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
36366 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 /Rules and Regulations

notice also contains a correction of a

citation in the interim rule.

EFFECTIVE DATE: July 6, 1998.

FOR FURTHER INFORMATION CONTACT: H.

Edward Odom, Chief, Legislation and

Regulations Division, Visa Services,

Department of State, Washington, DC

20520–0106, (202) 663–1204.

SUPPLEMENTARY INFORMATION: An

interim rule implementing the new

subsection 222(g) of the Immigration

and Nationality Act (INA), and

requesting comments, was published on

January 7, 1998 [63 FR 669]. The period

for comments has expired; no comments

have been received. The rule will thus

stand as originally published, with a

correction of the reference to INA 214(k)

in 22 CFR 41.101(c)(1) which should

read 214(l). As there are now two

214(l)’s in the INA, this reference is to

the first one, i.e., the subsection relating

to a waiver of the 2-year foreign

residence requirement.

As the final regulation is identical to

the interim regulation other than for the

correction of a citation, it is not being

reprinted in full herein.

List of Subjects in 22 CFR Part 41

Aliens, Nonimmigrants, Passports,

Visas.

In view of the foregoing, the interim

rule amending 22 CFR parts 40 and 41

which was published at 63 FR 669 on

January 7, 1998, is adopted as a final

rule with the following change:

PART 41—[CORRECTED]

1. The authority citation for part 41

continues to read:

Authority: 8 U.S.C. 1104.

§ 41.101 [Corrected]

2. In § 41.101(c)(1), correct the

reference to ‘‘INA 214(k)’’ to read ‘‘INA

214(l)’’.

Dated: May 20, 1998.

Donna J. Hamilton,

Acting Assistant Secretary for Consular

Affairs.

[FR Doc. 98–17735 Filed 7–2–98; 8:45 am]

BILLING CODE 4710–06–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300666; FRL–5794–6]

RIN 2070–AB78

Pyriproxyfen (2-[1-methyl-2-(4-

phenoxyphenoxy)ethoxy]pyridine;

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for combined residues of

pyriproxfen in or on cotton seed and

cotton gin byproducts. Valent U.S.A.

Corporation requested this tolerance

under the Federal Food, Drug, and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act of 1996

(Pub. L. 104-170).

DATES: This regulation is effective July

6, 1998. Objections and requests for

hearings must be received by EPA on or

before September 4, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300666],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300666], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300666]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Joseph Tavano, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305-6411, e-mail:

tavano.joseph@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 6, 1998 (63

FR 11240) (FRL–5777–5), EPA, issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(e) announcing

the filing of a pesticide petition (PP

6F4737) for tolerance by Valent U.S.A.

Corporation, 1333 N. California Blvd.,

Walnut Creek, CA 94596. This notice

included a summary of the petition

prepared by Valent U.S.A. Corporation,

the registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.534 be amended by establishing

tolerances for combined residues of the

insecticide, pyriproxfen, in or on cotton

seed and cotton gin byproducts at 0.05

and 2.0 parts per million (ppm)

respectively.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’