[Federal Register Volume 68, Number 250 (Wednesday, December 31, 2003)]
[Rules and Regulations]
[Pages 75411-75413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-32101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 2002F-0220]


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 (ACK) as a general-purpose sweetener and flavor enhancer in 
food, not including meat and poultry. This action

[[Page 75412]]

is in response to a food additive petition filed by Nutrinova, Inc. It 
will simplify the existing regulations by replacing all of the 
currently listed uses of ACK with a single-use category for food.

DATES: This rule is effective December 31, 2003. Submit written or 
electronic objections and requests for a hearing by January 30, 2004.

ADDRESSES: Submit written objections and requests for a hearing to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
objections at http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3106.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register on May 20, 2002 (67 
FR 35552), FDA announced that Nutrinova, Inc., 285 Davidson Ave., suite 
102, Somerset, NJ 08873, had filed a food additive petition (FAP 
2A4735). The petition proposed to amend Sec.  172.800 Acesulfame 
potassium (21 CFR 172.800) to provide for the safe use of ACK as a 
general-purpose sweetener and flavor enhancer.
    ACK is currently approved under Sec.  172.800 for use in 12 food 
categories at levels determined by current good manufacturing practice. 
The existing regulation has resulted from the approval of seven food 
additive petitions (FAPs). The practical effect of the amendment 
requested in the current petition would be to broaden the regulation to 
include any additional food category not allowed by the current 
regulation, with the exception, as discussed in the following 
paragraphs, of meat and poultry, and to replace the 12 currently listed 
uses of ACK with a single-use category for food.
    The acceptable daily intake (ADI) of 15 milligrams per kilogram 
body weight per day (mg/kg bw/d) or 900 mg per person per day (mg/p/d) 
was established for ACK as a result of FDA's review of FAP 2A3659 (53 
FR 28379, July 28, 1988), which resulted in the agency's initial 
approval of ACK in several food categories. The ADI is the level of 
consumption that has been determined to be safe for human consumption 
every day over an entire lifetime. The present petition does not 
contain any new information that would cause FDA to alter this 
previously determined ADI for ACK.
    FDA's review of the petitions submitted subsequent to FAP 2A3659 
involved primarily the following factors: (1) An assessment of the 
estimated exposure from each additional use; and (2) a determination of 
whether the cumulative estimated exposure, including the newly 
requested use, would cause the ADI for ACK to be exceeded over a 
lifetime by individuals who consume ACK at high levels. In its 
evaluation of ACK for use in nonalcoholic beverages, including beverage 
bases, FDA also assessed the safety from exposure to acetoacetamide-N-
sulfonic acid (AAS) and acetoacetamide (AAA), the two principal 
hydrolysis products of ACK (63 FR 36344 at 36346 to 36355, July 6, 
1998).
    Although the functionality of ACK was addressed in earlier FAPs, in 
the current petition, Nutrinova, Inc., provided the results from taste 
panel studies demonstrating the sweetness profile of ACK as a function 
of concentration in a variety of foods. These data demonstrate that ACK 
can be used alone or in blends with other intense sweeteners or bulk 
sweeteners (e.g., sucrose) at self-limiting levels depending on the 
food application (Ref. 1).

II. Determination of Safety

    Under the general safety standard provisions of section 
409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a 
particular use unless a fair evaluation of the data available to FDA 
establishes that the additive is safe for that use. FDA's food additive 
regulations (21 CFR 170.3(i)) define safe as a ``reasonable certainty 
in the minds of competent scientists that the substance is not harmful 
under the intended conditions of use.''
    The food additives anticancer, or Delaney, clause (section 
409(c)(3)(A) of the act) further provides that no food additive shall 
be deemed to be 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. Thus, 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 properly evaluated under 
the general safety standard 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)).

III. Evaluation of Safety for the Petitioned Uses of the Food Additive

    To determine whether ACK can be safely used as a general-purpose 
sweetener and flavor enhancer, FDA focused its evaluation on whether 
human exposure to ACK from these uses would exceed the ADI of 15 mg/kg 
bw/d, and on the potential health risk from exposure to the primary 
hydrolysis products, AAS and AAA, and the impurity, methylene chloride.

A. Exposure to ACK, AAS, and AAA

    FDA has determined the cumulative estimated daily intake (CEDI) for 
ACK from its use as a general-purpose sweetener and flavor enhancer in 
food for eaters-only at the 90th percentile intake to be 313 mg/p/d 
(Refs. 2 and 3). This CEDI is based on the following factors: (1) The 
amount of ACK that may be used in the currently regulated food 
categories and (2) the maximum use level of ACK in other representative 
food categories in which the sweetener may be used. FDA concludes that 
the updated CEDI for ACK is well below the ADI (900 mg/p/d). FDA has 
determined that the updated CEDIs for AAS and AAA are 250 micrograms 
per person per day ([mu]g/p/day) and 0.36 [mu]g/p/day, respectively 
(Refs. 1 and 3). These hydrolysis products are formed only under 
extreme conditions of temperature and/or pH. The agency has determined 
that the increase in exposure to AAS and AAA, due to the additional 
uses, is negligible and does not pose any safety concerns (Refs. 3, 4, 
and 5).

B. Methylene Chloride

    Methylene chloride, a carcinogenic chemical, is a potential 
impurity in ACK resulting from its use as a solvent in the initial 
manufacturing step of the sweetener. Data previously submitted in FAP 
0A4212 show that methylene chloride could not be detected in the final 
product at a limit of detection (LOD) of 40 parts per billion (ppb) as 
discussed in the July 6, 1998, final rule (63 FR 36344 at 36346). In 
the past, FDA has assumed that methylene chloride is present in ACK at 
the LOD of 40 ppb (worst-case scenario) and has evaluated its safety by 
performing a risk assessment for methylene chloride based on this 
level. No new information has been received to change FDA's previous 
risk assessment for methylene chloride. Moreover, FDA does not expect 
that methylene chloride will be present in ACK due to the following

[[Page 75413]]

factors: (1) The multi-step purification process used in the 
manufacture of ACK and (2) the volatility of methylene chloride (Ref. 
1).

IV. Conclusion

    FDA has reviewed the information available in its files on ACK and 
its hydrolysis products, as well as the current petition, and concludes 
that there is a reasonable certainty that no harm will result from the 
use of ACK as a general-purpose sweetener and flavor enhancer in foods. 
However, in accordance with a memorandum of understanding between the 
Food Safety and Inspection Service (FSIS), United States Department of 
Agriculture, and FDA (65 FR 51758, August 25, 2000), a restriction from 
use ``in meat and poultry'' is included in the ACK regulation. This 
restriction is applied when the petitioner does not specify that the 
food additive is intended for such use. At this time, FSIS has not 
evaluated data on the suitability of use of ACK in meat or poultry. 
Therefore, FDA concludes that the food additive regulations should be 
amended as set forth in this document.
    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. As provided in Sec.  171.1(h), FDA will 
delete from the documents any materials that are not available for 
public disclosure before making the documents available for inspection.

V. Environmental Effects

    FDA has carefully considered the potential environmental effects of 
this action. FDA concluded that the action will not have a significant 
impact on the human environment, and that an environmental impact 
statement is not required. FDA's finding of no significant impact and 
the evidence supporting that finding, contained in an environmental 
assessment, may be seen in the Division of Dockets Management (see 
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Division of Dockets Management (see ADDRESSES) 
written or electronic objections on or before January 30, 2004. 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 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 Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Memorandum from D. Robie, Division of Petition Review, 
Chemistry Review Group, to B. Anderson, Division of Petition Review, 
Regulatory Group II, October 7, 2002, and addendum memorandum from 
S. E. Carberry, Division of Petition Review, Chemistry Review Group, 
to B. Anderson, Division of Petition Review, Regulatory Group I, 
August 28, 2003.
    2. Memorandum from D. Robie, Division of Petition Review, 
Chemistry Review Group to B. Anderson, Division of Petition Review, 
Regulatory Group II, March 19, 2003, and addendum memorandum from S. 
E. Carberry, Division of Petition Review, Chemistry Review Group, to 
B. Anderson, Division of Petition Review, Regulatory Group I, August 
28, 2003.
    3. Memorandum to the file, July 7, 2003.
    4. Memorandum from M. Bleiberg, Division of Petition Review, 
Toxicology Review Group I, to B. Anderson, Division of Petition 
Review, Regulatory Group I, December 18, 2002.
    5. Memorandum from M. Bleiberg, Division of Petition Review, 
Toxicology Review Group I, to B. Anderson, Division of Petition 
Review, Regulatory Group II, April 2, 2003.

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

0
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

0
1. The authority citation for 21 CFR Part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Section 172.800 is amended by revising the introductory paragraph 
and paragraph (c), and by removing paragraphs (d) and (e) to read as 
follows:


Sec.  172.800  Acesulfame potassium.

    Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as 
acesulfame K, may be safely used as a general-purpose sweetener and 
flavor enhancer in foods generally, except in meat and poultry, in 
accordance with current good manufacturing practice and in an amount 
not to exceed that reasonably required to accomplish the intended 
technical effect in foods for which standards of identity established 
under section 401 of the Federal Food, Drug, and Cosmetic Act do not 
preclude such use, under the following conditions:
    (a) * * *
    (b) * * *
    (c) If the food containing the additive is represented to be for 
special dietary uses, it shall be labeled in compliance with part 105 
of this chapter.

    Dated: December 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.

[FR Doc. 03-32101 Filed 12-30-03; 8:45 am]
BILLING CODE 4160-01-S