must be submitted to the agency in order to be

considered by the agency in its decision on the petition.

Any request for extension of this period for comments on the

olestra food additive petition should conform to the provisions of 21

CFR 10.40(b).

Dated: November 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95-28359 Filed 11-13-95; 4:16 pm]

BILLING CODE 4160-01-F