[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
