[Federal Register Volume 60, Number 85 (Wednesday, May 3, 1995)]
[Rules and Regulations]
[Pages 21700-21702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10897]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 93F-0286]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Acesulfame Potassium
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of acesulfame
potassium as a nonnutritive sweetener in alcoholic beverages. This
action is in response to a petition filed by Hoechst Celanese Corp.
DATES: Effective May 3, 1995; written objections and requests for a
hearing by June 2, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Patricia A. Hansen, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3098.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of September 10, 1993 (58 FR 47746), FDA announced that a food
additive petition (FAP 3A4391) had been filed by Hoechst Celanese
Corp., Rt. 202-206 North, Somerville, NJ 08876, proposing that
Sec. 172.800 Acesulfame potassium (21 CFR 172.800) be amended to
provide for the safe use of acesulfame potassium as a nonnutritive
sweetener in alcoholic beverages.
I. Determination of Safety
Under Section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic
Act (the act)(21 U.S.C. 348(c)(3)(A)), the so-called ``general safety
clause,'' a food additive cannot be listed for a particular use unless
a fair evaluation of the evidence establishes that the additive is safe
for that use. The concept of safety embodied in the Food Additives
Amendment of 1958 is explained in the legislative history of the
provision: ``Safety requires proof of a reasonable certainty that no
harm will result from the proposed use of the additive. It does not--
and cannot--require proof beyond any possible doubt that no harm will
result under any conceivable circumstance'' (H. Rept. 2284, 85th Cong.,
2d sess. 4 (1958)). This concept of safety has been incorporated into
FDA's food additive regulations (21 CFR 170.3(i)).
The food additives anticancer, or Delaney, clause (section
409(c)(3)(A) of the act) further provides that no food additive shall
be deemed safe if it is found to induce cancer when ingested by man or
animal. Importantly, however, the Delaney clause applies to the
additive itself and not to constituents of the additive. That is, where
an additive has not been shown to cause cancer, even though it contains
a carcinogenic impurity, the additive is not subject to the legal
effect of the Delaney clause. Rather, the additive is
[[Page 21701]] properly evaluated under the general safety clause using
risk assessment procedures to determine whether there is a reasonable
certainty that no harm will result from the proposed use of the
additive (Scott v. FDA, 728 F.2d 322 (6th Cir. 1984)).
II. Evaluation of Safety of the Petitioned Use of the Additive
In its original evaluation of acesulfame potassium, FDA concluded
that a review of animal feeding studies showed that there is no
association between neoplastic disease (cancer) and consumption of this
additive (53 FR 28379 at 28380 and 28381, July 28, 1988). No new
information has been received that would change that conclusion.
Therefore, FDA has evaluated the safety of the petitioned use of
acesulfame potassium under the general safety clause, considering all
available data.
In determining whether the proposed use of an additive is safe, FDA
considers, among other things, whether an individual's estimated daily
intake of the additive will be less than the acceptable daily intake
established from toxicological information. The agency has established
an acceptable daily intake for acesulfame potassium of 15 milligrams
per kilogram (mg/kg) of body weight per day (equivalent to 900 mg per
person per day (mg/p/d)). The agency described its analysis of the data
that led to the establishment of the acceptable daily intake in its
original decision on the use of acesulfame potassium (53 FR 28379). The
agency has considered consumer exposure to acesulfame potassium
resulting from its use in alcoholic beverages, as well as all currently
listed uses and other uses in a pending petition. FDA has calculated
the 90th percentile estimated daily intake from these combined uses to
be 180 mg/p/d, which is well below the acceptable daily intake.
A. Special Conditions Relevant to Use in Alcoholic Beverages
The use of acesulfame potassium as a nonnutritive sweetener in
alcoholic beverages (e.g. malt beverages, wine coolers, presweetened
cordials and cocktails) may subject the sweetener to conditions other
than those considered in the petitions that supported the currently
listed uses of this additive. FDA has evaluated data in the subject
petition and other information regarding the stability of acesulfame
potassium under a variety of conditions that characterize the proposed
uses in alcoholic beverages. Based on these data and information, the
agency concludes that acesulfame potassium is stable under the proposed
conditions of use.
B. Methylene Chloride
Residual amounts of reactants and manufacturing aids are commonly
found as contaminants in chemical products, including food additives.
FDA, in its evaluation of the safety of acesulfame potassium, reviewed
both the safety of the additive and the chemical impurities that may be
present in the additive from the manufacturing process.
In the current manufacturing process for acesulfame potassium,
methylene chloride, a carcinogenic chemical, is used as a solvent in
the initial step. Subsequently, the product is neutralized, stripped of
methylene chloride, and recrystallized from water. Data submitted by
the petitioner show that methylene chloride could not be detected in
the final product at a limit of detection of 40 parts per billion
(ppb).
FDA has recently discussed the significance of the use of methylene
chloride in the production of acesulfame potassium. That discussion,
published in the Federal Register of December 1, 1994 (59 FR 61538,
61540, and 61543), is incorporated into the agency's determination on
the subject petition.
Specifically, in evaluating the safety of certain uses of the
additive that are currently listed, FDA concluded, using risk
assessment procedures, that the estimated upper-bound limit of
individual lifetime risk from the potential exposure to methylene
chloride resulting from the uses of acesulfame potassium, including the
use of acesulfame potassium in alcoholic beverages, is 2.6 x 10-
11, or less than 3 in 100 billion. The agency also concluded that,
because of the numerous conservative assumptions used in calculating
this estimated upper-bound limit of risk, this upper-bound limit would
be expected to be substantially higher than any actual risk (59 FR
61538 at 61539, 61540 at 61542, and 61543 at 61544, December 1, 1994).
No new information has been received that would change the agency's
previous conclusion (Ref. 1). Therefore, the agency concludes that
there is a reasonable certainty of no harm from the exposure to
methylene chloride that might result from the proposed use of
acesulfame potassium.
In the evaluation described above, the agency also considered
whether a specification is necessary to control the amount of potential
methylene chloride impurity in acesulfame potassium. FDA concluded that
there is no reasonable possibility that methylene chloride will be
present in amounts that present a health concern, and that there would
thus be no justification for requiring manufacturers to monitor
compliance with a specification (59 FR 61538 at 61539, 61540 at 61542,
and 61543 at 61544, December 1, 1994). No new information has been
received that would change the agency's previous conclusion. Therefore,
the agency affirms its prior determination that a specification for
methylene chloride impurity in acesulfame potassium is unnecessary.
III. Conclusion of Safety
FDA has evaluated the data in the petition and other relevant
material and concludes that the use of acesulfame potassium in
alcoholic beverages is safe. Therefore, the agency concludes that
Sec. 172.800 should be amended as set forth below.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed above. As provided in 21 CFR
171.1(h), the agency will delete from the documents any materials that
are not available for public disclosure before making the documents
available for inspection.
IV. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
V. Objections
Any person who will be adversely affected by this regulation may at
any time on or before June 2, 1995, file with the Dockets Management
Branch (address above) written objections thereto. Each objection shall
be separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
[[Page 21702]] waiver of the right to a hearing on that objection. Each
numbered objection for which a hearing is requested shall include a
detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
VI. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from M. DiNovi, Chemistry Review Branch, CFSAN,
FDA, to P. Hansen, Biotechnology Policy Branch, CFSAN, FDA, dated
April 28, 1994.
List of Subjects in 21 CFR Part 172
Food additives, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371,
379e).
2. Section 172.800 is amended by adding new paragraph (c)(12) to
read as follows:
Sec. 172.800 Acesulfame potassium.
* * * * *
(c) * * *
(12) Alcoholic beverages.
* * * * *
Dated: April 24, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-10897 Filed 5-2-95; 8:45 am]
BILLING CODE 4160-01-F