[Federal Register Volume 60, Number 221 (Thursday, November 16, 1995)]
[Notices]
[Pages 57586-57587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28359]



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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