36362 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 /Rules and Regulations

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.

IX. References

The following sources are referred to

in this document. References marked

with an asterisk (*) have 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.

References without an asterisk are not

on display; they are available as

published articles, books, and reports.

*1. Memorandum, from M. DiNovi,

Chemistry Review Branch, to P. Hansen,

Biotechnology Policy Branch, dated April 28,

1994.

*2. Memorandum to the file FAP 0A4212,

from M. DiNovi, K. Ekelman, and P. Hansen,

dated June 3, 1998.

*3. Memorandum, from M. DiNovi,

Chemistry Review Branch, to P. Hansen,

Biotechnology Policy Branch, dated

November 9, 1994.

*4. Memorandum, from K. Ekelman,

Division of Health Effects Evaluation, to P.

Hansen, Regulatory Policy Branch, dated

June 2, 1998.

5. Green, W. L., ‘‘Mechanisms of Action of

Antithyroid Compounds,’’ pp. 77–87 in: The

Thyroid, edited by S. C. Werner and S. H.

Ingbar, Harper & Row, New York, 1978.

6. Hill, R. N. et al., ‘‘Thyroid Follicular Cell

Carcinogenesis,’’ Fundamental and Applied

Toxicology, 12:629–697, 1989.

*7. Report, Borzelleca, J. F., C. C. Capen,

M. S. Christian, and B. N. LaDu, ‘‘Summary

and Consensus of the Acesulfame K

Scientific Expert Panel on the Safety of

Acetoacetamide-N-Sulfonic Acid and

Acetoacetamide,’’ dated October 13, 1992.

*8. Letter, from C.C. Capen, Ohio State

University, to J. Simplicio, Hoechst-Celanese

Corp., dated December 6, 1991.

9. Gaylor, D. W., and R. L. Kodell, ‘‘Linear

Interpolation Algorithm for Low Dose

Assessment of Toxic Substances,’’ Journal of

Environmental Pathology and Toxicology,

4:305–315, 1980.

10. National Academy of Sciences/National

Research Council, ‘‘Risk Assessment in the

Federal Government: Managing the Process,’’

Washington, DC, 1983.

11. Lorentzen, R. J., ‘‘FDA Procedures for

Carcinogenic Risk Assessment,’’ Food

Technology, pp. 108–111, 1984.

12. Gold, L.S. et al., ‘‘Target Organs in

Chronic Bioassays of 533 Chemical

Carcinogens,’’ Environmental Health

Perspectives, 93:233–246, 1991.

13. McConnell, E. E., ‘‘Thyroid Follicular

Cell Carcinogenesis: Results from 343 2–Year

Carcinogenicity Studies Conducted by the

NCI/NTP,’’ Regulatory Toxicology and

Pharmacology, 16:177–188, 1992.

14. IRIS (1995), Cincinnati: Office of Health

and Environmental Assessment,

Environmental Criteria and Assessment

Office, EPA.

15. Curran, P. G., and L. J. DeGroot, ‘‘The

Effect of Hepatic Enzyme-Inducing Drugs on

Thyroid Hormones and the Thyroid Gland,’’

Endocrine Reviews, 12(2):135–150, 1991.

16. Donaich, I., ‘‘Aetiological

Considerations of Thyroid Carcinoma,’’ vol.

6, pp. 55–72, in: Tumors of the Thyroid

Gland, edited by D. Smithers, E & S

Livingstone, Edinburgh, 1970.

17. Capen, C. C. and S. L. Martin,

‘‘Mechanisms that Lead to Disease in the

Endocrine System in Animals,’’ Toxicologic

Pathology, 17:234–249, 1989.

18. Handbook of Carcinogenic Potency and

Genotoxicity Databases, edited by L. S. Gold

and E. Zeiger, CRC Press, Boca Raton, FL,

1997.

19. Goddard, M. J., D. J. Murdoch, and D.

Krewski, ‘‘Temporal Aspects of Risk

Characterization,’’ Inhalation Toxicology,

7:1005–1018, 1995.

20. Kodell, R. L., D. W. Gaylor, and J. J.

Chen, ‘‘Using Average Lifetime Dose Rate for

Intermittent Exposures to Carcinogens,’’ Risk

Analysis, 7:339–345, 1987.

*21. Memorandum, from F. Hines,

Diagnostic Pathology Branch, to L. Taylor,

Additives Evaluation Branch, dated June 6,

1986.

22. ‘‘Health Effects Test Guidelines,’’ U.S.

EPA, June, 1996.

*23. Memorandum, from L. Taylor,

Additives Evaluation Branch, to P.

McLaughlin, Petitions Control Branch, dated

November 17, 1982.

*24. Memorandum, Cancer Assessment

Committee (CAC) (covers conferences of

November 21, 1983, February 21, 1985,

December 12, 1985, and June 17, 1986, and

information in Ref. 25 of this document).

*25. Memorandum, from L. Taylor,

Additives Evaluation Branch, to Cancer

Assessment Committee, dated June 19, 1986.

List of Subjects in 21 CFR 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: 21 U.S.C. 321, 341, 342, 348,

371, 379e.

2. Section 172.800 is amended by

adding paragraph (c)(13) to read as

follows:

§ 172.800 Acesulfame potassium.

* * * * *

(c) * * *

(13) Nonalcoholic beverages,

including beverage bases.

* * * * *

Dated: June 29, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

[FR Doc. 98–17700 Filed 6–30–98; 10:34 am]

BILLING CODE 4160–01–F

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 Foods for Human

Consumption; Acesulfame Potassium

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; response to

objection, confirmation of effective date.

SUMMARY: The Food and Drug

Administration (FDA) is overruling the

objection that it has received on the

final rule that amended the food

additive regulations to provide for the

safe use of acesulfame potassium (ACK)

as a nonnutritive sweetener in alcoholic

beverages. After reviewing the objection

to the final rule, the agency has

concluded that the objection does not

provide a basis for revoking the

amendment to the regulation. Therefore,

FDA is confirming the effective date for

the final rule. The final rule was issued

in response to a food additive petition

filed by Hoechst Celanese Corp.

DATES: The effective date of the final

rule published at 60 FR 21700 is

confirmed as May 3, 1995.

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,

202–418–3093.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of May 3, 1995

(60 FR 21700), FDA issued a final rule

amending its regulations to permit the

use of acesulfame potassium (ACK) as a

nonnutritive sweetener in alcoholic

beverages (the ‘‘alcoholic beverages final

rule’’). This amendment of the

regulation, codified at 21 CFR

172.800(c)(12), was issued in response

to a food additive petition (FAP No.

3A4391) filed by Hoechst Celanese

Corp. FDA based its decision to permit

the use of ACK in alcoholic beverages

on the data in this petition and other

relevant information in its files,

including data and information from
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 /Rules and Regulations 36363

1Acesulfame potassium, the potassium salt of 6-

methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide,

was first approved for a variety of uses as a

nonnutritive sweetener on July 28, 1988 (53 FR

28379). Subsequent to its initial approval decision

on the use of ACK, FDA approved the following

additional uses for ACK in response to petitions in:

Baked goods and baking mixes, including frostings,

icings, and fillings for baked goods; yogurt and

yogurt-type products; frozen and refrigerated

desserts; sweet sauces, toppings, and syrups; and

alcoholic beverages on December 1, 1994 (59 FR

61538, 61540, 61543) and on May 3, 1995 (60 FR

21700).

2 In its 1988 objections to the dry uses final rule,

CSPI objected to the agency conclusions drawn

from each of the three long-term safety studies of

ACK conducted in rodents and sought revocation of

the rule. CSPI asked FDA to consider four separate

objections to the rule and to hold a public

evidentiary hearing on the issues raised in each of

its objections. FDA considered the issues raised by

CSPI and responded to them, in detail, in the

Federal Register of February 27, 1992 (57 FR 6667,

‘‘1992 response to objections’’). The agency

concluded, after reviewing the objections, that no

genuine issues of material fact had been raised that

would justify a hearing and, accordingly, denied

CSPI’s requests for a hearing.

3 In its 1988 objections to the dry uses final rule,

CSPI requested a stay of the rule until the hearing

it had also requested could be held. FDA denied

both the requests for a hearing and a stay.

4Memorandum from M. DiNovi, Chemistry

Review Branch, CFSAN, FDA to P. Hansen,

Biotechnology Policy Branch, CFSAN, FDA, April

28, 1994 (Ref. 1 in the alcoholic beverages final

rule).

5Specifically, in its original review of the safety

of ACK, 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). FDA also established an

acceptable daily intake (ADI) for ACK, based on the

information from the animal feeding studies. Based

on all of the information before it, FDA concluded

that ACK was safe for the uses proposed in the

original petition.

In its evaluation of the safety of ACK for use in

alcoholic beverages, FDA considered, among other

things, various conditions relevant to the proposed

use. One consideration was whether an individual’s

estimated daily intake (EDI) of ACK would be less

Continued

previous petitions for various uses of

ACK.1

II. Summary of Objection

Following the publication of the

alcoholic beverages final rule, the

Center for Science in the Public Interest

(CSPI) filed a timely submission

objecting to the approval of ACK for use

in alcoholic beverages. CSPI’s

submission consisted of a letter, dated

June 1, 1995, and a copy of CSPI’s

objections to FDA’s original approval

decision on ACK (the ‘‘dry uses final

rule’’) (July 28, 1988, 53 FR 28379).2

CSPI specifically requests that FDA

‘‘withdraw this approval, and, instead,

require that acesulfame potassium

(including its breakdown products) be

evaluated for carcinogenicity in

properly conducted long-term animal

feeding tests.’’ CSPI also requests that

FDA reconsider and act favorably on its

previous objections to the dry uses final

rule, alleging that FDA has not

addressed these previous objections in a

substantive manner. CSPI does not

request a hearing on its objection to the

alcoholic beverages final rule, nor does

it request a stay of the rule.3

III. Provisions for Objections and

Hearing Requests

The agency’s regulations regarding

food additive petitions (21 CFR 171.110)

provide that objections and hearings

relating to food additive regulations are

to be governed by part 12 (21 CFR part

12). Under § 12.24(a), the Commissioner

of Food and Drugs is to review all

objections and hearing requests and

make three determinations: (1) Whether

the regulation at issue should be

modified or revoked, (2) whether a

hearing has been justified, and (3)

whether an alternative form of hearing

(e.g., before a Public Board of Inquiry

under 21 CFR part 13), if requested, has

been justified. As provided for in

§ 12.30(a), a person may submit

objections and waive the right to a

hearing; such waiver may be express or

may result from the failure to request a

hearing (see § 12.22(a)). Even when no

hearing has been requested, the

Commissioner has the discretion to

order a hearing under § 12.30(b) and

should exercise such discretion when it

is in the public interest to do so.

Because issuance of a final rule

constitutes a finding that such action is

in the public interest, a substantial

showing is required to justify the

Commissioner’s exercise of his

discretion to order a hearing to

reconsider a final rule.

The objector to the alcoholic

beverages final rule for ACK, CSPI, has

waived its right to a hearing by failing

to request a hearing (see § 12.22(a)(4)).

Thus, the only remaining question

under § 12.24(a) is whether CSPI’s

objection, and the information

submitted in support of the objection,

establish that the food additive

regulation for ACK should be revoked or

modified. If revocation or modification

has not been justified, FDA must then

evaluate the record to determine

whether there is a reason for the

Commissioner to exercise his discretion

to order a hearing.

As discussed in detail in section IV of

this document, FDA has concluded that

CSPI has not established a basis for

revocation or modification of the food

additive regulation for ACK. Thus, the

agency is overruling CSPI’s objection.

Likewise, because CSPI has not

identified new relevant information or

articulated an interpretation of existing

information not previously addressed by

FDA, there is no factual dispute to be

resolved. Further, there has been no

showing that such a hearing would

otherwise be in the public interest.

Accordingly, there is no reason for the

Commissioner to exercise his discretion

and order a hearing.

IV. Analysis of the Objection

In order to justify a revocation or

modification of the food additive

regulation authorizing the use of ACK in

alcoholic beverages, CSPI must establish

that FDA failed to conduct a fair

evaluation of the evidence in the record

and thus erroneously concluded that

there is a reasonable certainty of no

harm from the use of ACK in alcoholic

beverages. As shown in section IV of

this document, CSPI’s objections cite no

new data or information and simply

reiterate issues that FDA has previously

considered and resolved. Thus, FDA has

concluded that there is no basis to

modify or revoke the food additive

regulation for ACK.

A. FDA’s Determination of Safety

In its June 1, 1995 letter, objecting to

the alcoholic beverages final rule, CSPI

quotes from an FDA memorandum4

‘‘* * * The use of acesulfame

potassium in alcoholic beverages

contributes only a very small percentage

of acesulfame potassium intake to the

total because of the limited number of

users of these products and their low

intakes.’’ CSPI indicates its agreement

with FDA’s assessment of the dietary

intake of ACK, but also goes on to state:

‘‘* * * we expect minimal public

exposure to acesulfame potassium in the

alcoholic beverages covered in the

approval. However, de minimis

exposure of the public does not solve

the safety problems associated with

acesulfame potassium * * *.’’

Although CSPI implies that FDA’s

decision on the safe use of ACK in

alcoholic beverages was based on intake

data alone, this is not the case. In

concluding that the use of ACK in

alcoholic beverages was safe, FDA

reviewed data and information in the

petition as well as other relevant

information from its files, including

data and information contained in

previous petitions for various uses of

ACK. As discussed in the alcoholic

beverages final rule (60 FR 21700 at

21701), FDA made its determination

based on an analysis of the safety data

and a consideration of conditions

relevant to the proposed use in

alcoholic beverages, including the

estimated low increase in dietary

exposure to ACK from its use in

alcoholic beverages.5
36364 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 /Rules and Regulations

than the ADI that had been previously established

from toxicological information. The agency

concluded that the EDI for ACK resulting from its

use in alcoholic beverages, as well as all uses listed

at that time and other uses in a pending petition,

was well below the ADI. On the basis of all the

information before it, FDA concluded that the

proposed use in alcoholic beverages was safe.

6These products are acetoacetamide-N-sulfonic

acid (AAS) and acetoacetamide (AAA).

7As discussed in detail in the dry uses final rule

(53 FR 28379 at 28380), the safety data originally

submitted by the petitioner included a feeding

study performed in mice and a feeding study

performed in rats. FDA concluded that the mouse

study was adequate for the safety evaluation of

ACK, but that the rat study (‘‘the first rat study’’)

was inadequate for a safety evaluation of ACK. The

petitioner then conducted a second feeding study

in rats (‘‘the second rat study’’); the agency

concluded that this second rat study was adequate

to assess the safety of ACK. The agency also

concluded that the results of the second rat study,

together with the results of the mouse study,

established that there was no association between

neoplastic disease (cancer) and consumption of

ACK.

8 In the 1992 response to objections (57 FR 6667

at 6669) FDA denied CSPI’s request for a hearing

on this issue because the data and information

identified by CSPI in support of this objection, even

if established at a hearing, would not have been

adequate to justify resolution, in CSPI’s favor, of the

factual questions about adequacy of dosing. Because

the information cited was not sufficient to establish

CSPI’s factual assertion, a hearing was not granted

on this issue (see § 12.24(b)(3)).

9Even if the objections raise material issues of

fact, FDA need not grant a hearing if those same

issues were adequately raised and considered in an

earlier proceeding. Once an issue has been so raised

and considered, a party is estopped from raising

that same issue in a later proceeding without new

evidence. The various judicial doctrines dealing

with finality are validly applied to the

administrative process. In explaining why these

principles ‘‘self-evidently’’ ought to apply to an

agency proceeding, the D.C. Circuit wrote: ‘‘The

underlying concept is as simple as this: Justice

requires that a party have a fair chance to present

his position. But overall interests of administration

do not require or generally contemplate that he will

be given more than a fair opportunity.’’ (Retail

Clerks Union, Local 1401, R.C.I.A. v. National Labor

Relations Board, 463 F.2d 316, 322 (D.C. Cir. 1972).

(See Costle v. Pacific Legal Foundation, 445 U.S.

198, 214–215 (1980), reh. den., 445 U.S. 947 (1980).

See also Pacific Seafarers, Inc. v. Pacific Far East

Line, Inc., 404 F.2d 804 (D.C. Cir. 1966))).

10 In the 1992 response to objections (57 FR 6667

at 6669 through 6670) FDA denied CSPI’s request

for a hearing on this objection because the data and

information identified by CSPI in support of this

objection, even if established at a hearing, would

not have been adequate to justify resolution, in

CSPI’s favor, of the factual questions about the

duration of, and dosing used in, this study. Because

the information cited was not sufficient to establish

CSPI’s factual assertion, a hearing was not granted

on this issue (see § 12.24(b)(3)).

CSPI’s objection to the alcoholic

beverages final rule does not provide

any new evidence or identify any

evidence that FDA overlooked in

previous evaluations that would call

into question FDA’s determination of

safety. Moreover, CSPI has not provided

a basis for concluding that the

information FDA has evaluated is

inadequate to support a finding that the

use of ACK in alcoholic beverages is

safe. Thus, with respect to this issue,

CSPI has not provided any basis for

FDA to revoke the alcoholic beverages

final rule.

B. Long-Term Testing; Breakdown

Products of ACK

As previously noted, in CSPI’s

objection to the alcoholic beverages

final rule, the organization requests that

FDA require long-term animal testing of

the breakdown products of ACK.6

CSPI’s submission does not, however,

provide any information to support its

view that such testing is necessary to

establish the safety of ACK for use in

alcoholic beverages. Because CSPI’s

submission provides no information to

support its request, it provides no basis

for FDA to reconsider its decision to

issue the alcoholic beverages final rule.

Thus, the agency is overruling this

aspect of CSPI’s objection and is

denying the request that FDA require

additional testing of the breakdown

products of ACK.

C. Long-Term Testing; ACK

In its objection to the alcoholic

beverages final rule, CSPI also asks that

FDA require additional long-term

testing of ACK.7 CSPI alleges that

‘‘* * * technical flaws render several

key safety studies inadequate, and

* * * available evidence suggests that

acesulfame potassium may pose a

cancer risk’’ and mentions four specific

issues with respect to the existing longterm animal testing of ACK, quoting

directly from its objections to the dry

uses final rule. In support of this aspect

of its objection to the alcoholic

beverages final rule, CSPI submitted a

copy of its objections to the dry uses

final rule. CSPI asked FDA to ‘‘* * *

reconsider and act favorably on our

1988 objections.’’

One of the issues raised by CSPI in its

June 1, 1995, letter concerns the

adequacy of one of the long-term studies

of ACK that was conducted in rats:

‘‘* * * the doses of acesulfame

potassium given in the petitioner’s

second long-term rat study were too low

to make that study adequate to show

that the chemical does not cause cancer

in rats * * *.’’ CSPI raised exactly the

same issue in its objections to the dry

uses final rule, and FDA responded, in

detail, to this issue in the agency’s 1992

response to objections.8 In its objection

to the alcoholic beverages final rule,

CSPI provides no additional evidence or

analysis to support its assertion

regarding dosing. Thus, the agency

incorporates its 1992 discussion of the

dosing in the second rat study, in full,

into the present response. Specifically,

FDA reaffirms its earlier determination

that the dosing levels in this study were

appropriate to evaluate the safe use of

ACK, and that this study demonstrated

the safety of ACK (57 FR 6667 at 6669,

see also 53 FR 28379, 28380).

Once an issue has been considered in

a prior proceeding, a party is estopped

from raising that same issue in a

subsequent proceeding in the absence of

new evidence.9 Because CSPI’s

objection to the alcoholic beverages

final rule neither identifies nor contains

any new evidence or new analysis to

support its assertion that the dosing in

the second rat study was inadequate, it

provides no basis for reconsideration of

this issue by FDA. Moreover, CSPI’s

objection does not provide any

information that links this issue to

FDA’s determination that the use of

ACK in alcoholic beverages is safe and,

thus, provides no basis for FDA to

revoke the alcoholic beverages final

rule.

Another issue raised by CSPI in its

June 1, 1995, letter concerns the

adequacy of the long-term study of ACK

that was conducted in mice: ‘‘* * * the

petitioner’s long-term mouse study fell

short of FDA guidelines and standards

because: (1) A subchronic study needed

to set the proper high dose was not

done, and the high dose used was too

low, and (2) the chronic study lasted

only 80 weeks, not the minimum 104

weeks * * *.’’ CSPI made precisely the

same claims in its objections to the dry

uses final rule, and FDA responded, in

detail, to this issue in the agency’s 1992

response to objections.10 In its objection

to the alcoholic beverages final rule,

CSPI provides no additional evidence or

analysis to support its assertions

regarding dosing and study length.

Thus, the agency incorporates its 1992

discussion of the mouse study, in full,

into the present response. Specifically,

FDA reaffirms its earlier determination

that both the length of, and the dosing

in, the mouse study were adequate for

an assessment of ACK’s carcinogenic

potential and that the mouse study

demonstrated the safety of ACK (57 FR

6667 at 6669, see also 53 FR 28379,

28380).

As noted, once an issue has been

considered in a prior proceeding, a

party is estopped from raising that same

issue in a subsequent proceeding in the

absence of new evidence. Because

CSPI’s objection to the alcoholic

beverages final rule neither identifies

nor contains any new evidence or new

analysis to support its assertion that the

mouse study was inadequate, it

provides no basis for reconsideration of
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 /Rules and Regulations 36365

11CSPI claimed that there were increased

incidences in lymphoreticular tumors and several

types of other tumors; CSPI also disputed FDA’s

reasons for concluding that this study was

inadequate for a safety evaluation of ACK. FDA

considered and addressed all of the points in this

objection in the 1992 response to objections (57 FR

6667 at 6670 to 6677). FDA denied CSPI’s request

for a hearing on this objection on several different

grounds, specifically, a threshold burden of

identifying specific evidence was not met (see

§ 12.24(b)(2)), the data and information identified

were insufficient to justify the factual determination

in CSPI’s favor (see § 12.24(b)(3)), and the factual

issues identified were not determinative with

respect to the action requested (see § 12.24(b)(4)).

12Because of deficiencies and confounding

factors in the first rat study, FDA further concluded

that this study is ‘‘inadequate for assessing the

carcinogenic potential of the test compound or for

any other purposes of a safety evaluation’’ (53 FR

28379 at 28381). As noted, the petitioner

subsequently performed a second study in a

different strain of rat.

13CSPI identified two issues in this objection: (1)

The incidence of rare tumors and (2) the incidence

of mammary gland tumors. CSPI also raised four

separate points with regard to the occurrence of

mammary tumors. FDA considered and addressed

all of the points in this objection in the 1992

response to objections (57 FR 6667 at 6674 through

6675). FDA denied CSPI’s request for a hearing on

this objection on several different grounds: (1) A

threshold burden of identifying specific evidence

was not met (see § 12.24(b)(2)), (2) the data and

information identified were insufficient to justify

the factual determination in CSPI’s favor (see

§ 12.24(b)(3)), and (3) the factual issues identified

were not determinative with respect to the action

requested (see § 12.24(b)(4)).

this issue by FDA. Moreover, CSPI’s

objection does not provide any

information that would link this issue to

FDA’s determination that the use of

ACK in alcoholic beverages is safe and,

thus, provides no basis for FDA to

revoke the alcoholic beverages final

rule.

A third issue raised by CSPI in its

June 1, 1995, letter concerns the results

of the first rat study: ‘‘* * * the

petitioner’s first long-term rat study

shows that acesulfame potassium

induced tumors in rats, even though

design flaws biased this study against

finding carcinogenicity* * *.’’ CSPI has

raised this particular issue twice before,

once as a comment on the petition that

supported the dry uses final rule and

once as an objection to the dry uses final

rule. FDA considered this issue and

addressed it in the dry uses final rule;

FDA also responded, in detail, to this

issue in the agency’s 1992 response to

objections.11 In its objection to the

alcoholic beverages final rule, CSPI

provides no additional evidence or

analysis to support its claim that ACK

induced tumors in the animals used in

the first rat study. Thus, the agency

incorporates both of its earlier

discussions of this issue (from both the

dry uses final rule and the agency’s

1992 response to objections), in full,

into the present response. Specifically,

the agency reaffirms its earlier

determination that the data and

information from the first rat study do

not establish a carcinogenic effect of

ACK (57 FR 6667 at 6670).12

Again, because this particular issue

has been considered in a prior

proceeding, CSPI is estopped from

raising that same issue subsequently in

the absence of new evidence. Because

CSPI’s objection to the alcoholic

beverages final rule neither identifies

nor contains any new evidence or new

analysis to support its assertion that the

first rat study shows that ACK induces

tumors in rats, it provides no basis for

reconsideration of this issue by FDA.

Moreover, CSPI’s objection does not

provide any information that would

undermine FDA’s determination that

the use of ACK in alcoholic beverages is

safe and, thus, provides no basis for

FDA to revoke the alcoholic beverages

final rule.

A fourth issue raised by CSPI in its

June 1, 1995, letter concerns the results

of the second rat study: ‘‘* * * the

second long-term rat study shows that

acesulfame potassium induces tumors

in rats * * *.’’ CSPI raised precisely

this same issue in its objections to the

dry uses final rule, and FDA responded,

in detail, to this issue in the agency’s

1992 response to objections.13 In its

objection to the alcoholic beverages

final rule, CSPI provides no additional

evidence or analysis to support its

assertion regarding the results of the

second rat study. Thus, the agency

incorporates its 1992 discussion of the

results of the second rat study, in full,

into the present response. Specifically,

FDA reaffirms its earlier determination

that the second rat study did not

demonstrate an association between the

occurrence of tumors and treatment

with ACK (57 FR 6667 at 6674, see also

53 FR 28379 at 28380 and 28381).

Once an issue has been considered in

a prior proceeding, a party is estopped

from raising that same issue in a

subsequent proceeding in the absence of

new evidence. Because CSPI’s objection

to the alcoholic beverages final rule

neither identifies nor contains any new

evidence or new analysis to support its

assertion that the second rat study

shows that ACK induces tumors in rats,

it provides no basis for reconsideration

of this issue by FDA. Moreover, CSPI’s

objection provides no information that

would call into question FDA’s

determination that the use of ACK in

alcoholic beverages is safe and, thus,

provides no basis for FDA to revoke the

alcoholic beverages final rule.

V. Conclusions

The safety of ACK has been

thoroughly tested and the data have

been reviewed by the agency. As

discussed previously, FDA concluded

that the available data and information

establish the safety of ACK as a

nonnutritive sweetener in alcoholic

beverages.

The petitioner has the burden to

demonstrate safety before FDA can

approve a particular use of a food

additive. Nevertheless, once the agency

makes a finding of safety in an approval

document, the burden shifts to an

objector, who must come forward with

evidence that calls into question FDA’s

conclusion (American Cyanamid Co. v.

FDA, 606 F2d. 1307, 1314–1315 (D.C.

Cir. 1979)).

CSPI has not identified any

information in the record to support its

claim that the FDA incorrectly

concluded that the use of ACK in

alcoholic beverages is safe. Nor has CSPI

established that the agency overlooked

significant information in reaching its

conclusion. Indeed, the objection has

not presented any information or

analysis that has not already been

carefully reviewed and weighed by the

agency. FDA has determined that the

objection provides no basis for FDA to

revoke the alcoholic beverages final rule

or to require additional safety testing.

Accordingly, FDA is overruling the

objection.

FDA is confirming May 3, 1995, as the

effective date of the amendment to the

regulation.

Dated: June 29, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

[FR Doc. 98–17701 Filed 6-30-98; 10:34 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Parts 40 and 41

[Public Notice 2800]

Documentation of Nonimmigrants

Under the Immigration and Nationality

Act, as Amended—Place of Application

AGENCY: Bureau of Consular Affairs,

DOS.

ACTION: Final rule; correction.

SUMMARY: This document confirms as a

final rule the interim rule published on

January 7, 1998, that establishes the

venue for a nonimmigrant visa

application by an applicant whose

previous nonimmigrant visa has been

voided due to an overstay of an

authorized period of admission. This