[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]



=======================================================================
-----------------------------------------------------------------------

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.

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

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